NCT04513418Active, not recruitingPhase 3
Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- First submitted
- 7 Aug 2020
- Start date
- 10 Nov 2020
- Primary completion date
- 16 Mar 2025
- Lead sponsor
- Hecheng Li M.D., Ph.D
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04513418
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 244
- From 10 Nov 2020 to the primary completion date, 16 Mar 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous thoracic or abdominal surgery
Other illness
- 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 other malignant tumor (previous or current)
Other
- Expected survival time less than 6 months
- Complete dysphagia
- Pregnant or breast-feeding women
- Unable to obey the interventions because of any reasons
- Patients with primary small cell carcinoma of the esophagus
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Ningbo Medical Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Zhongshan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.