Clinical and biomarker analyses of hepatic arterial infusion chemotherapy plus lenvatinib and PD-1 inhibitor for...

Area of Science:

• Oncology
• Gastroenterology
• Immunotherapy

Background:

• Intrahepatic cholangiocarcinoma (iCCA) is an aggressive liver cancer with limited treatment options.
• Current therapies for advanced iCCA often yield poor prognoses.

Purpose of the Study:

• To evaluate the efficacy and safety of a triple combination therapy for advanced iCCA.
• To identify predictive biomarkers for treatment response in iCCA patients.

Main Methods:

• Retrospective study of 46 advanced iCCA patients treated with lenvatinib, PD-1 inhibitor, and FOLFOX-HAIC.
• Progression-free survival (PFS) and overall survival (OS) were primary endpoints.
• Tumor biopsy sequencing (whole exome, RNA) was performed for biomarker analysis.

Main Results:

• Median PFS was 9.40 months; median OS was 16.77 months.
• Objective response rate (ORR) was 47.8%; disease control rate (DCR) was 91.3%.
• High baseline immune signatures and CD8+ T cell density predicted better outcomes, while tumor mutation burden did not.

Conclusions:

• The triple combination of FOLFOX-HAIC, lenvatinib, and PD-1 inhibitor shows significant antitumor activity and manageable safety in advanced iCCA.
• Pre-existing tumor immunity is a potential predictive biomarker for this treatment regimen.