Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC

Phase 1

• Conditions: Lenvatinib; Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Drug: Lenvatinib

• Registration Number: NCT04911959
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

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 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.

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Status Verified: 2022-07
• Study Start: 2022-07-01
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	TACE	patients receive transcatheter arterial chemoembolization (TACE) only.
Intervention group	TACE	patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
Intervention group	Lenvatinib	patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival (RFS) evaluation	Through study completion, an average of 1 year	To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment
Incidence of adverse events	Up to 8 weeks	To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Changes in tumor volume	Up to 8 weeks	To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC

Secondary Outcome Measures

Name	Time	Method
Disease recurrence time evaluation	Through study completion, an average of 1 year	To evaluate the tumor recurrence time of patients with MVI-positive HCC after TACE combined with lenvatinib treatment
Overall survival ( OS) evaluation	Through study completion, an average of 1 year	Overall survival time as assessed by IRC

Trial Locations

Locations (2)

Weilin Wang; 🇨🇳 Hangzhou, None Selected, China

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China