Safety and Efficacy of Mitomycin C-based Hyperthermic Intraperitoneal Chemotherapy After Spontaneously Ruptured Hepatocellular Carcinoma and Peritoneal Metastasis: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- recurrence-free-survival
研究概览
简要总结
Hepatocellular carcinoma (HCC) is featured by the spontaneously rupture when suffering severe cirrhosis and intratumoral overpressure. It is a fatal complication with an acute mortality. Importantly, it is served as an independent risk factor for peritoneal metastasis (PM) of HCC with poor prognosis. The systematic agents effective to extrahepatic lesions confers modest efficacy towards PM. HIPEC, as a novel strategy, has been proved by overwhelming studies that it is effective to peritoneal malignant tumors. However, there is absence of prospective study of HIPEC efficacy towards HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC patients have been diagnosed by NCCN clinical practice guidelines in oncology, Hepatobiliary cancers, version 2.
- •ECOG score of 0-2 points;
- •Child-Pugh class A-B liver function only;
- •Consistent with the diagnosis of srHCC: symptoms: acute abdominal pain and peritonitis; blood routine tests: decrease of erythrocyte count; increase of leucocyte count, especially the proportion of neutrophils; radiological features: contrast materials extravasation from lesions confirmed by abdominal contrast enhanced computed tomography or promethean magnetic resonance imaging; intraoperative findings of tumor rupture and postoperative pathology are more confidently conclusive.
- •Consistent with PM of HCC: histological evaluations: biopsy of peritoneal nodules or ascites cytology or postoperative pathological verification; radiological diagnose: early enhancement and late wash-out radiological property of peritoneal nodule or mutual confirmation by two senior radiologists.
- •All of selections have received open or laparoscopic hepatectomy to reach complete macroscopic resection or less than 2.5mm of residual tumor tissue, which is equal to 0 or 1 degree of completeness of cytoreduction.
- •Patients voluntarily participated and signed the informed consent.
排除标准
- •Contraindications of HIPEC, such as: extensive intra-abdominal adhesions caused by various reasons; complete intestinal obstruction; severe kidney insufficiency; myelosuppression caused by previous targeted therapy or own blood system disease; severe cardiovascular system disease; infection, especially abdominal infection; bleeding tendency or coagulation dysfunction; the vital signs are unstable; cachexia;
- •Extraperitoneal metastasis;
- •Patients who refuse to accept clinical trials;
- •Those who are deemed unsuitable for inclusion by the researchers.
结局指标
主要结局
recurrence-free-survival
时间窗: 2years
the time from the first administration to the date of first recurrence, including local recurrence and PM and distant metastasis, or death for any cause.
次要结局
未报告次要终点
研究者
Jiwei Huang
Department of Liver Surgery and Liver Transplantation Centre
West China Hospital