Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT04513418

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

Led by Hecheng Li M.D., Ph.D · Updated on 2025-05-14

244

Participants Needed

6

Research Sites

424 weeks

Total Duration

On this page

Sponsors

H

Hecheng Li M.D., Ph.D

Lead Sponsor

S

Shanghai Chest Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed esophageal cancer
  • Staging as cT2N0M0 with high-risk lesions (lymphovascular invasion, ≥3cm, poorly differentiated) or cT1b-2N+M0 or cT3-4aN0-3M0 requiring neoadjuvant therapy before radical esophagectomy
  • Tolerance with oral intake of at least fluid diet
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Body Mass Index (BMI) of 18.5 kg/m2 or higher before recruitment
  • Patient's approval and written informed consent
Not Eligible

You will not qualify if you...

  • Expected survival time less than 6 months
  • Complete dysphagia
  • Pregnant or breast-feeding women
  • Unable to follow the interventions for any reason
  • Serious co-morbidities (cardiac, pulmonary, liver, kidney, brain, hematologic, endocrine, and other diseases) preventing tolerance of neoadjuvant therapy and/or surgery
  • History of previous thoracic or abdominal surgery
  • History of other malignant tumors (previous or current)
  • Patients with primary small cell carcinoma of the esophagus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200011

Actively Recruiting

2

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

3

Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

4

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

5

Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

6

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China, 315048

Actively Recruiting

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Research Team

H

Hecheng Li, PhD, MD

CONTACT

Y

Yuqin Cao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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