mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer

Exploratory Study on the Efficacy and the Safety of mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer

This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6; another group will use mFOLFOX6 combined with apatinib. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.

Inclusion Criteria:

1. signed informed consent form;
2. confirmed as colorectal cancer by pathology, and the stage is IIIB /IIIC according to the NCCN guidelines;
3. patients with primary colorectal cancer;
4. radical resection of colon cancer (CME) or radical resection of rectal cancer (TME) has done;
5. 3~4 weeks after radical resection ;
6. patients did not receive any radiotherapy and chemotherapy before operation

Exclusion Criteria:

1. emergency operation for colorectal cancer patients;
2. the situation after operation can not tolerance for systemic adjuvant chemotherapy (hemoglobin <95g/L, white blood cell <3 * 109/L, granulocyte <1.5 * 109/L and platelet <75 * 109/L, bilirubin>2.5N, alanine aminotransferase >2.5N, alkaline phosphatase >2.5N, urea nitrogen >2.5N, creatinine >2.5N, proteinuria, hematuria, temperature of >38 degree);
3. serious diseases such as cardiac insufficiency, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases;
4. patients participated in other clinical trials at the same time;
5. pregnant or perinatal women;
6. combined with other malignant tumors;
7. a history of neuropsychiatric disorders;
8. patients have used anti angiogenesis targeted drugs (such as bevacizumab, cetuximab);
9. patients had a history of severe trauma within 4 weeks before admission;
10. allergic to chemotherapy drugs or apatinib;
11. active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension