A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC

Inclusion criteria

• Signed the Informed Consent Form (ICF) voluntarily.
• Age ≥18 years at time of signing ICF.
• Histologic or cytologic confirmation of HCC, or clinical diagnosis of HCC as per AASLD criteria.
• BCLC stage B or C, and not suitable for curative surgical or local therapy.
• Participants have progressed on the prior first-line systemic treatment with atezolizumab plus bevacizumab combination treatment.
• At least one measurable lesion according to RECIST v1.1.
• Child-Pugh Class A .
• ECOG performance status of 0 or 1.
• With a life expectancy of ≥3 months.
• Adequate organ and hematologic function.

Exclusion criteria

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Tumor thrombus invasion of superior mesenteric vein.
• Has a known history of, or any evidence of CNS metastases.
• Has received anti-cancer therapy for HCC within 3 weeks prior to the first dose of study treatment.
• Has received systemic anti-cancer therapy other than atezolizumab and bevacizumab.
• Has participated in another clinical study within 4 weeks prior to the first dose.
• History of liver transplantation.
• History of hepatic encephalopathy.
• Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.
• History of bleeding event due to esophageal and/or gastric varices within 6 months prior to the first dose of study treatment.