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
Parallel
Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2, IV) every 2 weeks for 12 months
DrugThe study drugs will be administered per the regimen defined in the NAPOLI-3 clinical trial. Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2, IV) every 2 weeks for 12 months.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in patients receiving Nalirifox per Napoli-3 regimen as first-line chemotherapy for advanced non-resectable small intestine and appendiceal cancers
This measure evaluates the safety and tolerability of Nalirifox per Napoli-3 regimen by reporting the number of participants experiencing treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Data will be collected through clinical assessments, including physical examinations, laboratory tests, and patient-reported adverse events, and summarized as the total count and severity of events per participant.
Duration of response to Nalirifox per Napoli-3 regimen as first-line chemotherapy in patients with advanced non-resectable small intestine and appendiceal cancers, assessed by RECIST v1.1
This measure evaluates the duration of response to Nalirifox per Napoli-3 regimen, defined as the time from the first documented objective response (complete response or partial response) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 until disease progression or death, whichever occurs first. Data will be collected through radiographic assessments (e.g., CT or MRI scans) at regular intervals and summarized as the median duration of response in months.
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