NCT06752811

Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Clinical Trial for Evaluating the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Plus Gemcitabine and Paclitaxel for Injection (Albumin-bound) Plus Gemcitabine for Injection in the First-line Treatment of Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Shanghai Yizhong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.

Detailed description

Based on the widespread use of paclitaxel in pancreatic cancer, this study aims to develop a clinical protocol of paclitaxel polymeric micelles for injection in combination with gemcitabine as first-line treatment for metastatic pancreatic cancer, in order to find a more effective treatment option for pancreatic patients and thus improve survival outcomes.

Conditions

• Pancreatic Cancer Metastatic

Interventions

Type	Name	Description
DRUG	paclitaxel polymeric micelles for injection	Paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle.
DRUG	Gemcitabine Hydrochloride for Injection	The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.
DRUG	Paclitaxel for Injection (albumin bound )	Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle.
DRUG	Gemcitabine Hydrochloride for Injection	The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks.

Timeline

• Start date: 2025-02-05
• Primary completion: 2027-07-01
• Completion: 2027-12-31
• First posted: 2024-12-31
• Last updated: 2026-02-10

Locations

2 sites across 1 country: China