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Irinotecan Liposome,Albumin Paclitaxel and Gemcitabine First-line Treatment for Pancreatic Cancer
Sponsor: Harbin Medical University
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.
Official title: Irinotecan Liposome Combined With Albumin Paclitaxel and Gemcitabine as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2024-09-01
Completion Date
2027-12-31
Last Updated
2024-07-22
Healthy Volunteers
No
Conditions
Interventions
Irinotecan liposome(40mg/m2)
irinotecan Liposome was administered 40mg/m2, D1,iv. q2w
Nab-paclitaxel
Nab-paclitaxel was administered 125mg/m2 D1、D8、D15,iv. q4w
Gemcitabine
gemcitabine was administered 1000 mg D1、D8、D15,iv. q4w
Irinotecan Liposome(60mg/m2)
irinotecan Liposome was administered 60mg/m2, D1,iv. q2w