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)

NCT07229625 | Recruiting Phase 3

• 1 other identifier: SHR-8068-303
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Up to 15 months.

Secondary Outcomes (8)

• Disease Control Rate (DCR)

  Up to 7 months.

• Duration of Response (DoR)

  Up to 7 months.

• Progression free Survival (PFS)

  Up to 7 months.

• Objective Response Rate (ORR)

  Up to 7 months.

• Time to Progression (TTP)

  Up to 7 months.

Study Arms (2)

SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group

EXPERIMENTAL

Drug: SHR-8068 Injection; Drug: Adebrelimab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin Injection

Durvalumab + Cisplatin and Gemcitabine Group

ACTIVE COMPARATOR

Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin Injection; Drug: Durvalumab Injection

Interventions

SHR-8068 Injection DRUG

SHR-8068 injection.

SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group

Adebrelimab Injection DRUG

Adebrelimab injection.

SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group

Gemcitabine Hydrochloride for Injection DRUG

Gemcitabine Hydrochloride for injection.

Durvalumab + Cisplatin and Gemcitabine Group; SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group

Cisplatin Injection DRUG

Cisplatin injection.

Durvalumab + Cisplatin and Gemcitabine Group; SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group

Durvalumab Injection DRUG

Durvalumab injection.

Durvalumab + Cisplatin and Gemcitabine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Interventions

Gemcitabine; Injections; Cisplatin; durvalumab

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Xin Shi

CONTACT

+86-0518-82342973; xin.shi.xs3@hengrui.com

Xin Xu

CONTACT

+86-0518-82342973; xin.xu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)