Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT04415567
Eligibility Criteria:
Inclusion Criteria:
1. The recipients who underwent liver transplantation with the pathologic diagnosis of hepatocellular carcinoma.
2. The extrahepatic metastasis was excluded preoperatively.
3. 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 Criteria:
1. The patients took lenvatinib before liver transplantation and assessed as SD or PD according to the mRECIST criteria.
2. The patients suffered from other incurable malignancies within 5 years or at the same time.
3. Distant metastasis of tumor was confirmed by imaging before or within 1 month after transplantation.
4. The patients have not received regular antiviral treatment.
5. The patients had a history of mental illness or abuse of psychoactive drugs.
6. The patients deemed unsuitable by attending doctors.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
69 Years
Study:
NCT04415567
Study Brief:
Protocol Section:
NCT04415567