High Risk of RecurrenceEarly Phase 1NCT06327269
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
A Early Phase 1 study testing Lenvatinib 10 mg in people with High Risk of Recurrence, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High Risk of Recurrence
- What is being tested?
- Lenvatinib 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2021to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Targeted therapy is acceptable within 1-2 months after liver transplantation.
- Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
- All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
- The definition of high-risk patients:
- The PET scan is positive before LDLT;
- Tumors beyond USCF criteria
- Poorly-differentiated tumor;
- The patients who has poor AFP response (<15%)or AFP>400 ng/ml after LRT after conventional LRT (RFA、PEI or TACE)
Who cannot join
- Life expectancy is less than 3 months
- Patients are with other malignant tumors simultaneously.
- Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.
- Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).
- Preoperative history of severe cardiovascular disease: congestive heart failure > NYHA grade 2; active coronary heart disease (myocardial infarction occurred within 6 months before entry into the study); severe arrhythmia requiring antiarrhythmic treatment (allowable use of beta-blockers or digoxin); uncontrolled hypertension.
- History of HIV infection.
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- Severe clinical active infections (> NCI-CTCAE version 3.0).
- Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).
- Patients with kidney diseases requires renal dialysis.
- Drug abuse, medical symptoms, mental illness or social status that may interfere with participants' participation in research or evaluation of research results.
- Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Surgery
Kaohsiung City, 833
Chih-Che Lin, Ph.D, +88677317123 ext. 8880, chihchelin@cgmh.org.tw
I-Hsuan Chen, Ph.D, +88677317123 ext. 8582, ann0401@cgmh.org.tw
About this study
The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT.
- Conditions
- High Risk of Recurrence
- Being tested
- Lenvatinib 10 mg
- Keywords
- living donor liver transplantation (LDLT), hepatocellular carcinoma (HCC), PET, proton, yttrium 90, Lenvatinib, adjuvant treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib 10 mgDrug
Also called Lenvima®
Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.
| Study group | Role | What they receive |
|---|---|---|
| A new generation of targeted therapies and adjuvant therapy after LDLT. | Active comparator | The proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. Lenvatinib is applied to adjuvant therapy after LDLT. Receives: Drug: Lenvatinib 10 mg |
| prolong the recurrence-free survival to high risk of HCC after LDLT | Active comparator | Lenvatinib which is applied to adjuvant therapy after LDLT may prolong the recurrence-free survival Receives: Drug: Lenvatinib 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival with adjuvant therapy
Lenvatinib treatment may prolong the recurrence-free survival rate after LDLT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Risk of RecurrenceStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327269
- Sponsor's protocol ID
- MOHW111-TDU-B-221-114009
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han B, Ding H, Zhao S, Zhang Y, Wang J, Zhang Y, Gu J. Potential Role of Adjuvant Lenvatinib in Improving Disease-Free Survival for Patients With High-Risk Hepatitis B Virus-Related Hepatocellular Carcinoma Following Liver Transplantation: A Retrospective, Case Control Study. Front Oncol. 2020 Dec 7;10:562103. doi: 10.3389/fonc.2020.562103. eCollection 2020.
PubMed 33365268
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06327269
- Acronym / sponsor ID
- MOHW111-TDU-B-221-114009
- Conditions
- High Risk of Recurrence
- Keywords
- living donor liver transplantation (LDLT), hepatocellular carcinoma (HCC), PET, proton, yttrium 90, Lenvatinib, adjuvant treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Mar 2024 (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 challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A new generation of targeted therapies and adjuvant therapy after LDLT. | Active comparator | Drug: Lenvatinib 10 mgThe proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. Lenvatinib is applied to adjuvant therapy after LDLT. |
| prolong the recurrence-free survival to high risk of HCC after LDLT | Active comparator | Drug: Lenvatinib 10 mgLenvatinib which is applied to adjuvant therapy after LDLT may prolong the recurrence-free survival |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Targeted therapy is acceptable within 1-2 months after liver transplantation.
- Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
- All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
- The definition of high-risk patients:
- The PET scan is positive before LDLT;
Key exclusion criteria (11 listed)
- Life expectancy is less than 3 months
- Patients are with other malignant tumors simultaneously.
- Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.
- Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).
- Preoperative history of severe cardiovascular disease: congestive heart failure > NYHA grade 2; active coronary heart disease (myocardial infarction occurred within 6 months before entry into the study); severe arrhythmia requiring antiarrhythmic treatment (allowable use of beta-blockers or digoxin); uncontrolled hypertension.
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 |
|---|---|---|
| Lenvatinib 10 mgAlso: Lenvima®Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment. | Drug | A new generation of targeted therapies and adjuvant therapy after LDLT., prolong the recurrence-free survival to high risk of HCC after LDLT |
Primary outcome
Recurrence-free survival with adjuvant therapy
Time frame: 2 years
Lenvatinib treatment may prolong the recurrence-free survival rate after LDLT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Results publication: PubMed 33365268Han B, Ding H, Zhao S, Zhang Y, Wang J, Zhang Y, Gu J. Potential Role of Adjuvant Lenvatinib in Improving Disease-Free Survival for Patients With High-Risk Hepatitis B Virus-Related Hepatocellular Carcinoma Following Liver Transplantation: A Retrospective, Case Control Study. Front Oncol. 2020 Dec 7;10:562103. doi: 10.3389/fonc.2020.562103. eCollection 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lenvatinib 10 mg in people with High Risk of Recurrence, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Apr 2024. 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 Taiwan. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Che Lin, Ph.D (+88677317123 ext. 8880, chihchelin@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival with adjuvant therapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327269, which also lists 1 linked publication.
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 18 Apr 2024.