A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)

Prior treatment

• Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
• Major vascular disease occurred in the 6 months before randomization.
• Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
• Major surgery within 28 days before randomization or expected to require major surgery during the study period.
• Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period

Other illness

• Patients with other malignancies currently or within the past 5 years.
• With known severe allergic reactions to any other monoclonal antibodies.
• Patients with hypertension which cannot be well controlled by antihypertensives.
• Uncontrolled cardiac diseases or symptoms.
• Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
• Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.

Lab values

• Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC \> 15×109/L at baseline.

Other

• Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
• Patients with known CNS metastasis or hepatic encephalopathy.
• Patients with symptomatic ascites or pleural effusion.
• Patients with other potential factors that may affect the study results.

• Able and willing to provide a written informed consent.
• ≥ 18 years old, both male and female.
• Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
• At least one measurable lesion based on RECIST v1.1 criteria.
• Barcelona clinic liver cancer: Stage B or C.
• No previous systemic antitumor therapy for HCC.
• ECOG PS of 0-1.
• Child-Pugh score of A or B7.
• Expected survival period ≥ 12 weeks.
• Adequate organ function.
• Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.