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

NCT04428437 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2023-10-05

No results posted yet for this study

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

Interventions

DRUG

Lenvatinib

Prescribed by physician.

Sponsors & Collaborators

  • Beijing 302 Hospital

    collaborator OTHER

  • Kindai University Faculty of Medicine

    collaborator UNKNOWN

  • Humanity & Health Medical Group Limited

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-02
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428437 on ClinicalTrials.gov