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NCT04940286 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer
A Phase 2 study of Borderline Resectable Pancreatic Adenocarcinoma and Stage IIA Pancreatic Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04940286: Active Phase 2 study of Borderline Resectable Pancreatic Adenocarcinoma and Stage IIA Pancreatic Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04940286 is a Phase 2 study of Borderline Resectable Pancreatic Adenocarcinoma and Stage IIA Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 13 participants, below the 49-participant average among 7 other Borderline Resectable Pancreatic Adenocarcinoma trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04940286, a Phase 2 study of Borderline Resectable Pancreatic Adenocarcinoma and Stage IIA Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effects of gemcitabine, nab-paclitaxel, durvalumab, and oleclumab in treating patients with primary pancreatic cancer that may be able to be removed by surgery (resectable/borderline resectable). Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and oleclumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving gemcitabine, nab-paclitaxel, durvalumab, and oleclumab may help control the disease in patients with resectable/borderline resectable primary pancreatic cancer.
Primary Outcome
A Chi square- or Fisher's exact test will be used to evaluate the association between patient prognostic factor and response. Paired t-tests will be used to determine parameter changes before and after surgery in various immune-based conditions.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- BIOLOGICAL Oleclumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2027-10-30 |
| Phase | Phase 2 |
What the registry record for NCT04940286 still lists
NCT04940286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 49-participant average among 7 other Borderline Resectable Pancreatic Adenocarcinoma trials with a reported enrollment target (73% lower).
The record links to 6 conditions, with Borderline Resectable Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.
NCT04940286 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04940286 about?
NCT04940286 is a clinical study titled "Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer". This phase II trial studies the effects of gemcitabine, nab-paclitaxel, durvalumab, and oleclumab in treating patients with primary pancreatic cancer that may be able to be removed by surgery (resectable/borderline resectable). Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in diff...
What is the current status of trial NCT04940286?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-09-28. Estimated completion is 2027-10-30.
What conditions does trial NCT04940286 study?
This clinical trial studies the following conditions: Borderline Resectable Pancreatic Adenocarcinoma, Stage IIA Pancreatic Cancer AJCC v8, Resectable Pancreatic Adenocarcinoma, Stage IIB Pancreatic Cancer AJCC v8, Stage IA Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT04940286?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Oleclumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04940286?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04940286 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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