Trial Information

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.

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.