NCT03412994

Clinical Study of Apatinib Combined With Second - Line Chemotherapy for Metastatic Colorectal Cancer

A Randomized, Parallel-controlled, Exploratory Clinical Trial of Second-line Chemotherapy With Second-line Chemotherapy Versus Second-line Chemotherapy With Apatinib in the Treatment of Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Liqiang Zhong · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

(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.

Detailed description

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%.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer
DRUG	standard second-line chemotherapy	The second line standard chemotherapy regimen recommended by the NCCN

Timeline

• Start date: 2018-02-28
• Primary completion: 2020-02-28
• Completion: 2021-02-28
• First posted: 2018-01-29
• Last updated: 2018-01-29