Actively Recruiting
Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable or Borderline Resectable Pancreatic Ductal Adenocarcinoma
Led by Emory University · Updated on 2026-04-22
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of gemcitabine, cisplatin, and nab-paclitaxel as a combined neoadjuvant chemotherapy treatment for patients with resectable or borderline resectable pancreatic ductal adenocarcinoma. This phase II trial aims to determine the major pathological response rate, feasibility, and safety of this treatment before surgery, and also to assess if it enhances immune response in the tumor area. Pancreatic cancer that can be removed by surgery has standard treatment involving surgery and chemotherapy, but this study explores giving chemotherapy first to potentially improve outcomes. Participants receive the study drugs intravenously: nab-paclitaxel over 30 minutes, cisplatin over 60 minutes, and gemcitabine over 30 minutes, on days 1 and 15 of each 28-day cycle. Up to four cycles are given if there is no disease progression or unacceptable side effects. After chemotherapy, patients with stable disease or tumor response undergo surgical removal of the tumor. During the study, participants also have biopsies, blood samples, and imaging scans such as CT or MRI before and during treatment. Participants are followed up every 3 to 4 months for up to 24 months after completing treatment to monitor clinical response to chemotherapy and other outcomes. Assessments include pathological response, safety events, radiological response, surgery success, survival, and tumor marker levels. This comprehensive monitoring helps researchers understand how well the treatment works and its effects over time.
CONDITIONS
Brief Title
Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed resectable or borderline resectable pancreatic ductal adenocarcinoma
- Resectable disease defined by no tumor contact with major arteries and limited vein involvement per NCCN guidelines
- Borderline resectable disease including specific tumor contacts or lymph node involvement without distant metastasis
- Adults 18 years or older
- Able to give informed consent and follow study visits
- ECOG performance status of 0 or 1
- Absolute neutrophil count 2 1,500 cells/ul
- Platelet count 2 100,000 cells/ul
- Hemoglobin 2 9 g/dL
- Serum total bilirubin 1.5 times institutional upper limit of normal
- AST and ALT 2.5 times institutional upper limit of normal
- Albumin 2 3 g/dl
- Creatinine 1.5 times institutional upper limit of normal
- Male or non-pregnant, non-lactating female
- Women of child-bearing potential must agree to effective contraception or true abstinence
- Male subjects must agree to use condoms or abstain during treatment and for 6 months after treatment
You will not qualify if you...
- Peripheral neuropathy of grade 2 or higher
- Severe or uncontrolled medical conditions that could affect study participation, such as unstable angina, recent heart attack, arrhythmias, heart failure, uncontrolled diabetes, serious infections, or psychiatric illness
- Pregnancy or breastfeeding
- Known central nervous system disease except treated brain metastases without progression
- Other untreated cancers within the past 5 years except nonmelanoma skin cancer or in situ carcinomas
- Allergy or hypersensitivity to study drugs
- Current abuse of alcohol or illicit drugs
- Unable or unwilling to sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 intravenous nab-paclitaxel, cisplatin, and gemcitabine on days 1 and 15 of each 28-day cycle for up to 4 cycles, unless disease progresses or toxicity occurs. Biopsies, blood sample collections, and CT or MRI scans are done before and during treatment.
2 visits per 28-day cycle for up to 4 cycles
Duration - Variable based on scheduling
Participants with stable disease or response undergo surgical resection of the pancreatic tumor per standard care.
1 visit for surgery
Duration - Up to 24 months
After treatment and surgery, participants are followed every 3 to 4 months to monitor health and disease status for up to 24 months.
Visits every 3 to 4 months
Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
H
Hussein M. Hamad, MD, MPH
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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