Article Text

Download PDFPDF

658 Preoperative short course radiotherapy with envafolimab, endostatin and SOX regimen in locally advanced gastric
  1. Dandan Yu1,
  2. Peng Zhang1,
  3. Lei Zhao1,
  4. Pingdong Li1,
  5. Zhenyu Lin1,
  6. Yupin Yin1,
  7. Jin Wang1,
  8. Kaixiong Tao1 and
  9. Tao Zhang1,2
  1. 1Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
  2. 2Huazhong University of Science, Wuhan, Hubei, China
  • Journal for ImmunoTherapy of Cancer (JITC) preprint. The copyright holder for this preprint are the authors/funders, who have granted JITC permission to display the preprint. All rights reserved. No reuse allowed without permission.


Background There is no consensus on the beneficiary population, regimen selection, and efficacy evaluation of neoadjuvant therapy for locally advanced gastric cancer. Existing evidence shows that neoadjuvant chemoradiotherapy can increase pCR, reduce tumor staging, and improve R0 resection rate for locally advanced gastric cancer. However, due to the insufficiently high pCR and survival benefits, there is an urgent need for more effective neoadjuvant treatment regimens to improve patient outcomes. Immune checkpoint inhibitor (ICI) combined with chemotherapy has become a standard first-line treatment for gastroesophageal junction adenocarcinoma (GEJ) and gastric adenocarcinoma. In addition, radiotherapy combined with ICI may enhance the efficacy of immunotherapy. Preliminary studies have shown that short-course radiotherapy combined with ICIs and chemotherapy for neoadjuvant treatment of colorectal cancer has good efficacy and safety. Envafolimab is the world’s first approved novel subcutaneously injectable PD-L1 inhibitor, which can significantly improve treatment convenience and compliance, and has shown good efficacy in multiple solid tumors including gastric cancer, small cell lung cancer, and liver cancer. The purpose of this study is to explore the efficacy and safety of short-course radiotherapy combined with envafolimab, recombinant human vascular endothelial inhibitor, and SOX regimen for neo-adjuvant treatment of resectable locally advanced gastric/gastroesophageal junction adenocarcinoma.

Methods This study is a prospective, single-arm, phase II clinical trial (NCT05387681). The study plans to recruit 35 newly diagnosed patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (aged 18–75 years; cT2–4aN+ M0; ECOG score ≤1). Patients who meet the inclusion criteria will receive preoperative short-course radiotherapy according to the study plan, with a tumor dose of 25Gy (5Gy/day × 5 days, from day 1 to day 5). After a one-week rest, they will receive three cycles of enovolimab (300 mg/dose, Q3W, subcutaneous injection) combined with recombinant human vascular endothelial inhibitor (210 mg, Q3W, intravenous pump infusion, given on the first three days of each cycle), and SOX regimen treatment. Radical surgery will be performed 2–4 weeks after the completion of the last neoadjuvant treatment, and adjuvant therapy will be administered based on staging, followed by survival follow-up. The primary endpoint of the study is the pathological complete response rate(pCR), and the secondary endpoints include R0 resection rate, major pathological response (MPR), and safety.

Trial Registration This study for identifier (NCT number): NCT05387681

Ethics Approval This study has been approved by the Medical Ethics Committee of the Union Hospital Tongji Medical College Huazhong University of Science and Technology, with review number UHCT-IEC-SOP-016–03-03.

Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.