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Clinical Study of Apatinib and 5-Fu Combination Regimen to Treat Advanced Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT03210064
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Hui ting Xu,MD, Hubei Cancer Hospital

Brief Summary:
This study makes an observation over the objective response rate of Apatinib and 5-Fu combination regimen in the three-line treatment of metastatic colorectal cancer. All the participants will randomly receive the treatment of Apatinib and 5-Fu combination regimen or 5-Fu.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Apatinib Drug: 5-fluorouracil Phase 2

Detailed Description:
5-Fu chemotherapy is an effective therapy for colorectal cancer. Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. A phase II trail of Apatinib has been demonstrated that Apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental: apatinib combined with 5-Fu
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Study on Apatinib and 5-Fu Combination Regimen in the Treatment of Advanced Colorectal Cancer Patients
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : April 24, 2018
Estimated Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib and 5-Fluorouracil
Apatinib 500 mg qd po.5-Fluorouracil 400mg/m2 iv d1,2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
Drug: Apatinib
Apatinib Mesylate Tablets 500 mg qd po
Other Name: 5-fluorouracil

Drug: 5-fluorouracil
5-Fluorouracil 400mg/m2 iv d1,2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
Other Name: 5-Fluorouracil derivatives

Active Comparator: 5-Fluorouracil
5-Fluorouracil 400mg/m2 iv d1,2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
Drug: 5-fluorouracil
5-Fluorouracil 400mg/m2 iv d1,2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
Other Name: 5-Fluorouracil derivatives




Primary Outcome Measures :
  1. ORR [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited. ]
    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)


Secondary Outcome Measures :
  1. DCR [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited. ]
    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)

  2. PFS [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited. ]
    PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

  3. OS [ Time Frame: From assignment of the first subject until 30 death events observed, up to 2 years. ]
    OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

  4. QoL [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited. ]
    The general well-being of participants, outlining negative and positive features of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 and ≤ 70 years of age

    • Histological confirmed advanced or metastatic colorectal Cancer,at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
    • Have failed for ≥ 2 lines of chemotherapy
    • Life expectancy of more than 3 months
    • ECOG performance scale ≤ 1
    • Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks for operation, radiotherapy or cytotoxic agents
    • Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 10E+9/L, neutrophil > 1.5 × 10E+9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.25 ULN, and serum transaminase ≤ 2.5× ULN)
    • Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
    • Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
  • Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Any factors that influence the usage of oral administration Evidence of CNS metastasis
  • URT: urine protein ≥ (++)and > 1.0 g of 24 h
  • PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
  • Abuse of drugs
  • Certain possibility of gastric or intestine hemorrhage
  • Less than 4 weeks from the last clinical trial
  • Viral hepatitis type B or type C
  • Prior VEGFR inhibitor treatment
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210064


Contacts
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Contact: Hui ting XU 15307176219 ext 86 2891533@qq.com
Contact: Hong li XU 13554458191 ext 86 xu2010ky@163.com

Locations
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China, Hubei
Hui ting Xu Recruiting
Wuhan, Hubei, China, 027
Contact: Hui ting XU, MD    15307176219 ext 86    2891533@qq.com   
Sponsors and Collaborators
Hui ting Xu,MD
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Yan li Nie, MD Hu bei CH
Study Director: Liu Yang, MD Hu bei CH

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Responsible Party: Hui ting Xu,MD, Deputy Chief Physician, Hubei Cancer Hospital
ClinicalTrials.gov Identifier: NCT03210064     History of Changes
Other Study ID Numbers: HXu
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hui ting Xu,MD, Hubei Cancer Hospital:
Apatinib

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Apatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors