hepatic metastasis of colonic carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must have histologically (cytological) confirmed hepatic metastasis of colonic carcinoma (Primary tumor has been surgically removed); 2. To be aged 18 to 75 years old; 3. Must have a life expectancy at least 90 days; 4. KPS score more than 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. Peripheral blood picture: WBC more than 4000/ul, PLT more than 100000/ul; 9. Renal function test: Cr more than 1.3mg/dl, BUN less than 1.25*N; 11. Liver function test: STB less than 2.0mg/dl, ALT less than 2.4*N, AST less than 2.5*N, AKP less than 2.5*N; 10. Must have good compliance; 11. 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 colonic carcinoma; 3. Patient needing concomitant therapy (surgery, radiotherapy, etc.) while on study; 4. Patient with acute bacteria or virus infection; 5. Patient with severe, uncontrolled medical disease(s); 6. Patient with active brain metastasis; 7. Patient with obvious abnormal vital sign and heart, liver & renal function; 8. Patient who has a known allergy to test drug or its components; 9. Patient who is pregnant or lactating; 10. Patient with uncontrolled epilepsy and central nervous system disease(s); 11. Patient with only unmeasurable lesions such as cancerous pleural effusion, ascites, bone metastasis and meninges, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival time;PFS;radiographic parameters;progress free survival; | — |
Countries
China