Irinotecan Liposome，Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer

Sponsor
Harbin Medical University
Study ID
NCT06513455
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan liposome（40mg/m2） — DRUG
    irinotecan Liposome was administered 40mg/m2, D1，iv. q2w
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w
  • Gemcitabine — DRUG
    gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w
  • Irinotecan Liposome（60mg/m2） — DRUG
    irinotecan Liposome was administered 60mg/m2, D1，iv. q2w

Study Details

This is a Phase I/II , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage. The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxel，gemcitabine and liposomal irinotecan at different dose Levels(40 mg/m2, iv. q2w or 60 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses . This study aims to evaluate the safety and efficacy of liposomal irinotecan，nab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer.

Key Dates

Start date
Sep 1, 2024
Status verified
Jul 2024
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w，gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w，irinotecan Liposome was administered 40mg/m2, D1，iv. q2w
  • Experimental: Cohort B
    Nab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w，gemcitabine was administered 1000 mg D1、D8、D15，iv. q4w，irinotecan Liposome was administered 60mg/m2, D1，iv. q2w

Primary Outcome Measure

MTD /DLT (phase I) [ Time Frame: Within four weeks after administration ]

Central Contacts

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