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

Quality of Life Clinical Trial

— EXECC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577392
• Other study ID #: SIM-ED-1512
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: April 2019
• Source: Sichuan Provincial People's Hospital
• Contact: Ke Xie, MD PhD
• Phone: 008618981838382
• Email: 840246753[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clear pathology diagnosis of stage for the ? 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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sichuan Provincial People Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital	Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival	4 years
Secondary	local control	To describe local control and out-of-field disease progression	4 years
Secondary	Overall survival	comparison to maintenance XELOX chemotherapy alone.	4 years