Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC
NCT ID: NCT04911959
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2022-07-01
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control group
patients receive transcatheter arterial chemoembolization (TACE) only.
TACE
TACE treatment once.
Intervention group
patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
Lenvatinib
Lenvatinib is taken orally.
TACE
TACE treatment once.
Interventions
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Lenvatinib
Lenvatinib is taken orally.
TACE
TACE treatment once.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Zhongquan Sun
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Weilin Wang
Hangzhou, None Selected, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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yan2020-629
Identifier Type: -
Identifier Source: org_study_id
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