Clinical trial · Interventional
Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy
NCT04513418CI-TRIAL-00113284POINTactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative immunonutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional group
- description
- 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.
- interventionNames
- Dietary Supplement: Preoperative immunonutrition
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy.
Primary outcomes (1)
- measure
- Rate of postoperative nutrition and immune-related complications
- timeFrame
- Up to 30 days after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDCheng Y, Cao 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, Tan L, Wang H, Shi Y, Li H. Updated protocol of the POINT trial: a multicenter randomized controlled trial investigating effects of preoperative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy. Trials. 2025 Oct 10;26(1):401. doi: 10.1186/s13063-025-09117-w. PMID 41074192
- BACKGROUNDCao 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