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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04428437
• Other study ID #: VICI-6
• Status: Terminated
• Start date: July 2, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Humanity & Health Medical Group Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Lenvatinib
Prescribed by physician.

Locations

Country	Name	City	State
Hong Kong	Humanity & Health Clinical Trial Centre	Hong Kong	Hong Kong SAR

Sponsors (3)

Lead Sponsor	Collaborator
Humanity & Health Medical Group Limited	Beijing 302 Hospital, Kindai University Faculty of Medicine

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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