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← Bile Duct Cancer (Cholangiocarcinoma)

NCT05185947 · STUDY IN CONTEXT

Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

We calculated the rate of downstaging of peritoneal disease burden to become resectable based on PCI score of initial and subsequent laparoscopy, or magnetic resonance imaging and/or computed tomography imaging if laparoscopy is not planned. Disease burden will be considered stable when PCI score at laparoscopy (lap) #3 is \< 4 points higher or lower compared to PCI score at lap #2. Complete Response is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) has at least 4 points increase in PCI. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI. To document PCI scoring for each participant, the rubric will be completed following each laparoscopy. The PCI is scaled from 0-39, with higher scores indicating higher disease burden and worse prognosis.

7/21 participants were analyzed because 12 participants were not treated and 2 declined further treatment. When the study was designed, we anticipated having some participants reach a point where their disease is resectable.

→

primary · POSTED

The proportion of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval. This outcome measure evaluates how many participants with initially inoperable (unresectable) peritoneal carcinomatosis became eligible for surgery after receiving bidirectional chemotherapy (intravenous and intraperitoneal paclitaxel and oral nilotinib).

7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.

→

secondary · POSTED

OS is defined as the time from the start of treatment until time of death from any cause, for up to 3 years after completion of therapy. OS will be reported using the Kaplan-Meier method, along with a 95% confidence interval.

7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.

→

secondary · POSTED

Percent pPFS will be reported using the Kaplan-Meier method, along with a 95% confidence interval for each histology. PFS is defined as the duration of time from the start of the treatment until time of peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, or death, whichever comes first, and after completion of therapy. Response was assessed by the Peritoneal Carcinomatosis Index (PCI) and the Response Evaluation Criteria in Solid Tumors (RECIST). Disease relapse is CR is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Disease progression is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progressions. The Kaplan-Meier method calculates a survival function S(t), which represents the probability of "surviving" (remaining event-free) beyond time t. It is not calculated directly as a percentage.

7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. In this table, there are 0 participants analyzed in the 1st, 2nd, 3rd, and 4th groups/columns because there were no Colorectal participants in those groups. That is the case for the other histologies as well.

→

secondary · POSTED

Safety will be assessed by analyzing the type, grade and frequency of toxicities. Adverse events (AEs) will be assessed using CTCAE v.5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.

→

secondary · POSTED

Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life. The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores. Total score range: 0-144. For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life. Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits. A single value (average) was calculated for "during treatment immediate

6/21 participants were analyzed because 12 participants were not treated, 2 refused further treatment and 1 was non-English speaking. 0 participants were analyzed in the Group "Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1" during treatment immediately prior to Cycles 3 and 6 and after treatment (Follow-up at 4-8 weeks post-treatment) because no participants in this group completed the survey at the later timepoints (i.e.,no data collected).

