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

Overview

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.

Full Title of Study: “Study on the Safety and Effectiveness of Transcatheter Arterial Chemoembolization (TACE) Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With Microvascular Invasion (MVI) Positive Hepatocellular Carcinoma (HCC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2024

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.

Interventions

  • Drug: Lenvatinib
    • Lenvatinib is taken orally.
  • Procedure: TACE
    • TACE treatment once.

Arms, Groups and Cohorts

  • Active Comparator: control group
    • patients receive transcatheter arterial chemoembolization (TACE) only.
  • Experimental: Intervention group
    • patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse events
    • Time Frame: 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
    • Time Frame: Up to 8 weeks
    • To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
  • Recurrence-free survival (RFS) evaluation
    • Time Frame: 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

Secondary Measures

  • Disease recurrence time evaluation
    • Time Frame: 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
    • Time Frame: Through study completion, an average of 1 year
    • Overall survival time as assessed by IRC

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhongquan Sun, Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Overall Contact(s)
    • Weilin Wang, +8657187783820, wam@zju.edu.cn

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.