Actively Recruiting
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
Eligibility Criteria
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
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
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
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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