A Randomized Study Comparing Concurrent Versus Sequential Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy in Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating two different ways to combine hepatic arterial infusion chemotherapy (HAIC) with targeted drugs and immunotherapy in patients who have potentially removable intermediate to advanced hepatocellular carcinoma (HCC), a type of liver cancer. The study aims to find out whether giving all three treatments at the same time or giving HAIC first followed by the other treatments based on response leads to better surgical outcomes, survival, and safety. Participants are randomly divided into two groups. One group receives two cycles of HAIC combined with targeted drug lenvatinib and PD-1 antibody immunotherapy simultaneously, followed by tumor response evaluation. Depending on the response, they may have surgery, continue treatment, or switch to other therapies. The second group receives two cycles of HAIC alone first, then tumor response is evaluated; those without complete response receive two additional cycles of HAIC combined with the targeted drug and immunotherapy. After four cycles, patients are re-evaluated for surgery or further treatment. During the study, participants undergo tumor response assessments after two and four treatment cycles, with ongoing safety monitoring for about three years. Researchers will measure overall survival from the time of randomization until death, progression-free survival, response rates, and safety profiles. Participants will be closely followed to track treatment effects, surgical outcomes, and any side effects over this period.

Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC