NCT05616494

A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer

A Single-arm, Multicenter, Phase Ⅱ Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer Who Have Received at Least One Line of Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) in patients with pancreatic cancer.

Detailed description

Simon two-stage design will be adopted in this study. In the first stage, 24 patients will be enrolled, if at least 2 of them get response (CR or PR), the second stage of the study will be conducted, and 29 additional patients will be enrolled. If there is only one or no patients get response (CR or PR) in the first stage, the study will be early terminated.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel for injection (Albumin-bound)	Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks.

Timeline

• Start date: 2022-12-06
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2022-11-15
• Last updated: 2023-03-22

Locations

1 site across 1 country: China