NCT05047991

Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase II Study to Evaluate the Differences of Safety and Efficacy of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open-lable, parallel-controlled phase II study of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma. The purpose of this study is to evaluate the differences of safety and efficacy of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma.

Detailed description

This is a multicentre randomized, open-label, parallel-controlled, phase II study to evaluate the efficacy and safety of irinotecan liposome injection-containing regimens. Eligible patients will be randomly divided into two cohorts at a ratio of 2:1. The patients in cohort 1 (the experimental group) will receive irinotecan liposome injection combined with 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin.The patients in cohort 2 (the control group) will receive nab-paclitaxel plus gemcitabine.

Conditions

• Pancreatic Cancer Non-resectable
• Pancreatic Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Irinotecan Liposome Injection	Irinotecan Liposome Injection, intravenously, over 90 min on day 1and day 15 of every 28-day cycle
DRUG	Fluorouracil	5-Fluorouracil (5-Fu), intravenously, over 46 h on day 1 and day 15 of every 28-day cycle
DRUG	Leucovorin	Leucovorin (LV), intravenously, over 30 min on day 1 and day 15 of every 28-day cycle
DRUG	Oxaliplatin	Oxaliplatin, intravenously, over 2 h on day 1 and day 15 of every 28-day cycle
DRUG	Nab paclitaxel	Paclitaxel (albumin bound), intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle
DRUG	Gemcitabine	Gemcitabine, intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-11-01
• Completion: 2024-11-01
• First posted: 2021-09-17
• Last updated: 2021-09-17