advanced colorectal cancer
Conditions
Interventions
experimental group:FOLFIRI combined with apatinib
Sponsors
Shanxi Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-75 years male and female; 2. Advanced colorectal cancerr(with non resectable metastatic) with distant metastasis at the same time, or accepted recurrence and metastasis after primary radical resection; 3. Confirmed by pathology with measurable lesions, (CT scan Long diameter of tumor=10mm, CT scan Long diameter of lymph node lesion=15mm, scan slice thickness>5mm); 4. Estimated survival time=3 mouths; 5. ECOG 0-2; 6. The main organ function is normal, and meet the following standards(patients has not using blood transfusion , blood products or GCF and other correction of hematopoietic stimulating factor within 14 days): (1) The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=100×10^9/L,WBC=3.5×10^9/L; (2) Biochemical tests should meet the following criteria: TBIL50ml/min. 7. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 8. Patients voluntarily entered the study and signed informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Take part in other drug clinical studies before screen; 2. Received apatinib or other VEGFR inhibitors, such as bevacizumab, Solafinib, Sunitinib; 3. Variety of factors affecting oral drugs (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 4. Metastases of the central nervous system with symptoms; 5. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg); 6. Urinary protein is more than + + and confirmed the 24 hour urinary protein quantitative > 1 g; 7. Coagulopathy (INR>1.5×ULN APTT>1.5×ULN), with Bleeding tendency; 8. pregnant or lactating women; 9. Other cases the researchers judged that could affect the outcome of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate of transformation operation;OS;ORR;DCR;Safty;Quality of life; | — |
Countries
China
Contacts
Public ContactLiuHaiyi, Wen Lu, Wang Yusheng
Shanxi Tumor Hospital
Outcome results
None listed