RecruitingNot ApplicableNCT06609850

The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma

The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study


Sponsor

Sun Yat-sen University

Enrollment

116 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment approaches for people with intermediate-stage recurring liver cancer (hepatocellular carcinoma that has come back after initial treatment). One group gets a combination of TACE (a procedure to block blood supply to the tumor) plus the targeted drug lenvatinib. The other group gets the same combination plus tumor ablation (a procedure that destroys tumor tissue using heat or cold). Researchers want to find out which approach controls the cancer better. **You may be eligible if...** - You are between 18 and 75 years old - Your liver cancer has returned (recurrent HCC) and is at an intermediate stage (2–3 lesions, at least one over 3 cm, no more than 6 tumors total, each under 5 cm) - There is no spread outside the liver and no major blood vessel involvement - Your liver is still functioning reasonably well (Child-Pugh A or B) - You showed no progression after your first TACE treatment **You may NOT be eligible if...** - Your cancer has spread outside the liver - You have primary (not recurrent) liver cancer - You have more than 6 tumors or a tumor larger than 5 cm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETACE

TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.

PROCEDUREAblation

Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.

DRUGLenvatinb

Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )


Locations(1)

Chinese PLA General hospital

Beijing, None Selected, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06609850


Related Trials