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Gemcitabine, Nab-paclitaxel, and TheraBionic P1 for Metastatic Pancreatic Cancer

This study is looking into whether a combination of treatments is safe and effective for people with metastatic pancreatic adenocarcinoma (a type of pancreatic cancer that has spread). The treatments being tested are two chemotherapy drugs, nab-paclitaxel and gemcitabine, along with a device called TheraBionic P1. The TheraBionic P1 device delivers low levels of radio waves into the body. To join, you must have pancreatic adenocarcinoma that has spread and at least one measurable tumor. The main goal is to see how many participants are still alive and without their cancer progressing after 6 months. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study with a planned enrollment of 30 participants. The study type is not specified (e.g., single-arm or randomized).
What's involved
You would receive nab-paclitaxel and gemcitabine infusions weekly or every two weeks. The TheraBionic P1 device treatment involves using a spoon-shaped antenna in your mouth three times a day for an hour each time.
Compensation
Not stated in the trial record.
Follow-up
The study measures progression-free survival at 6 months, indicating follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06576115

Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Barbara Ann Karmanos Cancer Institute
~30 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Nab paclitaxelGemcitabineTheraBionic P1

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6 Month Progression-Free Survival Rate (PFS 6)
Measured over 6 months

Conditions

Metastatic Pancreatic Adenocarcinoma

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NCT06576115

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Karmanos Cancer Institute

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Clarkston

    Clarkston, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Flint

    Flint, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Lapeer Region

    Lapeer, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

    Petoskey, Michiganstudy coordinator listed

    Recruiting

  • Karmanos Cancer Institute at McLaren Port Huron

    Port Huron, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anthony F Shields, M.D. PhD · PRINCIPAL_INVESTIGATOR · Barbara Ann Karmanos Cancer Institute

Who to contact

Anthony F Shields, MD PhD
[email protected]
3135768735
Email the study team

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Eligibility criteria

Inclusion

Patients must have histologically or cytologically proven advanced metastatic adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT or MRI or PET scans
If female patient is of childbearing potential must have a negative serum pregnancy test (βhCG) documented up to 48 hrs prior to administration of chemotherapy.
Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Age above 18 years
Based on prior studies, patients 80 years of age and older are considered to be at higher risk for fatal neutropenic sepsis. These patients should be thoroughly evaluated including geriatric assessment prior to enrollment. Clinical judgment should be exercised regarding patients' susceptibility for sepsis or infection (presence of biliary tract infection, uncontrolled diabetes, etc.). The patients in this age group should be not enrolled should there be any concern for rapid deterioration of clinical and functional status.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Parameter Levels:
Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion

Patients who have had chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to entering the study in the adjuvant or neo-adjuvant setting.
Patients receiving any other investigational agents.
Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and nab-paclitaxel.
No history of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible.
Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are not allowed in the study unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment. (Refer to Appendix D for a comprehensive list of excluded medications)
Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy is completed.
Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or could compromise patients' safety.
Patient with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or pneumonitis.
Pregnant women are excluded from this study because of potential risk for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy and AM RF EMF, patients who are breastfeeding will be excluded to participate in this study.
Patient has localized resectable or locally advanced tumor.
Patients has undergone major surgery, other than diagnostic surgery or procedures, within 4 weeks prior to the treatment day.
Patients is unable to comply with study procedures or anticipating a situation that would result in a treatment break for 14 or more consecutive days after the start of the study.
Patient is enrolled in any other clinical interventional trial.

What this trial measures

  • 6 Month Progression-Free Survival Rate (PFS 6)6 months

    Progression-free survival (PFS) is defined from the time of study treatment initiation until progression or death of any cause, whichever occurs first. The six months PFS rate (PFS 6) is defined as the proportion of patients alive and progression-free at six months from treatment initiation. PFS will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines.