TACE With Thermosensitive Nanogel Versus Embosphere for HCC

Официальное название

Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial

Обзор

To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.

Подробное описание

This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group，with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.

Вмешательства

• Устройство Thermosensitive Nanogel Embolic Agent
  Thermosensitive Nanogel Embolic Agent

Первичные конечные точки

• Disease control rate (DCR) [Срок оценки: One month after the last TACE]

Вторичные конечные точки (5)

• Success rate of target lesion embolization [Срок оценки: One month after the last TACE]
• Objective response rate (ORR) [Срок оценки: One month after the last TACE treatment]
• Disease control rate (DCR) [Срок оценки: Three and six months after the first TACE]
• Equipment performance evaluation [Срок оценки: One month after the first TACE]
• Adverse events [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;
• Liver function status: Child-Pugh A or B
• Eastern Cooperative Oncology Group score: 0-2 points;
• With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
• Willing to participate in this trial and sign the informed consent.

Критерии исключения

• The target lesion has been embolized before or require combined with other treatment(s);
• Diffuse or with extrahepatic metastasis;
• Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
• Severe renal dysfunctions (creatinine clearance rate <30 ml/min);
• Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);
• Main portal vein was completely occluded and no collateral blood supply was established;
• With uncorrectable arteriovenous fistula or portal vein fistula;
• Severe cachexia or hepatic encephalopathy;
• With active infection;
• Significant reductions in white blood cells or platelets (white blood cells<3.0x109/L, platelets<50x109/L) that cannot be corrected;
• Pregnant or lactating women;
• Difficulty in selective catheterization;
• With the severe risk of non-target embolization;
• Severely allergic to contrast agents or the embolic materials;
• Participating in ongoing trial;
• Unsuitable judged 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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Gao-Jun Teng — Нанкин

Идентификаторы

NCT: NCT06593964 · CHANCE-2416

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