The purpose of this phase Ib/II multicenter randomized control study is to investigate the efficacy and safety of peri-operative treatment with combination of CTLA-4, PD-1 antibodies and bevacizumab in resectable HCC
Written informed consent shall be obtained prior to any trial-related procedures.
Male or female patients aged ≥18 years and ≤75 years.
Initial resectable hepatocellular carcinoma (HCC) confirmed by imaging, pathology or cytology.
No macrovascular tumor thrombus or extrahepatic metastasis detected on imaging examinations.
Histologically or cytologically confirmed tumors containing components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other mixed subtypes.
History of hepatic encephalopathy or prior liver transplantation.
Currently participating in an interventional clinical trial, or received any investigational medicinal product or investigational device within 4 weeks prior to the first study drug administration.
Prior receipt of any of the following therapies: anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other T-cell co-stimulatory or co-inhibitory receptors (including but not limited to CTLA-4, OX-40, CD137).
Parallel
IBI310+ sintilimab + bevacizumab
Drugsystemic therapy
IBI310+ sintilimab
Drugsystemic therapy
sintilimab + bevacizumab
Drugsystemic therapy
Average depth of pathological response
Pathological response depth is defined as the proportion of non-viable tumors in surgical specimens to the total sample after neoadjuvant therapy. The average pathological response depth is defined as the average value of the pathological response depth.
1y-RFS rate
The proportion of patients without disease recurrence or death within 1 year following the second randomization
1y-EFS rate
The proportion of patients without disease progression precluding surgical resection, post-operative disease recurrence, or death within 1 year after the first randomization
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This trial is not recruiting at the moment. You can still explore other options:
