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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2026-01-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-21
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229625 on ClinicalTrials.gov