Clinical Trial

A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma

Recruiting Phase 2
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Summary
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy for intrahepatic cholangiocarcinoma with narrow margin (\<1cm) or nodal involvement. Eligibility patients will receive IMRT or VMAT. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg/m² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg/m² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. The primary endpoint is 2-year recurrence-free survival. The secondary endpoints are 2-year overall survival, local-regional control rate and incidence of grade 3 or higher adverse events.
Trial Details
NCT Number NCT07063888
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Intrahepatic Cholangiocarcinoma (Icc), Adjuvant Chemoradiotherapy, Narrow Margin, Lymph Node Involvement
Enrollment 66 participants
Start Date 2025-05-16
Primary Completion 2028-05-15 (estimated)
Study Completion 2028-05-15 (estimated)
Updated on ClinicalTrials.gov 2025-07-14