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)

January 27, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

604

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yanbo Liang
        • Principal Investigator:
          • Xueli Bai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
Drug: SHR-8068 Injection
SHR-8068 injection.
Drug: Adebrelimab Injection
Adebrelimab injection.
Drug: Cisplatin Injection
Cisplatin injection.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Active Comparator: Durvalumab + Cisplatin and Gemcitabine Group
Drug: Cisplatin Injection
Cisplatin injection.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for injection.
Drug: Durvalumab Injection
Durvalumab injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 15 months.
Up to 15 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-8068-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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