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

• Status: Enrolling by invitation
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Treatments: Apatinib; Fluorouracil; Oxaliplatin

Criteria

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