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT05185947
qol key
qol-0005
source section id
NCT05185947-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact-c' in the study's own wording
scale title
Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument
measure definition
Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life. The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores. Total score range: 0-144. For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life. Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits. A single value (average) was calculated for "during treatment immediate
time frame
Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
6/21 participants were analyzed because 12 participants were not treated, 2 refused further treatment and 1 was non-English speaking. 0 participants were analyzed in the Group "Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1" during treatment immediately prior to Cycles 3 and 6 and after treatment (Follow-up at 4-8 weeks post-treatment) because no participants in this group completed the survey at the later timepoints (i.e.,no data collected).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Participants Quality of Life (QOL) Using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT05185947
qol key
qol-0010
source section id
NCT05185947-om-0010
source outcome index
10
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Participants Quality of Life (QOL) Using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
measure definition
Outcomes from QOL using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire comparing results before to after treatment: physical and mental health-related quality of life will be reported. The EQ-5D-5L questionnaire assesses participants' physical and mental health-related quality of life (QOL). Questionnaires will be provided to the participants in an electronic application-based format to be filled out at baseline, and immediately prior to Cycles 3 and 6 and in follow-up. An index score of 100 is considered perfect health with no problems in any dimension. A score of 0.0 would be dead. A single value (average) was calculated for "during treatment immediately prior to Cycles 3 and Cycle 6".
time frame
Participants were followed from baseline (within 6 weeks prior to the start of treatment), during treatment immediately prior to Cycles 3 and 6, and after treatment (Follow-up at 4-8 weeks post-treatment) through study completion for 27 months, 14 days
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. 0 analyzed in the first Arm/Group "During" and "After Treatment" because participants were off study, non-English speaking and/or failed to complete the QOL. 0 participants were analyzed in the last 2 Arm/Groups "After Treatment" due to death.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-bile-duct-cancer-cholangiocarcinoma
nct id
NCT05185947
trial label
Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
4
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0000
    source section id
    NCT05185947-om-0000
    source outcome index
    0
    endpoint
    Proportion of Participants Who Are Successfully Down Staged to Resectable Based on Peritoneal Carcinomatosis Index (PCI) and Principal Investigator (PI) Discretion Reported Along With a 95% Confidence Interval
    endpoint definition
    We calculated the rate of downstaging of peritoneal disease burden to become resectable based on PCI score of initial and subsequent laparoscopy, or magnetic resonance imaging and/or computed tomography imaging if laparoscopy is not planned. Disease burden will be considered stable when PCI score at laparoscopy (lap) #3 is \< 4 points higher or lower compared to PCI score at lap #2. Complete Response is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) has at least 4 points increase in PCI. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI. To document PCI scoring for each participant, the rubric will be completed following each laparoscopy. The PCI is scaled from 0-39, with higher scores indicating higher disease burden and worse prognosis.
    time origin
    Participants were followed from baseline (within 6 weeks prior to the start of treatment), and every 9 weeks during treatment through study completion for 27 months, 14 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    7/21 participants were analyzed because 12 participants were not treated and 2 declined further treatment. When the study was designed, we anticipated having some participants reach a point where their disease is resectable.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0001
    source section id
    NCT05185947-om-0001
    source outcome index
    1
    endpoint
    Proportion of Participants Who Are Successfully Down-staged to Resectable by Use of Chemotherapy Reported Along With a 95% Confidence Interval.
    endpoint definition
    The proportion of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval. This outcome measure evaluates how many participants with initially inoperable (unresectable) peritoneal carcinomatosis became eligible for surgery after receiving bidirectional chemotherapy (intravenous and intraperitoneal paclitaxel and oral nilotinib).
    time origin
    Baseline, every 9 weeks during treatment, and then every 3 months, up to 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0002
    source section id
    NCT05185947-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS is defined as the time from the start of treatment until time of death from any cause, for up to 3 years after completion of therapy. OS will be reported using the Kaplan-Meier method, along with a 95% confidence interval.
    time origin
    Participants were followed from time of initiation of study treatment to death or last follow-up through study completion for 27 months, 14 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0003
    source section id
    NCT05185947-om-0003
    source outcome index
    3
    endpoint
    Percent Probability of Peritoneal Progression-free Survival (pPFS)
    endpoint definition
    Percent pPFS will be reported using the Kaplan-Meier method, along with a 95% confidence interval for each histology. PFS is defined as the duration of time from the start of the treatment until time of peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, or death, whichever comes first, and after completion of therapy. Response was assessed by the Peritoneal Carcinomatosis Index (PCI) and the Response Evaluation Criteria in Solid Tumors (RECIST). Disease relapse is CR is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Disease progression is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progressions. The Kaplan-Meier method calculates a survival function S(t), which represents the probability of "surviving" (remaining event-free) beyond time t. It is not calculated directly as a percentage.
    time origin
    From baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy up to a percent probability of PFS at 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. In this table, there are 0 participants analyzed in the 1st, 2nd, 3rd, and 4th groups/columns because there were no Colorectal participants in those groups. That is the case for the other histologies as well.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0004
    source section id
    NCT05185947-om-0004
    source outcome index
    4
    endpoint
    Number of Grades 3, 4, and/or 5 Serious and/or Non-serious Toxicities by Type Assessed Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    endpoint definition
    Safety will be assessed by analyzing the type, grade and frequency of toxicities. Adverse events (AEs) will be assessed using CTCAE v.5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
