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

RecruitingPhase 2Ages 18 Years - 80 YearsAllCancer Institute and Hospital, Chinese Academy of…
NCT07063888 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost
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Where

1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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