Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07797816
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Hydrochloride Liposome Injection (II) — DRUG
    Liposomal irinotecan (II) 60 mg/m² is administered by intravenous infusion over 90 minutes (±30 minutes), or according to institutional clinical practice, on Day 1 every 2 weeks (Q2W).
  • Fluorouracil — DRUG
    Fluorouracil (5-FU) 2000 mg/m² is administered as a continuous intravenous infusion over 46 hours on Day 1 every 2 weeks (Q2W).
  • Leucovorin — DRUG
    Leucovorin (LV) 200 mg/m² is administered by intravenous infusion over more than 30 minutes on Day 1 every 2 weeks (Q2W).
  • Sintilimab — DRUG
    Sintilimab 200 mg is administered by intravenous infusion on Day 1 every 3 weeks (Q3W).
  • Stereotactic Body Radiation Therapy — RADIATION
    Participants without disease progression after four administrations of chemotherapy will receive stereotactic body radiation therapy (SBRT) to the primary biliary tract tumor between the sixth and seventh chemotherapy administrations. The prescribed radiation doses are 50 Gy in 10 fractions to the planning gross tumor volume (PGTV) and 30 Gy in 10 fractions to the planning target volume (PTV).
  • Radical Surgical Resection — PROCEDURE
    After eight administrations of chemotherapy (approximately 16 weeks), participants will undergo multidisciplinary evaluation for surgical resectability. Participants considered surgically resectable will undergo radical surgical resection. Successful conversion is defined as R0 or R1 resection.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Jan 8, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT
    Participants will receive liposomal irinotecan (II) plus fluorouracil/leucovorin (5-FU/LV) and sintilimab. Participants without disease progression after four administrations of chemotherapy will receive sequential stereotactic body radiation therapy (SBRT) to the primary biliary tract tumor between the sixth and seventh chemotherapy administrations. After eight administrations of chemotherapy (approximately 16 weeks), participants will undergo multidisciplinary evaluation for surgical resectability. Participants considered eligible for surgery will undergo radical surgical resection followed by four administrations of adjuvant chemotherapy. Participants who remain unresectable will continue the original treatment regimen until disease progression or another protocol-specified reason for discontinuation.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From the first dose of study treatment until radiographic disease progression, initiation of new anticancer therapy, death, or study completion, assessed up to approximately 30 months ]

Central Contacts

Related Studies