NCT07062328

A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC

Efficacy and Safety of Recaticimab (PCSK9 Inhibitor) and Adebrelimab Combined With Chemotherapy as First-line Treatment for Unresectable/ Advanced Biliary Tract Carcinoma: A Single-arm, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The investigators are conducting a clinical research study to evaluate the effectiveness and safety of a novel combination therapy for patients with advanced, unresectable biliary tract carcinoma

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-10
• Primary completion: 2026-12-10
• Completion: 2028-04-20
• First posted: 2025-07-14
• Last updated: 2025-07-14