Actively Recruiting
Sequential Neoadjuvant Chemotherapy Using Gemcitabine - Abraxane Followed by mFOLFIRINOX for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Led by Wake Forest University Health Sciences · Updated on 2026-03-25
64
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is focused on evaluating the effects, both positive and negative, of using a sequence of chemotherapy drugs—Gemcitabine with Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX—in patients with borderline resectable and locally advanced pancreatic adenocarcinoma. These treatments have been approved individually as first-line therapies for advanced pancreatic cancer, but their sequential use is being studied to see if it improves outcomes such as the chance of complete tumor removal (R0 resection). Participants will receive Gemcitabine and nab-Paclitaxel weekly for one month, with dosing schedules either on days 1, 8, and 15 or days 1 and 15 in a 28-day cycle. Following this, they will transition to mFOLFIRINOX chemotherapy, which includes Oxaliplatin, Irinotecan, 5-FU, and Leucovorin administered every two weeks over two months. Treatment is outpatient, and imaging assessments after two months determine if therapy continues or stops due to disease progression. After four months of therapy, patients may proceed to surgery, radiation, or additional chemotherapy based on clinical decisions. Throughout the study, patients will have CT scans of the chest, abdomen, and pelvis approximately every eight weeks to monitor tumor response. Researchers will evaluate outcomes including the rate of complete tumor removal, progression-free survival, overall survival, tumor response, and disease control. Safety and tolerability of the treatment sequence will also be assessed. Participants are involved for up to one year post-treatment for follow-up and monitoring of adverse events and survival.
CONDITIONS
Brief Title
Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma, including mixed tumors with predominant adenocarcinoma
- Diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma following NCCN guidelines or multidisciplinary consensus
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function including hemoglobin ≥8 g/dL, absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, total bilirubin ≤1.5 times institutional upper limit (or ≤3 mg/dL if managed), AST/ALT <2.5 times upper limit, creatinine ≤1.5 times upper limit or creatinine clearance >50
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior chemotherapy with gemcitabine, nab-paclitaxel, or FOLFIRINOX for pancreatic cancer
- Use of other investigational anti-cancer agents
- History of other malignancy within last 3 years except certain treated skin or prostate cancers
- Active uncontrolled infections requiring systemic treatment
- Uncontrolled illnesses such as symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
- Known interstitial lung disease or pneumonitis requiring oxygen support
- Surgery other than minor or diagnostic procedures within 4 weeks before study treatment
- Pregnant or breastfeeding individuals
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive sequential neoadjuvant chemotherapy starting with Gemcitabine and nab-Paclitaxel for one month, followed by mFOLFIRINOX for one month. Treatment is given on an outpatient basis. Participants will have imaging assessments to evaluate response and determine continuation.
Weekly or biweekly outpatient visits for chemotherapy infusion over 8 weeks; CT or MRI imaging every 8 weeks
Duration - Up to 1 year after treatment completion
After completing neoadjuvant chemotherapy, participants are followed for safety, disease progression, and survival outcomes for up to 1 year.
Periodic follow-up visits for assessments including imaging and monitoring for adverse events
Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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