This trial is an open-label, dose-escalation, and randomized controlled Phase Ib/II clinical study for second-line treatment in participants with advanced hepatocellular carcinoma (HCC). Its primary objective is to evaluate the safety, tolerability, pharmacokinetic profiles, and efficacy of transcatheter arterial infusion of HA131 combined with systemic therapy in the second-line treatment of participants with advanced HCC.
1.Aged 18 to 75 years (inclusive), regardless of gender;
2.Diagnosed with hepatocellular carcinoma (HCC) by histopathology, cytology, or imaging;
3.HCC classified as B/C stage per BCLC (Barcelona Clinic Liver Cancer) staging system, or IIb/IIIa/IIIb stage as defined in Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition) (organized by the Guidelines Committee of the Chinese Society of Clinical Oncology, 2024);
4.Child-Pugh liver function class ≤ 7 points within 7 days prior to the first dose administration;
1.Pathologically confirmed fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocellular carcinoma, or combined hepatocellular-cholangiocarcinoma;
2.History of liver surgery and/or local treatment for HCC within 4 weeks prior to the first dose;
3.Previous antineoplastic treatment with lenvatinib;
4.Use of traditional Chinese medicine (TCM) preparations with indicated efficacy for anti-HCC within 14 days prior to the first dose; having received immune checkpoint inhibitors within 28 days prior to the first dose.