RecruitingEarly Phase 1NCT06327269

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


Sponsor

Chang Gung Memorial Hospital

Enrollment

40 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests an innovative treatment approach for people with high-risk liver cancer (hepatocellular carcinoma) who are receiving a living-donor liver transplant (LDLT). High-risk patients are those whose tumors don't meet standard criteria for transplant (e.g., tumors are too large or numerous). Researchers are testing whether adding targeted therapy (lenvatinib) after transplant can reduce the risk of the cancer coming back. **You may be eligible if...** - You are receiving a liver transplant from a living donor - You have high-risk liver cancer based on defined criteria: positive PET scan before transplant, tumors beyond UCSF criteria, poorly differentiated tumors, or poor AFP response to prior local treatment - You can tolerate the immunosuppressive and targeted therapy regimen **You may NOT be eligible if...** - Your life expectancy is less than 3 months - You have another active cancer at the same time - You are allergic to lenvatinib or its inactive ingredients Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib 10 mg

Lenvatinib would be used on patients with advanced liver cancer after Liver transplantation as an adjuvant treatment.


Locations(1)

Department of Surgery

Kaohsiung City, Taiwan

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NCT06327269