Gastric Adenocarcinoma Clinical Trial
Official title:
Phase II Trial of Perioperative PD-L1 Inhibition With Avelumab and Docetaxel, Cisplatin and 5-Fluorouracil for Resectable Locally Advanced Esophago-Gastric Adenocarcinoma
This is a single-center, single-arm, open-label, Simon 2-stage, phase II trial in up to 55
patients with a potentially resectable, histologically-proven, adenocarcinoma or poorly
differentiated carcinoma of the stomach, esophagogastric junction (EGJ), or lower third of
the esophagus.
Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the
modified chemotherapy regimen of docetaxel, cisplatin, 5- fluorouracil. Following surgery,
pathologic response will be assessed. Patients will then receive adjuvant therapy consisting
of 4 cycles of mDCF + avelumab. Patients will be followed to assess two-year disease-free
survival rates.
The primary objective of this study is to assess the effect on pathologic complete response
rate (pCR) of adding avelumab to an mDCF regimen. The secondary objectives of this study are
to determine the safety of adding avelumab to an mDCF regimen and assess its effect on
two-year disease-free survival.
n/a
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