The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.
The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).
Patients in observation group will not receive any anti-cancer therapy.
Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Overall Survival
defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Time frame: two years
Recurrence-free Survival
defined as the time from randomization until disease recurrence or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence-free. Patients not having an event will be censored at the date last seen alive.
Time frame: two years
Adverse Events
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Time frame: two years
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45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.