advanced colorectal cancer
Conditions
Interventions
test group:patinib po +FOLFIRI chemotherapy
Sponsors
A Affiliated Tumour Hospital Of General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed by histopathology of second-line treatment of unresectable advanced metastatic colorectal cancer patientshave measurable indicators (10 mm or higher spiral CT scan, RECIST 1.1 standard) 2. aged 18 to 75 years; 3. ECOG PS 0-2; expected to survive =12 weeks 4. The blood routine: Hb=9 g/Dl, WBC=4.0×10^9/L, ANC=1.5×10^9/L, PLT=80×10^9/L, 5. Liver function and biochemical examination as following criteria: TBIL=1.5 folders ULN, AST and ALT=2.5 folders ULN, AKP=5 fold ULN, If liver metastasis AST and ALT =5 folders (ULN); 6. Renal function examination as following criteria: Scr=1.5 folders (ULN) or CCR=60 mL/min; 7. Women of childbearing age are willing to using appropriate methods of contraception during the test and 8 weeks after having the last experimental drug, and should have a pregnancy check before test if necessary, the result should be negative; 8. Judging by the researchers, to observe the test plan; 9. Signed informed consent (informed consent need approval by independent ethics committee, and before starting any substantive test program to get the patient's informed consent).
Exclusion criteria
Exclusion criteria: 1. Have other malignant tumours, but does not include has cured skin basal cell carcinoma and cervical carcinoma in situ in recent 5 years; 2. Contains irinotecan chemothrapy treatment in first-line; 3. Patients with uncontrolled CNS metastasis, even if has previously treated, if suspected of CNS metastasis, patients should be scan MRI or PET CT within 28 days before the group; 4. AST and(or) ALT>2.5 fold ULN, and alkaline phosphatase >5 fold ULN; 5. Accepted focus radiotherapy ( the pain relief purposes of palliative radiotherapy and evaluation of lesions is not within the radiation field except); 6. have any uncontrolled systemic diseases, including active infection, uncontrolled high blood pressure, diabetes, unstable angina and congestive heart failure, myocardial infarction (1 year) before the start of treatment, need drug therapy of severe arrhythmia, liver kidney and metabolic disease; 7. accept other clinical research of experimental treatment at the same time (in the treatment of clinical research phase); 8. Have been identified allergic to possible used chemotherapy drug; 9. There is evidence that patients with other diseases, nervous or metabolic dysfunction, abnormal physical or laboratory abnormalities and suspect there may be is taboo for studying drug or will cause the high risk of complications associated with therapy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;DCR;Safety;QoL; | — |
Countries
China
Contacts
Public ContactTao Ma
A Affiliated Tumour Hospital Of General Hospital of Ningxia Medical University
Outcome results
None listed