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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-06-30

Brief Summary

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single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of microvascular invasion (MVI) positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Detailed Description

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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 safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of MVI-positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Conditions

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Hepatocellular Carcinoma Lenvatinib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

patients receive transcatheter arterial chemoembolization (TACE) only.

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

TACE treatment once.

Intervention group

patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.

Group Type EXPERIMENTAL

Lenvatinib

Intervention Type DRUG

Lenvatinib is taken orally.

TACE

Intervention Type PROCEDURE

TACE treatment once.

Interventions

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Lenvatinib

Lenvatinib is taken orally.

Intervention Type DRUG

TACE

TACE treatment once.

Intervention Type PROCEDURE

Other Intervention Names

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Transcatheter Arterial Chemoembolization

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weilin Wang

Role: CONTACT

+8657187783820

Yuan Ding

Role: CONTACT

+8618858101960

Facility Contacts

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Weilin Wang, M.D.

Role: primary

+86 0571 87783820

Yuan Ding, M.D.

Role: primary

+86 18858101960

Weilin Wang, M.D.

Role: backup

+86 0571 87783820

Other Identifiers

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yan2020-629

Identifier Type: -

Identifier Source: org_study_id

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