Quality of Life
Conditions
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.
Interventions
DRUGoxaliplatin + 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.
DRUGrebombniant 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.
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Sichuan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 4 years | Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local control | 4 years | To describe local control and out-of-field disease progression |
| Overall survival | 4 years | comparison to maintenance XELOX chemotherapy alone. |
Countries
China
Contacts
Primary ContactKe Xie, MD PhD
Outcome results
None listed