This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.
This is an Open, Two Arm, Exploratory and Phase II Clinical Trial of SBRT Combined With Adbelimumab (an Anti-PD-L1 Inhibitor) and Apatinib in Patients With Hepatocellular Carcinoma(HCC) as Perioperative and Conversion Treatment. we conduct this study in order to observe and evaluate the efficacy and safety of SBRT Combined With Adbelimumab and Apatinib in treatment of patients with HCC. Primary Efficacy Endpoint: Perioperative cohort-Pathological complete response Rate (pCR); Conversion cohort-Objective Response(ORR) (According to RECIST Version 1.1).Secondary Efficacy Endpoints:Perioperative cohort-Major pathologic response (MPR) ,Event-free survival (EFS) and Overall survival (OS );Conversion cohort-Radical (R0) resection rate,Disease control rate (DCR),Progression free survival(PFS) and Overall survival (OS ).Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
adbelimumab:1200mg iv d1 q3w
SBRT: SBRT: 8-30Gy/1-6F(dose is determined according to the tumor diameter); tumor thrombus dose 30Gy /5-6F;
apatinib:250mg po, qd
Pathological complete response Rate (Perioperative cohort)
No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors
Time frame: 4 months
Objective Response (Conversion cohort)
It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
Time frame: 12 months
Event-free survival
Refers to the time from the start of the group to the occurrence of any event
Time frame: 5 year
Major pathologic response
It is defined as residual tumors less than 10% after neo-adjuvant therapy
Time frame: 4 months
Overall survival
It is defined as the time from randomization to death from any cause during the course of the study
Time frame: 5 year
Safety as measured by the rate of AEs
Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs)
Time frame: 1 month
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