Status:
UNKNOWN
Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Hepatocellular Carcinoma
Lenvatinib
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of mi...
Detailed Description
Focusing on the current status of clinical treatment of microvascular invasion (MVI) positive postoperative hepatocellular carcinoma (HCC) , single-center clinical trial studies have verified the safe...
Eligibility Criteria
Inclusion
- Radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was HCC after surgery, and MVI was positive
- Child-Pugh score ≤9 points (Child-Pugh A-B), PS score 0-2 points, BCLC stage A-B
- The main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent
- With sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements
- Physical fitness score ECOG 0～2
- Expected survival\> 3 months
- No other systemic malignancies
- Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period
- Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents
Exclusion
- Histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- Severe liver dysfunction (Child-Pugh C), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation
- The main portal vein is completely blocked, and the formation of collateral vessels is small
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04911959
Start Date
July 1 2022
End Date
June 30 2024
Last Update
February 6 2023
Active Locations (2)
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1
Weilin Wang
Hangzhou, None Selected, China, 310009
2
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009