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

Recruiting now · Phase 2

Conditions studied: 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

In brief

This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy is more feasible and could improve outcomes compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.

Key facts

Study ID: NCT06423326
Run by: Emory University
People needed: 36
Starts: 2024-08-06
Expected to finish: 2027-12-31
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Resectable disease will be defined as:
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
Borderline resectable disease will be defined as:
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)

You may not qualify if…

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

Where it is running

Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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