TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma

Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or those complicated with portal vein tumor thrombosis (PVTT). Hepatic arterial infusion chemotherapy (HAIC), as an alternative locoregional therapy, has demonstrated advantages in treating these refractory cases. Therefore, this study innovatively designs a prospective cohort study to conduct a comparison of the two triple-combination regimens-"HAIC plus PD-1 inhibitor and lenvatinib" versus "TACE plus PD-1 inhibitor and lenvatinib"-in terms of real-world efficacy and safety, with a focus on enrolling patients who are likely to have suboptimal responses to TACE. This research aims to provide high-level evidence for selecting the optimal combined locoregional strategy for uHCC patients, thereby directly guiding clinical practice and potentially advancing the optimization of treatment strategies and personalized precision medicine to improve patient survival outcomes.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* Aged between 18 and 75 years;
* Tumor stage classified as BCLC-A to -C, with no evidence of extrahepatic metastasis;
* Newly diagnosed, treatment-naïve hepatocellular carcinoma with no prior anticancer therapy;
* Child-Pugh liver function score ≤ 7;
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
* Absence of severe organic diseases affecting major organs (e.g., heart, lung, brain).

Exclusion Criteria:

* Decompensated liver cirrhosis;
* Concurrent other malignancies or recurrent hepatocellular carcinoma;
* Any active, known, or suspected autoimmune disease;
* History of hypersensitivity to any component of PD-1 inhibitors or lenvatinib;
* Human immunodeficiency virus (HIV) infection; or active viral hepatitis (e.g., hepatitis B or C);
* Tumor thrombus involving the inferior vena cava, hepatic veins, or the main portal vein trunk.