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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

Phase Ib-II, Non-randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With modFOLFIRINOX for Front-line Treatment of Metastatic Pancreatic Adenocarcinoma (NOVOFFOX)

TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC) (NCT07284277) is a Phase 1 / Phase 2 interventional studying Pancreatic Adenocarcinoma Metastatic and Pancreatic Ductal Adenocarcinoma, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. 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

The purpose of this clinical trial is to assess the safety and tolerability of TTFields in combination with chemotherapy in adults with metastatic pancreatic adenocarcinoma based on treatment-emergent adverse events of chemotherapy (modFOLFIRINOX) or device (TTFields). The main questions it aims to answer are: * Is TTFields treatment safe for the patients in combination with modFOLFIRINOX? * Are participants compliant with the treatment? * Is Is TTFields treatment effective in combination with modFOLFIRINOX against metastatic pancreatic adenocarcinoma?

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 Pancreatic Adenocarcinoma Metastatic, 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 30 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: All the patients should comply with the following criteria for inclusion: 1. Histological/cytological diagnosis of pancreatic adenocarcinoma. 2. The patient should be 18 years of age and older. 3. The patient has given consent to participate in the study. 4. The patient should be able to comply with all the requirements of the clinical trial. 5. expected to live at least 3 months. 6. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy. 7. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 9. Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX. 10. Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment. 11. Able to operate the Novo TTF-200T System independently or with the help of a caregiver. 12. Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1. 1. WBC higher than or equal to 2.5 x 10\^9/L. 2. ANC higher than or equal to 1.5 x 10\^9/L without granulocyte colony-stimulating factor support. 3. Platelet count higher than or equal to 100 x 10\^9/L without transfusion. 4. Hemoglobin higher than or equal to 9 g/dL. Patients may be transfused to meet this criterion. 5. Albumin higher than or equal to 2.5 g/dL. 6. Serum bilirubin lower than or equal to 1.5 times the upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value lower than or equal to 3 x ULN. 7. INR and aPTT lower than or equal to 1.5 x ULN. 8. AST, ALT, lower than or equal to 5 x ULN. ...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: All the patients should comply with the following criteria for inclusion: 1. Histological/cytological diagnosis of pancreatic adenocarcinoma. 2. The patient should be 18 years of age and older. 3. The patient has given consent to participate in the study. 4. The patient should be able to comply with all the requirements of the clinical trial. 5. Life expectancy of at least 3 months. 6. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy. 7. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 9. Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX. 10. Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment. 11. Able to operate the Novo TTF-200T System independently or with the help of a caregiver. 12. Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1. 1. WBC higher than or equal to 2.5 x 10\^9/L. 2. ANC higher than or equal to 1.5 x 10\^9/L without granulocyte colony-stimulating factor support. 3. Platelet count higher than or equal to 100 x 10\^9/L without transfusion. 4. Hemoglobin higher than or equal to 9 g/dL. Patients may be transfused to meet this criterion. 5. Albumin higher than or equal to 2.5 g/dL. 6. Serum bilirubin lower than or equal to 1.5 times the upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value lower than or equal to 3 x ULN. 7. INR and aPTT lower than or equal to 1.5 x ULN. 8. AST, ALT, lower than or equal to 5 x ULN. 9. Serum creatinine lower than or equal to 1.5 x ULN or Creatinine Clearance higher than or equal to 30ml/min (calculated using Cockcroft-Gault formula). 13. For women of childbearing potential: Negative serum pregnancy test within 14 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of lower than or equal to 1 percentage per year during the treatment period (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal o transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable o implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion or vasectomized partner) and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (higher than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Exclusion Criteria: Patients who present any of the following criteria for exclusion cannot be included in the clinical trial: 1. Malignancies other than pancreatic cancer within 3 years prior to Cycle 1 Day 1 (C1D1) with the exceptions of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival higher than 90 percentage), treated with expected curative outcome (such as but not limited to: adequately treated in situ carcinoma of the cervix, basal squamous or melanomatous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent). 2. Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma. 3. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to study entry. 4. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity. 5. Previous radiation therapy within 14 days prior to C1D1 and/or persistence of radiation-related adverse effects. 6. Implantable electronic medical devices in the torso, such as pacemakers. 7. Known severe hypersensitivities to medical adhesives or hydrogel, or history of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study treatments used. 8. Spinal cord compression not definitively treated with surgery and/or radiation. 9. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 10. Pregnant and lactating women 11. Patients who have received brivudine, sorivudine or analogues 4 weeks prior to Fluoracile administration. 12. Serious co-morbidities, including but not limited to: 1. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree hart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse. 2. History of cerebrovascular accident (CVA) within 3 months prior to randomization or that is not stable. 3. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy. 4. History of any psychiatric condition that might impair patient´s ability to understand or comply with the requirements of the study or to provide consent.

Treatments Being Tested

COMBINATION_PRODUCT

TTFields concomitant with modFOLFIRINOX

Patients will receive the following medication in 14-day cycles: ModFOLFIRINOX * Folic acid (Leucovorin) 400mg/m2 (D,L, racemic form) or 200mg/m2 (L-isomer form) * 5-fluorouracil (5Fu) 2400 mg/m2 * Oxaliplatin 85mg/m2 * Irinotecan 150-180mg/m2 Combined with TTFields, which is a portable battery operated system intended for continuous home use (at least 18h/day) which delivers TTFields at a frequency of 150kHz to produces electric forces intended to disrupt cancer cell division.

Locations (5)

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.

Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain
Hospital de Galdakao
Galdakao, Vizcaya, Spain
Fundación Jiménez-Díaz
Madrid, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Álava, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07284277), the sponsor (Clinica Universidad de Navarra, Universidad de Navarra), 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 NCT07284277 clinical trial studying?

The purpose of this clinical trial is to assess the safety and tolerability of TTFields in combination with chemotherapy in adults with metastatic pancreatic adenocarcinoma based on treatment-emergent adverse events of chemotherapy (modFOLFIRINOX) or device (TTFields). The main questions it aims to answer are: * Is TTFields treatment safe for the patients in combination with modFOLFIRINOX? * Are participants compliant with the treatment? * Is Is TTFields treatment effective in combination with modFOLFIRINOX against metastatic pancreatic adenocarcinoma? The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07284277?

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 NCT07284277?

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 NCT07284277. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07284277. 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.