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Recruiting NCT06353126

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

Phase IV Interventional Liver Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DEB-TACE.
Who it may be relevant to
Registry conditions: Liver Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure DEB-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 l

Primary outcome measures

  • Recurrence-free survival (RFS) [Time frame: 2 years]
Secondary outcome measures (4)
  • Overall survival (OS) [Time frame: 5 years]
  • Pathological response rate (Pathological Response) [Time frame: 1 year]
  • Proportion of patients completing living donor liver transplantation [Time frame: at the time of the surgery]
  • Adverse events related to DEB-TACE [Time frame: from DEB-TACE to the surgery]

Eligibility criteria

Inclusion criteria

  • Age 18-75 years;
  • Subjects with viral hepatitis or cirrhosis are clinically diagnosed according to AASLD standards, which require a history of viral hepatitis or cirrhosis combined with imaging examinations (enhanced CT, MRI, second-generation ultrasound contrast agents). When the tumor diameter is greater than 2 cm, a diagnosis can be made if one imaging technique shows typical arterial phase rapid enhancement and rapid washout. If the diameter is 1-2 cm, two imaging techniques must confirm this, or one imaging technique confirms it and alpha-fetoprotein (AFP) is greater than 400 ng/ml. For subjects who cannot be clinically diagnosed, histological or cytological biopsy confirmation is required; original biopsy records can also be used for diagnosis.
  • Child-Pugh score A-B grade;
  • Tumor present in the right lobe of the liver;
  • Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;
  • ECOG-PS score 0-1;
  • Scheduled for living donor liver transplantation as the primary treatment;
  • Signed informed consent form.

Exclusion criteria

  • Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct;
  • Severe hepatic encephalopathy;
  • Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV);
  • Severe contrast agent allergy;
  • Irreversible hepatic artery to hepatic vein shunt;
  • Special types of anatomical variations (Asan portal vein type III);
  • Extrahepatic metastatic tumors;
  • Concurrent active hepatitis or severe infection;
  • Tumor dissemination or distant metastasis, expected survival <3 months;
  • Renal dysfunction, creatinine >176.8 umol/L or creatinine clearance rate <30ml/min;
  • White blood cell count <3.0x109/L, platelet count <50x106/L, and unable to correct;
  • Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease);
  • Severe psychiatric illness;
  • Other reasons deemed unsuitable for participation by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06353126 · DTACELT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