A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases

Обзор

This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.

Подробное описание

This is a single-center, parallel-controlled clinical study. The study plans to enroll 10 subjects, with 5 in the multi-mode ablation group (experimental group) and 5 in the conventional radiofrequency ablation group (control group). The entire study includes a screening period, treatment period and follow-up period. By comparing multi-mode ablation with conventional radiofrequency ablation, the study aims to observe the efficacy, safety of the multi-mode ablation technique in subjects and its impact on the systemic anti-tumor immunity of subjects.

Вмешательства

• Устройство Multi-mode tumor treatment system
  All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. The treatment procedure includes: rapid freezing of the tumor tissue to form an ice ball extending 5mm beyond the lesion, maintaining this state for 5 minutes, followed by thawing and rewarming; subsequently, RFA is performed to ensure complete ablation, with the ablation zone includ
• Устройство Radiofrequency ablation therapeutic apparatus
  All subjects are treated using the radiofrequency ablation therapeutic apparatus (MedSphere International (Shanghai) Co., Ltd.), with the treatment procedure conducted according to the preset power and time parameters to ensure a safety margin of 5-10mm.

Первичные конечные точки

• Anti-tumor immune response [Срок оценки: max 24 months]

Вторичные конечные точки (4)

• 6-Month Local Control Rate [Срок оценки: 6 months]
• 6-Month Progression-Free Survival [Срок оценки: 6 months]
• 1-Year Progression-Free Survival [Срок оценки: 1 year]
• 1-Year Overall Survival [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age 18-75 years, female gender;
• Pathologically confirmed breast cancer liver metastases, in patients who are unable to tolerate or refuse surgical resection;
• The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm;
• At least an interval of 1 month since the last local treatment;
• Child-Pugh class A or B;
• ECOG PS score ≤2, with an expected survival of >3 months.

Критерии исключения

• Liver function Child-Pugh class C;
• Systemic widespread metastasis, with an expected survival of < 3 months;
• History of esophageal (gastric fundus) variceal bleeding within the past month;
• Dysfunction or failure of vital organs;
• Presence of an active infection;
• Irreparable coagulation abnormality;
• Refractory massive ascites, pleural effusion or cachexia;
• Pregnancy, altered consciousness or patients unable to cooperate with treatment;
• Previously participated in other clinical studies and still within the follow-up period;
• Any other factors deemed inappropriate for inclusion or that may affect the patient's participation in the study, as determined 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

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

Идентификаторы

NCT: NCT06567353 · 0306v1.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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