Borderline Resectable Pancreatic Ductal AdenocarcinomaPhase 2NCT06423326
Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer
A Phase 2 study testing Biopsy, Biospecimen Collection and Cisplatin in people with Borderline Resectable Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Adenocarcinoma, run by Georgetown University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Adenocarcinoma, Stage I Pancreatic Cancer AJCC v8
- What is being tested?
- Biopsy, Biospecimen Collection and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2024to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Adequate Bone marrow reserves as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/ul
- Platelet count ≥ 100,000 cells/ul
- Hemoglobin ≥ 9 g/dL
- Adequate hepatic function as evidence by:
- 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
- Adequate renal function as evidenced by 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Kathleen M. Coleman, kathleen.marie.coleman@emory.edu
Hussein Hamad, MD, MPH
- Not yet recruiting
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
Susan Lawrence, RN, 202-784-2725, sl2328@georgetown.edu
MIhir M. Shah, MD
About this study
Official title: A Single-Arm Phase II Clinical Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the clinical response rate of biweekly gemcitabine, cisplatin and nab-paclitaxel (GCN) in the neoadjuvant setting for patients with resectable and borderline resectable pancreatic ductal adenocarcinoma.
SECONDARY OBJECTIVE:
- Determine if neoadjuvant GCN increases tumoral infiltration of lymphocytes with local and systemic phenotypic features that assist in the antitumor immune response.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease, partial or complete response undergo surgical resection per standard of care. Additionally, patients undergo biopsy on study and undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) at pre-study and on study.
After completion of study treatment, patients are followed up every 3-4 months for 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
- Being tested
- Biopsy, Biospecimen Collection, Cisplatin, Computed Tomography, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Nab-paclitaxelDrug
Also called ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel
Given IV
Pancreatic Surgical ProcedureProcedure or surgery
Also called Pancreatic Surgery
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nab-paclitaxel, cisplatin, gemcitabine) | Experimental | Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease, partial or complete response undergo surgical resection per standard of care. Additionally, patients undergo biopsy on study and undergo blood sample collection and CT or MRI at pre-study and on study. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Gemcitabine; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Procedure: Pancreatic Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate to Neoadjuvant Chemotherapy
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.
Measured: Up to 24 months
Secondary outcomes (10)
Treatment Completion
Feasibility will be defined as completion of all preoperative and operative therapy. Treatment completion will reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method.
Measured: Up to 24 months
Incidence of Adverse Events (AEs)
AEs, with severity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be reported, using frequencies and percentages for each toxicity.
Measured: Up to 28 days after last dose of study treatment
Radiologic Response Rate
Radiological response rate will be defined as complete response, partial response or stable disease after study treatment evaluated using Response Evaluation Criteria in Solid Tumors version 1.1. Radiologic response rate will be reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method.
Measured: Up to 24 months
Pathological Response Rate
To assess the major pathological response rate (CAP 0-1) in the surgical resection specimen
Measured: Up to 24 months
Neoadjuvant Systemic Chemotherapy Rate
To assess the rate of neoadjuvant systemic chemotherapy completion (Duration 4 months) without dose reduction
Measured: Up to 4 months
R0 Resection Rate
R0 resection indicates a microscopically margin-negative resection. R0 resection rate will reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method.
Measured: At time of surgery
Nodal Status
N0, N1, and N2 will be reported using frequencies and percentages.
Measured: Up to 24 months
Recurrence-Free Survival (RFS)
RFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median RFS will be estimated using the Brookmeyer-Crowley approach.
Measured: From surgery to recurrence or death, assessed up to 24 months
Overall Survival (OS) Rate
OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach.
Measured: From study treatment start to date of death, assessed up to 24 months
Carbohydrate Antigen (CA)19-9 response
CA19-9 response will be defined as > 50% decrease from baseline will be correlated with tumor response. CA19-9 will be reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. CA19-9 will be correlated with RFS and OS using log-rank tests and Cox proportional hazards regression. Model assumptions will be checked and verified.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start6 Aug 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Mihir M. Shah, MD, MS, FACS, FSSO, Principal investigator, Georgetown University Lombardi Comprehensive Cancer Center, Medstar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423326
- Sponsor's protocol ID
- STUDY00010624
- Other IDs
- WINSHIP6093-23, STUDY00006976
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No