Trial of Neoadjuvant Durvalumab Plus Docetaxel Oxaliplatin S-1 Followed by Surgery and Adjuvant Durvalumab Plus S-1 Chemotherapy in Potentially Resectable MMR Proficient Gastric or Gastroesophageal Junction Adenocarcinoma
Neoadjuvant durvalumab (MEDI4736) plus docetaxel, oxaliplatin, S-1 (DOS) followed by surgery
and adjuvant durvalumab plus S-1 chemotherapy in potentially resectable MMR proficient (pMMR)
gastric or gastroesophageal junction (GEJ) adenocarcinoma
Treatment for the main treatment group (pMMR tumor)
Neoadjuvant treatment Durvalumab 1120 mg IV on day (D) 1, Docetaxel 50 mg/m2
intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally
on D1-14, will be administered every three weeks for three cycles.
Adjuvant treatment After 4-6 weeks from surgery, S-1 40 mg/m2 bid orally on D1-28
plus durvalumab 1120 mg on D1 and D22 will be administered every 6 weeks for 12
months as an adjuvant treatment.
Treatment for the exploratory group (dMMR tumor)
Neoadjuvant treatment Durvalumab 1500 mg IV and tremelimumab 75 mg IV on D1 will be
administered every four weeks for three cycles.
Adjuvant treatment After 4-6 weeks from surgery, durvalumab 1500 mg on D1 will be
administered every 4 weeks for 12 months as an adjuvant treatment.
Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Durvalumab and Tremelimumab,
Docetaxel, Oxaliplatin, S-1 and Durvalumab
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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