Recruiting
Phase 2

EUS-RFA

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04990609

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)

Neoadjuvant Chemotherapy (NAC)

Study Details

Brief summary:

The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Study ID

NCT04990609

Start date

Aug 13, 2021

Status verified date

Jul, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed and histologically-confirmed PDAC by biopsy
  • Permanent street address
  • Consent to study participation
  • Axial CT scan consistent with PDAC
  • No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

  • Male or female patients < 18 years of age
  • No permanent street address or telephone number
  • Pregnant patients
  • Inmates or prisoners
  • Unable to provide informed consent

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)

Interventions

Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)

Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) consists of the application of an alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor; which induces the release of large amounts of cellular debris. This cellular debris represents a source of tumor antigens that can trigger a host adaptive immune response against the tumor.

Neoadjuvant Chemotherapy (NAC)

The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Primary outcome measure

  • Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection [ Time Frame: From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months) ]

Central Contacts and Locations

Central contacts

Amatullah Alibhai, B.A., M.B.A.

713-486-1443amatullah.alibhai@uth.tmc.edu

Nicole Fatheree, B.B.A.

713-500-5669Nicole.Fatheree@uth.tmc.edu

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Amatullah Alibhai, B.A., M.B.A.

713-486-1443amatullah.alibhai@uth.tmc.edu

Nicole Fatheree, B.B.A.

713-500-5669Nicole.Fatheree@uth.tmc.edu

Principal Investigator:

Nirav Thosani, MD, MHA

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-07-29.