To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.
Age ≥ 18 years at time of study entry.
Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies.
HCC confirmed by radiology, histology or cytology.
No prior systemic therapy for HCC.
Prior systemic therapy for HCC
Active autoimmune disease requiring immunosuppression.
Active infection requiring IV antibiotics.
HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).
Patients with advanced hepatocellular carcinoma planed to receive first-line immunotherapy.
Cohort
Prospective
Sintilimab
DrugSintilimab will be administered by IV, 200 mg every 3 weeks
Bevacizumab Biosimilar
DrugBevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.
Camrelizumab
DrugCamrelizumab will be administered by IV, 200 mg every 2 weeks.
Rivoceranib
DrugRivoceranib will be administered by oral 250 mg once daily.
Nivolumab
DrugNivolumab will be administered by IV, 1 mg/kg every 3 weeks for up to four doses, followed by nivolumab 480 mg every 4 weeks
Ipilimumab
DrugIpilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.
Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.
Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD).
Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment.
Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed.
Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)
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