This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer will be eligible for participation in the study.
Male or female ≥18 years of age.
Histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer.
Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Absolute neutrophil count ≤1500 cells/mm3
Platelets ≤100,000 cells/mm3
Hemoglobin ≤9 g/dL
>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or