What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

This trial aimed to evaluate the long-term survival benefits of neoadjuvant chemoradiotherapy in esophageal squamous cell carcinoma patients.

January 14, 2026

Three-year outcomes and multi-omics biomarker discovery of locally advanced esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy and anti-PD-1 antibody from the phase II trial NEOCRTEC1901.

Key Points

This trial aimed to evaluate the long-term survival benefits of neoadjuvant chemoradiotherapy in esophageal squamous cell carcinoma patients.
44 esophageal squamous cell carcinoma patients enrolled from December 2019 to July 2021.
Patients received neoadjuvant treatment with paclitaxel, cisplatin, radiotherapy, and anti-PD-1 antibody Toripalimab.
Minimally invasive esophagectomy was performed 6 to 8 weeks after treatment completion.
Pre-treatment tumor biopsies were analyzed using PD-L1 immunohistochemistry staining and RNA sequencing.
3-year disease-free survival rate was 65.6%, while overall survival rate was 70.5%.
50% of surgical patients achieved pathological complete response, indicating better survival rates.
PD-L1 positivity correlated with improved disease-free and overall survival, with specific hazard ratios reported.

Abstract

371 Background: This trial aimed to evaluate the long-term survival benefit of neoadjuvant chemoradiotherapy combined with PD-1 inhibitors Toripalimab (NICRT) in treating local advanced esophageal squamous cell carcinoma (ESCC) and explore the biomarkers of treatment efficacy. Methods: From December 2019 to July 2021, 44 ESCC patients were enrolled in this phase II trial. All patients received chemotherapy (paclitaxel and cisplatin), Toripalimab and concurrent radiotherapy (44 Gy /20 times), and were subjected to minimally invasive esophagectomy within 6 to 8 weeks after completing neoadjuvant treatment. Pre-treatment tumor biopsies of 41 patients were subjected to PD-L1 immunohistochemistry staining, 28 of which were also used for RNA sequencing. Results: The median follow-up time was 38.6 months (95%CI: 36.3-40.3 months). A total of 13 tumor recurrence events and 12 deaths were observed, the incidence of non-cancer-related deaths was 2.2% (1/44). The 3-year disease-free survival (DFS) rate was 65.6% (95%CI: 50.5%-85.1%), and 3-year overall survival (OS) rate was 70.5% (95%CI: 58.2%-85.3%). Among patients receiving surgery, 50% of patients (21/42) achieved pathological complete response (pCR) , those with pCR demonstrating a higher 3-yr DFS rate (85.0% in pCR v.s. 44.9% in non-pCR, P=0.047) and OS rate (85.7% v.s. 61.9%, P=0.063) than non-pCR patients. PD-L1 positivity (CPS> 5) indicated better DFS (HR: 0.42, 95%CI: 0.14-1.35, P=0.14) and OS (HR: 0.27, 95%CI：0.09-0.87, P=0.029). Cancer transcriptome analysis revealed a three-gene non-exhausted CD8+ T cell-associated expression signature (CD8A/IL32/VIM) in pre-treatment samples for accurate prediction of pCR in ESCC patients receiving NICRT with an area under the receiver operative characteristics curve (AUC) of 0.9. Moreover, patients with high expression signature (≥median value) experienced significantly better DFS than those with low expression signature (P5) and the three-gene signature in pre-treatment ESCC specimens are promising biomarkers in predicting long-term prognosis of NICRT. Clinical trial information: NCT04006041 .

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Cite This Study

Mai et al. (Sat,) studied this question.

synapsesocial.com/papers/6966e6f513bf7a6f02bfef96 https://doi.org/https://doi.org/10.1200/jco.2026.44.2_suppl.371

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