drugset / Trial / NCT05047991

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

NCT05047991 ↗

Phase 2 Unknown 153 enrolled CSPC Ouyi Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-10
Primary completion
2023-11
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule — Intravenous
Subject Irinotecan Small molecule — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Comparator Paclitaxel Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous