Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Recurrence-free survival with adjuvant therapy
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Lenvatinib 10 mg (Drug)
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
Intervention: Lenvatinib 10 mg (Drug)
Outcomes
Primary Outcomes
Recurrence-free survival with adjuvant therapy
Time Frame: 2 years
Lenvatinib treatment may prolong the recurrence-free survival rate after LDLT.
Secondary Outcomes
No secondary outcomes reported