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Trial record 5 of 5 for:    24024839 [PUBMED-IDS]

Clinical Study of Apatinib and XELOX Combination Regimen to Treat Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02829385
Recruitment Status : Unknown
Verified July 2016 by Shoucheng Ma, LanZhou University.
Recruitment status was:  Recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Shoucheng Ma, LanZhou University

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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Apatinib and XELOX combined treatment group Phase 2

Detailed Description:

XELOX chemotherapy is an effective therapy for metastatic colorectal cancer as first-line treatment.

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 : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Study on Apatinib and XELOX Combination Regimen in the First-line Treatment of End-stage Colorectal Cancer Patients
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib combined treatment group

Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14)

Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs.

Drug: Apatinib and XELOX combined treatment group

Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14)

Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs.

Other Name: Apatinib combined treatment group




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 9 months ]
    ORR=complete response (CR) + partial response (PR) .And expected ORR is 0.55.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 2 years ]
    time from randomization to documented progressive disease or death due to any cause, whichever occurs first

  2. Overall Survival (OS) [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable colorectal cancer confirmed by histological means with measurable indication(a minimum size of 10mm by spiral CT scan,which meets the criteria of RECIST 1.1).
  • Time interval traced back to the latest administration of xelox and folfox combination must be no less than 1 year.
  • age range: ≥18 and ≤75.
  • ECOG PS scale 0 or 1;expected survival time ≥12 weeks.
  • Sufficient blood function:absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥80×109/L and hemoglobin≥9g/dL.
  • Sufficient hepatic function:total bilirubin ≤1.5 times upper normal limit(ULN), AST ≤2.5 times ULN, ALT ≤2.5 times ULN and AKP ≤5 times ULN.

    *AST,ALT relevant criteria alters into AST ≤5 times ULN and ALT ≤5 times ULN if with hepatic metastasis.

  • sufficient renal function: serum creatinin ≤ULN, creatinine clearance rate ≥60 mL/min
  • Female patients under age 50 with complete uterus must be tested negative for pregnancy within 28 days before enrollment (except for those who suffered amenorrhea for more than 24 months). If the pregnancy test was carried out more than 7 days before the first administration, then the urine pregnancy test is required for validation. (within the 7-day interval before administration)
  • Informed consent subscription. (The consent should be approved by independent Ethics Committee, and signed by patients before any substantial trial is initiated.)

Exclusion Criteria:

  • Have got other malignant tumors within last 5 years, excluding basal cell skin cancer and cervical carcinoma in situ that has already been cured.
  • With evidence of CNS metastasis, even if the treatment had been carried out before, patients with doubts of CNS metastasis should be conducted MRI or enhanced CT scan on within 28 days before enrollment for ruling out.
  • AST ≤2.5 times ULN and/or ALT ≤2.5 times ULN
  • Had been treated with chemotherapy for last 12 months
  • Had been treated with radiotherapy (except for palliative radiotherapy with evaluable focus outside radiotherapy field on purpose of alleviating pains)
  • With any uncontrolled systemic disease, including active infection, hypertension without treatment, diabetes mellitus, angina pectoris, congestive heart failure, myocardial infarction, severe arrhythmia requires treatment and hepatic/renal/metabolic diseases
  • Taking experimental treatment from another clinical trial study.
  • Being allergic to any relevant chemotherapy drug.
  • With evidence-proved other diseases, neural or metabolic disorders, physical or lab examination abnormalities, which might be contraindication of study drugs or leading to treating-related lethal complications.

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): NCT02829385


Contacts
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Contact: Shoucheng Ma, Master (86)13893453504 mashoucheng@medmail.com.cn

Locations
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China, Gansu
Cancer Cnter,The First Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Shoucheng Ma, Master    (86)13893453504    mashoucheng@medmail.com.cn   
Sponsors and Collaborators
Shoucheng Ma
Investigators
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Study Chair: Da Zhao, Bachelor Cancer Center of the First Hospital of Lanzhou University

Publications of Results:

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Responsible Party: Shoucheng Ma, director of cancer center, LanZhou University
ClinicalTrials.gov Identifier: NCT02829385     History of Changes
Other Study ID Numbers: LZU-123
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shoucheng Ma, LanZhou University:
Apatinib
XELOX Regimen
metastatic colorectal cancer

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
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action