NCT07191548尚未招募不适用
Treatment of LIVER METastases From Colorectal Cancer by IRreversible Electroporation: A Prospective, International, Multi-centre Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Target Tumour Eradication
研究概览
简要总结
Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.
- •Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.
- •Eastern Co-operative Oncology Group (ECOG) Score ≤
- •Rockwood Frailty Score ≤
- •Serum bilirubin < 30 µmol/L.
- •Serum creatinine < 150 µmol/L.
- •Up to two lung metastases (< 2cm in size permitted at enrolment).
- •Prior treatment with at least one course of systemic chemotherapy (± biologic agent) mandated. Chemotherapy protocol is not specified and is at clinician discretion.
- •Primary rectal tumour can remain in situ treated with radiotherapy/chemoradiotherapy according to tumour board recommendations. Primary colonic tumour can remain in situ.
- •No prior hepatic tumour ablation
排除标准
- •Patients involved in other research studies.
- •Inability to give informed consent.
- •Patients who are pregnant.
- •Accepted exclusions to IRE from consensus criteria including:
- •Platelet count < 50x109 U/L.
- •International normalised ratio (INR) for blood clotting > 1.
- •Prior hepatic tumour ablation.
- •Cardiovascular fitness related exclusions:
- •History of ventricular arrhythmia.
- •Implanted pacemaker or defibrillator.
- •Congestive cardiac failure NYHA Class ≥
- •Tumour-related exclusions:
- •Tumour ≥ 4 cm in size.
- •Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, > 2 lung metastases, all segment involvement multiple liver metastases.
- •Jaundice (serum bilirubin > 30 µmol/L).
- •MDT/tumour recommends use of thermal ablation instead of IRE for any given lesion.
结局指标
主要结局
Target Tumour Eradication
时间窗: 6 months
The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria.
次要结局
- Complications of IRE: Episode-related complications:(30 days)
- Complications of IRE: Intervention for local liver-related complications of IRE(12 months)
- Oncological Outcomes: Other liver-directed interventions(12 months)
- Quality of life - pre procedure(pre procedure up to 7 days)
- Oncological outcomes: Local progression at site of IRE-treated lesion(12 months)
- Oncological Outcomes: Re-ablation and modality.(12 months)
- Oncological Outcomes: Post IRE Chemotherapy(12 months)
- Oncological Outcomes: New lesions(12 months)
- Oncological Outcomes: Disease-free and overall survival from time of IRE.(12 months)
- Quality of life - 7 days follow-up(7 days)
- Quality of life - 6 months(6 months)
研究者
研究点 (2)
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