colorectal cancer
Conditions
Interventions
Experimental group:SALIRI
Control group:FOLFIRI
Sponsors
Bangwei Cao
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male or female patients, 18-75 years old; (2) Patients with colon cancer who were diagnosed by pathology and / or cytology and failed to be treated with fluorouracil; (3) According to the response evaluation criteria in solid tumors 1.1, patients have at least one target lesion (tumor focus CT) with measurable diameter >=10 mm, lymph node focus CT scan with short diameter >=15 mm and scanning layer thickness =12 weeks; (6) The function of main organs is good, that is to say, the relevant examination indexes in the first 14 days of randomization meet the following requirements: blood routine tests(no blood transfusion in the first 14 days before screening, no drugs used to raise white blood and platelets in 4 weeks): hemoglobin > 90g/L; neutrophils > 1.5109/l; platelets > 100x10^9/L; biochemical examination: AST and alt =60 ml/min (Cockcroft Gault formula); (7) Echocardiographic evaluation: left ventricular ejection fraction >=50%; (8) The informed consent of name and time has been signed, indicating that the patient has been informed of all relevant matters before entering the group; (9) Good compliance, patients and their families agreed to cooperate to receive survival follow-up.
Exclusion criteria
Exclusion criteria: (1) Previously or simultaneously suffering from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; (2) Those who are currently receiving other anti-tumor treatment (including radiotherapy); (3) Participated in clinical trials of other drugs within four weeks; (4) Patients with known or history of central nervous system metastasis before screening; (5) Severe medical diseases such as cardiovascular diseases, including sinus tachycardia, supraventricular tachycardia, atrial fibrillation and congestive heart failure; (6) Active gastrointestinal hemorrhage and gastrointestinal perforation; (7) For women of childbearing age, the serum or urine pregnancy test was positive within 7 days before the study was enrolled, or they were in lactation; (8) Those who have a history of abuse of psychotropic substances and are unable to give up or have mental disorders; (9) Patients who refuse to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactBangwei Cao
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed