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← Liver Neoplasm

NCT01730937 · STUDY IN CONTEXT

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

An event for overall survival (OS) is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 153 deaths were reported.

Eligible participants

→

secondary · POSTED

Progression (failure) is defined as any of the following events: new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant metastases that were present at study entry, new HCC within the liver including tumor thrombosis, and vascular thrombosis events=progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. Time to progression was measured from the date of randomization to the date of first failure, death (competing risk), or last follow-up (censored). Progression rates are estimated by the cumulative incidence method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.

Eligible participants

→

secondary · POSTED

Failure for progression-free survival (PFS) include death, new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant Mets that were present at study entry, new HCC within liver including tumor thrombosis, and vascular thrombosis events =progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. PFS time is defined as the time from randomization to the date of first failure, date of death, or last known follow-up (censored). PFS rates are estimated by the Kaplan-Meier method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.

Eligible participants

→

secondary · POSTED

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Eligible, started treatment, and were assessed for adverse events.

→

secondary · POSTED

The FACT-Hep total score measures quality of life in patients with hepatobiliary cancer. Possible scores range from 0 to 180, with higher scores indicating a better outcome. Improvement in FACT-Hep total score is defined as an increase from the baseline to 6-month score of at least 5 points.

Eligible participants who consented to the quality of life component and had data at baseline and six months.

→

secondary · POSTED

Complete response: Complete resolution of thrombosis, with recanalization of vessel. Partial response (PR): * Partial recanalization (if prior complete blockage) * Unequivocal reduction in the maximal girth * Unequivocal reduction in the volume, or elimination, of arterial enhancing portion Progressive disease (PD): any unequivocal, unambiguous * New enhancing tumor thrombosis * Increase in the volume of enhancing portion * Unequivocal progression of thrombosis (non-measurable disease), the increase in overall tumor burden (enhancing thrombosis) must be comparable to the increase required for the Response Evaluation Criteria in Solid Tumor 1.1 definition of PD of measurable disease (e.g. ≥ 73% increase in volume, which is similar to 20% increase in diameter, and at least a 5 mm absolute increase). Stable disease: * No/small changes that do not meet the above criteria for PR or PD * Increase in the volume of non-enhancing thrombosis * New bland non-enhancing thrombosis

Eligible participants who had vascular thrombosis at study entry

→

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 · Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01730937
qol key
qol-0004
source section id
NCT01730937-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-hep' in the study's own wording
scale title
Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment
measure definition
The FACT-Hep total score measures quality of life in patients with hepatobiliary cancer. Possible scores range from 0 to 180, with higher scores indicating a better outcome. Improvement in FACT-Hep total score is defined as an increase from the baseline to 6-month score of at least 5 points.
time frame
Baseline and 6 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating a better
population note
Eligible participants who consented to the quality of life component and had data at baseline and six months.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Quality Adjusted Life Years

