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.
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
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
Single group
Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost
RadiationEligibility 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.
Two-year Disease-free Survival
Disease-free survival was calculated from the date of surgical resection to the date of the first recurrence or death
Two-year Overall Survival
Overall survival was calculated from the date of surgical resection to the date of death from any cause
Local-Regional Control Rate
Patients with stable disease \[SD\], partial response \[PR\] or complete response\[CR\] were recorded as local control.
Incidence of Grade 3 or Higher Adverse Events
Adverse events was evaluated during received protocol therapy according to CTCAE 5.0
Click on the lead sponsor to view all of their trials.
