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Chemotherapy Sequence for Pancreatic Cancer

This study is testing a new sequence of chemotherapy drugs for people with pancreatic adenocarcinoma that is either borderline resectable (meaning surgery might be possible) or locally advanced (cancer that has grown into nearby tissues but hasn't spread far). You would first receive Gemcitabine and Nab-paclitaxel (GA) for one month, followed by mFOLFIRINOX for another month. Researchers want to see if this specific order of treatments improves the chance of completely removing the tumor with surgery (called R0 resection rate). The study is looking for 64 participants aged 18 and older with a confirmed diagnosis of pancreatic adenocarcinoma. The study status is currently unclear.

Study design
This is an interventional study with a planned enrollment of 64 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive chemotherapy on an outpatient basis. You would also have CT scans of your chest, abdomen, and pelvis every 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your R0 resection rate will be measured approximately every 8 weeks, for up to 9 months.

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

NCT05825066

Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~64 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Nab paclitaxelGemcitabineRadiological AssessmentsmFOLFIRINOX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
R0 Resection Rate - Borderline Resectable Prostate Cancer Participants
Measured over Approximately every 8 weeks, up to 9 months
+1 more outcome measured

Conditions

Pancreas Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Ravi K Paluri, MD, MPH · PRINCIPAL_INVESTIGATOR · Wake Forest Baptist Comprehensive Cancer Center

Who to contact

Project Manager
[email protected]
336-716-5772
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per National Comprehensive Cancer Network (NCCN) guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus.
Age 18 or above.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Patients must have organ and marrow function as defined below:
Hemoglobin ≥8 g/dL
Absolute neutrophil count ≥1,500/mcL
Platelets ≥100,000/mcL
Total bilirubin ≤1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
Creatinine ≤1.5 X institutional upper limit of normal or CrCL\>50
It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion

Patients who have had prior chemotherapy with gemcitabine and/or nab-paclitaxel or FOLFIRINOX for pancreatic cancer.
Patients receiving any other investigational anti-neoplastic agents.
History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible.
Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed.
Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the patient's safety.
Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible.
Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment.
Patients who are pregnant or breastfeeding.

What this trial measures

  • R0 Resection Rate - Borderline Resectable Prostate Cancer ParticipantsApproximately every 8 weeks, up to 9 months

    The R0 resection is assessed only in patients who undergo surgery. R0 resection is a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. Participants are considered to be evaluable if they receive at least one sequence of treatments with GA and mFFX (1 cycle GA followed by 1 cycle of m FFX). Primary analysis for each cohort will calculate the R0 resection rate with one-sided 95% confidence interval.

  • R0 Resection Rate - Locally Advanced Prostate Cancer ParticipantsApproximately every 8 weeks, up to 9 months

    The R0 resection is assessed only in patients who undergo surgery. R0 resection is a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. Participants are considered to be evaluable if they receive at least one sequence of treatments with GA and mFFX (1 cycle GA followed by 1 cycle of m FFX). Primary analysis for each cohort will calculate the R0 resection rate with one-sided 95% confidence interval.