To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
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).
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).
Single group
First-line Cohort
DrugIparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd
Second-line Cohort
DrugIparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd
PFS
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
OS
Time from randomization to death from any cause
Objective Response Rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)
Adverse Events
It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug
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