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

Conditions

• Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Docetaxel, Oxaliplatin, S-1 and Durvalumab — DRUG
  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.
• Durvalumab and Tremelimumab — DRUG
  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 Details

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

Key Dates

Start date

May 13, 2020

Status verified

Apr 2026

Primary completion

Apr 8, 2025

Completion

Apr 8, 2025

Study Design

Enrollment

68 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: the main treatment group
  pMMR tumor
• Active Comparator: the exploratory group
  dMMR tumor

Primary Outcome Measure

Pathologic complete regression (pCR) rate [ Time Frame: 3 years ]