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

NCT04513418 | Recruiting Phase 3

• 1 other identifier: RTS-011
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 6

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 determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms; Neoadjuvant Therapy; Enteral Nutrition; Nutrition Therapy

Outcome Measures

Primary Outcomes (1)

• Rate of postoperative nutrition and immune-related complications

  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).

  Up to 30 days after surgery

Secondary Outcomes (14)

• Completion rate of neoadjuvant therapy and esophagectomy

  2-3 months before surgery

• Adverse events during neoadjuvant chemoradiotherapy

  2-3 months before surgery

• Pathological complete response rate (pCR)

  2-3 months before surgery

• Blood loss

  At operation day

• Duration of surgery

  At operation day

Other Outcomes (3)

• Minimal residual disease (MRD)

  Before and after neoadjuvant chemoradiotherapy, 7-14 days after surgery

• Microbiomics analysis

  1 week before neoadjuvant chemoradiotherapy, 2-3 days before surgery

• Metabolomic analysis

  1 week before neoadjuvant chemoradiotherapy, 2-3 days before surgery

Study Arms (2)

Interventional group

EXPERIMENTAL

Patients receive omega-3 fatty-acid enriched enteral nutritional emulsion during the neoadjuvant chemoradiotherapy. Patients are meanwhile encouraged to intake 25-30kcal/kg through regular food.

Dietary Supplement: Preoperative immunonutrition

Control group

NO INTERVENTION

Patients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy.

Interventions

Preoperative immunonutrition DIETARY_SUPPLEMENT

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.

Interventional group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hecheng Li M.D., Ph.D: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator

Study Sites (6)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315048, China

RECRUITING

Related Publications (1)

• Cao Y, Han D, Yang S, Shi Y, Zhao S, Jin Q, Li J, Li C, Zhang Y, Shen W, He J, Wang M, Ji G, Li Z, He Y, Chen Q, Wei W, Chen C, Gong X, Wang J, Tan L, Wang H, Li H. Effects of pre-operative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy: protocol for a multicenter randomized controlled trial (point trial, pre-operative immunonutrition therapy). BMC Cancer. 2022 Jun 13;22(1):650. doi: 10.1186/s12885-022-09721-y.

  PMID: 35698100 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hecheng Li, PhD, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hecheng Li, PhD, MD

CONTACT

00862164370045; lihecheng2000@hotmail.com

Yuqin Cao, MD

CONTACT

008613918933069; caoyuqin314@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 14, 2020
• Study Start: November 10, 2020
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)