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

PHASE2RecruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

May 13, 2020

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
Interventions
DRUG

Docetaxel, Oxaliplatin, S-1 and Durvalumab

"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."

DRUG

Durvalumab and Tremelimumab

"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."

Trial Locations (1)

Unknown

RECRUITING

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT04221555 - 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 | Biotech Hunter | Biotech Hunter