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

April 2, 2019 updated by: ming zeng, MD, Sichuan Provincial People's Hospital

Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 61007
        • Recruiting
        • Sichuan Provincial People Hospital
        • Contact:
          • ke xie, MD PhD
        • Contact:
          • Xiong jingyan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control
Time Frame: 4 years
To describe local control and out-of-field disease progression
4 years
Overall survival
Time Frame: 4 years
comparison to maintenance XELOX chemotherapy alone.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Ke Xie, MD PhD, Sichuan Provincial People Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

June 23, 2018

First Submitted That Met QC Criteria

June 23, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM-ED-1512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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