NCT03274011

Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma: A Phase II, Prospective, Single-arm, Multicenter Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is no standard treatment strategy for recurrent or metastatic esophageal squamous cell carcinoma patients now, especially after the second-line treatment. Most of the patients have the bad ECOG (Eastern Cooperative Oncology Group) score and prognosis. Chemotherapy, radiotherapy, surgery are usually unacceptable for them. Previous data showed that apatinib treatment significantly improved OS(overall survival) and PFS(progression-free survival) with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.

Conditions

• Esophageal Neoplasms

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular en-dothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. Previous data showed that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-03-15
• Completion: 2019-06-26
• First posted: 2017-09-06
• Last updated: 2021-01-26

Locations

1 site across 1 country: China