This study was a prospective, single-arm, single-center, phase II exploratory clinical study. To investigate the efficacy and safety of radiotherapy combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus.
After signing informed consent, patients received sintilimab 200 mg intravenously on the first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose 3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between the first administration of sintilimab and the second administration of bevacizumab, but it should be noted that the interval between before and after the administration of sintilimab and bevacizumab was at least 3 days. Patients will be performed enhanced CT/MRI every 2 months, to access the efficiency according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, undergoing enhanced CT/MRI. The overall survival (OS) was calculated as the time from enrollment until death or the last follow-up. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 to access the safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
After signing informed consent, patients received sintilimab 200 mg intravenously on the first day of each cycle, Q3W; Bevacizumab biosimilar 7.5mg/kg was administered intravenously on the first day of each cycle, Q3W; Concurrent radiotherapy (single dose 3-8Gy, times 3-10, total dose 20-50Gy; The duration of radiotherapy was completed between the first administration of sintilimab and the second administration of bevacizumab, but it should be noted that the interval between before and after the administration of sintilimab and bevacizumab was at least 3 days.
Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGObjective Response rate
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Time frame: up to 2 years from enrollment
Objective Response rate, assessed according to the modified Response Evaluation Criteria
assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI
Time frame: up to 2 years from enrollment
overall survival
the time from enrollment until death or the last follow-up
Time frame: up to 2 years from enrollment
number of participants with treatment-related adverse events
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 2 years from enrollment
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