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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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
Department of Surgery
RECRUITING
Kaohsiung City
Contact Information
Primary
Chih-Che Lin, Ph.D
chihchelin@cgmh.org.tw
+88677317123
Backup
I-Hsuan Chen, Ph.D
ann0401@cgmh.org.tw
+88677317123
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
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.
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
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital
Collaborators: Ministry of Health and Welfare, Taiwan

This content was sourced from clinicaltrials.gov