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

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

To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).

Inclusion Criteria:

• First-line Cohort:

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

Second-line Cohort:

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

Exclusion Criteria:

1. Concomitant hepatic encephalopathy.
2. History of any nephrotic syndrome.
3. 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.
4. 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).
5. History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.
6. Main portal vein thrombosis visible on baseline imaging.
7. Pleural or peritoneal effusion requiring clinical intervention.
8. Gastroesophageal varices.
9. Portal vein invasion (VP3 or VP4).