Trial reportJournal for immunotherapy of cancer2025
Phase 2 study of neoadjuvant durvalumab plus docetaxel, oxaliplatin, and S-1 with surgery and adjuvant durvalumab plus S-1 for resectable locally advanced gastric cancer.
Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.
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Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Neoadjuvant immune checkpoint inhibitors for localized dMMR/MSI-H gastric cancer: a meta-analysis.ESMO open · 2026Pooled it
- Proximal vs. total gastrectomy for proximal advanced gastric cancer after neoadjuvant chemotherapy: a systematic review and meta-analysis of propensity score-matched studies.Frontiers in oncology · 2026Pooled it
- Efficacy and safety of immunotherapy-based neoadjuvant regimens in locally advanced gastric cancer: a meta-analysis based on high-quality clinical trials.International journal of surgery (London, England) · 2025Pooled it
- Bridging paradigms and shaping the future of resectable gastric cancer: a narrative review of the post-MATTERHORN era.Gastroenterology report · 2026Review
- Neoadjuvant Chemotherapy for Gastric Cancer: Evolving Approaches and Supporting Evidence.Journal of gastric cancer · 2026Review
- Machine-learning-based prediction model for Clavien-Dindo grade ≥ II complications after neoadjuvant therapy and laparoscopic gastrectomy in gastric cancer.World journal of gastrointestinal surgery · 2025Article
- Author response to comment on "Phase 2 study of neoadjuvant durvalumab plus docetaxel, oxaliplatin, and S-1 with surgery and adjuvant durvalumab plus S-1 for resectable locally advanced gastric cancer".Journal for immunotherapy of cancer · 2025Article
- Comment on "Phase 2 study of neoadjuvant durvalumab plus docetaxel, oxaliplatin, and S-1 with surgery and adjuvant durvalumab plus S-1 for resectable locally advanced gastric cancer".Journal for immunotherapy of cancer · 2025Article
- Development and validation of a machine learning model for predicting early postoperative complications after radical gastrectomy.Frontiers in oncology · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBased on the phase 3 PRODIGY study, neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) have emerged as a viable treatment option for Asian patients with resectable locally advanced gastric cancer (LAGC). This phase 2 study evaluated the efficacy and safety of combining neoadjuvant durvalumab with DOS, followed by surgery and adjuvant durvalumab plus S-1 chemotherapy, for resectable LAGC.
methodsPatients with LAGC with cT2/3N+or cT4Nany tumors were enrolled in this study. Patients with proficient mismatch repair protein (pMMR) tumors received three cycles of neoadjuvant durvalumab plus DOS, administered every 3 weeks, followed by surgery and adjuvant S-1 plus durvalumab (main study arm). The primary endpoints were the rate of pathologic complete regression (pCR) and safety. An exploratory arm evaluated patients with deficient mismatch repair protein (dMMR) tumors, who received three cycles of neoadjuvant durvalumab and tremelimumab, followed by surgery and adjuvant durvalumab.
resultsIn the main study arm, 50 pMMR patients were enrolled, and received at least one dose of neoadjuvant treatment. The median age was 63 years, with 72.0% being men. 18 and 32 patients presented with clinical stage II and III tumors, respectively. 49 (98.0%) underwent surgery, with 45 achieving R0 resection. A pCR rate of 30.0% was observed, meeting the prespecified primary efficacy endpoint. With a median follow-up of 21.8 months, the 3-year progression-free survival and overall survival rates were 69.9% and 88.1%, respectively. 10% of patients experienced predefined unacceptable severe toxicities, including febrile neutropenia (n=3) and persistent G4 neutropenia (n=2) lasting more than 7 days, thereby meeting the primary safety endpoint. Nine patients with dMMR tumors were enrolled in the exploratory arm. All nine underwent surgery, with a pCR rate of 22.2%.
conclusionsThis study met its primary efficacy and safety endpoints. The combination of neoadjuvant durvalumab plus DOS, followed by surgery and adjuvant durvalumab plus S-1 chemotherapy, warrants further investigation in a phase 3 trial for Asian patients with LAGC. CLINICAL TRIAL INFORMATION: 04221555.
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