drugset / Trial / NCT07638501
Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |