Study of Hepatic Arterial Infusion Chemotherapy with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Liver Cancer After Systemic Therapy Failure

What this Trial Is About

Researchers are evaluating the safety and effectiveness of hepatic arterial infusion chemotherapy HAIC combined with PD-1 inhibitors and Lenvatinib for patients with intermediate or advanced hepatocellular carcinoma HCC who have not responded to systemic treatments recommended by the Barcelona Clinic Liver Cancer BCLC guidelines. The study focuses on patients with BCLC stage B or C HCC, particularly those with portal vein tumor thrombus, to better understand treatment options after prior therapies have failed. Participants will receive at least two cycles of HAIC, which includes chemotherapy agents like FOLFOX and RALOX delivered directly into the livers blood vessels. They will also get at least one cycle of PD-1 inhibitors such as Camrelizumab, Sintilimab, or Tislelizumab combined with Lenvatinib, a drug targeting cancer growth. The timing between HAIC and the combined PD-1 inhibitors and Lenvatinib treatment should be within two weeks. During the study, researchers will monitor overall survival and various measures of tumor progression, including intra-hepatic and extra-hepatic lesions and portal vein tumor thrombus, for up to about two years. They will also assess objective response rates using specific imaging criteria and track any adverse events using standard safety guidelines. Participants will undergo regular evaluations to measure treatment effects and safety throughout the study period.

HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC