OncoMatch/Clinical Trials/NCT07797816
Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer
Is NCT07797816 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Irinotecan Hydrochloride Liposome and Fluorouracil for biliary tract cancer.
Treatment: Irinotecan Hydrochloride Liposome · Fluorouracil · Leucovorin · Sintilimab — This is a prospective, single-arm, exploratory interventional study designed to evaluate the efficacy and safety of liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab with sequential stereotactic body radiation therapy (SBRT) as first-line treatment for patients with unresectable locally advanced biliary tract cancer (BTC) who have not received prior systemic anticancer therapy for their current disease. Approximately 31 participants will be enrolled. Participants will receive liposomal irinotecan (II), 5-FU/LV, and sintilimab. Participants without disease progression after initial systemic treatment will receive sequential SBRT to the primary biliary tract tumor. After eight administrations of chemotherapy (approximately 16 weeks), resectability will be assessed by a multidisciplinary team. Participants considered eligible for surgery will undergo radical surgical resection followed by adjuvant treatment, whereas those who remain unresectable will continue the study treatment until disease progression or another protocol-defined reason for discontinuation. 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), surgical conversion rate (SCR), and safety.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: immune checkpoint inhibitor
Cannot have received: irinotecan-based chemotherapy
Lab requirements
Blood counts
ANC ≥1.5 × 10^9/L; platelet count ≥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
serum albumin ≥30 g/L (3.0 g/dL); ALT and AST ≤2.5 × ULN; total bilirubin ≤1.5 × ULN
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 text for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07797816 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 80 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.
Check if I qualifyRelated pages