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.
Patients voluntarily provide written informed consent, with authorization obtained from the patient or legal representative prior to any protocol-related procedures.
Age ≥ 18 years and ≤ 75 years; both female and male
Histologically or cytologically confirmed, unresectable advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
No prior systemic anti-tumor treatment for BTC. Patients who developed recurrent disease >6 months after surgery with curative intent and, if given, >6 months after the completion of neo/adjuvant therapy (chemotherapy and/or radiation) will be eligible.
Histologically or cytologically confirmed rare biliary tract tumors, including ampullary cancer, neuroendocrine tumors, sarcoma, or mucinous cystic neoplasms.
Other active malignancy within the past 5 years or concurrent, except adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
History of carcinomatous meningitis or brain metastases.
Known hypersensitivity or allergic reaction to any study drug or any excipient therein.