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NOT YET RECRUITING
NCT06513455
PHASE1/PHASE2

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

Sponsor: Harbin Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

Irinotecan liposome(40mg/m2)

irinotecan Liposome was administered 40mg/m2, D1,iv. q2w

DRUG

Nab-paclitaxel

Nab-paclitaxel was administered 125mg/m2 D1、D8、D15,iv. q4w

DRUG

Gemcitabine

gemcitabine was administered 1000 mg D1、D8、D15,iv. q4w

DRUG

Irinotecan Liposome(60mg/m2)

irinotecan Liposome was administered 60mg/m2, D1,iv. q2w