NCT07529483 Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms
| NCT ID | NCT07529483 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Pancreatic Cystic Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2026-05-12 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
The Ohio State University Comprehensive Cancer Center
✉ OSUCCCClinicaltrials@osumc.edu📞 800-293-5066
Somashekar G Krishna, MD, MPH
PRINCIPAL INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07529483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cystic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07529483 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07529483 currently recruiting?
Yes, NCT07529483 is actively recruiting participants. Contact the research team at OSUCCCClinicaltrials@osumc.edu for enrollment information.
Where is the NCT07529483 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07529483 clinical trial?
NCT07529483 is sponsored by Ohio State University Comprehensive Cancer Center. The principal investigator is Somashekar G Krishna, MD, MPH at Ohio State University Comprehensive Cancer Center. The trial plans to enroll 35 participants.