Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms (ERASE-Chemo)

Endoscopic Ultrasound-Guided Chemoablation of Pancreatic Cysts - An Efficacy Trial

This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. Pancreatic cysts are a common precancerous lesion that may develop into pancreatic cancer. An EUS is a procedure in which an endoscope is inserted into the body. An endoscope is a thin, tube-like instrument that has a light and a lens for viewing. A probe at the end of the endoscope is used to bounce high-energy sound waves (ultrasound) off internal organs to make a picture (sonogram). EUS-guided chemoablation uses a fine needle inserted into the pancreatic cyst to deliver chemotherapy, such as gemcitabine and paclitaxel, directly into the cyst ("intracystic"). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. An EUS-guided chemoablation, with gemcitabine and paclitaxel, may be an effective minimally invasive strategy to destroy abnormal or precancerous cells while reducing exposure to the rest of the body in patients with pancreatic cysts.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cystic Neoplasm
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Cholangiopancreatography; Procedure: Ablation Therapy; Procedure: Biospecimen Collection; Procedure: Endoscopic Ultrasound; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration; Drug: Gemcitabine Hydrochloride; Drug: Paclitaxel

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the efficacy of EUS-chemoablation of pancreatic cystic neoplasms (PCNs).

SECONDARY OBJECTIVES:

I. To assess the safety of EUS-guided chemoablation of PCNs. II. To assess the long-term response to EUS-chemoablation.

OUTLINE:

Patients undergo EUS-guided fine needle aspiration (FNA) and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic fine needle injection (FNI) on day 0. Patients also undergo blood and cyst fluid sample collection and magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography (MRCP) or computed tomography (CT) throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.

After completion of study treatment, patients are followed every 3-6 or 6-12 months as per standard of care for at least 3 years.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Principal Investigator: Somashekar G. Krishna, MD, MPH
      • Contact: Somashekar G. Krishna, MD, MPH; Phone Number: 6143668716; Email: somashekar.krishna@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• A diagnosis of a pancreatic cystic neoplasm (PCN) confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) including cyst fluid next-generation sequencing (NGS) and/or EUS-needle based confocal laser endomicroscopy (nCLE) and/or EUS-through the needle biopsy (TTNB)
• The pancreatic cystic lesion (PCL) measures at least 1 cm in diameter on CT, MRI/MRCP, or EUS
• This cohort may include patients with PCNs previously treated with other ablative modalities include EUS-radiofrequency ablation (RFA) (NCT05961982, institutional review board [IRB]: 2023C0004) or EUS-pulsed electric field (PEF) (IRB 20251089) who have shown either no response or only a partial response to therapy

• The patient is not a surgical candidate. Common clinical scenarios include-

  • Cirrhosis of the liver (common clinical scenario)
  • Advanced (≥ 75 years) age (common clinical scenario)
  • Morbid obesity
  • Significant cardiorespiratory comorbidity
  • Patient's choice (patient elects for non-surgical management)
  • Other significant comorbid conditions that impose prohibitive surgical risks
• Estimated life expectancy of at least 1 year
• Capable of giving written informed consent or has a legally authorized representative (LAR) to consent for them
• Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients undergoing endoscopy and sedation for endoscopy

Exclusion Criteria:

• Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study
• Any psychiatric disorder making reliable informed consent impossible

• Pregnancy or breast-feeding

  • Pregnant patients will be excluded due to confounding variables
• Contraindication to general anesthesia after review by Ohio State University (OSU) Preoperative Assessment Clinic (OPAC)
• Non-English speaking individuals are excluded because study materials, consent forms, and validated patient-reported assessments are available only in English, and interpreter-mediated consent could compromise comprehension of procedural risks associated with an investigational intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel); Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.

Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Diagnostic CAT Scan; Diagnostic CAT Scan Service Type; Other: Electronic Health Record Review; Ancillary studies; Procedure: Magnetic Resonance Cholangiopancreatography; Undergo MRCP; Other Names: MRCP; Procedure: Ablation Therapy; Undergo EUS-guided chemotherapy ablation; Other Names: Ablation; Catheter Ablation; Local Ablation Therapy; Local Ablative Therapy; Ablation, NOS; Procedure: Biospecimen Collection; Undergo blood and cyst fluid sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Procedure: Endoscopic Ultrasound; Undergo EUS and EUS-guided chemoablation; Other Names: endosonography; EUS; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration; Undergo EUS-guided FNA; Other Names: EUS-FNA; endoscopic ultrasound-guided fine needle aspiration; Drug: Gemcitabine Hydrochloride; Given via EUS-guided intracystic FNI; Other Names: Gemzar; dFdCyd; Difluorodeoxycytidine Hydrochloride; Gemcitabine HCI; LY-188011; LY188011; LY 188011; Drug: Paclitaxel; Given via EUS-guided intracystic FNI; Other Names: Taxol; Anzatax; Asotax; Bristaxol; Praxel; Taxol Konzentrat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with > 50% to < 90% reduction in cyst volume	Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound	At 12 months after EUS-guided chemoablation
Number of participants with < 50% reduction in cyst volume	Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound	At 12 months after EUS-guided chemoablation
Number of participants with greater than 90% reduction in cyst volume	Number of participants with greater than 90% reduction in cyst volume - Determined using standard of care surveillance imaging, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computed tomography (CT) with pancreas protocol, or endoscopic ultrasound (EUS).	At 12 months after endoscopic ultrasound (EUS)-guided chemoablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of adverse events attributable to EUS-chemoablation	Proportion of adverse events attributable to EUS-chemoablation - Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to 30 days post procedure

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Somashekar G Krishna, MD, MPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytological Techniques; Biopsy; Cytodiagnosis; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Health Care Economics and Organizations; Diagnostic Techniques, Surgical; Diagnostic Imaging; Chemistry Techniques, Analytical; Spectrum Analysis; Ablation Techniques; Radiofrequency Ablation; Radiofrequency Therapy; Ultrasonography; Biopsy, Fine-Needle; Biopsy, Needle; Image-Guided Biopsy; Ultrasonography, Interventional; Economics; Gemcitabine; Paclitaxel; Specimen Handling; Magnetic Resonance Spectroscopy; Catheter Ablation; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Taxes
• Other Study ID Numbers: OSU-25163 (Other Identifier: Ohio State University Comprehensive Cancer Center); NCI-2026-01895 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No