NCT06997913

Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk Resectable Extrahepatic Cholangiocarcinoma（AICRC）

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Hengchao Yu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.

Detailed description

This is a single-arm, prospective clinical study designed to evaluate the efficacy and safety of tislelizumab injection combined with capecitabine and radiotherapy as first-line adjuvant therapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma (ECC) resection. The study will enroll patients with ECC who have not received prior systemic therapy. The primary endpoint is the 2-year recurrence-free survival rate (2y-RFS), with a planned enrollment of approximately 65 subjects. After providing full informed consent, eligible patients will receive treatment with tislelizumab injection combined with capecitabine and radiotherapy. Each study treatment cycle is 3 weeks, and treatment will continue until the criteria for terminating study treatment are met. Treatment regimen for the treatment group: 1. Tislelizumab injection: 200 mg via intravenous infusion (D1), administered every 21 days (Q3W), with maintenance treatment for at least half a year or until disease progression. 2. Capecitabine: 1000 mg/m², twice daily (D1-14), administered every 21 days (Q3W) for a total of 6 treatment cycles. 3. Radiotherapy: 50Gy to regional lymph nodes and preoperative tumor bed.

Conditions

• Lymph Node Metastasis
• Neurovascular Invasion
• Pathology Showed R1 Resection

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma（AICRC）	The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-05-30
• Completion: 2027-12-30
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: China