Study of NALIRIFOX for Advanced Small Bowel Tumors That Cannot Be Removed by Surgery

Sponsor: Tiago Biachi de Castria

Sponsor score: 0

ClinicalTrials ID:NCT06835387

Provider View

This clinical trial is testing a treatment called NALIRIFOX for patients with advanced small bowel tumors that cannot be surgically removed. The treatment involves a combination of medications given through an IV on specific days of a 28-day cycle.

Patient Parameters

Program Overview

In this study, patients will receive a combination of medications called NALIRIFOX, which includes nanoliposomal irinotecan, oxaliplatin, leucovorin, and 5-FU. These medications are given through an IV on Day 1 and Day 15 of each 28-day cycle. Patients can receive up to 6 cycles of this treatment. Depending on how the cancer responds, the treatment may continue without oxaliplatin. The treatment will continue until the cancer progresses, side effects become too severe, or the patient or doctor decides to stop.

Eligibility Criteria

Inclusion Criteria

  • Must be informed about the study and agree to participate by signing a consent form.
  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a confirmed diagnosis of small bowel adenocarcinoma that has not been treated in the metastatic setting.
  • Must have cancer that is mismatch repair proficient (MMRp) or microsatellite stable (MSS).
  • Must have at least one measurable metastatic lesion.
  • Must have adequate organ function based on specific blood tests.
  • Must have a normal ECG without significant findings.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use effective contraception if sexually active with a woman of childbearing potential.
  • HIV-positive patients are eligible if they meet specific health criteria.
  • Patients with hepatitis B or C must have controlled or treated infections.

Exclusion Criteria

  • Cancer originating in the ampulla or appendix.
  • Neuroendocrine or other non-adenocarcinoma histology.
  • Previous treatment with irinotecan.
  • Previous treatment for metastatic small bowel adenocarcinoma.
  • Known brain metastases unless stable.
  • Significant gastrointestinal disorders or other serious health conditions.
  • Pregnant or breastfeeding women.
  • History of another cancer within the last 2 years, except for certain skin cancers.
  • Known allergies to study medications.
  • Serious heart or liver conditions.
  • Active infections or unexplained fever.
  • Recent major surgery.
  • Use of certain medications that interact with the study drugs.
  • History of certain lung diseases or connective tissue disorders.
  • Recent live vaccination.
  • Known deficiency in dihydropyridine dehydrogenase (DPD) activity.

Locations

FACILITYZIPCITYSTATE
Moffitt Cancer Center33612TampaFlorida

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