Back to search results

Gemcitabine, Cisplatin, and Nab-Paclitaxel for Pancreatic Cancer

This study is testing a treatment combination of gemcitabine, cisplatin, and nab-paclitaxel given before surgery for patients with pancreatic cancer that can be removed (resectable) or is borderline resectable. The goal is to see how well this treatment works and if it can improve outcomes compared to surgery first. Researchers will measure the clinical response rate to this chemotherapy before surgery. You may be able to join if you are 18 or older and have pancreatic cancer that is resectable or borderline resectable, confirmed by a biopsy. The study is planning to enroll 36 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 36 participants. It is testing a specific treatment combination before surgery.
What's involved
You would receive nab-paclitaxel, cisplatin, and gemcitabine intravenously every 28 days for up to 4 cycles. You would also undergo biopsies, blood sample collections, and CT scans.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up every 3-4 months for up to 24 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.

NCT06423326

Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Emory University
~36 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionCisplatinComputed TomographyGemcitabineMagnetic Resonance Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Response Rate to Neoadjuvant Chemotherapy
Measured over Up to 24 months

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma
Resectable Pancreatic Adenocarcinoma
Stage I Pancreatic Cancer AJCC v8
Stage II Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT06423326

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Hussein M Hamad, MD, MPH · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Hussein M. Hamad, MD, MPH
[email protected]
404-778-3307
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Histologically or cytologically confirmed - resectable and borderline resectable pancreatic ductal adenocarcinoma
Resectability will be defined as per National Comprehensive Cancer Network (NCCN) guidelines using cross-sectional imaging (contrast-enhanced computed tomography or magnetic resonance imaging scans of the abdomen, and pelvis)
Decisions about resectability status will be made in consensus at multidisciplinary meetings/discussions
No interface of the tumor with celiac artery, common hepatic artery (CHA), or superior mesenteric arteries (SMA) (and, if present, variants)
Less than 180° interface between tumor and vessel wall of the portal or superior mesenteric veins (SMV) without vein contour irregularity
For tumors of the body and tail of the pancreas, interface with the splenic artery and splenic vein of any degree will be considered resectable disease
To include at least one of the following:
Tumor abutment \< 180° of the superior mesenteric artery or celiac axis
Solid tumor contact with CHA without extension to celiac artery (CA) or hepatic artery bifurcation allowing for safe and complete resection and reconstruction
Solid tumor contact with variant arterial anatomy (ex: accessory right hepatic artery, replaced right hepatic artery, replaced CHA, and the origin of replaced or accessory artery)
Tumor induced narrowing of SMV, portal vein (PV) or SMV-PV of \> 180˚ of the diameter of the vessel
Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction
Solid tumor contact with inferior vena cava
Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA)
No distant extrapancreatic disease (M0)
Adults \> 18 years of age
Able to give informed consent
Able to adhere to study visit schedule and other protocol requirements
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
Absolute neutrophil count (ANC) ≥ 1,500 cells/ul
Platelet count ≥ 100,000 cells/ul
Hemoglobin ≥ 9 g/dL
Serum total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Albumin ≥ 3 g/dl
Creatinine ≤ 1.5 x ULN
Male, or a non-pregnant and non-lactating female
Women of child-bearing potential - defined as a sexually mature woman who has not undergone hysterectomy - the surgical removal of the uterus or bilateral oophorectomy - the surgical removal of both ovaries or has not been naturally postmenopausal for at least 24 consecutive months, i.e., has had menses at any time during the preceding 24 consecutive months, must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel (including dose interruptions) until treatment with gemcitabine/cisplatin/nab-paclitaxel is complete
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/nab-paclitaxel and for 6 months following gemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has undergone a successful vasectomy

Exclusion

Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations
Pregnancy (positive pregnancy test) or lactation
Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery \[RS\]; Gamma Knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
Previous (within the past 5 years) or concurrent presence of other untreated cancer, except nonmelanoma skin cancer and in situ carcinomas
History of allergy or hypersensitivity to any of the study drugs
Current abuse of alcohol or illicit drugs
Inability or unwillingness to sign the informed consent form

What this trial measures

  • Clinical Response Rate to Neoadjuvant ChemotherapyUp to 24 months

    Clinical response is defined as biochemical, radiological, pathological response or stable disease. • Biochemical response (or CA 19-9 response) is defined as \>50% decrease from baseline with tumor response. Radiologic response is defined as complete response (CR), partial response (PR) or stable disease (SD) after the neoadjuvant therapy per RECIST 1.1. Pathologic response is defined by CAP scoring system as 0 (complete response), 1 (moderate response), 2 (minimal response) and 3 (poor or no response). Stable disease is defined as the absence of biochemical response (\>50% CA 19-9 reduction), radiological response (per RECIST 1.1), or major pathological response (CAP Score 0-1), without metastasis / unresectability, and patient undergoes surgical resection. Clinical response rate (including clinical, biochemical, radiological, pathological response or stable disease) will be reported as a proportion, with an exact 90% confidence interval estimated using the Clopper-Pearson method.