About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost