HAI Via Interventionally Implanted Port Catheter Systems
Colorectal Cancer - Liver Neoplasms - Hepatocellular Carcinoma - Gallbladder Cancer - Bile Duct Cancer
Conditions: official terms
Carcinoma, Hepatocellular - Cholangiocarcinoma - Gallbladder Neoplasms - Liver Neoplasms - Neoplasms
Conditions: Keywords
colorectal neoplasms, hepatocellular carcinoma, gallbladder cancer, bile duct cancer, hepatic arterial infusion
Study Type
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: interventionally implanted hepatic arterial port catheter
Type: Device
Overall Status
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

see above

Exclusion Criteria:

see above
Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK
Berlin, Germany
Status: Recruiting
Contact: Bert Hildebrandt, MD - ++49 30 450 553 636 - bert.hildebrandt@charite.de
Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg
Magdeburg, Germany
Status: Recruiting
Contact: Maciej Pech, MD - +49 391 67-13030 - radiologie@uni-magdeburg.de
Start Date
April 2002
Completion Date
April 2008
Charite University, Berlin, Germany
Charite University, Berlin, Germany
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page