There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .
Age of 18-75 full years (inclusive), male or female.
Subjects are with unresectable advanced HCC by histologically or cytologically confirmed diagnosis, Stage B or C based on Barcelona Clinic Liver Cancer [BCLC] ,that is not eligible for surgery and/or locoregional therapy or disease progression after surgery and/or locoregional therapy , surgery and/or locoregional therapy must be finished more than 4 weeks before baseline imaging scan .
Subjects have not received any systemic therapy for HCC previously (mainly including systemic chemotherapy, anti-angiogenic drugs or other molecular targeted therapy, antibodies/drugs targeting T cell co-regulatory proteins (such as anti-CTLA-4, anti-PD-1 /PD-L1, anti-OX-40, anti-CD137, anti-TIM-3, anti-LAG-3 antibodies, etc.).
Subjects with at least one measurable lesion by RECIST1.1, baseline imaging scan should be performed within 21 days prior to first administration，target lesions located in the field of previous radiotherapy or in the area of local treatment (interventional or ablative) are considered measurable if radiographic progression is confirmed.
Fibrolamellar-HCC, sarcomatoid, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.
History of other malignancy(ies) in the past 5 years, except for locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix, etc.).
Palliative radiotherapy was performed for bone metastases within 2 weeks prior to firstl administration; Received drugs with anti-liver cancer effect (including Traditional Chinese medicine preparations) within 2 weeks before the first administration.Toxicity induced by previous therapy (except alopecia) not recovered to ≤ grade 1 (NCI-CTCAE v5.0).
Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate peritoneal effusion at screening.
Parallel
Rulonilimab+Lenvatinib
DrugRulonilimab, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily
Rulonilimab placebo +Lenvatinib
DrugRulonilimab placebo, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily
ORR
Objective Response Rate (ORR) Based on RECIST 1.1 Assessed by Independent Review Committee(IRC)
PFS
Progression-free survival (PFS) evaluated by the Blinded Independent Central Review
OS
Overall survival (OS)
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