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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Procedure: DEB-TACE

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kang He; Phone Number: 13621621415; Email: hekang@renji.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Renji Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Kang Associate chief physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years;
2. 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.
3. Child-Pugh score A-B grade;
4. Tumor present in the right lobe of the liver;
5. Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;
6. ECOG-PS score 0-1;
7. Scheduled for living donor liver transplantation as the primary treatment;
8. Signed informed consent form.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	the time from DEB-TACE treatment until death from any cause.	5 years
Pathological response rate (Pathological Response)	at the time of the surgery	1 year
Proportion of patients completing living donor liver transplantation	1 year	at the time of the surgery
Adverse events related to DEB-TACE	2 weeks	from DEB-TACE to the surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Jianjun Zhang, MD, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: DTACELT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No