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NCT07030283 · ClinicalTrials.gov registry record · Phase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
A Phase 1 study of Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07030283 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma (PDAC) that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 296-participant average among 16 other Pancreatic Ductal Adenocarcinoma (PDAC) trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07030283, a Phase 1 study of Pancreatic Ductal Adenocarcinoma (PDAC), is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This goal of this clinical trial is to learn whether the drug combination of intraperitoneal paclitaxel (chemotherapy given directly into the abdominal cavity) and intravenous NALIRIFOX (chemotherapy given into a vein, including fluorouracil, leucovorin, oxaliplatin, and liposomal irinotecan) is safe and works in adults with pancreatic cancer that has spread to the peritoneum. The main questions it aims to answer are: * Are people with pancreatic cancer able to tolerate the combination drug regimen? * How well does the combination drug regimen work to treat pancreatic cancer? Participants will: * Obtain a port that goes into the abdomen to deliver intraperitoneal paclitaxel (called an intraperitoneal catheter) * Receive treatment with intravenous NALIRIFOX once every 2 weeks and intraperitoneal paclitaxel on days 1 and 8 of each 14-day cycle * Visit the clinic with each treatment for checkups and laboratory testing * Have imaging scans and blood lab testing to determine response to treatment * Have abdominal fluid lab testing that may help determine if the cancer is responding to treatment * Fill out questionnaires to see how the treatment affects how participants feel and function * Continue follow up after treatment ends to track survival Some participants may be able to have surgery later if the cancer responds well. This is called conversion surgery. To be eligible for surgery, the cancer must have shrunk or stayed the same, peritoneal fluid (from the abdomen) must no longer show cancer cells, and a tumor marker called CA 19-9 must decrease or return to normal. The decision to do surgery will depend on the treating surgeon. By testing this new treatment strategy, researchers hope to find a safer and more effective way to treat people with pancreatic cancer that has spread to the abdomen. If successful, this approach may lead to longer survival, better quality of life, and more people becoming eligible for surgery.
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG NALIRIFOX
Study Locations (1)
Colorado
- University of Colorado Cancer Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-12-31 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07030283
The ClinicalTrials.gov registry entry for NCT07030283 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 296-participant average among 16 other Pancreatic Ductal Adenocarcinoma (PDAC) trials with a reported enrollment target (97% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma (PDAC) appearing as the primary indexed condition, and to 2 interventions - of which Paclitaxel is the first listed.
NCT07030283 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT07030283 about?
NCT07030283 is a clinical study titled "Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis". This goal of this clinical trial is to learn whether the drug combination of intraperitoneal paclitaxel (chemotherapy given directly into the abdominal cavity) and intravenous NALIRIFOX (chemotherapy given into a vein, including fluorouracil, leucovorin, oxaliplatin, and liposomal irinotecan) is saf...
What is the current status of trial NCT07030283?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2025-12-31. Estimated completion is 2030-07-01.
What conditions does trial NCT07030283 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma (PDAC).
What interventions are being tested in trial NCT07030283?
The interventions under investigation include: Paclitaxel (DRUG), NALIRIFOX (DRUG).
Who is sponsoring clinical trial NCT07030283?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07030283 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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