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Studying ctDNA to Guide Treatment for Metastatic Pancreatic Cancer

This study is looking at whether a blood test called circulating tumor DNA (ctDNA) can help doctors decide sooner if your treatment for metastatic pancreatic cancer is working. Currently, doctors wait 8 weeks for imaging scans. This trial will give participants standard mFOLFIRINOX chemotherapy (a combination of 5-Fluorouracil, Oxaliplatin, Leucovorin, and Irinotecan). Researchers will measure changes in ctDNA levels and tumor shrinkage to see if ctDNA can help make treatment decisions faster. You may be eligible if you have newly diagnosed metastatic pancreatic adenocarcinoma and are at least 18 years old. The study aims to enroll 50 participants.

Study design
This is an interventional study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive standard mFOLFIRINOX chemotherapy, which involves intravenous infusions every two weeks. Blood tests will be taken at baseline and up to 4 weeks after starting treatment, and imaging scans will be assessed for up to 1.5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in tumor size for up to 1.5 years, and for progression-free survival for up to 3.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07096362

Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Miami
~50 participants
Updated 2025-09-23 on ClinicalTrials.gov
What's tested:5-FluorouracilOxaliplatinLeucovorinIrinotecanGemcitabineNab Paclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1:Change in ctDNA fold-change at Week 4
Measured over Baseline, Up to 4 weeks (after intervention)
+2 more outcomes measured

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma
Pancreatic Ductal Adenocarcinoma

Explore related trials

Pancreatic Ductal AdenocarcinomaCirculating Tumor-Derived DNA Negative

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Gretel Terrero, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Siudy Vasquez
[email protected]
(305) 243-2647
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥ 1.0 × 109 cells/L.
Platelet count ≥ 100,000 cells/mm3 (100 × 109 cells/L). Supportive platelet transfusions are acceptable.
Hemoglobin (Hgb) ≥ 9 g/dL. Supportive packed red blood cell transfusions are acceptable. 9. Adequate blood chemistry levels at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
Aspartate aminotransferase (AST) - serum glutamic-oxaloacetic transaminase (SGOT); alanine transaminase (ALT) - serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 × upper limit of normal (ULN) range, unless liver metastases are present, then ≤ 5 × ULN is allowed.
Total bilirubin ≤ 1.5 × Upper Limit of Normal.
Estimated creatinine clearance of \> 60 mL/min (per Cockcroft-Gault formula).
Albumin ≥ 3.0 g/dL. 10. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to ≤ 1. 11. Must be a modified Folfirinox chemotherapy candidate. 12. For participants not qualified or able to give legal consent, consent must be obtained from their legally authorized representative (LAR).

Exclusion

History of myocardial infarction, angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within six months prior to study entry
Documented cardiomyopathy 8. Grade 2 or greater sensory peripheral neuropathy. 9. History of chronic diarrhea. 10. Pregnant or nursing. 11. Concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or integrity of the study data. 12. Concurrently enrolled in any other interventional clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer. 13. Patient is unwilling or unable to comply with study procedures. 14. Patients with impaired decision-making capacity. 15. No other medical condition or reason that, in the opinion of the investigator, would preclude study participation.

What this trial measures

  • Part 1:Change in ctDNA fold-change at Week 4Baseline, Up to 4 weeks (after intervention)

    Circulating tumor Deoxyribonucleic Acid (ctDNA) fold-change at week 4 is defined as the ratio between ctDNA quantity at week 4 relative to baseline. The quantity of ctDNA will be measured in ng/mL. At week 4 among participants in Part 1 will be reported as a Tumor Methylation Score (TMS) in plasma samples. The ratio between the TMS at week 4 (TMS4) and the TMS at baseline (TMS0) will be calculated.

  • Part 1: Number of Radiographic Response Status Responders vs. Number of Non-RespondersUp to 1.5 years (after intervention)

    Radiographic response status among participants in Part 1 will be reported in numbers. Participants will undergo Positron Emission Tomography/Computed Tomography (PET/CT) radiographic imaging scans at the end of week 8. Participants will be subdivided into two groups: responders vs. non-responders to modified Folfirinox treatment. Responders will be defined as the number of participants achieving complete response (CR), partial response (PR) or exhibiting stable disease (SD). Non-responders will be defined as the number of participants exhibiting progressive disease (PD). Response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

  • Part 2: Progression-Free Survival (PFS)Up to 3.5 years (after intervention)

    Progression-Free Survival (PFS) is defined as elapsed time in months from day 1 of starting second-line (2L) chemotherapy until the date of documented progressive disease (PD) or death.