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

Sponsor
Fudan University
Study ID
NCT03274011
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2017
Status verified
Feb 2019
Primary completion
Mar 15, 2019
Completion
Jun 26, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib Treatment
    Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Primary Outcome Measure

Progression Free Survival [ Time Frame: 12 weeks ]

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