RecruitingPhase 4NCT06353126

DEB-TACE Prior to Liver Transplantation in the Treatment of HCC

A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to Liver Transplantation in the Treatment of Hepatocellular Carcinoma

Sponsor

RenJi Hospital

Enrollment

40 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Cancer

Summary

The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for living donor liver transplantation receive DEB-TACE 2 weeks prior to the surgery. The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing living donor liver transplantation; 4) Adverse events related to DEB-TACE.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a technique called DEB-TACE (drug-eluting bead transarterial chemoembolization — a procedure where tiny beads loaded with chemotherapy are delivered directly to liver tumors through a blood vessel) as a treatment to stabilize liver cancer (HCC) in patients waiting for a liver transplant. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cancer (hepatocellular carcinoma, HCC), confirmed by imaging or biopsy - You have underlying viral hepatitis or cirrhosis - You are being evaluated for or are on the waiting list for a liver transplant - Your liver function is adequate (Child-Pugh class A or B) **You may NOT be eligible if...** - Your liver function is too poor to safely undergo the procedure - Your tumor has spread outside the liver - You have blockage of the main portal vein - You have other serious conditions that make the procedure too risky - You are pregnant or breastfeeding 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.

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Interventions

PROCEDUREDEB-TACE

DEB-TACE, or Drug-Eluting Bead Transarterial Chemoembolization, is a minimally invasive interventional radiology procedure primarily used in the treatment of hepatocellular carcinoma (HCC), which is the most common type of liver cancer. This procedure combines two treatment modalities: transarterial chemoembolization (TACE) and the use of drug-eluting beads (DEB). During DEB-TACE, tiny beads loaded with chemotherapy drugs are injected directly into the blood vessels supplying the tumor in the liver. These drug-eluting beads gradually release chemotherapy agents, delivering a targeted and sustained dose directly to the cancerous tissue while minimizing systemic side effects. Additionally, the beads themselves act as embolic agents, blocking the blood flow to the tumor and causing ischemia, which further contributes to the destruction of the tumor cells.

Locations(1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

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NCT06353126

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