Status:
COMPLETED
Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With HBV-related HCC After Liver Transplantation
Lead Sponsor:
Jinyang Gu
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
8-69 years
Brief Summary
High-risk patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) suffer from a high ratio of recurrence after liver transplantation (LT). Lenvatinib, as a novel targeted drug, ha...
Detailed Description
The investigators retrospectively reviewed 23 Chinese HCC patients with HBV infection, who underwent LT in our hospital from June 2018 to December 2019. All donor grafts were allocated by the China Or...
Eligibility Criteria
Inclusion
- The recipients who underwent liver transplantation with the pathologic diagnosis of hepatocellular carcinoma.
- The extrahepatic metastasis was excluded preoperatively.
- The patients were defined as "high-risk" for recurrence according to the following criteria:
- (1) beyond Milan criteria confirmed either by radiology before LT or by pathology after LT, (2) tumor with intrahepatic vascular invasion, (3) Alpha-fetoprotein (AFP)≥400ng/L before LT, (4) presence of microvascular invasion (MVI), (5) tumor with histological poor differentiation according to Edmondson-Steiner classification system(21), (6) multiple satellite lesions around the largest tumors detected either by radiology before LT or by histology after LT, (7) tumor penetrating hepatic capsule, (8) recurrent HCC after resection. 4. ECOG score between 0-1 within 1 week before took lenvatinib. 5. The patients have received regular antiviral treatment. 6. Life expectancy more than 3 months.
Exclusion
- The patients took lenvatinib before liver transplantation and assessed as SD or PD according to the mRECIST criteria.
- The patients suffered from other incurable malignancies within 5 years or at the same time.
- Distant metastasis of tumor was confirmed by imaging before or within 1 month after transplantation.
- The patients have not received regular antiviral treatment.
- The patients had a history of mental illness or abuse of psychoactive drugs.
- The patients deemed unsuitable by attending doctors.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04415567
Start Date
June 1 2018
End Date
March 31 2020
Last Update
June 4 2020
Active Locations (1)
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1
Xinhua Hospital Affiliated to Shanghai Jiao Tong University Medical School
Shanghai, China, 200092