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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
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.
Sichuan Provincial People Hospital
Chengdu, Sichuan, China
RECRUITINGProgression free survival
Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival
Time frame: 4 years
local control
To describe local control and out-of-field disease progression
Time frame: 4 years
Overall survival
comparison to maintenance XELOX chemotherapy alone.
Time frame: 4 years
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