About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- IBI310+ sintilimab + bevacizumab
- IBI310+ sintilimab
- sintilimab + bevacizumab