The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.
The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Arm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy. Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of treatment-emergent adverse events
Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria
Time frame: 1 year
Overall response rate (ORR)
Objective response rate based on RECIST v1.1 criteria
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
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