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

NCT ID: NCT06353126

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2027-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

DEB-TACE

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kang He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianjun Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Kang He

Role: CONTACT

hekang@renji.com

13621621415

Facility Contacts

Kang Associate chief physician

Role: primary

Other Identifiers

DTACELT

Identifier Type: -

Identifier Source: org_study_id