DEB-TACE Prior to Liver Transplantation in the Treatment... | NCT06353126

NCT06353126

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Boston Scientific Corporation	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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.