Unresectable advanced pancreatic cancer
Conditions
Interventions
Gemcitabine was i.v. administered at a fixed dose of 1000 mg/m2 for 30 min on days 1,15 of each 28-day cycle. nafamostat mesilate is administered via a port-catheter system for 24 h through the commo
1.25 m2 80 mg/day 1.25-1.5 m2 100 mg/day >
=1.5 m2 120 mg/day
Sponsors
Jikei University school of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosed as pancreatic cancer Determination of unresectability was evaluated by helical computed tomography scan, abdominal angiography and endoscopic ultrasound by using the criteria defined in the National Comprehensive Cancer Network guidelines for pancreatic cancer. Histologically diagnosis is desirable 2)Patients of age 20-79 3)KPS 7-10 4)Life expectancy more than 3 months 5)hemoglobin >=9.0 g/dl WBC>=3,000/mm3,12,000/mm3 neutrophils >=1,500/mm3 platelets=100,000/mm3 AST/ALT </=2.5 x ULN total bilirubin <=2.0 x ULN serum creatinine <=1.0 x ULN creatinine clearance>=60 ml/min PaO2 >= 70 torr 7)No replaced common hepatic artery, gastroduodenal artery and celiac artery 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Pulmonary fibrosis or interstitial pneumonitis 2)Active bacterial or fungal infection 3)Uncontrollable heart disease 4)Uncontrollable DM 5)Pregnant or lactating women or women fo childearing potential, and men who want to get partner pregnat 6)Severe drug allergy 7)Simultaneous or metachronous double cancers 8)uncontrollable ascites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, PFS, Disease control rate, one-year survival rate | — |
Countries
Japan
Contacts
Public ContactTadashi Uwagawa
Jikei University school of Medicine Department of surgery, Division of hepatobiliary pancreatic surgery
Outcome results
None listed