HAI Via Interventionally Implanted Port Catheter Systems

Charité University Medicine Berlin

Status and phase

Unknown

Phase 2

Conditions

Gallbladder Cancer

Bile Duct Cancer

Liver Neoplasms

Hepatocellular Carcinoma

Colorectal Cancer

Treatments

Device: interventionally implanted hepatic arterial port catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT00356161

CVK-HAI 1

Details and patient eligibility

About

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.

Full description

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.

Patients are followed up and evaluated for primary and secondary endpoints. After the inclusion of 50 patients treated and follow up at our institution, the study population has been extended to 100 patients in 8/2004.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

see above

Exclusion criteria

see above