The study is a single-arm, phase II trial. The purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-PD-1 antibody in unresectable biliary tract cancer patients.
The trial will recruit 36 patients, and they will undergo radiotherapy plus anti-PD-1 antibody. Patients will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a total dose more than 45Gy. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
The total radiation dose is over 45Gy without damaging organic fucntion. Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy. Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death or withdrawal. If disease progression is confirmed by radiologic examinations, another 200mg camrelizumab should be applied to the patient, then another radiologic examination will be performed 4 weeks later to confirm or exclude progression. If progression is confirmed, the camrelizumab should be stopped.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival, PFS
defined as the time from the commencement of radiotherapy until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date of the last adequate tumor assessment. Patients not having an event will be censored at the date of the last adequate tumor assessment. If patients don't have baseline tumor assessments, they will be censored at the date of the first treatment.
Time frame: one years
Overall survival, OS
defined as the time from the commencement of radiotherapy until death from any cause. Patients who withdraw or are lost to follow-up or still alive will be at the date last known to be alive.
Time frame: one years
Adverse events, AE
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Time frame: one years
Objective response rate, ORR
defined as the proportion of participants with a complete response or partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
Time frame: one years
Disease control rate, DCR
defined as the proportion of participants with a complete response, partial response, or stable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
Time frame: one years
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