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)

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT07229625
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-8068 Injection — DRUG
    SHR-8068 injection.
  • Adebrelimab Injection — DRUG
    Adebrelimab injection.
  • Gemcitabine Hydrochloride for Injection — DRUG
    Gemcitabine Hydrochloride for injection.
  • Cisplatin Injection — DRUG
    Cisplatin injection.
  • Durvalumab Injection — DRUG
    Durvalumab injection.

Study Details

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.

Key Dates

Start date
Jan 21, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
604 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-8068 + Adebrelimab + Cisplatin and Gemcitabine Group
  • Active Comparator: Durvalumab + Cisplatin and Gemcitabine Group

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 15 months. ]

Central Contacts

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