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

NCT03365765 | Completed Phase 3 DMC

• 1 other identifier: KY2017-299
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Apatinib

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  observe the recurrence of colorectal cancer after operation

  5 years

Secondary Outcomes (2)

• overall survival

  5 years

• incidence of adverse reactions after chemotherapy

  one year

Study Arms (2)

mFOLFOX6 & apatinib

EXPERIMENTAL

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.

Drug: Apatinib; Drug: Oxaliplatin; Drug: 5-fluorouracil

mFOLFOX6

ACTIVE COMPARATOR

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.

Drug: Oxaliplatin; Drug: 5-fluorouracil

Interventions

Apatinib DRUG

Apatinib tablet

Also known as: YN968D1

mFOLFOX6 & apatinib

Oxaliplatin DRUG

Oxaliplatin Intravenous

Also known as: Eloxatin

mFOLFOX6; mFOLFOX6 & apatinib

5-fluorouracil DRUG

5-fluorouracil Intravenous

Also known as: Adrucil, Carac, Efudex, Efudix

mFOLFOX6; mFOLFOX6 & apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \~4 weeks after radical resection ;
• patients did not receive any radiotherapy and chemotherapy before operation

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Location

Related Publications (5)

• 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.

  PMID: 26020064 RESULT

• 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.

  PMID: 20876799 RESULT

• 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.

  PMID: 22212563 RESULT

• 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.

  PMID: 21443688 RESULT

• 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.

  PMID: 14745444 RESULT

MeSH Terms

Interventions

apatinib; Oxaliplatin; Fluorouracil

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: This study has one Intervention Type of Drug.

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 7, 2017
• Study Start: February 12, 2018
• Primary Completion: December 22, 2022
• Study Completion: December 31, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)