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NCT06835387 · ClinicalTrials.gov registry record · Phase 2
Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors
A Phase 2 study of Small Bowel Adenocarcinoma, sponsored by Tiago Biachi de Castria.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 5
- Study locations
NCT06835387 is a Phase 2 study of Small Bowel Adenocarcinoma that is actively recruiting participants, run by Tiago Biachi de Castria. The registered enrollment target is 36 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT06835387, a Phase 2 study of Small Bowel Adenocarcinoma, is actively recruiting participants, sponsored by Tiago Biachi de Castria.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 5
- Study locations
Study Summary
The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg/m2, followed by oxaliplatin 60 mg/m2, followed by leucovorin at 400 mg/m2 30 minutes after completion of oxaliplatin, followed by 5-FU 2400 mg/m2 60 minutes after leucovorin completion. Subjects will receive up to 6 cycles of NALIRIFOX then based on response and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue. Subjects will continue de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Nanoliposomal irinotecan
- DRUG 5 fluorouracil
Study Locations (5)
Florida
- Moffitt Cancer Center - Tampa
Illinois
- University of Illinois Cancer Center - Chicago
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Atlantic Health System - Morristown
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-06-30 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06835387
The ClinicalTrials.gov registry entry for NCT06835387 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tiago Biachi de Castria, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Small Bowel Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Leucovorin is the first listed.
NCT06835387 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Florida, Illinois, Missouri.
Frequently Asked Questions
What is clinical trial NCT06835387 about?
NCT06835387 is a clinical study titled "Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors". The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg/m2, followed by oxaliplatin 60 mg/m2, followe...
What is the current status of trial NCT06835387?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-06-30. Estimated completion is 2028-08.
What conditions does trial NCT06835387 study?
This clinical trial studies the following conditions: Small Bowel Adenocarcinoma.
What interventions are being tested in trial NCT06835387?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Nanoliposomal irinotecan (DRUG), 5 fluorouracil (DRUG).
Who is sponsoring clinical trial NCT06835387?
This trial is sponsored by Tiago Biachi de Castria, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06835387 being conducted?
This trial has 5 study locations across Florida, Illinois, Missouri, New Jersey, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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