Metastatic Pancreatic AdenocarcinomaPhase 2NCT06576115
Gemcitabine, Nab-paclitaxel Plus the TheraBionic P1 (an Amplitude-Modulated Radiofrequency Electromagnetic Fields) Device to Treat Metastatic Pancreatic Cancer
A Phase 2 study testing Nab paclitaxel, Gemcitabine and TheraBionic P1 in people with Metastatic Pancreatic Adenocarcinoma, run by Barbara Ann Karmanos Cancer Institute at 7 sites in United States.
Trial summary
The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Nab paclitaxel, Gemcitabine and TheraBionic P1
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Feb 2025to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Parameter Levels:
- Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets > 100,000/mcL Total bilirubin ≤ 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) < 2.5 X ins Creatinine ≤ 1.5 X institutional upper limit of normal Or CrCL > 50
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Who cannot join
- 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)
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
Anthony F Shields, M.D., PhD, 1-248-922-6650, shieldsa@karmanos.org
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48021
Anthony F Shields, M.D. PhD, shieldsa@karmanos.org
Anthony F Shields, M.D. PhD
- Recruiting
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
Anthony F Shields, M.D., PhD, 1-810-342-3800, shieldsa@karmanos.org
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Anthony F Shields, M.D., PhD, 1-517-975-9500, shieldsa@karmanos.org
- Recruiting
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, 48446
Anthony F Shields, M.D., PhD, 1-810-667-4994, shieldsa@karmanos.org
- Recruiting
Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey
Petoskey, Michigan, 49770
Anthony F Shields, M.D., PhD, 1-231-487-3390, shieldsa@karmanos.org
- Recruiting
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060
Anthony F Shields, M.D., PhD, 1-810-982-5200
About this study
Official title: Treatment of Patients With Metastatic Pancreatic Cancer With Gemcitabine and Nab-Paclitaxel and Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)
The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Nab paclitaxel, Gemcitabine, TheraBionic P1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxelDrug
Also called Abraxane
125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first
GemcitabineDrug
Also called Gemzar
1000 mg/m2 weekly, on day 1,8 and 15 or 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab- paclitaxel infusion
TheraBionic P1Device
This treatment consists of delivering preset low levels of radio waves into the body with a spoon-shaped antenna placed in the mouth, three times a day, for an hour each time.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/Nab-Paclitaxel plus TheraBionic Device | Experimental | Metastatic pancreatic cancer patients will be treated with amplitude-modulated radiofrequency electromagnetic fields using TheraBionic device in combination with standard chemotherapy, gemcitabine- nab-paclitaxel. amplitude-modulated radiofrequency electromagnetic fields will be delivered by the TheraBionic device. Receives: Drug: Nab paclitaxel; Drug: Gemcitabine; Device: TheraBionic P1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Progression-Free Survival Rate (PFS 6)
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.
Measured: 6 months
Secondary outcomes (6)
Adverse Event Incidence
Evaluate the safety and tolerability of the combination of nab-paclitaxel, gemcitabine and AM RF EMF categorized and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5). The adverse event incidence rate will be defined as a proportion of patients who experience adverse events among the safety population.
Measured: Up to 1 year
Median Progression Free Survival (PFS)
PFS is defined from the time of study treatment initiation until progression or death of any cause, whichever occurs first. PFS will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. The median PFS will be estimated using Kaplan-Meier estimate.
Measured: Up to 1 year
6-month Overall Status rate (OS 6)
Overall survival (OS) is defined from the time of study treatment initiation until the death of any cause. The six months OS rate (OS 6) is defined as the proportion of patients alive at six months from treatment initiation.
Measured: 6 Months
Median OS
OS is defined from the time of study treatment initiation until death of any cause. The median OS will be estimated using Kaplan-Meier estimate.
Measured: Up to 1 year
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with partial or complete responses based on Radiographic Determination of Treatment Response by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by CT Scan or MRI:
- Complete Response (CR): Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm. All disease must be assessed using the same technique as baseline.
- Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions.
Measured: Up to 1 year
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of patients with disease control (complete or partial response or stable disease) based on RECISTv1.1 criteria:
- Complete Response (CR): Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm. All disease must be assessed using the same technique as baseline.
- Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions.
- Stable disease: Does not qualify for CR, PR, Progression or Symptomatic Deterioration. All target measurable lesions must be assessed using the same techniques as baseline.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start28 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute
- Investigators
- Anthony F Shields, M.D. PhD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576115
- Sponsor's protocol ID
- 2023-104
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Metastatic Pancreatic Cancer With Gemcitabine and Nab-Paclitaxel and Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)
- ClinicalTrials.gov ID
- NCT06576115
- Acronym / sponsor ID
- 2023-104
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/Nab-Paclitaxel plus TheraBionic Device | Experimental | Drug: Nab paclitaxel, Drug: Gemcitabine, Device: TheraBionic P1Metastatic pancreatic cancer patients will be treated with amplitude-modulated radiofrequency electromagnetic fields using TheraBionic device in combination with standard chemotherapy, gemcitabine- nab-paclitaxel. amplitude-modulated radiofrequency electromagnetic fields will be delivered by the TheraBionic device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab paclitaxelAlso: Abraxane125 mg/m2 weekly, on days 1,8, and 15 or on days 1 and 15 as a 30-40 minute infusion administered first | Drug | Gemcitabine/Nab-Paclitaxel plus TheraBionic Device |
| GemcitabineAlso: Gemzar1000 mg/m2 weekly, on day 1,8 and 15 or 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab- paclitaxel infusion | Drug | Gemcitabine/Nab-Paclitaxel plus TheraBionic Device |
| TheraBionic P1This treatment consists of delivering preset low levels of radio waves into the body with a spoon-shaped antenna placed in the mouth, three times a day, for an hour each time. | Device | Gemcitabine/Nab-Paclitaxel plus TheraBionic Device |
Primary outcome
6 Month Progression-Free Survival Rate (PFS 6)
Time frame: 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.
6 secondary outcomes
Adverse Event Incidence
Time frame: Up to 1 year
Median Progression Free Survival (PFS)
Time frame: Up to 1 year
6-month Overall Status rate (OS 6)
Time frame: 6 Months
Median OS
Time frame: Up to 1 year
Objective Response Rate (ORR)
Time frame: Up to 1 year
Disease Control Rate (DCR)
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony F Shields, M.D. PhD principal investigator
Barbara Ann Karmanos Cancer Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab paclitaxel, Gemcitabine and TheraBionic P1 in people with Metastatic Pancreatic Adenocarcinoma, run by Barbara Ann Karmanos Cancer Institute at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony F Shields, MD PhD (3135768735, shieldsa@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Month Progression-Free Survival Rate (PFS 6) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.