Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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).

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Cisplatin/Gemcitabine Regimen. A regimen consisting of cisplatin and gemcitabine that can be used in the treatment of biliary tract, bladder, cervical, kidney, occult primary, pancreatic, ovarian, fallopian tube, primary peritoneal, and vulvar cancers, peritoneal and pleural mesothelioma, non-small cell lung cancer (NSCLC), gestational trophoblastic neoplasia (GTN), cancer of the nasopharynx, and ampullary adenocarcinoma. NCI Drug Dictionary

carboplatin/paclitaxel regimen. A regimen consisting of carboplatin and paclitaxel that may be used for the treatment of breast, kidney, cervical, vulvar, endometrial, ovarian, fallopian tube, primary peritoneal, head and neck, including cancer of the nasopharynx, esophageal and esophagogastric junction, and gastric cancers; non-small cell lung cancer (NSCLC); anaplastic carcinoma; anal, small bowel and non-urothelial and urothelial bladder cancer; salivary gland, malignant germ cell and malignant sex cord-stromal tumors; cutaneous and uveal melanoma; squamous cell skin cancer; thymomas and thymic carcinoma; occult primary adenocarcinoma or squamous cell carcinoma. Paclitaxel/carboplatin every 21 days regimen may be used for the treatment of esophageal and esophagogastric junction, and gastric cancers. NCI Drug Dictionary

Treatments listed in the registry

• Nab paclitaxel (Drug): 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 (Drug): 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.
• Radiological Assessments (Other): CT imaging of chest abdomen and pelvis will be performed every 8 weeks. MRI may be used.
• mFOLFIRINOX (Drug): 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.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• CT scans: Part of the study plan
• MRI: Part of the study plan
• surgery: Part of the study plan

Main goals

• R0 Resection Rate - Borderline Resectable Prostate Cancer Participants (Approximately every 8 weeks, up to 9 months)
• R0 Resection Rate - Locally Advanced Prostate Cancer Participants (Approximately every 8 weeks, up to 9 months)

Other goals

• Incidences of Adverse Events - Safety
• Number of Participants to Complete Study Intervention- Tolerability
• Progression-Free Survival (PFS)
• Overall Survival (OS)
• Tumor Response
• Disease Control

Planned enrollment: 64 (estimated).

• Levine Cancer Institute, Charlotte, North Carolina
• Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05825066
• NCI Drug Dictionary: C961
• NCI Drug Dictionary: C2688

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 27, 2026. Public record; not medical advice.