Apatinib
Conditions
Brief summary
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.
Interventions
DRUGApatinib
Apatinib tablet
DRUGOxaliplatin
Oxaliplatin Intravenous
DRUG5-fluorouracil
5-fluorouracil Intravenous
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study has one Intervention Type of Drug.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 5 years | observe the recurrence of colorectal cancer after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | observe the postoperative survival rate in patients with stage IIIB and IIIC colorectal cancer |
| incidence of adverse reactions after chemotherapy | one year | observe the adverse reaction of apatinib or combined chemotherapy using apatinib |
Countries
China
Outcome results
None listed