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

NCT06353126 | Recruiting Phase 4

• 1 other identifier: DTACELT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS)

  the time from DEB-TACE treatment until tumor recurrence in the original site, transplanted liver, other tissues and organs, or death, whichever occurs first.

  2 years

Secondary Outcomes (4)

• Overall survival (OS)

  5 years

• Pathological response rate (Pathological Response)

  1 year

• Proportion of patients completing living donor liver transplantation

  at the time of the surgery

• Adverse events related to DEB-TACE

  from DEB-TACE to the surgery

Study Arms (1)

DEB-TACE prior to living donor liver transplantation

EXPERIMENTAL

Patients with HCC scheduled for living donor liver transplantation treatment receive DEB-TACE 2 weeks prior to the surgery

Procedure: DEB-TACE

Interventions

DEB-TACE PROCEDURE

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.

DEB-TACE prior to living donor liver transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Jianjun Zhang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kang He

CONTACT

13621621415; hekang@renji.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 8, 2024
• Study Start: October 16, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)