Trial reportBMC cancer2025
The immune signatures predict gastric/gastroesophageal junction cancer response to first-line anti-PD-1 blockade or chemotherapy.
Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03745170 (Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
Who cites it
2 citing papers in PubMed.
- Review
- Spatial immune niches in gastric cancer immunotherapy resistance: mechanisms and translational implications.Frontiers in immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundAnti-programmed cell death-1 (PD-1) immunotherapy and platinum-based chemotherapy are key components of first-line treatment for advanced Gastric or Gastroesophageal Junction (G/GEJ) cancer. However, the role of immune cells infiltrating the tumor microenvironment (TME) in predicting both therapy responses is still unclear.
methodsORIENT-16 is a randomized, double-blind, placebo-controlled, phase 3 clinical trial, and enrolled 650 patients with unresectable locally advanced or metastatic G/GEJ cancer between January 3, 2019, and August 5, 2020. For patients enrolled from the First Affiliated Hospital of Zhejiang University School of Medicine, we analyzed progression-free survival(PFS) and overall survival (OS) based on PD-L1 expression and landmark analysis, and developed a multiplexed immunofluorescence (mIF) assay for CD4, CD8, PD-L1, CD68 and FoxP3 coupled with digital image analysis and machine learning to assess prognostic survival associations of immune cells.
resultsA total of 54 eligible patients were enrolled in this study, 35 received sintilimab plus platinum-based chemotherapy and 19 received placebo plus platinum-based chemotherapy. For patients with PD-L1 combined positive score (CPS) < 10, survival disparities between anti-PD-1 immunotherapy and chemotherapy emerged 300 days post-treatment. High PD-L1 expression correlated with longer survival in anti-PD-1 therapy but less benefit in platinum-based chemotherapy. The mIF analysis also demonstrated significantly higher stromal PD-L1 density in immunotherapy responders, but tended to be lower in chemotherapy responders. Besides, high tumor stromal CD8 expression could be used as a positive biomarker in anti-PD-1 immunotherapy, and high tumor stromal CD4 expression was found associated with worse prognosis in platinum-based chemotherapy.
conclusionsIncreased PD-L1 expression was associated with an increased effect on anti-PD-1 immunotherapy and reduced benefit from chemotherapy. The signature of TME immune cells has the potential to predict the response of anti-PD-1 immunotherapy and chemotherapy in G/GEJ cancer.
trial registrationClinicalTrials.gov Identifier: NCT03745170.
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