Recruiting
Phase 2

EUS-Guided Chemoablation

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07529483

Conditions

Pancreatic Cystic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ablation Therapy

Biospecimen Collection

Computed Tomography

Electronic Health Record Review

Endoscopic Ultrasound

Study Details

Brief 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%. 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.

Conditions

Pancreatic Cystic Neoplasm

Study ID

NCT07529483

Start date

May 12, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Ablation Therapy

Undergo EUS-guided chemotherapy ablation

Biospecimen Collection

Undergo blood and cyst fluid sample collection

Computed Tomography

Undergo CT

Electronic Health Record Review

Ancillary studies

Endoscopic Ultrasound

Undergo EUS and EUS-guided chemoablation

Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Undergo EUS-guided FNA

Gemcitabine Hydrochloride

Given via EUS-guided intracystic FNI

Magnetic Resonance Cholangiopancreatography

Undergo MRCP

Magnetic Resonance Imaging

Undergo MRI

Paclitaxel

Given via EUS-guided intracystic FNI

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 ]
  • Number of participants with > 50% to < 90% reduction in cyst volume [ Time Frame: At 12 months after EUS-guided chemoablation ]
  • Number of participants with < 50% reduction in cyst volume [ Time Frame: At 12 months after EUS-guided chemoablation ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Somashekar G. Krishna, MD, MPH

6143668716somashekar.krishna@osumc.edu

Principal Investigator:

Somashekar G. Krishna, MD, MPH

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-05-29.