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

StatusNot Yet Recruiting
PhasePhase 2
Started2026-06-15
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07638501
Lead Sponsor Eastern Hepatobiliary Surgery Hospital
Conditions Biliary Tract Cancer (BTC)
Enrollment 123 participants
Start Date 2026-06-15
Primary Completion 2028-06-15 (estimated)
Study Completion 2029-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-10