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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353126
• Other study ID #: DTACESALT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: Kang He
• Phone: 13621621415
• Email: hekang[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to SALT (Sequential Adult Left Lateral 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 SALT 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 SALT; 4) Adverse events related to DEB-TACE.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years;

2. Child-Pugh score A-B grade;

3. Tumor present in the right lobe of the liver;

4. Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;

5. ECOG-PS score 0-1;

6. Scheduled for SALT as the primary treatment;

7. 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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	the time from DEB-TACE treatment until death from any cause.	5 years
Secondary	Pathological response rate (Pathological Response)	at the time of the first stage of surgery	1 year
Secondary	Proportion of patients completing SALT	1 year	at the time of the second stage of surgery
Secondary	Adverse events related to DEB-TACE	1 year	from DEB-TACE to the first stage of the surgery