drugset
drugset / Trial / NCT06320301

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

NCT06320301 ↗

Phase 2 Unknown 43 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Suzhou Suncadia Biopharmaceuticals Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment

Summary

Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX).

Timeline

Start
2024-04-01
Primary completion
2026-02-01
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 20 mg/kg Intravenous
Subject Catequentinib Small molecule 12 mg Oral
Subject Gemcitabine Small molecule 800 mg/m2 Intravenous
Subject Lenvatinib Small molecule 8 mg —
Subject Lenvatinib Small molecule 12 mg —
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Rivoceranib Small molecule 250 mg Oral
Subject Sorafenib Small molecule 0.4 g —

Indications

biliary tract cancer