Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma

April 16, 2024 updated by: Chang Gung Memorial Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • Department of Surgery
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A new generation of targeted therapies and adjuvant therapy after LDLT.
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.
Drug: Lenvatinib 10 mg
Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.
Other Names:
  • Lenvima®
Active Comparator: prolong the recurrence-free survival to high risk of HCC after LDLT
Lenvatinib which is applied to adjuvant therapy after LDLT may prolong the recurrence-free survival
Drug: Lenvatinib 10 mg
Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.
Other Names:
  • Lenvima®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival with adjuvant therapy
Time Frame: 2 years
Lenvatinib treatment may prolong the recurrence-free survival rate after LDLT.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Health and Welfare, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOHW111-TDU-B-221-114009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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