Updated protocol of the POINT trial: a multicenter randomized controlled trial investigating effects of preoperative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy

Abstract

Background: The Preoperative Immunonutrition Therapy (POINT) trial compares immunonutrition supplements with a regular diet for surgically resectable esophageal patients during neoadjuvant chemoradiotherapy. The last patient is expected to be included by the end of 2025. The purpose of this update is to present all amendments to the POINT trial protocol as approved by the Ethics Committee of Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital.

Design: The initial protocol of the POINT trial has been previously published ( https://doi.org/10.1186/s12885-022-09721-y ). In this ongoing, multicenter, open-labeled, randomized controlled trial, patients are randomly assigned to nutrition therapy group or control group with a 2:1 ratio. Patients in the nutrition therapy group received immune-enhanced enteral nutritional emulsion during the neoadjuvant chemoradiotherapy. Both groups receive neoadjuvant chemoradiotherapy with concurrent radiotherapy followed by minimally invasive esophagectomy. The primary outcome is the rate of nutrition and immune-related complications after surgery.

Update: Amendments to the participants include the addition of exclusion criteria and the specification of written informed consent. Amendments to the intervention include an extended window period from neoadjuvant chemoradiotherapy to surgery. Amendments to the outcome include two additional exploratory endpoints, which are minimal residual disease and differences in the distribution of gut microbiota and metabolomics before and after neoadjuvant chemoradiotherapy. An independent assessment committee has been established to perform ongoing safety surveillance outcome evaluation.

Conclusion: These amendments do not affect the overall outcomes of the trial compared to the original protocol. The last patient is expected to be included by the end of 2025.

Keywords: Esophageal cancer; Neoadjuvant chemoradiotherapy; Preoperative enteral immunonutrition; Updated protocol.

Fig. 1

Flowchart and the ongoing recruitment of the trial