Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
Chemotherapy/Avelumab Plus Radiotherapy to Primary Esophageal Tumor for Newly Diagnosed Metastatic Esophageal Squamous Cell Carcinoma: The Ave-CRT Study
This is a single institutional, single arm, open labeled phase II study to assess the overall radiographic response of adding Avelumab to chemotherapy and palliative radiotherapy in patients with metastatic advanced esophageal squamous cell carcinoma.
Avelumab belongs to the group of immune checkpoint blockade cancer therapies. Avelumab binds to the programmed death-ligand 1 (PD-L1) and therefore inhibits binding to its receptor programmed cell death 1 (PD-1). In the case of avelumab, the formation of PD-1/PDL1 ligand pairs is blocked and CD8+ T cell immune response should be increased. This study comprises 2 phases, the concurrent immune-chemoradiotherapy (Ave-PF-CRT) phase and the immune-chemotherapy (Ave-PF) phase. In the immune-chemoradiotherapy phase, patients are treated with PF-CRT and concomitant Avelumab. In the immune-chemotherapy phase, patients are treated with PF plus Avelumab. Overall radiological response, time to progression, overall survival and adverse events will be evaluated. Subjects' health-related quality of life will be assessed as well. ;
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