Hepatocellular CarcinomaNCT04428437
Safety and Efficacy of Lenvatinib in Subjects With HCC Progression After First Line Treatment With Checkpoint Inhibitors
An observational study of Hepatocellular Carcinoma, run by Humanity & Health Medical Group Limited at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Lenvatinib
- How many people
- 17 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jul 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with HCC progression after first line treatment with checkpoint inhibitors
Who may be able to join
- Age ≥ 18 years old on the day of consent
- Capable of understanding and complying with the protocol requirements and signed informed consent
- Documented histological or cytological diagnosis of HCC
- HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1
Who cannot join
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- Prior TKI treatment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Humanity & Health Clinical Trial Centre
Hong Kong, Hong Kong SAR
About this study
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
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
- Being tested
- Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called Lenvima, E7080
Prescribed by physician.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib | Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib. Receives: Drug: Lenvatinib | |
| Non-Lenvatinib | Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Secondary outcomes (1)
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start2 Jul 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Why it stopped: The sponsor withdrawed the sponsorship to the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity & Health Medical Group Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, Kindai University Faculty of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428437
- Sponsor's protocol ID
- VICI-6
- Status last verified
- Oct 2023
- First submitted
- 9 Jun 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04428437
- Acronym / sponsor ID
- VICI-6
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor withdrawed the sponsorship to the study.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Humanity & Health Medical Group LimitedUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, Kindai University Faculty of Medicine
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib | – | Drug: LenvatinibSubjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by lenvatinib. |
| Non-Lenvatinib | – | –Subjects with HCC progression after first line treatment with checkpoint inhibitors will get the treatment by non-lenvatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with HCC progression after first line treatment with checkpoint inhibitors
Key inclusion criteria (4 listed)
- Age ≥ 18 years old on the day of consent
- Capable of understanding and complying with the protocol requirements and signed informed consent
- Documented histological or cytological diagnosis of HCC
- HCC progression after first line treatment with checkpoint inhibitors per RECIST 1.1
Key exclusion criteria (2 listed)
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
- Prior TKI treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibAlso: Lenvima, E7080Prescribed by physician. | Drug | Lenvatinib |
Primary outcome
Response rate (RR)
Time frame: 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
1 secondary outcome
Adverse Events
Time frame: 12 month
Results and safety
The study was stopped early (reason given: The sponsor withdrawed the sponsorship to the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Humanity & Health Medical Group Limited at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The sponsor withdrawed the sponsorship to the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (RR) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.