    time origin
    Day-4 through completion of surveillance post-treatment, up to 2 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0005
    source section id
    NCT05185947-om-0005
    source outcome index
    5
    endpoint
    Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument
    endpoint definition
    Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life. The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores. Total score range: 0-144. For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life. Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits. A single value (average) was calculated for "during treatment immediate
    time origin
    Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    6/21 participants were analyzed because 12 participants were not treated, 2 refused further treatment and 1 was non-English speaking. 0 participants were analyzed in the Group "Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1" during treatment immediately prior to Cycles 3 and 6 and after treatment (Follow-up at 4-8 weeks post-treatment) because no participants in this group completed the survey at the later timepoints (i.e.,no data collected).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    regimen
    Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    regimen
    Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
    regimen
    Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
    regimen
    Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    regimen
    Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    regimen
    Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
    regimen
    Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
    regimen
    Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    regimen
    Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    regimen
    Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
    regimen
    Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
    regimen
    Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05185947-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    harm key
    EG000
    source section id
    NCT05185947-ae
    event group key
    EG000
    event group label
    Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    0
    collection period
    All-Cause Mortality was monitored/assessed an average of 5.60 months. Adverse Events were monitored/assessed Day-4 through completion of surveillance post-treatment, up to 2 years.
    event definition
    "Participants Enrolled, and Assigned to an Arm/Cohort, But Not Treated", and "Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated" are excluded in the table because only treated participants were assessed for death and adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    harm key
    EG001
    source section id
    NCT05185947-ae
    event group key
    EG001
    event group label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
    serious affected
    0
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    All-Cause Mortality was monitored/assessed an average of 5.60 months. Adverse Events were monitored/assessed Day-4 through completion of surveillance post-treatment, up to 2 years.
    event definition
    "Participants Enrolled, and Assigned to an Arm/Cohort, But Not Treated", and "Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated" are excluded in the table because only treated participants were assessed for death and adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    harm key
    EG002
    source section id
    NCT05185947-ae
    event group key
    EG002
    event group label
    Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    All-Cause Mortality was monitored/assessed an average of 5.60 months. Adverse Events were monitored/assessed Day-4 through completion of surveillance post-treatment, up to 2 years.
    event definition
    "Participants Enrolled, and Assigned to an Arm/Cohort, But Not Treated", and "Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated" are excluded in the table because only treated participants were assessed for death and adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    harm key
    EG003
    source section id
    NCT05185947-ae
    event group key
    EG003
    event group label
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
    serious affected
    0
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    All-Cause Mortality was monitored/assessed an average of 5.60 months. Adverse Events were monitored/assessed Day-4 through completion of surveillance post-treatment, up to 2 years.
    event definition
    "Participants Enrolled, and Assigned to an Arm/Cohort, But Not Treated", and "Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated" are excluded in the table because only treated participants were assessed for death and adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    qol key
    qol-0005
    source section id
    NCT05185947-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact-c' in the study's own wording
    scale title
    Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument
    measure definition
    Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life. The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores. Total score range: 0-144. For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life. Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits. A single value (average) was calculated for "during treatment immediate
    time frame
    Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    6/21 participants were analyzed because 12 participants were not treated, 2 refused further treatment and 1 was non-English speaking. 0 participants were analyzed in the Group "Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1" during treatment immediately prior to Cycles 3 and 6 and after treatment (Follow-up at 4-8 weeks post-treatment) because no participants in this group completed the survey at the later timepoints (i.e.,no data collected).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    nct id
    NCT05185947
    qol key
    qol-0010
    source section id
    NCT05185947-om-0010
    source outcome index
    10
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Participants Quality of Life (QOL) Using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
    measure definition
    Outcomes from QOL using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire comparing results before to after treatment: physical and mental health-related quality of life will be reported. The EQ-5D-5L questionnaire assesses participants' physical and mental health-related quality of life (QOL). Questionnaires will be provided to the participants in an electronic application-based format to be filled out at baseline, and immediately prior to Cycles 3 and 6 and in follow-up. An index score of 100 is considered perfect health with no problems in any dimension. A score of 0.0 would be dead. A single value (average) was calculated for "during treatment immediately prior to Cycles 3 and Cycle 6".
    time frame
    Participants were followed from baseline (within 6 weeks prior to the start of treatment), during treatment immediately prior to Cycles 3 and 6, and after treatment (Follow-up at 4-8 weeks post-treatment) through study completion for 27 months, 14 days
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment. 0 analyzed in the first Arm/Group "During" and "After Treatment" because participants were off study, non-English speaking and/or failed to complete the QOL. 0 participants were analyzed in the last 2 Arm/Groups "After Treatment" due to death.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice