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)

Not Applicable

Not yet recruiting

• Conditions: Advanced Biliary Tract Cancer
• Interventions: Drug: SHR-8068 Injection; Drug: Adebrelimab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Durvalumab Injection; Drug: Cisplatin Injection

• Registration Number: NCT07229625
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-11-01
• Study First Submitted: 2025-11-13
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-17
• Last Update Posted: 2025-11-17
• Primary Completion: 2029-12
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 604

Inclusion Criteria

1. Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
2. No previous systemic anti-tumor treatment has been received;
3. At least one measurable lesion that complies with the RECIST v1.1 standard;
4. ECOG PS score: 0-1 point;
5. The expected survival period is ≥ 3 months;
6. Good organ function level;
7. Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
8. Patients voluntarily joined this study and signed informed consent.

Exclusion Criteria

1. Other pathological types of cholangiocarcinoma other than adenocarcinoma;
2. Malignant tumor of the ampulla;
3. Have had or concurrently suffered from other malignant tumors;
4. Those with concurrent biliary obstruction and at risk of biliary tract infection;
5. Those with any active or known autoimmune diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group	SHR-8068 Injection	-
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group	Cisplatin Injection	-
Durvalumab + Cisplatin and Gemcitabine Group	Cisplatin Injection	-
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group	Adebrelimab Injection	-
SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group	Gemcitabine Hydrochloride for Injection	-
Durvalumab + Cisplatin and Gemcitabine Group	Gemcitabine Hydrochloride for Injection	-
Durvalumab + Cisplatin and Gemcitabine Group	Durvalumab Injection	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 15 months.

Secondary Outcome Measures

Name	Time	Method
Time to Response (TTR)	Up to 7 months.
Adverse events (AEs)	Up to approximately 15 months.
Serious adverse events (SAEs)	Up to approximately 15 months.
Duration of Response (DoR)	Up to 7 months.
Progression free Survival (PFS)	Up to 7 months.
Disease Control Rate (DCR)	Up to 7 months.
Objective Response Rate (ORR)	Up to 7 months.
Time to Progression (TTP)	Up to 7 months.

Trial Locations

Locations (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China