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-liver-neoplasm
nct id
NCT01730937
qol key
qol-0006
source section id
NCT01730937-om-0006
source outcome index
6
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Quality Adjusted Life Years
measure definition
Quality adjusted life years is calculated as the weighted sum of the number of years spent in different health states. The weight value is a utility score between 0 (worst health state) and 1 (best health state) derived from the EQ-5D-5L questionnaire, designed to describe and value health based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
time frame
The EQ-5D-5L is administered at baseline, six months and one year.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The protocol states that this endpoint would be addressed if and only if the primary endpoint supports the primary hypothesis, therefore data is not reported.
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-liver-neoplasm
nct id
NCT01730937
trial label
Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0000
    source section id
    NCT01730937-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    An event for overall survival (OS) is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 153 deaths were reported.
    time origin
    From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants
    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-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0001
    source section id
    NCT01730937-om-0001
    source outcome index
    1
    endpoint
    Time to Progression
    endpoint definition
    Progression (failure) is defined as any of the following events: new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant metastases that were present at study entry, new HCC within the liver including tumor thrombosis, and vascular thrombosis events=progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. Time to progression was measured from the date of randomization to the date of first failure, death (competing risk), or last follow-up (censored). Progression rates are estimated by the cumulative incidence method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.
    time origin
    From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants
    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-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0002
    source section id
    NCT01730937-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival
    endpoint definition
    Failure for progression-free survival (PFS) include death, new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant Mets that were present at study entry, new HCC within liver including tumor thrombosis, and vascular thrombosis events =progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. PFS time is defined as the time from randomization to the date of first failure, date of death, or last known follow-up (censored). PFS rates are estimated by the Kaplan-Meier method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.
    time origin
    From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants
    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-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0003
    source section id
    NCT01730937-om-0003
    source outcome index
    3
    endpoint
    Number of Participants by Highest Grade Adverse Event Reported
    endpoint definition
    Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
    time origin
    From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible, started treatment, and were assessed for adverse events.
    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-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0004
    source section id
    NCT01730937-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment
    endpoint definition
    The FACT-Hep total score measures quality of life in patients with hepatobiliary cancer. Possible scores range from 0 to 180, with higher scores indicating a better outcome. Improvement in FACT-Hep total score is defined as an increase from the baseline to 6-month score of at least 5 points.
    time origin
    Baseline and 6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants who consented to the quality of life component and had data at baseline and six months.
    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-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0005
    source section id
    NCT01730937-om-0005
    source outcome index
    5
    endpoint
    Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable)
    endpoint definition
    Complete response: Complete resolution of thrombosis, with recanalization of vessel. Partial response (PR): * Partial recanalization (if prior complete blockage) * Unequivocal reduction in the maximal girth * Unequivocal reduction in the volume, or elimination, of arterial enhancing portion Progressive disease (PD): any unequivocal, unambiguous * New enhancing tumor thrombosis * Increase in the volume of enhancing portion * Unequivocal progression of thrombosis (non-measurable disease), the increase in overall tumor burden (enhancing thrombosis) must be comparable to the increase required for the Response Evaluation Criteria in Solid Tumor 1.1 definition of PD of measurable disease (e.g. ≥ 73% increase in volume, which is similar to 20% increase in diameter, and at least a 5 mm absolute increase). Stable disease: * No/small changes that do not meet the above criteria for PR or PD * Increase in the volume of non-enhancing thrombosis * New bland non-enhancing thrombosis
    time origin
    From randomization to last follow-up. Imaging occurs every 3 months for two years then every six months. Maximum follow-up at time of analysis was 7.6 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants who had vascular thrombosis at study entry
    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-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Sorafenib Alone
    regimen
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    92
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0000
    arm key
    OG001
    arm label
    SBRT Followed by Sorafenib
    regimen
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Sorafenib Alone
    regimen
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    92
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0001
    arm key
    OG001
    arm label
    SBRT Followed by Sorafenib
    regimen
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Sorafenib Alone
    regimen
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    92
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0002
    arm key
    OG001
    arm label
    SBRT Followed by Sorafenib
    regimen
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Sorafenib Alone
    regimen
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    88
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0003
    arm key
    OG001
    arm label
    SBRT Followed by Sorafenib
    regimen
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    83
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Sorafenib Alone
    regimen
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0004
    arm key
    OG001
    arm label
    SBRT Followed by Sorafenib
    regimen
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    17
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Sorafenib Alone
    regimen
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    outcome key
    om-0005
    arm key
    OG001
    arm label
    SBRT Followed by Sorafenib
    regimen
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    62
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01730937-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01730937
    harm key
    EG000
    source section id
    NCT01730937-ae
    event group key
    EG000
    event group label
    Sorafenib Alone
    serious affected
    20
    serious at risk
    88
    other affected
    88
    other at risk
    88
    frequency threshold
    5
    collection period
    From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
    event definition
    All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for 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-liver-neoplasm
    nct id
    NCT01730937
    harm key
    EG001
    source section id
    NCT01730937-ae
    event group key
    EG001
    event group label
    SBRT Followed by Sorafenib
    serious affected
    19
    serious at risk
    83
    other affected
    83
    other at risk
    83
    frequency threshold
    5
    collection period
    From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
    event definition
    All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for 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-liver-neoplasm
    nct id
    NCT01730937
    qol key
    qol-0004
    source section id
    NCT01730937-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fact-hep' in the study's own wording
    scale title
    Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment
    measure definition
    The FACT-Hep total score measures quality of life in patients with hepatobiliary cancer. Possible scores range from 0 to 180, with higher scores indicating a better outcome. Improvement in FACT-Hep total score is defined as an increase from the baseline to 6-month score of at least 5 points.
    time frame
    Baseline and 6 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores indicating a better
    population note
    Eligible participants who consented to the quality of life component and had data at baseline and six months.
    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-liver-neoplasm
    nct id
    NCT01730937
    qol key
    qol-0006
    source section id
    NCT01730937-om-0006
    source outcome index
    6
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Quality Adjusted Life Years
    measure definition
    Quality adjusted life years is calculated as the weighted sum of the number of years spent in different health states. The weight value is a utility score between 0 (worst health state) and 1 (best health state) derived from the EQ-5D-5L questionnaire, designed to describe and value health based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
    time frame
    The EQ-5D-5L is administered at baseline, six months and one year.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The protocol states that this endpoint would be addressed if and only if the primary endpoint supports the primary hypothesis, therefore data is not reported.
    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