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

Summary

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.

Conditions

• Biliary Tract Cancer

Interventions

DRUG

Irinotecan Hydrochloride Liposome Injection (II)

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).

DRUG

Fluorouracil

Fluorouracil (5-FU) 2000 mg/m² is administered as a continuous intravenous infusion over 46 hours on Day 1 every 2 weeks (Q2W).

DRUG

Leucovorin

Leucovorin (LV) 200 mg/m² is administered by intravenous infusion over more than 30 minutes on Day 1 every 2 weeks (Q2W).

DRUG

Sintilimab

Sintilimab 200 mg is administered by intravenous infusion on Day 1 every 3 weeks (Q3W).

RADIATION

Stereotactic Body Radiation Therapy

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).

PROCEDURE

Radical Surgical Resection

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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  lead OTHER

Principal Investigators

• Juan Du · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-08

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• China

Study Locations