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

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Lenvatinib

• Registration Number: NCT04428437
• Lead Sponsor: Humanity & Health Medical Group Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2022-07-02
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Response rate (RR)	12 month	It is the sum of the proportion of stable disease (SD), complete response (CR) and partial response(PR) per RECIST 1.1. That is, RR = SD + CR + PR

Secondary Outcome Measures

Name	Time	Method
Adverse Events	12 month	An adverse event (AE) refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v4.0 were recorded.

Trial Locations

Locations (1)

Humanity & Health Clinical Trial Centre; 🇭🇰 Hong Kong, Hong Kong SAR, Hong Kong