Lenvatinib Therapy in the Patients With High-risk Hepatocellular Carcinoma After LDLT

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

New guidelines have been successfully established to distinguish the patients who were suitable for LT. This is important for long-term recurrence free and overall survival rate. We stratified patients with PET diagnosis and fetal protein response to confirm if they were the high-risk group for HCC recurrence. According to our new guidelines, high-risk tumor biology and tumor necrosis have important indicators for improving overall survival. Response to topical therapy is associated with tumor biology and post-transplant recurrence risk. In addition, 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female patients aged 18 to 75.

• 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)

Locations
Other Locations
Taiwan
Kaohsiung Cheng Gang
RECRUITING
Kaohsiung City
Contact Information
Primary
I-HSUAN CHEN, PhD
ann0401@hotmail.com
+88677317123
Backup
CHICHE LIN, PhD
immunologylin@gmail.com
+88677317123
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Related Therapeutic Areas
Sponsors
Leads: Kaoshiung Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov