Clinical trial NCT04911959: Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Lenvatinib
Keywords: TACE
Hepatocellular Carcinoma
MVI
Prognosis
Lenvatinib
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 8 weeks
measure: Changes in tumor volume
timeFrame: Up to 8 weeks
measure: Recurrence-free survival (RFS) evaluation
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Disease recurrence time evaluation
timeFrame: Through study completion, an average of 1 year
measure: Overall survival ( OS) evaluation
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Weilin Wang
state: None Selected
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhongquan Sun
role: PRINCIPAL_INVESTIGATOR
References: