Trial reportJournal for immunotherapy of cancer2023
Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma (KEEP-G 03): an open-label, single-arm, phase 2 trial.
Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03946969 (Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer), which is not on this map. Cited by 86 papers, 4 of them syntheses that pooled it.
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.
Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer: An Open-lable, Single-arm, Exploratory Clinical Study
Who cites it
86 citing papers in PubMed, 4 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- Pooled it
- The safety and efficacy of neoadjuvant immunochemotherapy in locally advanced esophageal squamous cell carcinoma: a meta-analysis and systematic review.Frontiers in immunology · 2026Pooled it
- Research trends in neoadjuvant therapy for esophageal cancer: a bibliometric and meta-analysis.Frontiers in immunology · 2025Pooled it
- The efficacy of neoadjuvant immunotherapy in gastric cancer, adenocarcinoma of the esophagogastric junction, and esophageal cancer: a meta-analysis.Frontiers in oncology · 2024Pooled it
- PET/CT-Guided Neoadjuvant Tislelizumab plus Chemotherapy/Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma: RATIONALE-213 Final Analysis.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Neoadjuvant camrelizumab combined with metronomic chemotherapy in patients with advanced esophageal squamous cell carcinoma: a pilot randomized phase 2 trial.BMC medicine · 2026Trial
- Trial
- Prognostic significance of PET/CT and its association with immuno-genomic profiling in oesophageal squamous cell carcinoma treated with immunotherapy plus chemoradiotherapy: results from a phase II study.British journal of cancer · 2024Trial
- Tumor microenvironment biomarkers predicting pathological response to neoadjuvant chemoimmunotherapy in locally advanced esophageal squamous cell carcinoma: post-hoc analysis of a single center, phase 2 study.Journal for immunotherapy of cancer · 2024Trial
- Perioperative tislelizumab with four cycles of neoadjuvant chemotherapy for resectable locally advanced esophageal squamous cell carcinoma: a phase 2 study.Frontiers in immunology · 2024Trial
- Concurrent versus sequential immune checkpoint inhibition in the neoadjuvant treatment of resectable esophageal squamous cell carcinoma: a systematic review and meta-analysis.Clinical and translational radiation oncology · 2027Review
- Intratumoral and peritumoral radiomics for preoperative prediction of pathological complete response to neoadjuvant immunochemotherapy in patients with esophageal squamous cell carcinoma.European journal of radiology open · 2026Article
- Optimal Neoadjuvant Approach for Resectable Esophageal Cancer in the Era of Immunotherapy.International journal of cancer · 2026Article
- Adjuvant Immunotherapy Improves Esophageal Squamous Cell Carcinoma Survival After Neoadjuvant Chemoimmunotherapy: A Multicenter Real-World Study.Annals of surgical oncology · 2026Observational
- The Efficacy and Safety of Neoadjuvant Immunotherapy in Pan-Squamous Cell Carcinomas: A Meta-Analysis of Esophageal, Head and Neck, Cervical, Lung, Cutaneous, and Oral Squamous Cell Carcinomas.Journal of clinical medicine · 2026Review
- Association of pathological response with long-term survival after neoadjuvant chemo-immunotherapy in resectable oesophageal squamous cell carcinoma: a systematic review and individual-patient-data meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Response-adapted perioperative therapy for resectable esophageal cancer in the immunotherapy era: a narrative review.Journal of thoracic disease · 2026Review
- Narrative review: clinical application and challenges of circulating tumor DNA in treatment response evaluation and prognostic prediction for esophageal cancer.Journal of thoracic disease · 2026Review
- RELB Overexpression Induced by DNA Hypomethylation Contributes to Perioperative Immunotherapy Resistance in Resectable Esophageal Squamous Cell Carcinoma by Modulating the mregDC-Treg Axis.Cancer medicine · 2026Article
- Efficacy and safety of neoadjuvant chemoimmunotherapy versus neoadjuvant chemoradiotherapy in locally advanced resectable esophageal squamous cell carcinoma.Journal of cancer research and clinical oncology · 2026Article
26 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe standard neoadjuvant treatments in patients with esophageal squamous cell carcinoma (ESCC) still have either poor safety or efficacy. Better therapies are needed in China.
methodsThis was an open-label, single-arm, phase 2 trial. Patients with potentially resectable ESCC (cT1b-3, Nany, M0 or T4a, N0-1, or M0) received preoperative intravenous sintilimab plus triplet chemotherapy (liposomal paclitaxel, cisplatin, and S-1) every 3 weeks for two cycles. The primary endpoints were safety and surgical feasibility; the secondary endpoint was major pathological response (MPR) rate. Genomic biomarkers (genetic mutations, tumor mutational burden (TMB), circulating tumor DNA status and immune microenvironment) in baseline tumor samples were investigated.
resultsAll 30 patients completed two cycles of neoadjuvant treatment and underwent surgical resection. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 36.7% (11/30) of patients. The most frequent TRAEs were decreased white cell count (76.7%), anemia (76.7%), and decreased neutrophil count (73.3%). All TRAEs were hematological toxicities; none caused ≥30 days surgical delay. The MPR and pathological complete response (pCR) rates were 50.0% (15/30; 95% CI 33.2 to 66.9) and 20.0% (6/30; 95% CI 9.5 to 37.3), respectively. Patients with higher TMB and more clonal mutations were more likely to respond. ERBB2 alterations and ctDNA high-releaser status have a negative correlation with neoadjuvant ICI response. No significant difference was observed between therapeutic response and tumor immune microenvironment.
conclusionsNeoadjuvant sintilimab plus platinum-based triplet chemotherapy appeared safe and feasible, did not delay surgery and induced a pCR rate of 20.0% in patients with potentially resectable ESCC. TRIAL REGISTRATION NUMBER: NCT03946969.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.