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Clinical Trial Summary

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


Clinical Trial Description

- Treatment for the main treatment group (pMMR tumor) 1. 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. 2. Surgery 3. 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) 1. Neoadjuvant treatment Durvalumab 1500 mg IV and tremelimumab 75 mg IV on D1 will be administered every four weeks for three cycles. 2. Surgery 3. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04221555
Study type Interventional
Source Asan Medical Center
Contact Min-Hee Ryu, MD, PhD
Phone +82-2-3010-5935
Email miniryu@amc.seoul.kr
Status Recruiting
Phase Phase 2
Start date May 13, 2020
Completion date April 30, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05960955 - Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma Phase 2