Recruiting

Neoadjuvant Treatment

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06320717

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood sample

Study Details

Brief summary:

To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.

The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.

Conditions

Pancreatic Ductal Adenocarcinoma

Study ID

NCT06320717

Start date

Jan 2, 2024

Status verified date

Jul, 2026

Completion date

Dec 2, 2026

Anticipated

Primary completion date

Dec 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria \[35\].
  • Availability of archival tumor tissue (diagnostic for PDAC) required
  • Have a documented ECOG Performance Status of ≤ 1
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.

Exclusion Criteria:

  • Has received prior systemic treatment (standard of care or experimental) for PDAC
  • Participant has a concurrent malignancy requiring active treatment during the study.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Borderline Resectable (Cohort A)

Pathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy

Patients with Resectable (Cohort B)

Pathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy

Interventions

Blood sample

To determine if there are any biomarkers in the blood that could be used to choose best treatment plan for future patients

Primary outcome measure

  • Retrospective prediction of pCR in resectable patients [ Time Frame: Up to 2 years ]
  • Retrospective prediction of pCR in borderline resectable patients [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Christos Fountzilas, MD

716-845-2300Christos.Fountzilas@roswellpark.org

Locations

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Good Samaritan University Hospital

Recruiting

West Islip, New York, United States, 11795

Contacts

John Loscalzo, MD

631-417-8600

Principal Investigator:

John Loscalzo, MD

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-07-23.