A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC
NCT07062328 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2025-07-14
Summary
The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC).
Conditions
- Biliary Tract Carcinoma
Interventions
- DRUG
-
Recaticimab and Adebrelimab
Patients would receive Recaticimab (150 mg, sc., q4w) and Adebrelimab (1200 mg, iv., q3w) plus GP chemotherapy in 21day cycles. Recaticimab and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.
- DRUG
-
GP chemotherapy
Gemcitabine/Cisplatin (gemcitabine 1000mg/m2 + cisplatin 25mg/m2) will be administered on D1/D8 in every three weeks cycle, up to 6 cycles.
Sponsors & Collaborators
-
Jiangsu Hengrui Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-10
- Primary Completion
- 2026-12-10
- Completion
- 2028-04-20
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