colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Advanced colorectal cancer confirmed by histology and cytology diagnosis; 2. At least one measurable objective tumor lesions, its largest diameter should be 1 cm or greater under spiral CT examination or PET - CT; its largest diameter should be 2 cm or greater under ordinary CT or MRI; 3. Expected life time for at least 12 weeks; 4. Aged 18 years old or above; 5. ECOG physical state of 0-2; 6. Has stopped chemotherapy or radiotherapy 3 weeks before involved into the group and has recovered from toxic effects of previous treatment.Patients received drugs with delayed toxicity (such as mitomycin or nitrourea) should stop treatment for 6 weeks; 7. Granular leukocytes=1.5×10^9/L, platelet>80×10^9/L; 8. Serum bilirubin should be =1.5 times of upper limits of normal (ULN); 9. ASTALT=2.5 times of upper limits of normal(=5times of ULN in patients with hepatic metastases); 10. Serum creatinine=1.5 times of upper limits of normal (ULN); 11. To be able to compliance research and follow-up procedures; 12. For all possible pregnant women,must do a pregnancy test within 72 hours before starting treatment and the results should be negative; 13. Signed informed consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Any instable systemic diseases(including gastrointestinal ulcers, active infection, four levels of high blood pressure, unstable angina pectoris, congestive heart failure, liver, kidney, metabolic disease, or fracture, the wound has not healed); 2. With any other malignant tumours within 5 years(excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer); 3. Systemic infection, infective wounds in delay no more; 4. Bone metastases as the only outcome; 5. Pregnant or lactating women; 6. Specifications specified contraindications for irinotecan and fluorouracil; 7. Known to be allergic to irinotecan and fluorouracil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;one-year survival rate; | — |
Countries
China
Contacts
Sichuan Cancer Hospital