DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

Официальное название

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial

Обзор

This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.

Подробное описание

This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.

Вмешательства

• Устройство DEB-TACE with visualable microspheres
  Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
• Устройство DEB-TACE with PVA microspheres
  Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres

Первичные конечные точки

• Disease control rate (DCR) for target lesions 1 month after the last TACE treatment [Срок оценки: 1 month after last TACE treatment]

Вторичные конечные точки (6)

• Visualization score of embolic area [Срок оценки: Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment]
• Embolization success rate of target lesions [Срок оценки: Immediately after each TACE treatment]
• Equipment performance evaluation [Срок оценки: From the begin to immediately after each TACE treatment]
• Disease control rate (DCR) for target lesions [Срок оценки: 1 month after the first TACE treatment, and 3 months after the last TACE treatment]
• Objective response rate（ORR） [Срок оценки: 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment]
• Number of TACE treatments for target lesions [Срок оценки: 6 month since the last TACE treatment]

Критерии участия

Критерии включения

• CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
• ECOG PS score of 0-2
• With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
• Agree to participate in this trial and voluntarily sign the informed consent form

Критерии исключения

• Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
• With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months With sepsis or multiple organ dysfunction
• Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine >2 mg/dL)
• Significant reductions in white blood cells or platelets (white blood cells <3.0×10\^9/L, platelets <50×10\^9/L, hemoglobin<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by >3 seconds above the upper limit of normal)
• With severe infection (>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
• With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
• Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
• Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
• Pregnant or lactating women
• Patients who are participating in other trial(s)
• Unsuitable for participation in this trial deemed by the researchers

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking University First Hospital — Пекин
• Zhongda Hospital，Southeast University — Нанкин

Идентификаторы

NCT: NCT06190665 · CHANCE 2305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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