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

Apatinib Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365765
• Other study ID #: KY2017-299
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 31, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apatinib
• Colorectal Neoplasms

Intervention

Drug:
• Apatinib
Apatinib tablet
• Oxaliplatin
Oxaliplatin Intravenous
• 5-fluorouracil
5-fluorouracil Intravenous

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Mi YJ, Liang YJ, Huang HB, Zhao HY, Wu CP, Wang F, Tao LY, Zhang CZ, Dai CL, Tiwari AK, Ma XX, To KK, Ambudkar SV, Chen ZS, Fu LW. Apatinib (YN968D1) reverses multidrug resistance by inhibiting the efflux function of multiple ATP-binding cassette transpor — View Citation

Scott AJ, Messersmith WA, Jimeno A. Apatinib: a promising oral antiangiogenic agent in the treatment of multiple solid tumors. Drugs Today (Barc). 2015 Apr;51(4):223-9. doi: 10.1358/dot.2015.51.4.2320599. — View Citation

Tian S, Quan H, Xie C, Guo H, Lu F, Xu Y, Li J, Lou L. YN968D1 is a novel and selective inhibitor of vascular endothelial growth factor receptor-2 tyrosine kinase with potent activity in vitro and in vivo. Cancer Sci. 2011 Jul;102(7):1374-80. doi: 10.1111 — View Citation

Tong XZ, Wang F, Liang S, Zhang X, He JH, Chen XG, Liang YJ, Mi YJ, To KK, Fu LW. Apatinib (YN968D1) enhances the efficacy of conventional chemotherapeutical drugs in side population cells and ABCB1-overexpressing leukemia cells. Biochem Pharmacol. 2012 M — View Citation

Willett CG, Boucher Y, di Tomaso E, Duda DG, Munn LL, Tong RT, Chung DC, Sahani DV, Kalva SP, Kozin SV, Mino M, Cohen KS, Scadden DT, Hartford AC, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Chen HX, Shellito PC, Lauwers GY, Jain RK. Direct ev — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	observe the recurrence of colorectal cancer after operation	5 years
Secondary	overall survival	observe the postoperative survival rate in patients with stage IIIB and IIIC colorectal cancer	5 years
Secondary	incidence of adverse reactions after chemotherapy	observe the adverse reaction of apatinib or combined chemotherapy using apatinib	one year