(1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS), overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and improve quality of life compared with standard second-line chemotherapy; (2) Observe the safety of apatinib for the treatment of advanced colorectal cancer.
Standard second line chemotherapy includes chemotherapy based on irinotecan or chemotherapy based on oxaliplatin. Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. A phase II trail of Apatinib has been demonstrated that Apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer
The second line standard chemotherapy regimen recommended by the NCCN
Progression-free survival (PFS)
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy
Time frame: Approximately 2 year
Overall survival (OS)
Defined as the time from randomize to death
Time frame: Approximately 3 years
Objective Response Rate (ORR)
ORR=complete response (CR) + partial response (PR)
Time frame: Approximately 2 years
Disease control rate(DCR)
Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines
Time frame: Approximately 2 years
Quality of life(QoL)
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Time frame: Approximately 2 year
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