OncoMatch/Clinical Trials/NCT07831993
Sintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer
Official title: A Randomized, Noncomparative, Open-Label, Exploratory Clinical Study of Sintilimab in Combination With NALIRIFOX (Liposomal Irinotecan [II] Plus 5-Fluorouracil/Leucovorin and Oxaliplatin) or GP (Gemcitabine Plus Cisplatin) as First-Line Treatment for Metastatic Biliary Tract Cancer
Is NCT07831993 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for biliary tract cancer.
Treatment: Sintilimab · Irinotecan Hydrochloride Liposome · Oxaliplatin · Leucovorin · Fluorouracil · gemcitabine · Cisplatin — This is a randomized, noncomparative, open-label, exploratory clinical study designed to evaluate the efficacy and safety of sintilimab in combination with NALIRIFOX or gemcitabine plus cisplatin (GP) as first-line treatment for patients with metastatic biliary tract cancer (BTC) who have not received prior systemic anticancer therapy for metastatic disease. Approximately 54 eligible participants will be randomized in a 1:1 ratio to two treatment groups. Participants in Group A will receive sintilimab in combination with NALIRIFOX, consisting of liposomal irinotecan (II), 5-fluorouracil/leucovorin, and oxaliplatin. Participants in Group B will receive sintilimab in combination with gemcitabine and cisplatin. The primary endpoint is objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Cholangiocarcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: immune checkpoint inhibitor
Prior treatment with an immune checkpoint inhibitor, including anti-PD-1, anti-PD-L1, anti-CTLA-4 therapy, or any cellular immunotherapy.
Cannot have received: irinotecan-based chemotherapy
Prior irinotecan- or liposomal irinotecan-based chemotherapy.
Cannot have received: anticancer therapy for biliary tract cancer at the current disease stage
No prior anticancer treatment for biliary tract cancer at the current disease stage, including radiotherapy, chemotherapy, immunotherapy, or biologic therapy.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L; hemoglobin ≥ 90 g/L (9.0 g/dL); no blood transfusion or hematopoietic growth factor support within 14 days before screening
Kidney function
serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
Liver function
ALT and AST ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 30 g/L (3.0 g/dL)
Cardiac function
Normal 12-lead ECG or clinically insignificant abnormalities, QTcF < 470 ms; LVEF ≥ 50%
Adequate hematologic, hepatic, renal, cardiac, and coagulation function within 14 days before initiation of study treatment, meeting all of the following requirements: ... (see full details above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07831993 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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