mDCF + Avelumab in Resectable Esophago-gastric Adenocarcinoma (EGA)

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

Summary:

This is a single-centre, 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.

Trial Description

Primary Outcome:

  • Pathologic Complete Response (pCR)
Secondary Outcome:
  • Two-Year Disease Free Survival (DFS)
  • Safety Assessment of Adding Avelumab to mDCF

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society