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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

A Phase I/Ib Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC (NCT04605913) is a Phase 1 / Phase 2 interventional studying Pancreas Cancer and Metastatic Pancreatic Cancer, sponsored by Mayo Clinic. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pancreas Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-confirmed) pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis. 1. Subjects with additional sites of metastasis, except known brain metastasis, are eligible. 2. Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled. 3. Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI/CT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult. 2. Patients with no prior lines of therapy for the treatment of stage IV metastatic disease. 1. Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemo-radiotherapy. i. Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress greater than 6 months after completion of the therapy; ii. Patients who progress while on adjuvant FOLFIRINOX can enroll immediately. 3. Male and female patients at least 18 years of age 4. Laboratory data as specified below: Hematology: \- ANC greater than 1500 cells/mm3, \- platelet count greater than 100,000 cells/mm3, and \- Hemoglobin greater than 8 g/dL. - Hepatic - Total bilirubin less than 1.5 X ULN; - alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 X ULN. For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 6.0 X ULN and total bilirubin less than 3 x ULN. - Renal: - serum creatinine WNL or creatinine clearance greater than 50 mL/min. 5. QT intervals: QTc less than or equal to 470 msec for men and less than or equal to 490 msec for women. (As measured by Hodges' Equation: QTc = QT + 1.75(rate-60) where QTc = corrected QT interval and rate = ventricular rate/min). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis. 1. Subjects with additional sites of metastasis, except known brain metastasis, are eligible. 2. Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled. 3. Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI/CT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult. 2. Patients with no prior lines of therapy for the treatment of stage IV metastatic disease. 1. Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemo-radiotherapy. i. Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress greater than 6 months after completion of the therapy; ii. Patients who progress while on adjuvant FOLFIRINOX can enroll immediately. 3. Male and female patients at least 18 years of age 4. Laboratory data as specified below: Hematology: \- ANC greater than 1500 cells/mm3, \- platelet count greater than 100,000 cells/mm3, and \- Hemoglobin greater than 8 g/dL. * Hepatic * Total bilirubin less than 1.5 X ULN; * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 X ULN. For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 6.0 X ULN and total bilirubin less than 3 x ULN. * Renal: * serum creatinine WNL or creatinine clearance greater than 50 mL/min. 5. QT intervals: QTc less than or equal to 470 msec for men and less than or equal to 490 msec for women. (As measured by Hodges' Equation: QTc = QT + 1.75(rate-60) where QTc = corrected QT interval and rate = ventricular rate/min). 6. Estimated life expectancy of at least 3 months 7. ECOG Performance Status 0-1. 8. Ability to operate the Novo TTF-100L (P) system. 9. Patients must have measurable disease on scans per RECIST 1.1. 10. Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment. Exclusion Criteria: 1\. Previous front-line therapy for metastatic disease. 1. Patients with known brain metastasis. 2. Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker. 3. Patient with cardiac or abdominal pacemakers or stimulators. 4. Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction. 5. Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible. 6. Concomitant use of drugs that have black box warning of Torsades de Pointes will also be prohibited if cannot be replaced by another drug. 7. Known sensitivity to conductive hydrogels. 10\. Patients who are pregnant or breastfeeding.

Treatments Being Tested

COMBINATION_PRODUCT

Modified GCN+TTF treatment

The regimen will consist of gemcitabine (G) administered at a dose of 800 mg/m2, cisplatin (C) 30 mg/m2, and protein-bound paclitaxel (N) 150 mg/m2 administered on cycle 1 day 1 and every 2 weeks thereafter and TTF will be administered daily (150kHz 18 hours/day) starting with Cycle 1 Day 1 (dose level 1). One cycle consists of 28 days including 2 chemotherapy treatments (same regimen studied in the PAXG trial: Reni BJC 2016 without capecitabine). After completing 6 cycles, patients will then transition to a maintenance phase of G administered at a dose of 1000 mg/m2 every 2 weeks and daily TTF (150 KHZ 18 hours/day) until progression of disease (POD) per RECIST v1.1.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Mayo Clinic in Florida
Jacksonville, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04605913), the sponsor (Mayo Clinic), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04605913 clinical trial studying?

This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04605913?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04605913?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04605913. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04605913. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.