Local advanced, unresectable and metastatic pancreatic cancer
Conditions
Interventions
Trial group:Kanglaite Injection+Gemzar: Kanglaite Injection 200ml/day, by intravenous drip, for 80 min(150ml/hr), administered from day 1 to day 21 (since it may have vein irritation, central venous d
control group:Gemzar alone: Gemzar 1000mg/m2, by intravenous drip, for 100 min(10mg/m2/min), administered on day 1, day 8 and day 15, then rest for 13 days, 4 weeks (28 days) as a cycle.The treatment
Sponsors
Tumor Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Must have histologically (cytological) confirmed pancreatic cancer, either unresectable or metastatic; 2. Age: 18-75 years old; 3. Must have a life expectancy >90 days; 4.KPS score >=70;5.Must at least have one measurable or evaluable tumor observation index, if within the field of radiation, radiotherapy must be discontinued for 2 months; 6. Must have completed any previous cancer surgery or radiotherapy at least 30 days before the clinical study; 7. Must not have previously received systemic chemotherapy; 8. Women in childbearing age must use appropriate birth control measures; 9. Peripheral blood picture: WBC>=4000/ul, PLT>=100000/ul; 10. Renal function test: Cr<=1.3mg/dl, BUN<=1.25*N; 11. Liver function test: STB<=2.0mg/dl, ALT<=2.4*N, AST<=2.5*N, AKP<=2.5*N; 12. Must have good compliance; 13. Must give written informed consent prior to treatment.
Exclusion criteria
Exclusion criteria: 1. Patient who is participating in other pharmaceutical study; 2. Patient with other uncured cancer (s), other than pancreatic cancer; 3. Patient who has had prior chemotherapy; 4. Patient needing concomitant therapy (surgery, radiotherapy, etc.) while on study; 5. Patient with acute bacteria or virus infection; 6. Patient with severe, uncontrolled medical disease(s); 7. Patient with active brain metastasis; 8. Patient with obvious abnormal vital sign and heart, liver & renal function; 9. Patient who has a known allergy to test drug or its components; 10. Patient who is pregnant or lactating; 11. Patient with uncontrolled epilepsy and central nervous system disease(s); 12. Patient with only unmeasurable lesions such as cancerous pleural effusion, ascites, bone metastasis and meninges, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS scale;Quality of life;Body weight;?Tumor objective response;Survival time;KPS score;Clinical benefit response; | — |
Countries
China
Contacts
Public ContactYan Sun
Outcome results
None listed