NCT07192731尚未招募不适用
Treatment of LIVER-limited HepatoCellular Carcinoma (HCC) in Patients With Preserved Liver Function 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 lesions from hepatocellular cancer 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 clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study.
- •Child-Pugh A up to A
- •Eastern Co-operative Oncology Group (ECOG) Score ≤
- •Rockwood Frailty Score ≤
- •Serum bilirubin < 30 µmol/L.
- •Serum creatinine < 150 µmol/L.
- •No extrahepatic metastases
- •IRE can be used for up to 3 tumours < 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.
排除标准
- •Patients involved in other research studies.
- •Patients under the age of 18 years.
- •Inability to give informed consent.
- •Patients who are pregnant.
- •Child-Pugh B or C.
- •Patients with an ECOG status of > 2 at time of recruitment.
- •Rockwood Frailty Score > 3
- •Impaired renal function (serum creatinine > 150 µmol/L)
- •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 ≥ 3 cm in size.
- •Extrahepatic metastatic disease.
- •Jaundice (serum bilirubin > 30 µmol/L).
- •MDT recommends use of thermal ablation 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. This is based on a per-lesion analysis.
次要结局
- Oncological Outcome: Survival (Progression-free & overall)(12 months)
- Complications of IRE: Episode-related complications:(30 days)
- Complications of IRE: Intervention for local liver-related complications of IRE(12 months)
- Oncological outcomes: Incomplete ablation requiring further intervention(6 months)
- Oncological outcome: Further anti-cancer intervention(12 months)
- Oncological Outcome: Progression at site of ablation(12 months)
- Oncologic Outcomes: Chemotherapy post-IRE(6 months)
- Quality of life: EQ-5D-5 pre-procedure(within 7 days prior to procedure)
- Quality of life: EQ-5D-5 post-procedure 7 days(7 days)
- Oncologic Outcomes: local progression(12 months)
- Quality of life: EQ-5D-5 - 6 months(6 months)
研究者
研究点 (2)
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