NCT04911959

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 microvascular invasion (MVI) positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 6, 2023

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

January 18, 2021

Last Update Submit

February 2, 2023

Conditions

Hepatocellular CarcinomaLenvatinib

Keywords

TACEHepatocellular CarcinomaMVIPrognosisLenvatinib

Outcome Measures

Primary Outcomes (3)

  • Incidence of adverse events

    To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC

    Up to 8 weeks

  • Changes in tumor volume

    To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC

    Up to 8 weeks

  • Recurrence-free survival (RFS) evaluation

    To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Disease recurrence time evaluation

    Through study completion, an average of 1 year

  • Overall survival ( OS) evaluation

    Through study completion, an average of 1 year

Study Arms (2)

control group

ACTIVE COMPARATOR

patients receive transcatheter arterial chemoembolization (TACE) only.

Procedure: TACE

Intervention group

EXPERIMENTAL

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

Drug: LenvatinibProcedure: TACE

Interventions

LenvatinibDRUG

Lenvatinib is taken orally.

Intervention group
TACEPROCEDURE

TACE treatment once.

Also known as: Transcatheter Arterial Chemoembolization
Intervention groupcontrol group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weilin Wang

Hangzhou, None Selected, 310009, China

RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Zhongquan Sun

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weilin Wang

CONTACT

+8657187783820wam@zju.edu.cn

Yuan Ding

CONTACT

+8618858101960dingyuan@zju.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

June 3, 2021

Study Start

July 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 6, 2023

Record last verified: 2022-07

Locations

CN(2)