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

Study Overview
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Brief Summary
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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.

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

Conditions
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Apatinib

Intervention / Treatment
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* Drug: Apatinib
* Drug: Oxaliplatin
* Drug: 5-fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent form; confirmed as colorectal cancer by pathology, and the stage is IIIB /IIIC according to the NCCN guidelines; patients with primary colorectal cancer; radical resection of colon cancer (CME) or radical resection of rectal cancer (TME) has done; 3 4 weeks after radical resection ; patients did not receive any radiotherapy and chemotherapy before operation Exclusion Criteria: emergency operation for colorectal cancer patients; 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); serious diseases such as cardiac insufficiency, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases; patients participated in other clinical trials at the same time; pregnant or perinatal women; combined with other malignant tumors; a history of neuropsychiatric disorders; patients have used anti angiogenesis targeted drugs (such as bevacizumab, cetuximab); patients had a history of severe trauma within 4 weeks before admission; allergic to chemotherapy drugs or apatinib; active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study has one Intervention Type of Drug.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mFOLFOX6 & apatinib<br>oxaliplatin 85mg/m2 intravenous infusion for 2 hours, intravenous infusion of leucovorin 400mg/m2 for 2 hours, intravenous infusion of 5- fluorouracil 400mg/m2, first days; 5- fluorouracil 2400mg/m2 continuous intravenous infusion for 46-48 hours, repeated 1 time every two weeks, a total of 12 cycles, 24 weeks. Patients also take apatinib, 1 time daily, 500mg each time, lasting 1 year, from the first chemotherapy of mFOLFOX6. | Drug: Apatinib<br>* Apatinib tablet<br>* Other names: YN968D1;Drug: Oxaliplatin<br>* Oxaliplatin Intravenous<br>* Other names: Eloxatin;Drug: 5-fluorouracil<br>* 5-fluorouracil Intravenous<br>* Other names: Adrucil, Carac, Efudex, Efudix;|
| Active Comparator: mFOLFOX6<br>oxaliplatin 85mg/m2 intravenous infusion for 2 hours, intravenous infusion of leucovorin 400mg/m2 for 2 hours, intravenous infusion of 5- fluorouracil 400mg/m2, first days; 5- fluorouracil 2400mg/m2 continuous intravenous infusion for 46-48 hours, repeated 1 time every two weeks, a total of 12 cycles, 24 weeks. | Drug: Oxaliplatin<br>* Oxaliplatin Intravenous<br>* Other names: Eloxatin;Drug: 5-fluorouracil<br>* 5-fluorouracil Intravenous<br>* Other names: Adrucil, Carac, Efudex, Efudix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | observe the recurrence of colorectal cancer after operation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | observe the postoperative survival rate in patients with stage IIIB and IIIC colorectal cancer | 5 years | 
| incidence of adverse reactions after chemotherapy | observe the adverse reaction of apatinib or combined chemotherapy using apatinib | one year |