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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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 l

Первичные конечные точки

• Recurrence-free survival (RFS) [Срок оценки: 2 years]

Вторичные конечные точки (4)

• Overall survival (OS) [Срок оценки: 5 years]
• Pathological response rate (Pathological Response) [Срок оценки: 1 year]
• Proportion of patients completing living donor liver transplantation [Срок оценки: at the time of the surgery]
• Adverse events related to DEB-TACE [Срок оценки: from DEB-TACE to the surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06353126 · DTACELT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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