Clinical trial · Interventional
Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lenvatinib | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- patients receive transcatheter arterial chemoembolization (TACE) only.
- interventionNames
- Procedure: TACE
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
- interventionNames
- Drug: Lenvatinib
- Procedure: TACE
Primary outcomes (3)
- measure
- Incidence of adverse events
- timeFrame
- Up to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available