NCT03531931

Apatinib Combined With Capecitabine Second-line Treatment of Advanced Gastric Cancer: a Single-arm Exploratory Clinical Pilot Trial

Single-arm Exploratory Clinical Study on the Second-line Treatment of Advanced Gastric Cancer With Apatinib Mesylate Plus Capecitabine

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Gastric cancer is the one of the leading cause of cancer death in the worldwide. Gastric cancer originates from the most superficial mucosal epithelial cells of the stomach wall, which can occur in various parts of the stomach, and can invade different depths and breadth of the gastric wall. Without chemotherapy treatment the GC patients' Median Survival Time (MST) lasts only 3-4 months. Although treated with multi-chemotherapy MST has been improved, the drugs show strong toxicities in the patients. Thus the more accurate, lower toxicity, targeted antitumor drugs are put into second-line treatment program for advanced gastric cancer. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus capecitatine can improve progression free survival in patients with advanced gastric cancer.

Conditions

• Progression-free Survival;Progression-free Survival;Disease Control Rate; Safety

Interventions

Type	Name	Description
DRUG	Apatinib/Capecitatine	Apatinib is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2), now being developed by Jiangsu Hengrui Medicine (China). Even at a low concentration apatinib can still perform magnificent VEGFR2 inhibitory activities, meanwhile at little higher concentration it can inhibit PDGFR and kinases as well, such as c-Kit and c-Src .The action sites of apatinib are the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamical study shows that apatinib is able to inhibit the tyrosine kinase activity of VEGFR, block signal conduction after the combination of VEGF, finally contribute to stopping new blood vessel formation in tumor tissue.

Timeline

• Start date: 2018-05-01
• Primary completion: 2023-05-01
• Completion: 2023-10-01
• First posted: 2018-05-22
• Last updated: 2018-05-22

Locations

1 site across 1 country: China