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

Hepatocellular Carcinoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04911959
• Other study ID #: yan2020-629
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Weilin Wang
• Phone: +8657187783820
• Email: wam[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Lenvatinib
• Recurrence

Intervention

Drug:
• Lenvatinib
Lenvatinib is taken orally.

Procedure:
• TACE
TACE treatment once.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Weilin Wang	Hangzhou	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Disease recurrence time evaluation	To evaluate the tumor recurrence time of patients with MVI-positive HCC after TACE combined with lenvatinib treatment	Through study completion, an average of 1 year
Secondary	Overall survival ( OS) evaluation	Overall survival time as assessed by IRC	Through study completion, an average of 1 year