Apatinib for Metastatic Esophageal Cancer.

Status Recruiting

Clinical Trial Summary

Patients with esophageal cancer that had metastatic lesions after been treated with surgery or definitive chemoradiotherapy are being asked to participate in this study.

Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.

The purpose of this study is to determine what effects apatinib has on metastatic esophageal cancer. These effects include whether apatinib could shrink the tumor or slow down its growth and what side effects apatinib will have on the tumor.

Clinical Trial Description

The purpose of this study is to determine what effects apatinib has on metastatic esophageal cancer patients after been treated with surgery or definitive chemoradiotherapy. These effects include whether apatinib could shrink the tumor or slow down its growth and what side effects apatinib will have on the tumor.

Eligible are patients with metastatic esophageal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least one separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded either at CT or MRI scanning. Apatinib (850mg) is given daily during the therapy for 28 days. Tumor response is evaluated by assessing clinical and CT/MRI response in the metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no tumor responses, the trial will be terminated. If there are one or more responses in Stage One, the trial will proceed to enroll an additional 19 patients. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02544737
Study type	Interventional
Source	Hangzhou Cancer Hospital
Contact	Shixiu Wu, MD
Phone	+8657186826086
Email	wushixiu@medmail.com.cn
Status	Recruiting
Phase	Phase 2
Start date	September 2015
Completion date	December 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.