What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

This research aims to evaluate the effectiveness of adding toripalimab to chemotherapy in patients with locally advanced gastric or gastroesophageal junction cancer.

January 14, 2026

Perioperative PD-1 antibody toripalimab combined with chemotherapy versus chemotherapy alone in locally advanced gastric or gastroesophageal junction cancer: 3-year follow-up of the prospective, randomized, phase 2 NEOSUMMIT-01 trial.

Key Points

This research aims to evaluate the effectiveness of adding toripalimab to chemotherapy in patients with locally advanced gastric or gastroesophageal junction cancer.
Open-label, randomized, phase 2 trial
Patients with resectable gastric or GEJ cancer were randomized 1:1 to receive chemotherapy alone or chemotherapy plus toripalimab
EFS and OS assessed in the intention-to-treat population after 3-year follow-up.
3-year EFS was 74.7% for the toripalimab plus chemotherapy group vs 56.2% for chemotherapy alone
3-year OS was 81.3% with toripalimab vs 72.2% for chemotherapy alone
Hazard ratio for EFS was 0.52, and for OS was 0.45, both indicating significant improvements.

Abstract

282 Background: The NEOSUMMIT-01 trial evaluated the efficacy of adding the PD-1 antibody toripalimab to perioperative chemotherapy in patients with locally advanced, resectable gastric or gastroesophageal junction (GEJ) cancer. Previously, we reported significant improvements in pathological complete or moderate regression (TRG 0/1) rate (44.4% vs 20.4%, P =0.009) and pathological complete response (pCR) rate (22.2% vs 7.4%, P =0.030) with the addition of toripalimab (2023 ASCO Abstract 4001; Nature Medicine 2024). Here, we present the 3-year survival outcomes after extended follow-up. Methods: In this open-label, randomized, phase 2 trial, patients with resectable gastric or GEJ cancer (clinical stage cT3–4a N+ M0) were randomized (1:1) to receive either three preoperative and five postoperative cycles of SOX/XELOX chemotherapy (chemotherapy group), or the same chemotherapy combined with toripalimab, followed by toripalimab monotherapy for 6 months (toripalimab plus chemotherapy group). The primary endpoint was pathological complete or moderate regression rate (TRG 0/1). Secondary endpoints included pathological complete response (pCR), R0 resection rate, objective response rate, disease control rate, event-free survival (EFS), overall survival (OS), and treatment safety. This analysis focuses on 3-year EFS and OS, assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT04250948). Results: Between October 12, 2019, and June 27, 2022, 108 patients were enrolled (toripalimab plus chemotherapy, n = 54; chemotherapy alone, n = 54) and included in the intention-to-treat analysis. As of the clinical cutoff date (August 29, 2025), the median follow-up was 43.2 months (IQR 36.6–53.7). The 3-year EFS was 74.7% (95% CI: 63.6–87.7%) in the toripalimab plus chemotherapy group and 56.2% (95% CI: 43.3–73.0%) in the chemotherapy group, with a hazard ratio (HR) of 0.52 (95% CI: 0.27–1.00; P = 0.047). The 3-year OS was 81.3% (95% CI: 71.4–92.4%) versus 72.2% (95% CI: 61.2–85.2%), respectively, with an HR of 0.45 (95% CI: 0.21–0.95; P = 0.031). Conclusions: Perioperative toripalimab combined with chemotherapy demonstrated significantly improved 3-year EFS and OS compared to chemotherapy alone, suggesting it as a promising treatment option for patients with locally advanced, resectable gastric or GEJ adenocarcinoma. Clinical trial information: NCT04250948 .

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