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Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer. (EXECC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03577392
Recruitment Status : Recruiting
First Posted : July 5, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
ming zeng, MD, Sichuan Provincial People's Hospital

Tracking Information
First Submitted Date  ICMJE June 23, 2018
First Posted Date  ICMJE July 5, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2018)
Progression free survival [ Time Frame: 4 years ]
Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03577392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2018)
  • local control [ Time Frame: 4 years ]
    To describe local control and out-of-field disease progression
  • Overall survival [ Time Frame: 4 years ]
    comparison to maintenance XELOX chemotherapy alone.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.
Official Title  ICMJE Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer
Brief Summary To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Quality of Life
Intervention  ICMJE
  • Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
    Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.
  • Drug: rebombniant human endostatin
    Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.
Study Arms  ICMJE
  • Experimental: XELOX chemotherapy with recombinant human endotatin
    Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.
    Interventions:
    • Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
    • Drug: rebombniant human endostatin
  • Active Comparator: XELOX chemotherapy without recombinant human endotatin
    Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.
    Intervention: Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.
  • There are at least 1 imaging examinations according to the standard of RECIST(the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT).
  • Male or female , age 18~75
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The patients had to have a life expectancy of at least 3 months.
  • A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values.
  • Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l;a creatinine value less than 130 lmol/l.
  • Informed consent was obtained from all patients.

Exclusion Criteria:

  • Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.
  • a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.
  • patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.
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: Ke Xie, MD PhD 008618981838382 840246753@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03577392
Other Study ID Numbers  ICMJE SIM-ED-1512
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ming zeng, MD, Sichuan Provincial People's Hospital
Study Sponsor  ICMJE Sichuan Provincial People's Hospital
Collaborators  ICMJE Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Chair: Ke Xie, MD PhD Sichuan Provincial People Hospital
PRS Account Sichuan Provincial People's Hospital
Verification Date April 2019

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