Clinical Trial

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

Not Yet Recruiting Phase 1/2
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Summary
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.
Trial Details
NCT Number NCT06513455
Lead Sponsor Harbin Medical University
Conditions Pancreatic Cancer
Enrollment 132 participants
Start Date 2024-09-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-22