Clinical trial · Interventional
Oral Immunonutrition Therapy to Reduce Acute Toxicity After Neoadjuvant Chemoradiotherapy Pancreatic Cancer Patients
Efficacy of Oral Immunonutrition Therapy in Reducing Acute Toxicity After Neoadjuvant Chemoradiotherapy Among Pancreatic Cancer Patients: a Prospective, Single-arm Clinical Trial
NCT06736678CI-TRIAL-00083853unknownN/AClinicalTrials.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)
A prospective, single-arm clinical trial is conducted to investigate the role of oral immunonutrion in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunonutrition | — | UNRESOLVED | — |
| Neoadjuvant Chemoradiotherapy | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Immunonutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Dietary Supplement: Oral Immunonutrition
Primary outcomes (1)
- measure
- Incidence rate of grade 3 or higher acute toxicity related to neoadjuvant chemoradiotherapy
- timeFrame
- Baseline, week 17
- description
- Grading of acute toxicity would be assessed according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Secondary outcomes (10)
- measure
- Usual Body Weight Percentage(UBW%)
- timeFrame
- Baseline, Week 3,5,7,9,13,17
- description
- The baseline weight would be considered as usual body weight. UBW%= current weight/usual weight ×100%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Pathologically confirmed pancreatic ductal epithelial malignant tumors; * 2\. Resectable pancreatic cancer treated with neoadjuvant chemoradiotherapy, or nonresectable locally advanced pancreatic cancer treated with neoadjuvant or radical chemoradiotherapy; * 3.Nutritional Risk Screening 2002 (NRS2002) ≥3 and Patient-Generated Subjective Global Assessment (PG-SGA) performance status B; * 4\. Age 18 years and older; * 5\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; * 6\. Expected survival time more than 3 months; * 7\. History of antineoplastic therapy; Exclusion Criteria: * 1\. Known allergy or intolerance to any component of investigational Oral Immunonutrition; * 2\. History of Oral Immunonutrition use within one month prior to enrollment; * 3\. Tumor compresses the major duodenal papilla, and /or appeared jaundice, acute pancreatitis; * 4\. Patients with contraindications for antineoplastic therapy, such as coronary heart disease, cerebral infarction, cerebral hemorrhage or other serious diseases; * 5\. Liver, kidney and blood coagulation function failure; * 6\. Patients with hemopathy; * 7\. Patients with active infections; * 8\. Patients with other primary tumor; * 9\. Patients with other medical diseases that seriously affected nutritional status; * 10.Subjects deemed by the investigator have other factors that may be ineligible for enrollment;
References
Publications (0)
Data not yet available
No reference posted for this study.