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Pancreatic Cystic NeoplasmPhase 2ERASE-ChemoNCT07529483

Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms

A Phase 2 study testing Ablation Therapy, Biospecimen Collection and Computed Tomography in people with Pancreatic Cystic Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cystic Neoplasm
What is being tested?
Ablation Therapy, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
12 May 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 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)
Show all 14Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Somashekar G. Krishna, MD, MPH, 6143668716, somashekar.krishna@osumc.edu

    Somashekar G. Krishna, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Ablation Therapy, Biospecimen Collection, Computed Tomography, Electronic Health Record Review, Endoscopic Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ablation TherapyProcedure or surgery

    Also called Ablation, Ablation, NOS, Catheter Ablation, Local Ablation Therapy

    Undergo EUS-guided chemotherapy ablation

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and cyst fluid sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Endoscopic UltrasoundProcedure or surgery

    Also called endosonography, EUS

    Undergo EUS and EUS-guided chemoablation

  • Endoscopic Ultrasound-Guided Fine-Needle AspirationProcedure or surgery

    Also called endoscopic ultrasound-guided fine needle aspiration, EUS-FNA

    Undergo EUS-guided FNA

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar

    Given via EUS-guided intracystic FNI

  • Magnetic Resonance CholangiopancreatographyProcedure or surgery

    Also called MRCP

    Undergo MRCP

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given via EUS-guided intracystic FNI

Study groups in NCT07529483
Study groupRoleWhat they receive
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)ExperimentalPatients 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.
Receives: Procedure: Ablation Therapy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Endoscopic Ultrasound; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Cholangiopancreatography; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At 12 months after endoscopic ultrasound (EUS)-guided chemoablation

  2. 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

    Measured: At 12 months after EUS-guided chemoablation

  3. 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

    Measured: At 12 months after EUS-guided chemoablation

Secondary outcomes (1)

  1. 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.

    Measured: Up to 30 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start12 May 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07529483
Sponsor's protocol ID
OSU-25163
Other IDs
NCI-2026-01895, OSU-25163
Acronym
ERASE-Chemo
Status last verified
May 2026
First submitted
7 Apr 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ablation Therapy, Biospecimen Collection and Computed Tomography in people with Pancreatic Cystic Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with greater than 90% reduction in cyst volume (time frame: At 12 months after endoscopic ultrasound (EUS)-guided chemoablation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07529483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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