NALIRIFOX for Small Bowel Cancer

This trial tests a treatment called NALIRIFOX for individuals with small bowel cancer that has spread. NALIRIFOX combines 5-fluorouracil, Leucovorin, Nanoliposomal irinotecan, and Oxaliplatin. The goal is to evaluate how effectively this drug combination controls cancer and improves patient outcomes. Participants will receive the treatment through an IV on specific days of a 28-day cycle, with the option to continue with a modified treatment based on their response. Suitable candidates have confirmed small bowel adenocarcinoma that has not been treated in the metastatic setting and have one or more measurable metastatic lesions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

The trial requires participants to stop using strong inhibitors or inducers of certain enzymes (CYP3A, CYP2C8, and UGT1A1) at least 1-2 weeks before joining. If you're on these medications, you may need to stop them, but it's best to discuss with your doctor.

Research on NALIRIFOX has revealed important safety findings. NALIRIFOX combines four drugs: nanoliposomal irinotecan, oxaliplatin, leucovorin, and 5-fluorouracil (5-FU). Studies indicate that this combination is generally well-tolerated, though it can have side effects, like many cancer treatments.

One study found that patients experienced side effects such as nausea, tiredness, and diarrhea, which were often manageable with standard care. Another study noted that the safety profile aligned with expectations for these types of cancer drugs, meaning most side effects were known and controllable.

Unlike the standard chemotherapy regimens for small bowel cancer, which often include combinations like FOLFOX or FOLFIRI, NALIRIFOX introduces a unique formulation with nanoliposomal irinotecan that enhances drug delivery to tumors. This liposomal delivery system potentially increases the effectiveness of irinotecan by improving its absorption and targeting, while reducing side effects. Researchers are excited because this approach could offer a more efficient and tolerable treatment option, potentially leading to better outcomes for patients with small bowel cancer.

This trial will evaluate NALIRIFOX, a combination of four cancer-fighting drugs, for its potential to treat small bowel cancer. Studies have shown that NALIRIFOX can shrink tumors and extend the lives of patients with advanced cancers. In one study, patients taking NALIRIFOX experienced tumor reduction and manageable side effects. Another study found that even at lower doses, the treatment remained effective for some cancer types. These findings suggest NALIRIFOX might benefit small bowel cancer, but further research is needed to confirm its effectiveness for this specific condition.¹²³⁶⁷