Status:
RECRUITING
Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy
Lead Sponsor:
Hecheng Li M.D., Ph.D
Collaborating Sponsors:
Shanghai Chest Hospital
Shanghai Zhongshan Hospital
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 determi...
Detailed Description
Esophageal cancer ranks the fourth in mortality and the sixth in incidence among cancers in China according to the latest report of cancer epidemiology. Although the development of neoadjuvant therapy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04513418
Start Date
November 10 2020
End Date
December 31 2028
Last Update
May 14 2025
Active Locations (6)
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1
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
2
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
3
Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200030
4
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200032