A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma

Inclusion criteria

• First-line Cohort:

• Confirmed diagnosis of hepatocellular carcinoma (HCC), aged > 18 years. No prior systemic therapy.
• Child-Pugh class A/B at baseline.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
• Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
• Adequate organ and bone marrow function.

Second-line Cohort:

• Confirmed diagnosis of HCC, aged > 18 years.
• Prior first-line therapy (including targeted therapy or immunotherapy).
• Child-Pugh class A/B at baseline.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
• Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
• Adequate organ and bone marrow function.

Exclusion criteria

• Concomitant hepatic encephalopathy.
• History of any nephrotic syndrome.
• History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization.
• Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded).
• History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.
• Main portal vein thrombosis visible on baseline imaging.
• Pleural or peritoneal effusion requiring clinical intervention.
• Gastroesophageal varices.
• Portal vein invasion (VP3 or VP4).