Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors

An Observational Study to Evaluate the Safety and Efficacy of Lenvatinib in HCC Subjects Who Have Progressive Disease After First Line Treatment With Checkpoint Inhibitors

The objective of this study is to evaluate the efficacy of lenvatinib in HCC subjects who have progressive disease after first line treatment with checkpoint inhibitors.

Approximately 20 subjects will be enrollment to evaluate the efficacy and safety of lenvatinib.

CT/MRI assessments will be made at end of first line treatment with checkpoint inhibitors, and every 8-12 weeks thereafter. Disease status will be determined at the site (ie. Investigator and/or radiologist) using RECIST version 1.1.

The primary efficacy endpoint is response rate (RR) defined as proportion of subjects with SD/PR/CR per RECIST 1.1.

Inclusion Criteria:

1. Age ≥ 18 years old on the day of consent
2. Capable of understanding and complying with the protocol requirements and signed informed consent
3. Documented histological or cytological diagnosis of HCC
4. HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1

Exclusion Criteria:

1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
2. Prior TKI treatment