A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.
Trial Parameters
Brief Summary
An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years. 2. Histologically or cytologically confirmed hepatocellular carcinoma, or meets the clinical diagnostic criteria for hepatocellular carcinoma. 3. Barcelona Clinic Liver Cancer (BCLC) stage C; or stage B and assessed by the investigator as unsuitable for curative topical treatment. 4. For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellular carcinoma. 5. At least one measurable lesion according to RECIST v1.1 criteria. 6. Child-Pugh liver function score ≤7. ECOG performance status of 0 or 1. 7. Clinically controllable HBV or HCV infection. 8. Adequate organ and bone marrow function. Exclusion Criteria: 1. Previous histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. 2. Diagnosed with another malignancy within 3 years. 3. History of hepatic encephalopathy. 4. Presence of clinically significant pericardial effusion; symptomatic