Participant flow

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment · Source last updated 2026-04-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants were treated with irinotecan liposome injection 50 milligram per square meter (mg/m\^2) followed by oxaliplatin 60 mg/m\^2, followed by leucovorin (LV) 400 mg/m\^2 and then 5-fluorouracil (FU) 2400 mg/m\^2 intravenous (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.

   id

   FG000

   title

   NALIRIFOX

2. description

   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.

   id

   FG001

   title

   Nab-paclitaxel+Gemcitabine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         338

      2. group Id

         FG001

         num Subjects

         351

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         20

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         5

      type

      Progressive disease per RECIST

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         8

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      type

      Switched to commercial drug supply

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Transition to expanded access program

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant randomized in error

   10. reasons

       1. group Id

          FG000

          num Subjects

          4

       2. group Id

          FG001

          num Subjects

          0

       type

       Physician Decision

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Does Not Meet Entry Criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         383

      2. group Id

         FG001

         num Subjects

         387

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         370

      2. group Id

         FG001

         num Subjects

         379

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         383

      2. group Id

         FG001

         num Subjects

         387

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

This study consisted of a screening period (up to 28 days), treatment period (28-day cycles of treatment until radiologically determined disease progression per response evaluation criteria in solid tumors \[RECIST 1.1\]), unacceptable study medication related toxicity or withdrawal from study treatment followed by survival follow-up (until death or study closure, whichever occurred first). A total of 770 participants were randomized in 1:1 ratio using an interactive web response system (IWRS).

recruitment Details

This Phase 3, open-label study was conducted in participants with metastatic adenocarcinoma of the pancreas at 187 investigational sites in 18 countries (Australia, Brazil, Canada, Israel, Republic of Korea, United States, Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Portugal, Spain, United Kingdom, and Russia) between 11 February 2020 and 18 February 2025.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice