Back to resultsmFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer
Primary Purpose
Apatinib
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Apatinib
Oxaliplatin
5-fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Apatinib
Eligibility Criteria
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
Sites / Locations
- Huashan Hospital Affiliated to Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mFOLFOX6 & apatinib
mFOLFOX6
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
disease-free survival
observe the recurrence of colorectal cancer after operation
Secondary Outcome Measures
overall survival
observe the postoperative survival rate in patients with stage IIIB and IIIC colorectal cancer
incidence of adverse reactions after chemotherapy
observe the adverse reaction of apatinib or combined chemotherapy using apatinib
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03365765
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study has one Intervention Type of Drug.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mFOLFOX6 & apatinib
Arm Type
Experimental
Arm Description
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.
Arm Title
mFOLFOX6
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
YN968D1
Intervention Description
Apatinib tablet
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
Oxaliplatin Intravenous
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
Adrucil, Carac, Efudex, Efudix
Intervention Description
5-fluorouracil Intravenous
Primary Outcome Measure Information:
Title
disease-free survival
Description
observe the recurrence of colorectal cancer after operation
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Description
observe the postoperative survival rate in patients with stage IIIB and IIIC colorectal cancer
Time Frame
5 years
Title
incidence of adverse reactions after chemotherapy
Description
observe the adverse reaction of apatinib or combined chemotherapy using apatinib
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
our study protocol,statistical analysis plan,informed consent form and clinical study report are Chinese.
Citations:
PubMed Identifier
26020064
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.
Results Reference
result
PubMed Identifier
20876799
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.
Results Reference
result
PubMed Identifier
22212563
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.
Results Reference
result
PubMed Identifier
21443688
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/j.1349-7006.2011.01939.x. Epub 2011 May 9.
Results Reference
result
PubMed Identifier
14745444
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. Erratum In: Nat Med. 2004 Jun;10(6):649.
Results Reference
result
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mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer
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