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NCT06423326 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer
A Phase 2 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06423326: Recruiting Phase 2 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, sponsored by Emory University.
NCT06423326 is a Phase 2 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 36 participants, below the 59-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06423326, a Phase 2 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy has been shown to improve overall survival compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.
Primary Outcome
Clinical response is defined as biochemical, radiological, pathological response or stable disease. • Biochemical response (or CA 19-9 response) is defined as \>50% decrease from baseline with tumor response. Radiologic response is defined as complete response (CR), partial response (PR) or stable disease (SD) after the neoadjuvant therapy per RECIST 1.1. Pathologic response is defined by CAP scoring system as 0 (complete response), 1 (moderate response), 2 (minimal response) and 3 (poor or no r
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Biopsy
- DRUG Gemcitabine
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-08-06 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT06423326 shows while recruiting
NCT06423326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 59-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (39% lower).
The record links to 5 conditions, with Stage III Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06423326 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06423326 about?
NCT06423326 is a clinical study titled "Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer". This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resecta...
What is the current status of trial NCT06423326?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-08-06. Estimated completion is 2026-12-31.
What conditions does trial NCT06423326 study?
This clinical trial studies the following conditions: Stage III Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Resectable Pancreatic Adenocarcinoma, Stage I Pancreatic Cancer AJCC v8, Borderline Resectable Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT06423326?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Biopsy (PROCEDURE), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT06423326?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06423326 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06423326's enrollment target sits among peer trials
36 12th of 23 higher than 12 of 23 other Stage III Pancreatic Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Pancreatic Cancer AJCC v8 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.
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