NCT07229625

A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)

A Phase III, Randomized, Controlled, Open-Label, Multicenter Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer (BTC)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	SHR-8068 Injection	SHR-8068 injection.
DRUG	Adebrelimab Injection	Adebrelimab injection.
DRUG	Gemcitabine Hydrochloride for Injection	Gemcitabine Hydrochloride for injection.
DRUG	Cisplatin Injection	Cisplatin injection.
DRUG	Durvalumab Injection	Durvalumab injection.

Timeline

• Start date: 2026-01-21
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-11-17
• Last updated: 2026-01-28

Locations

1 site across 1 country: China