Clinical trial NCT03365765: mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Apatinib
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has one Intervention Type of Drug.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: incidence of adverse reactions after chemotherapy
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
References:
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citation: 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 transporters. Cancer Res. 2010 Oct 15;70(20):7981-91. doi: 10.1158/0008-5472.CAN-10-0111. Epub 2010 Sep 28.
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 Mar 1;83(5):586-97. doi: 10.1016/j.bcp.2011.12.007. Epub 2011 Dec 16.
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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 evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat Med. 2004 Feb;10(2):145-7. doi: 10.1038/nm988. Epub 2004 Jan 25.