NCT04428437

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Humanity & Health Medical Group Limited · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	Prescribed by physician.

Timeline

• Start date: 2022-07-02
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2020-06-11
• Last updated: 2023-10-05

Locations

1 site across 1 country: Hong Kong