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

Overview

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.

Full Title of Study: “Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 1, 2019

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Progression free survival
    • Time Frame: 4 years
    • Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sichuan Provincial People’s Hospital
  • Collaborator
    • Jiangsu Simcere Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: ming zeng, MD, Director of Cancer Center – Sichuan Provincial People’s Hospital
  • Overall Official(s)
    • Ke Xie, MD PhD, Study Chair, Sichuan Provincial People Hospital
  • Overall Contact(s)
    • Ke Xie, MD PhD, 008618981838382, 840246753@qq.com

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