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

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: Quality of Life
• Intervention / Treatment: Drug: oxaliplatin + capecitabine (XELOX chemotherapy); Drug: rebombniant human endostatin

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ke Xie, MD PhD; Phone Number: 008618981838382; Email: 840246753@qq.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	To describe local control and out-of-field disease progression	4 years
Overall survival	comparison to maintenance XELOX chemotherapy alone.	4 years

Collaborators and Investigators

• 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

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: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Capecitabine; Oxaliplatin; Endostatins
• 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