study of apatinib and capecitabine combination to maintain treating metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: to control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.

to control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mpfs; secondary endpoint include in mos, tolerance and security.

Eligibility criteria:
inclusion criteria: 1. informed consent form should be issued prior to conducting any research process; 2. men or women aged 18-75 years; 3. patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology; 4. patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy; 5. the estimated survival time is longer than 3 months; 6. ecog score was 0 or 1; 7. according to the recist v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through ct or mri(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress; 8. with sufficient organ and bone marrow function, defined as follows: * hb≥9 g/dl * absolute neutrophil count ≥1.0 × 109 /l * platelet count≥75 × 109 /l * serum bilirubin ≤ 1.5 × uln, which would not be appropriate for patients with gilbert syndrome (persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor * alt\&ast ≤ 2.5 × uln; for patients with liver metastases, alt\&ast ≤ 5 × uln calculate the creatinine clearance rate by cockcroft-gault formula * creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours\> 40 ml/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used) 9. women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration; 10. patients volunteered to participate in the trial and signed informed consent form with good compliance. exclusion criteria: 1. patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure \>140 mmhg / diastolic pressure \> 90 mmhg),patients with coronary heart disease more than grade ii, arrhythmia (including qtc interval prolongation men\>450 ms, women \>470 ms) and cardiac insufficiency; 2. with a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician; 4. abnormal coagulation function(inr\>1.5×uln、 aptt\>1.5×uln) with bleeding tendency; 5. with symptomatic central nervous system metastasis; 6. pregnant or lactating women; 7. other patients unsuitable for inclusion considered by the physician.

Keywords: metastatic colorectal cancer apatinib capecitabine