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

Humanity & Health Medical Group Limited

Status: Terminated

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lenvatinib

Study type: Observational

Funder types: Other

Identifiers

NCT04428437

VICI-6

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 2 patient groups

Lenvatinib

Description:

Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.

Treatment:

Drug: Lenvatinib

Non-Lenvatinib

Description:

Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib.