Actively Recruiting
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
Led by Ashish Manne · Updated on 2026-04-08
38
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
A
Ashish Manne
Lead Sponsor
N
NovoCure GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.
CONDITIONS
Official Title
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and HIPAA authorization
- Male or non-pregnant, non-lactating female aged 18 years or older at consent
- Karnofsky Performance Status of 70% or higher within 7 days before registration
- Histological or cytological confirmation of pancreatic adenocarcinoma
- Resectable primary tumor per NCCN 2.2021 criteria based on contrast-enhanced CT or MRI of chest, abdomen, and pelvis
- Measurable disease per RECIST v1.1 within 28 days before registration
- No prior surgery, radiation, chemotherapy, targeted therapy, or investigational therapy for pancreatic cancer
- Adequate organ function including ANC ≥ 1.5 K/mm3, hemoglobin ≥ 8.0 g/dL, platelets ≥ 100,000/mm3, creatinine clearance ≥ 30 cc/min, bilirubin ≤ 1.5 × ULN, AST ≤ 3 × ULN, ALT ≤ 3 × ULN
- Negative pregnancy test within 3 days for females of childbearing potential
- Agreement to use effective contraception or abstain from vaginal intercourse during study and for specified times after last treatment
- Ability to understand and comply with study procedures
- HIV-infected patients with undetectable viral load on effective therapy
- Patients with chronic HBV infection must have undetectable viral load on suppressive therapy
- Patients with treated and cured HCV infection or undetectable viral load if on treatment
You will not qualify if you...
- Evidence of distant metastasis
- Presence of electrical implantable devices in the torso such as pacemakers or defibrillators
- Significant uncontrolled cardiovascular disease including advanced heart block, ischemic heart disease, poorly controlled hypertension, or NYHA Class II or worse heart failure
- Symptomatic or treated arrhythmia except controlled atrial fibrillation or flutter
- Known allergy to medical adhesives or conductive hydrogel
- Pregnant or breastfeeding women
- Prior or concurrent malignancy that may interfere with study safety or efficacy assessments
- Severe or uncontrolled medical conditions that pose safety risks or interfere with compliance (e.g., chronic pancreatitis, active infections)
- Prior malignancy except adequately treated skin cancers or in situ cervical cancer with disease-free status for two years
- Unwillingness or inability to comply with study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Ashish Manne, MD
CONTACT
A
Ahran Lee
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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