drugset / Trial / NCT07638501

Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer

NCT07638501

Phase 2 Not yet recruiting 123 enrolled Eastern Hepatobiliary Surgery Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

According to current clinical guidelines, first-line treatment for advanced biliary tract cancer (BTC) is the gemcitabine plus cisplatin (GC) regimen combined with immunotherapy, which has been shown to improve patient outcomes. Additionally, the combination of radiotherapy and immunotherapy may synergistically enhance antitumor efficacy. Therefore, this study aims to assess the efficacy and safety of first-line treatment with radiotherapy in combination with sintilimab and gemcitabine/cisplatin versus sintilimab in combination with gemcitabine/cisplatin in patients with previously untreated, unresectable locally advanced or metastatic BTC.

Timeline

Start
2026-06-15
Primary completion
2028-06-15
Completion
2029-06-15

Drugs

EvaluationDrugModalityDoseRoute
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications