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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

NCT04221555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Min-Hee Ryu, MD, PhD · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2025-04-08
Completion
2025-04-08

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221555 on ClinicalTrials.gov