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

NCT04513418 · tracked via the Priya Life Science China tracker

Sponsor

Hecheng Li M.D., Ph.D

Phase

Phase 3

Started

2020-11-10

Last updated

2026-06-02

Condition(s) studied

Esophageal Neoplasms

Investigational drug(s) / intervention(s)

Preoperative immunonutrition

Preoperative immunonutrition: Preoperative immunonutrition includes an omega-3 fatty-acid enriched enteral nutritional emulsion given by oral intake, nasogastric feeding tube or jejunostomy 600ml per day, lasting for the whole period of neoadjuvant chemoradiation. Meanwhile, oral intake is encouraged to reach 25-30kcal/kg through regular food.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Histologically confirmed esophageal cancer * Staging as cT2N0M0 with high-risk lesions (lymphovascular invasion, ≥3cm, poorly differentiated) / cT1b-2N+M0 / cT3-4aN0-3M0 with the need of neoadjuvant therapy before radical esophagectomy * Tolerance with oral intake (at least fluid diet) * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Body Mass Index (BMI) ≥ 18.5 kg/m2 before recruitment * Patient's approval and written informed consent Exclusion Criteria: * Expected survival time less than 6 months * Complete dysphagia * Pregnant or breast-feeding women * Unable to obey the interventions because of any reasons * Serious co-morbidities (cardiac, pulmonary, liver, kidney, brain, hematologic, endocrine and other diseases) in patients who cannot tolerate neoadjuvant therapy and/or surgery * History of previous thoracic or abdominal surgery * History of other malignant tumor (previous or current) * Patients with primary small cell carcinoma of the esophagus

Primary outcome measure(s)

Rate of postoperative nutrition and immune-related complications — Up to 30 days after surgery
Rate of gastrointestinal complications (anastomotic leakage, gastrointestinal dysfunction), metabolic complications (electrolyte disturbances, liver or renal dysfunction) and infectious complications(wound infection, catheter-related infection, pneumonia, sepsis, or other infections requiring antibiotics).

Trial sites (6)

Facility	City	Region
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality
Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai Municipality
Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai Municipality
Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital	Hangzhou	Zhejiang
Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang

Other trials for the same condition

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Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer Recruiting

Distribution of Lymph Node Metastases in Esophageal Carcinoma Recruiting

Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer Recruiting

Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04513418 on ClinicalTrials.gov ↗ ← All trials in China