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Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT04605913•Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Detailed Description

GCN is predicted to be the front-line therapy for biliary and pancreatic cancer in the future given excellent results of current early clinical trials (ORR ≥ 67% in pancreatic cancer). This will change standard of care for front-line therapy in patients with stage IV pancreatic cancer. In this cohort of patients' tolerability after 6 cycles of therapy will be a challenge. Investigators hypothesize that developing a maintenance strategy with TTF+G will be cutting edge approach and can potentially transform front-line standard of care therapy in patients with stage IV pancreatic cancer. If this pilot study proves fruitful then a larger study to confirm findings can be conducted.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+15 more criteria

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.

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Key Dates

Start Date

April 1, 2022

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2028

Last Updated

February 25, 2026

Enrollment

ESTIMATED participants

Conditions

Pancreas CancerMetastatic Pancreatic CancerPancreatic AdenocarcinomaMetastatic Adenocarcinoma

Interventions

Modified GCN+TTF treatment

COMBINATION_PRODUCT

Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015 mayocliniccancerstudies@mayo.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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