A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma

Официальное название

A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma

Обзор

The goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres. The main questions it aims to answer are: * Is the treatment more effective than traditional TACE alone? * What additional medical issues arise when using the microspheres? Researchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes. Participants will: * Receive up to 3 treatments of TACE with or without microspheres * Undergo checkups and tests every 30 days * Keep records of tumor size and other safety issues

Вмешательства

• Устройство Magnesium Microspheres
  Biodegradable Magnesium Embolic Microspheres
• Процедура cTACE
  cTACE

Первичные конечные точки

• ORR [Срок оценки: 30 days after the last TACE treatment.]

Вторичные конечные точки (4)

• Success rate of embolization technique for the target lesion [Срок оценки: on the day of the surgery]
• DCR [Срок оценки: 30 days after the first TACE treatment]
• CR [Срок оценки: 30 days after the first TACE treatment]
• ORR [Срок оценки: 90 days after the last TACE treatment]

Критерии участия

Критерии включения

• Age range: 18 to 80 years inclusive, regardless of gender;
• Patients with primary hepatocellular carcinoma (HCC) at CNLC stage Ib to IIIa who require transarterial chemoembolization (TACE) treatment and are unsuitable for or refuse surgical resection, liver transplantation, and ablation therapy;
• ECOG score ≤ 2, and Child-Pugh classification of A or B;
• Presence of at least one untreated, measurable tumor lesion with a diameter ≥ 3.0 cm according to mRECIST criteria (the maximum diameter of the target lesion ≤ 10.0 cm);
• Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who are willing to receive antiviral treatment throughout the study period;
• Voluntary participation in this clinical trial and signing of the informed consent form by the subject.

Критерии исключения

• Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE;
• Received other antitumor systemic treatment within 28 days before enrollment;
• Unsuitable for TACE due to lesion characteristics or vascular issues;
• Vp3/Vp4 portal vein tumor thrombus;
• Tumor occupying ≥70% of liver volume;
• Decompensated cirrhosis or recent ascites drainage/TIPS;
• Severe allergies to contrast agents or embolization materials;
• Received blood products or certain corrective treatments within 7 days before enrollment;
• Abnormal blood counts (WBC, platelets, neutrophils, hemoglobin);
• Abnormal liver function tests (bilirubin, enzymes, albumin);
• Renal impairment (creatinine, creatinine clearance);
• Prolonged PT;
• Unsuitable feeding artery for TACE or embolization risks;
• Expected survival <6 months;
• Pregnant, lactating, or planning pregnancy;
• Factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases);
• Severe infections unsuitable for TACE;
• Participation in other clinical trials within 28 days before enrollment;
• Other reasons deemed unsuitable by the investigator.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• Anyang Tumor Hospital — Anyang
• Henan Cancer Hospital — Чжэнчжоу
• Zhongda Hospital Southeast University — Нанкин
• Lishui Central Hospital — Lishui
• The Third Affiliated Hospital,Sun Yat-Sen University — Гуанчжоу
• The First Hospital of Lanzhou University — Lanzhou
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang
• … и ещё 2 центра

Идентификаторы

NCT: NCT06779461 · BM601-Q001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