Open One-Arm Therapy Optimizing Trial on Regional Chemotherapy of the Liver Through an Interventionally Implanted A.Hepatica Port System in Patients With Liver Metastases or Primary Liver Neoplasms.
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Comparison of evaluation and intervention group
研究概览
简要总结
Procedures to provide interventional implantation of a port catheter system into the hepatic artery and adjacent regional chemotherapy of the liver are optimized in the scope of an open, single-arm trial in patients with metastases and cancers confined to the liver. The primary objective is the improvement of indication, implantation procedure, and regional chemotherapy. Secondary objectives are port patency, comparison of complications with a historical collective of patients provided with a surgical hepatic arterial port device (colorectal cancer patients only), progression free and overall survival, efficacy of maintaining regional chemotherapy with 5-FU in combination with systemic treatment in patients with extrahepatic progression, quality of life.
详细描述
Inclusion criteria:
- histologically confirmed hepatic cancer without symptomatic extrahepatic manifestation.
- non-resectable disease or hepatic resection or ablation in between the past 8 weeks.
- measurable disease (at least before hepatic resection)
- Karnofsky performance status => 70%, or ECOG status 0-2
- >18 years of age
- life expectancy > 6 months
- compliance of the patient
- written informed consent
Exclusion criteria:
- second neoplasia within the past 3 years, except for non-melanotic skin cancer, adequately treated Ca in situ of cervix uteri, or adequately resected second colorectal cancer (in patients with liver metastases of colorectal cancer)
- symptomatic extrahepatic disease, in particular disseminated bone metastases, brain metastases
- liver cirrhosis with portal hypertension, active hepatitis B or C, previous percutaneous radiotherapy of the liver
- active infection
- history of gastric or duodenal ulcer
- symptomatic or uncontrolled peripheral arterial occlusive disease, history of stenosis of the renal artery.
- history of dilatative cardiomyopathy, vitium of mitral or aortic valve, persisting foramen ovale, atrial fibrillation
- artificial heart valve or vascular
- history of diabetic microangiopathy
- uncontrolled hyperthyriodism
- other severe concomitant disease (heart failure >NYHA 2°, respiratory failure, renal failure >stage2, liver failure (TPZ <50%).
- inherited or acquired immunodeficiency syndrome
- contraindication against 5-FU
- pregnancy and nursing, no contraception
- limited contractual capability.
After enrollment, an a port catheter catheter system is interventionally implanted into the hepatic artery and the patient is scheduled for regional chemotherapy according one out of 8 pre-defined chemotherapy schedules. All regimens are based on 5-fluorouracil and leucovorin, and optionally contain intraarterial mitomycin, oxaliplatin, or additional intravenous irinotecan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of evaluation and intervention group
Complication rate (device implantation)
Safety of device and regional therapy
次要结局
- prospective evaluation of port duration
- comparison of complication and port duration with an historical collective of patients provided with a surgically implanted hepatic arterial port catheter system (liver metastases of colorectal cancer)
- response
- progression free and overall survival
- efficacy of maintaining regional therapy combined with systemic chemotherapy in patients with extrahepatic progression while on study
- quality of life