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

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.

Pancreatic cancer has a poor prognosis for its high malignancy. Radical surgical resection is an effective means for prolonging survival. However, only a few patients can be directly treated with surgical resection. Neoadjuvant therapy can reduce the tumor size, improve the relationship between the tumor and adjacent blood vessels，to gain surgical opportunities and prolonging patients' survival.

Nutritional treatment of cancer has been valued by more and more researchers. As an important branch of nutrition therapy, immunonutrition plays an important role in regulating the immune. Studies have shown that immunonutrition can reduce antitumor treatment related toxicity among patients with head and neck cancer, esophageal cancer. At present, most studies on immunonutrition therapy focus on perioperative patients, and there is no study on patients with pancreatic cancer undergoing radiotherapy.

This prospective, single-arm clinical trial aimed to explore the efficacy and safety of oral immunonutrition therapy in reducing acute toxicity after neoadjuvant chemoradiotherapy among pancreatic cancer patients. A total of 98 pancreatic cancer patients will be enrolled. All of the patients will receive oral immunonutrition therapy for 6 weeks from one week before radiotherapy. The total follow time is 4 months.

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;