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.
Parallel
Sintilimab + GC
DrugParticipants receive sintilimab (200 mg, intravenous \[IV\], day 1), gemcitabine (1000 mg/m², IV, day 1 and day 8), and cisplatin (25 mg/m², IV, day 1 and day 8) every 3 weeks (q3w). The drugs are administered sequentially with an interval of \>30 minutes between each, preferably on the same day. Different drugs require separate infusion bags and filters.
SBRT 7Gy✖️5 QD
RadiationStereotactic body radiotherapy (SBRT) is delivered only to participants in the experimental arm with total dose of 35 Gy in 5 fractions (7 Gy per fraction). SBRT is completed within 1 week before the first cycle of sintilimab+GC.
Progression-free Survival (PFS)
The time from the date of randomization to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause.
Progression-free Survival (PFS)
The time from the date of randomization to the date of the first documented tumor progression as determined by the investigator (per mRECIST), or death due to any cause.
Objevtive Response Rate (ORR)
Disease assessments based on investigator assessments were determined by using RECIST v1.1/mRECIST. The ORR was defined as the percentage of patients with complete response (CR) or partial response (PR).
Disease Control Rate (DCR)
Disease control rate based on investigator assessments according to RECIST v1.1/mRECIST was defined as the proportion of CR, PR or stable disease (SD).
Time to Response (TTR)
The time from randomization to the first evaluation of the tumor as CR, PR (per RECIST v1.1 and mRECIST).
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