Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

Официальное название

Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial

Обзор

The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is: • Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival? Participants will: * Receive chemotherapy treatment per standard procedure. * Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic. * Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit. * Participate in genetic testing, as a part of the standard of care for the treatment.

Подробное описание

This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been approved by the FDA with De Novo classification for non-invasive destruction of liver tumors. Up to 100 participants with colorectal cancer liver metastasis will be included.

Вмешательства

• Устройство HistoSonics Edison® System
  Histotripsy is a novel, totally non-invasive, non-ionizing, and non-thermal ablation technique that mechanically disrupts tumors through precisely controlled acoustic cavitation. Histotripsy is administered via HistoSonics Edison® System.
• Препарат Chemotherapy
  Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).

Первичные конечные точки

• Radiologic tumor viability [Срок оценки: 90 days post-treatment]

Вторичные конечные точки (12)

• Rate of Tumor Necrosis [Срок оценки: 30 days post-treatment]
• Percentage of Viable Tumor in Lesion [Срок оценки: 30 days post-treatment]
• Infiltration of CD4 [Срок оценки: 30 days post-treatment]
• Infiltration of CD8 [Срок оценки: Baseline, 30 days post-treatment]
• Infiltration of B-cells [Срок оценки: 30 days post- treatment]
• Infiltration of CD45 [Срок оценки: 30 days post-treatment]
• Infiltration of CD68 [Срок оценки: 30 days post-treatment]
• Infiltration of PD-1 [Срок оценки: 30 days post-treatment]
• Infiltration of PD-L1 [Срок оценки: 30 days after treatment]
• Infiltration of CTLA-4 [Срок оценки: 30 days post-treatment]
• Overall Survival [Срок оценки: Up to 24 months post-treatment]
• Progression Free Survival (PFS) [Срок оценки: Up to 24 months post-treatment]

Критерии участия

Критерии включения

• Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM
• Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within 3 months of beginning chemotherapy, or participants who have completed chemotherapy treatment within 1 month of the histotripsy evaluation
• Participants who have undergone other liver-directed therapy, such as ablation, embolization
• Participants with multiple unresectable metastases that cannot be completely treated with resection and/or ablation
• Participants aged ≥18 years

Критерии исключения

• Participants with resectable disease
• Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.
• Participants who are not able to tolerate general anesthesia
• Participants who have Childs C Cirrhosis
• Other non-skin malignancy within 2 years of study
• WBC count < 3,000 /uL
• Absolute Neutrophil Count < 1,500 /uL
• History of Non-malignant serious concurrent illness that would increase the risk of histotripsy
• Participants with MSI-High
• Participants aged < 18 years
• Pregnant participants

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland

Идентификаторы

NCT: NCT07044362 · CASE6224

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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