Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma Clinical Trial
Official title:
A Single Arm Phase II Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)
Esophageal cancer is the sixth most common cause of cancer deaths worldwide. Esophageal
adenocarcinoma has become more common in Western countries. In many Asian countries, however,
Esophageal Squamous Cell Carcinoma (ESCC) represents the most common esophageal cancer. In
palliative chemotherapy for metastatic or recurrent ESCC, A combination of 5-fluorouracil and
platinum was prescribed as a standard treatment for about 20 years. With this traditional
regimen, the median progression free survival is approximately 7 months, and 1-year survival
rate is reported to be 34%. Combinations of taxane and anthracycline are also considerable,
but also shows the median survival less than one year. Though cytotoxic chemotherapy is
current main treatment option, molecularly targeted agents are recently incorporated to
improve survival in ESCC. There is a strong rationale for investigation of biologic agents
targeting Epithelial Growth Factor Receptor (EGFR) family in ESCC. EGFR is frequently
overexpressed in esophageal cancer and is known to be associated with poor prognosis. Several
EGFR tyrosine kinase inhibitors (TKIs) have been studied in esophageal cancer subjects and
have shown clinical effects. In a recent Phase II trial using dacomitinib, pan-human
epidermal growth receptor TKI, Partial response was observed in 10 of the 49 esophageal
cancer subjects, with a response rate of 20.8%.
Based on notable rationale in exploring impact of EGFR inhibition, we suggest multicenter
phase II study to determine antitumor activity and safety of a other potent pan-HER
inhibitor, Poziotinib in Esophageal Squamous cell carcinoma.
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