Recruiting

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

ClinicalTrials.gov IDNCT07063888

PhasePHASE2

Enrollment66

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Age18 Years

SexALL

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Conditions studied

Intrahepatic Cholangiocarcinoma (Icc), Adjuvant Chemoradiotherapy, Narrow Margin, Lymph Node Involvement

About this study

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.

Interventions

Radiation: Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost — 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.

Primary outcomes

Two-year Disease-free Survival (up to 24 months)

Eligibility information

Inclusion Criteria: * Age \> 18 years, \< 80 years * Patients with primary surgical treatment * Postoperative pathology confirmed intrahepatic cholangiocarcinoma * Postoperative pathology showing narrow resection margin (\<1cm) or positive lymph nodes * R0/R1 resection * Postoperative Child-Pugh score A5-B7 * Patients meeting either of the following conditions must undergo preoperative or pre-radiotherapy PET-CT to exclude distant metastasis or lymph node metastasis beyond the region from the lower esophagus to the aortic bifurcation 1. Lymph node metastasis accounting for \>50% of dissected nodes 2. Lymph node metastasis involving the paracardial region or below the renal vein level * Postoperative contrast-enhanced liver MRI to exclude Intrahepatic satellite nodules * Recovery from surgery with Eastern Cooperative Oncology Group performance status score of 0-2 * Estimated life expectancy \>3 months Exclusion Criteria: * History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix * Had prior abdominal irradiation * Had prior liver transplantation * Had serious myocardial disease or renal failure * Had moderate or severe ascites with obvious symptoms 4 months after surgery * Duration from surgery ≥ 4 months

Study locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.