NCT05924880

A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)

A Phase IIIb, Single Arm, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as First Line Treatment for Chinese Patients With Unresectable Biliary Tract Cancers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIIb, open-label, single arm, multicentre study to assess the safety and efficacy of durvalumab in combination with investigator's choice of 3 different gemcitabine-based chemotherapy regimens in participants with aBTC with a WHO/ECOG PS of 0 to 2 at enrolment.

Detailed description

The primary objective of the study is to assess the safety of durvalumab combined with gemcitabine-based chemotherapy for participants with advanced BTC who have not previously received systemic therapy for advanced or metastatic BTC with WHO/ECOG PS of 0 to 2. Eligible participants will received durvalumab in combination with gemcitabine-based chemotherapy(Gemcitabine+Oxalipatin; Gemcitabine+S1, Gemcitabine+Cisplatin) by investigator's choice.

Conditions

• Biliary Tract Cancers

Interventions

Type	Name	Description
DRUG	durvalumab	Durvalumab 1500 mg as a 60-minute IV infusion in combination with gemcitabine-based chemotherapy Q3W. Upon completing chemotherapy, or discontinuing chemotherapy due to toxicity, durvalumab 1500 mg IV Q4W alone or in combination with gemcitabine.

Timeline

• Start date: 2023-07-21
• Primary completion: 2025-02-07
• Completion: 2025-02-07
• First posted: 2023-06-29
• Last updated: 2025-04-22

Locations

19 sites across 1 country: China