Skip to content
Triangle logo TriangleGet started
← metastatic Pancreatic Cancer

NCT04083235 · STUDY IN CONTEXT

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancre

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.

The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.

→

secondary · POSTED

PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique.

The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization. Only participants with PFS event are reported.

→

secondary · POSTED

The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.

The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-metastatic-aecf3979
nct id
NCT04083235
trial label
A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancre
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
3
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0000
    source section id
    NCT04083235-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.
    time origin
    Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.
    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-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0001
    source section id
    NCT04083235-om-0001
    source outcome index
    1
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique.
    time origin
    Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022 (maximum of 893 days)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization. Only participants with PFS event are reported.
    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-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0002
    source section id
    NCT04083235-om-0002
    source outcome index
    2
    endpoint
    Overall Response Rate (ORR)
    endpoint definition
    The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.
    time origin
    Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.
    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-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0000
    arm key
    OG000
    arm label
    NALIRIFOX
    regimen
    Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    analyzed count
    383
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04083235-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Nab-paclitaxel+Gemcitabine
    regimen
    Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    analyzed count
    387
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04083235-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0001
    arm key
    OG000
    arm label
    NALIRIFOX
    regimen
    Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    analyzed count
    249
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04083235-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Nab-paclitaxel+Gemcitabine
    regimen
    Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    analyzed count
    259
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04083235-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0002
    arm key
    OG000
    arm label
    NALIRIFOX
    regimen
    Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    analyzed count
    383
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04083235-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Nab-paclitaxel+Gemcitabine
    regimen
    Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    analyzed count
    387
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04083235-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    harm key
    EG000
    source section id
    NCT04083235-ae
    event group key
    EG000
    event group label
    NALIRIFOX
    serious affected
    207
    serious at risk
    370
    other affected
    364
    other at risk
    370
    frequency threshold
    5
    collection period
    Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
    event definition
    The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
    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-pancreatic-cancer-metastatic-aecf3979
    nct id
    NCT04083235
    harm key
    EG001
    source section id
    NCT04083235-ae
    event group key
    EG001
    event group label
    Nab-paclitaxel+Gemcitabine
    serious affected
    198
    serious at risk
    379
    other affected
    371
    other at risk
    379
    frequency threshold
    5
    collection period
    Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
    event definition
    The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
    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
    setting source links

      Preserved source evidence · Not medical advice