NALIRIFOX (Nal-IRI Plus 5-FU/LV Plus Oxaliplatin) as First-Line Treatment for Patients With Advanced Small Intestine and Appendiceal Cancers

Inclusion Criteria

• •1. Male or female ≥18 years of age.
• •2. Histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer.
• •3. Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• •4. Eastern Cooperative Oncology Group performance status of 0 or 1.
• •5. Life expectancy ≥6 months.
• •6. Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment.
• •5\. Serum creatinine or serum urea \>1.5 × ULN. 6. Estimated glomerular filtration rate \<50 mL/min. 7. Positive pregnancy test, pregnancy, or breastfeeding (female patients only). 8. Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.
• •9\. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:
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• •1. Arrhythmia
• •2. Bradycardia
• •3. Tachycardia
• •4. Symptomatic valvular disease
• •5. Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV
• •6. Unstable angina pectoris. 10. Myocardial infarction within the past 6 months. 11. Active bleeding diathesis. 12. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months.
• •13\. Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or another immunosuppressive agent (s) 14. Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.
• •15\. History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.
• •16\. History of malignancy or active treatment for malignancy (i.e., radiation or chemotherapy, including monoclonal antibodies) within 5 years. Note: Patients with squamous or basal cell carcinomas of the skin, carcinomas in situ of the cervix or uterus, ductal breast cancer in situ, resected low-grade prostate cancer, or other malignancies that in the opinion of the investigator are considered cured may participate.
• •17\. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month. Note: Influenza vaccine will be allowed if administered \>21 days.
• •18\. Receipt of any investigational agent or study treatment within the past 30 days.
• •19\. Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months.
• •20\. Allergies reaction to irinotecan or liposomal irinotecan.