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.

Study Overview

• Status: Terminated
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Lenvatinib

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong SAR
    • Hong Kong, Hong Kong SAR, Hong Kong
      • Humanity & Health Clinical Trial Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects with HCC progression after first line treatment with checkpoint inhibitors

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lenvatinib; Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib.	Drug: Lenvatinib; Prescribed by physician.; Other Names: E7080; Lenvima
Non-Lenvatinib; Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate (RR)	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	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	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.	12 month

Collaborators and Investigators

• Sponsor: Humanity & Health Medical Group Limited
• Collaborators: Beijing 302 Hospital; Kindai University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: VICI-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No