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Trial record 4 of 433 for:    colon cancer AND Capecitabine

Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03132025
Recruitment Status : Unknown
Verified April 2017 by Yanqiao Zhang, Harbin Medical University.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Yanqiao Zhang, Harbin Medical University

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE April 27, 2017
Last Update Posted Date April 27, 2017
Estimated Study Start Date  ICMJE April 30, 2017
Estimated Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged [ Time Frame: up to 10 months ]
Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
Official Title  ICMJE Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
Brief Summary To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.
Detailed Description To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mPFS; secondary endpoint include in mOS, tolerance and security.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: "Apatinib" and "Capecitabine"
    Combine "Apatinib" and "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer
    Other Name: Arm A
  • Drug: "Capecitabine"
    Single Drug "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer
    Other Name: Arm B
Study Arms  ICMJE
  • Experimental: A: "apatinib" and "capecitabine"
    Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w
    Intervention: Drug: "Apatinib" and "Capecitabine"
  • Active Comparator: B: "capecitabine" single drug
    Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w
    Intervention: Drug: "Capecitabine"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2018
Estimated Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent form should be issued prior to conducting any research process;
  2. Men or women aged 18-75 years;
  3. Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
  4. Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
  5. The estimated survival time is longer than 3 months;
  6. ECOG score was 0 or 1;
  7. According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress;
  8. With sufficient organ and bone marrow function, defined as follows:

    • Hb≥9 g/dL
    • Absolute neutrophil count ≥1.0 × 109 /L
    • Platelet count≥75 × 109 /L
    • Serum bilirubin ≤ 1.5 × ULN, which would not be appropriate for patients with Gilbert syndrome (Persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor
    • ALT&AST ≤ 2.5 × ULN; for patients with liver metastases, ALT&AST ≤ 5 × ULN Calculate the creatinine clearance rate by Cockcroft-Gault formula
    • Creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours> 40 mL/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used)
  9. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. Men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration;
  10. Patients volunteered to participate in the trial and signed informed consent form with good compliance.

Exclusion Criteria:

  1. Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure >140 mmHg / diastolic pressure > 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men>450 ms, women >470 ms) and cardiac insufficiency;
  2. With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
  3. Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician;
  4. Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency;
  5. With Symptomatic central nervous system metastasis;
  6. Pregnant or lactating women;
  7. Other patients unsuitable for inclusion considered by the physician.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03132025
Other Study ID Numbers  ICMJE 045186298222
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yanqiao Zhang, Harbin Medical University
Study Sponsor  ICMJE Yanqiao Zhang
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Harbin Medical University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP