Colonic and rectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. histopathology confirmed advanced colorectal cancer; 2. without chemotherapy (or non-CPT-11 after adjuvant chemotherapy program in progress) in patients with advanced; 3. have failed chemotherapy (not used CPT-11) in patients with advanced; 4. there are measurable lesions (diameter: General CT >= 20mm; spiral CT >=10mm), or can not be measured in patients with the disease (Observer OS); 5. age >= 18 years old; 6. ECOG status of acts score (see Appendix I) =3 months; 8. the results of laboratory tests required to meet the following criteria: blood: ANC >=1.5*10^9/L, PLT >=80*10^9 /L, Hb >=90g/L; renal function: Cr <1.25*N; liver function: no cases of liver metastases: total bilirubin <=1.25 *N, ALT <=1.5*N; there are cases of liver metastases: TBil <= 1.50*N, ALT<=3.0*N; 10. rehabilitation treatment from the people at the end of chemotherapy 4 weeks or more; 11. normal electrocardiogram.
Exclusion criteria
Exclusion criteria: 1. in the past has been the treatment of CPT-11; 2. history of chronic diarrhea; 3. inflammatory bowel disease or a history of extensive removal of the colon> 50% or extensive small bowel resection with chronic diarrhea; 4. in the past have received partial abdominal or pelvic radiation Treatment; 5. intestinal obstruction or incomplete intestinal obstruction; 6. serious peripheral neuropathy; 7. brain or meningeal transfer; 8. major organ failure; 9. beyond the control of severe infections; 10. or pregnancy Breast-feeding women; 11. at the same time the use of other experimental drugs or participate in other clinical trials; 12. serious heart and lung failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatality rate;Survival tim; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood picture;ECOG score;Renal and lver function; | — |
Countries
China