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

NCT03531931 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2018-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2023-05-31
Completion
2023-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531931 on ClinicalTrials.gov