Recruiting

Phase 2

Neoadjuvant ChemotherapyNeoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05825066

Conditions

Pancreas Adenocarcinoma

Borderline Resectable Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nab paclitaxel

Gemcitabine

Radiological Assessments

mFOLFIRINOX

Study Details

Brief summary:

The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.

Conditions

Pancreas Adenocarcinoma

Borderline Resectable Pancreatic Adenocarcinoma

Locally Advanced Pancreatic Adenocarcinoma

Study ID

NCT05825066

Start date

Aug 1, 2023

Status verified date

Aug, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.
If obstructive jaundice is present, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg/dL, then this inclusion criteria is met.
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 Criteria:

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.

Study Design

Enrollment

64 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)

Gemcitabine (1000 mg/m2 weekly, on day 1,8 and 15 OR 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion.
nab-Paclitaxel (125 mg/m2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month.

1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR
1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off
mFOLFIRINOX: Oxaliplatin, 85 mg/m² IV once every two weeks over 2 hours on Day 1; Irinotecan, 150 mg/m² IV once every two weeks over 90 minutes on Day 1; 5-FU, 2,400 mg/m² IV once every two weeks over 46-48 hours administered via infusion; Leucovorin, 400 mg/m2 IV every two weeks over 90 minutes on Day 1.

1 Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle

Interventions

Nab paclitaxel

The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month.

The patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician.

Gemcitabine

Radiological Assessments

CT imaging of chest abdomen and pelvis will be performed every 8 weeks. MRI may be used.

mFOLFIRINOX

Primary outcome measure

R0 Resection Rate - Borderline Resectable Prostate Cancer Participants [ Time Frame: Approximately every 8 weeks, up to 9 months ]
R0 Resection Rate - Locally Advanced Prostate Cancer Participants [ Time Frame: Approximately every 8 weeks, up to 9 months ]

Central Contacts and Locations

Central contacts

Project Manager

336-716-5772 Melani.Terry@advocatehealth.org

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Project Manager

336-716-5772 Melani.Terry@advocatehealth.org

Principal Investigator:

Ravi K Paluri, MD, MPH

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-11.