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We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastastic esophageal squamous carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.
Esophageal cancer is one of the most common malignant tumor in China. In Asian countries, esophageal squamous carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical treatment. Cisplatin (DDP, cisplatin), 5 - Fluorouracil (5 - Fluorouracil, 5 - FU) and taxane are the most adopted chemotherapy agents, with efficacy rates of 33%-40% as first-line treatment for metastatic or recurrent esophageal squamous carcinoma and a median overall survival of 6-10 months. New agents were needed. Apatinib Mesylate is a small molecule VEGFR tyrosine kinase inhibitors. The anti-tumor mechanism of Apatinib is inhibiting angiogenesis in malignancy by inhibiting VEGFR. Apatinib Mesylate was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer. In the previous clinical practice, we observed that part of the patients with esophageal squamous carcinoma resistant to conventional treatments benefited from Apatinib Mesylate. Based on the research situation mentioned above, we decided to conduct a phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastastic esophageal squamous carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Esophageal Squamous Cell Carcinoma
Sun Yat-sen University Cancer Center
Sun Yat-sen University
Published on BioPortfolio: 2016-11-30T15:45:10-0500
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A carcinoma derived from stratified squamous epithelium. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A mixed adenocarcinoma and squamous cell or epidermoid carcinoma.
Unusual tumor affecting any site of the body, but most often encountered in the head and neck. Considerable debate has surrounded the histogenesis of this neoplasm; however, it is considered to be a myoblastoma of, usually, a benign nature. It affects women more often than men. When it develops beneath the epidermis or mucous membrane, it can lead to proliferation of the squamous cells and mimic squamous cell carcinoma.
A skin carcinoma that histologically exhibits both basal and squamous elements. (From Dorland, 27th ed)