Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

February 1, 2026

Study Completion Date

June 1, 2026

Conditions
Biliary Tract CancerGemox Chemotherapy
Interventions
DRUG

Adebrelimab + GEMOX + TKI

"Adebrelimab 20 mg/kg, once every 3 weeks (Q3W), maintained for 1 year. The interval between two doses should not be less than 12 days.~Tyrosine kinase inhibitor (TKI) Lenvatinib: 12 mg (3 capsules 4 mg) or 8 mg (2 capsules 4 mg) once daily (QD) at fixed times daily, on an empty stomach or with food; Apatinib: 250mg orally, QD, 5 days of medication, 2 days off (5 on 2 off) or once every other day (QOD), half an hour after meals; Sorafenib: 0.4g (2 × 0.2g) twice or once daily on an empty stomach or with a low-fat or medium-fat diet Anlotinib: 12 mg orally before breakfast, QD. The drug was taken continuously for 2 weeks and stopped for 1 week.~GEMOX: gemcitabine 800mg/m2 and oxaliplatin 85mg/m2, intravenous infusion, D2, D15, D29, until 6 cycles of treatment were completed, or the patients who did not reach 6 cycles had intolerable adverse reactions, then the combination chemotherapy was terminated."

Trial Locations (1)

512000

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guanzhou

All Listed Sponsors
collaborator

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER