Actively Recruiting
Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
Led by THERABIONIC INC. · Updated on 2025-03-25
46
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
Sponsors
T
THERABIONIC INC.
Lead Sponsor
T
Therabionics
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this research is to find out what effects (good and bad), the combination of gemcitabine and nab-paclitaxel therapy (GEM-ABR for the rest of the document), standard chemotherapy for pancreatic cancer, and the TheraBionic device has on participants' condition.
CONDITIONS
Official Title
Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed untreated biopsy-proven metastatic adenocarcinoma of the pancreas
- One or more measurable metastatic tumors by RECIST v1.1 on chest, abdomen, and pelvis imaging
- Females of childbearing potential and sexually active males with partners must agree to use two forms of contraception during treatment and for 6 months after
- Age 18 years or older
- ECOG performance status of 0 or 1
- Adequate organ and marrow function meeting specified blood counts and liver and kidney tests
- Ability and willingness to sign informed consent
You will not qualify if you...
- Prior chemotherapy in the metastatic setting or gemcitabine/nab-paclitaxel chemotherapy within 6 months in adjuvant or neo-adjuvant setting
- Known brain metastases
- Allergic reactions to gemcitabine or nab-paclitaxel or similar compounds
- History of malignancy within last 3 years except certain treated cancers
- Use of calcium channel blockers unless modified before enrollment
- Active uncontrolled infection requiring systemic therapy
- Uncontrolled illnesses including heart failure, angina, arrhythmia, or psychiatric/social issues limiting compliance
- Diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis
- Pregnant or breastfeeding women
- Localized resectable or locally advanced tumor
- Surgery other than diagnostic or minor procedures within 4 weeks prior to treatment
- Inability to comply with study procedures or expected treatment breaks of 14 or more days
- Participation in other clinical interventional trials or use of investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
R
Ravi Paluri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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