RecruitingPhase 1Phase 2NCT07284277

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)


Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Enrollment

30 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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?


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether Tumor Treating Fields (TTFields) — a wearable device that uses electrical fields to disrupt cancer cell growth — combined with a standard chemotherapy regimen can improve outcomes for patients with metastatic pancreatic cancer. **You may be eligible if...** - You are 18 or older - You have been confirmed by biopsy to have metastatic pancreatic adenocarcinoma - You have at least one tumor in the liver that can be biopsied, plus at least one other measurable tumor - Your expected survival is at least 3 months - Your general health (ECOG) is 0 or 1 - Your doctor has assigned you to receive the FOLFIRINOX chemotherapy regimen - You are willing and able to comply with all trial requirements **You may NOT be eligible if...** - Your cancer is not metastatic or has not been confirmed as pancreatic adenocarcinoma - You do not have an accessible liver lesion for biopsy - You do not have additional measurable disease beyond the biopsy site - You are not a candidate for FOLFIRINOX chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTTTFields 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)

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

View Full Details on ClinicalTrials.gov

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NCT07284277


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