Trial · NCT07284277
TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)
NCT07284277, Phase 1, Phase 2, Recruiting, Clinica Universidad de Navarra, Universidad de Navarra
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC). Trials, record NCT07284277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07284277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)
- NCT number
- NCT07284277
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Conditions
- Pancreatic Adenocarcinoma Metastatic, Pancreatic Ductal Adenocarcinoma
- Interventions
- TTFields concomitant with modFOLFIRINOX
- First posted
- 2025-12-16
- Last updated
- 2025-12-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX | From the beginning of the first treatment cycle (cycle 1; each treatment cycle is 14 days) through study completion (for a maximum of 24 months per patient since inclusion) | Toxicity profile measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0 |
| Secondary | Total hours with TTField device functioning during every 14 days chemotherapy cycle | From the beginning of the first treatment cycle (cycle 1; each treatment cycle is 14 days) until discontinuation of last study treatment (for a maximum of 24 months per patient since inclusion). | Total account of hours with TTField device functioning during every 14days chemotherapy cycle in the ITT population. |
| Secondary | Quality of life (QoL) assessment | Screening visit, from cycle 13 (since completion of treatment with mFOLFIRINOX) onwards at each visit with test according to protocol, and at post-treatment termination visit (for a maximum of 24 months per patient since inclusion). | Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of 30 items (EORTC QLQ-30). Questions 1-28: scale from 1 to 4, where 1 means a better quality of life and 4 indicates a worse quality of life; questions 29-30: scale from 1 to 7, where low scores indicate poorer health and quality of life, while high scores indicate better health and quality of life. |
| Secondary | Progression-free survival (PFS) | Every 8 weeks from the beginning of the first treatment cycle (cycle 1) through study completion (for a maximum of 24 months per patient since inclusion). | The time in months from first modFOLFIRINOX administration until disease progression based on CT scan collected on the study according to RECIST 1.1 criteria or any cause related death, whichever occurs first. |
| Secondary | Overall survival (OS) | Since inclusion through study completion (for a maximum of 24 months per patient since inclusion). | The time from first modFOLFIRINOX administration until patient death (if it occurs). |
| Secondary | Overall response rate (ORR) | Every 8 weeks from the beginning of the first treatment cycle (cycle 1) through study completion (for a maximum of 24 months per patient since inclusion). | The percentage of patients with complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST 1.1. |
| Secondary | Disease control rate (DCR) | Every 8 weeks from the beginning of the first treatment cycle (cycle 1) through study completion (for a maximum of 24 months per patient since inclusion). | The percentage of patients with CR or PR and the percentage of subjects with stable (SD) of at least 12 weeks duration as BOR according to RECIST 1.1. |
| Secondary | Treatment impact on T-cell populations in the tumor and/or tumor periphery | At cycle 1 day 1 (each treatment cycle is 14 days), cycle 2 day 1, and cycle 5 day 1, and after discontinuation of last study treatment until disease progression (for a maximum of 24 months per patient since inclusion). | Exploratory analyses on T-cell populations may include but will not be limited to Tumor-infiltrating lymphocytes (TILS) percentage measurement (immunohistochemistry (IHC)), percentage of different T-cell populations (e.g. CD8 or CD3) and RNAseq (antitumoral gene signatures evaluation), PD1-PDL1 expression (IHC). |
| Secondary | Treatment impact on the immunosuppressive myeloid cells in the TME and peripheral blood: | At cycle 1 day 1 (each treatment cycle is 14 days), cycle 2 day 1, and cycle 5 day 1, and after discontinuation of last study treatment until disease progression (for a maximum of 24 months per patient since inclusion). | Exploratory analyses on myeloid cells may include but will not be limited to RNAseq (immunosuppressive gene signature evaluation) and cytometry (changes on peripheral blood mononuclear cells). |
| Secondary | Exploratory microbiome analysis | At screening, cycle 2 day 1 (each treatment cycle is 14 days), and cycle 5 day 1, and after discontinuation of last study treatment until disease progression (for a maximum of 24 months per patient since inclusion). | Evaluation of microbiome communities via metagenomics sequencing in stool samples and identification of bacterial-derived metabolites in plasma. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29313949 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07284277
GET https://conductscience.org/api/trials/v1/NCT07284277/registered