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Search / Trial NCT04513418

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

Launched by HECHENG LI M.D., PH.D · Aug 11, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Esophageal Neoplasms Neoadjuvant Therapy Enteral Nutrition Nutrition Therapy

ClinConnect Summary

This clinical trial is studying the effects of a special diet, called enteral immunonutrition, for patients with esophageal cancer who are about to undergo chemotherapy and radiation therapy before surgery. The goal is to see if this diet can help reduce complications and improve recovery after surgery. The trial is currently looking for participants, and anyone aged 18 to 75 with confirmed esophageal cancer that meets specific health criteria can potentially join.

To be eligible, participants need to be able to eat at least a liquid diet and be in fairly good health, with a body mass index (BMI) of 18.5 or higher. They must also provide their agreement and sign a consent form. During the trial, participants will receive either the special diet or standard care before their surgery and will be monitored for any side effects or improvements in their health. This study is important because it aims to find better ways to support patients facing treatment for esophageal cancer.

Gender

ALL

Eligibility criteria

  • 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

About Hecheng Li M.D., Ph.D

Hecheng Li, M.D., Ph.D., is a distinguished clinical trial sponsor with extensive expertise in medical research and patient care. With a robust background in both clinical practice and academic research, Dr. Li is committed to advancing innovative therapeutic solutions through rigorous clinical trials. His leadership ensures adherence to the highest ethical standards and regulatory compliance, fostering an environment of collaboration and scientific integrity. Dr. Li’s dedication to improving patient outcomes is reflected in his strategic approach to trial design and execution, making significant contributions to the field of medicine.

Locations

Shanghai, Shanghai, China

Fuzhou, Fujian, China

Shanghai, Shanghai, China

Shanghai, Shanghai, China

Shanghai, Shanghai, China

Shanghai, Shanghai, China

Hangzhou, Zhejiang, China

Ningbo, Zhejiang, China

Patients applied

0 patients applied

Trial Officials

Hecheng Li, PhD, MD

Principal Investigator

Ruijin Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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