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NCT07060014 · ClinicalTrials.gov registry record · Phase 1
NALIRIFOX (Nal-IRI Plus 5-FU/LV Plus Oxaliplatin) as First-Line Treatment for Patients With Advanced Small Intestine and Appendiceal Cancers
A Phase 1 study, sponsored by The Methodist Hospital Research Institute.
- Not yet
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT07060014: Clinical Trial Phase 1 study, sponsored by The Methodist Hospital Research Institute.
NCT07060014 is a Phase 1 study that has not yet begun recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07060014, a Phase 1 study, has not yet begun recruiting, sponsored by The Methodist Hospital Research Institute.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-07-18 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What is known before NCT07060014 opens enrollment
NCT07060014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which 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 is the first listed.
NCT07060014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07060014 about?
NCT07060014 is a clinical study titled "NALIRIFOX (Nal-IRI Plus 5-FU/LV Plus Oxaliplatin) as First-Line Treatment for Patients With Advanced Small Intestine and Appendiceal Cancers". 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 ...
What is the current status of trial NCT07060014?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2025-07-18. Estimated completion is 2026-12-31.
What interventions are being tested in trial NCT07060014?
The interventions under investigation include: 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 (DRUG).
Who is sponsoring clinical trial NCT07060014?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07060014's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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