NCT06513455

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

Irinotecan Liposome Combined With Albumin Paclitaxel and Gemcitabine as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of a dose escalation and expansion phase to determine the recommended Phase 2 dose (RP2D) for liposomal irinotecan combination with AG, and a dose confirmation phase which will further characterize the treatment of liposomal irinotecan in combination at the RP2D.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2024-07-22
• Last updated: 2024-07-22