NCT04513418: POINT

Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy

Recruiting now Phase 3 Last updated 14 May 2025

What this trial tests

Phase 3 trial testing Preoperative immunonutrition in Esophageal Neoplasms in 244 participants. Currently enrolling.

Timeline

10 November 2020

Primary endpoint
30 December 2025

31 December 2028

Quick facts

Lead sponsor	Hecheng Li M.D., Ph.D
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	244
Start date	10 November 2020
Primary completion	30 December 2025
Estimated completion	31 December 2028
Sites	6 locations across China

Drugs / interventions tested

• Preoperative immunonutrition

Conditions studied

• Esophageal Neoplasms — all drugs for Esophageal Neoplasms →

Sponsor

Hecheng Li M.D., Ph.D

Who can join

Adults 18 to 75, any sex, with Esophageal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gastrointestinal Cancer Patient Nutritional Management: From Specific Needs to Novel Epigenetic Dietary Approaches.
   Cencioni C, Trestini I, Piro G, Bria E, et al · · 2022 · cited 24× · PMID 35458104 · DOI 10.3390/nu14081542
2. Effects of pre-operative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy: protocol for a multicenter randomized controlled trial (point trial, pre-operative immunonutrition therapy).
   Cao Y, Han D, Yang S, Shi Y, et al · · 2022 · cited 15× · PMID 35698100 · DOI 10.1186/s12885-022-09721-y
3. Preoperative nutrition therapy in people undergoing gastrointestinal surgery.
   Sowerbutts AM, Burden S, Sremanakova J, French C, et al · · 2024 · cited 13× · PMID 38588454 · DOI 10.1002/14651858.cd008879.pub3
4. A machine learning approach using ¹⁸F-FDG PET and enhanced CT scan-based radiomics combined with clinical model to predict pathological complete response in ESCC patients after neoadjuvant chemoradiotherapy and anti-PD-1 inhibitors.
   Qi WX, Li S, Xiao J, Li H, et al · · 2024 · cited 13× · PMID 38352868 · DOI 10.3389/fimmu.2024.1351750
5. The addition of pembrolizumab to neoadjuvant chemoradiotherapy did not increase the risk of developing postoperative anastomotic leakage for ESCC: an analysis from a prospective cohort.
   Qi WX, Li S, Li H, Chen J, et al · · 2024 · cited 5× · PMID 39164624 · DOI 10.1186/s12885-024-12774-w
6. Characterization and dosimetric predictors for absolute lymphocyte count changes during neoadjuvant chemoradiotherapy with or without pembrolizumab for esophageal squamous cell carcinoma: an analysis of a prospective cohort.
   Qi WX, Li S, Zhang S, Li C, et al · · 2025 · cited 3× · PMID 39789555 · DOI 10.1186/s13014-024-02581-9
7. Online tools to predict individualised survival for primary oesophageal cancer patients with and without pathological complete response after neoadjuvant therapy followed by oesophagectomy: development and external validation of two independent nomograms.
   Cao Y, Huang B, Tang H, Dong D, et al · · 2024 · cited 2× · PMID 38538088 · DOI 10.1136/bmjgast-2023-001253
8. Whole Heart Dose Parameters Predict Severe Arrhythmias After Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Cancer: A Competing Risk Analysis of 358 Patients.
   Qi WX, Zhang H, Yang X, Li S, et al · · 2026 · cited 1× · PMID 41656107 · DOI 10.1002/cam4.71610