Unresectable Biliary cancer
Conditions
Interventions
Hepatic intra-arterial Gemcitabine : 1000mg/m2 (Day1,8) TS1 : 60-80mg/m2 (Day1-4) 21days cycle
Sponsors
Department of 4th Internal medicine,Sapporo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed as Biliary cancer. 2.No indication for surgical resection. 3.Recurrent cancer with liver metastases. 4.No previous chemotherapy and radiotherapy. 5.Patients with clinically significant refractory ascites or pleural effusion 6. Performance status(ECOG) is 0~2. 7. Survival is expected over 3 months. 8. Patients have an ability for a sufficient oral intake . 9. Function of main organ are enough. 10. Sign the letter of consent by voluntary agreement.
Exclusion criteria
Exclusion criteria: 1. Patienta with a medical history of severe hypersensitivity . 2. With severe allergy for GEM or TS-1. 3. Patients under treatment with flucytosine, phenytoin or warfarin potassium . 4. With steroid. 5. Active infection 6. Severe diarrhea. 7. Active double cancer. 8,9. Patients who are pregnant,lactating or are suspected to be a pregnant 10. With hepatomesenteric-type Variation of Hepatic artery. 11. With pulmonary fibrosis 12,13. With severe heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase1 safty Phase2 anti-tumor effect(response rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall survival Drug administration compliance | — |
Countries
Japan
Contacts
Public ContactHirotoshi Ishiwatari
Sapporo Medical University Department of 4th Internal medicine
Outcome results
None listed