Loading clinical trials...

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma; a Phase II Trial PANcreas CAncer RaDIofrequeNcy AbLation

NCT06831136•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic Pancreatic ductal adenocarcinoma (mPDAC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is willing and able to comply with the protocol for the duration of the study,including undergoing treatment and scheduled visits and examinations, including follow-up
•Biopsy-proven locally advanced unresectable or metastatic PDAC
•1. Patients who have undergone prior resection will be excluded unless there is recurrent pancreatic tumor that is amenable to EUS-RFA.
•2. If biliary metal stent is placed, during procedure of EUS-RFA, indwelling biliary metal stent will be removed during initial EUS-RFA and then replaced with plastic stent.
•Mental capacity to provide informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
•Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
•At least one measurable metastatic lesion on axial imaging per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
•No prior systemic therapy, including chemotherapy or chemoradiation is permitted with the following exceptions:
•1. Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if standard of care neoadjuvant or adjuvant therapy was completed at least 3 months prior to study enrollment. Prior adjuvant therapy may include mFFX, NALIRIFOX, GA or Capecitabine (Xeloda).
•2. If started on first-line treatment for mPDAC elsewhere (i.e., not at our study site), eligible participants can have undergone 3 months of chemotherapy with stable disease before study entry. Note: Imaging done outside the site will need to be reviewed for a 2nd opinion to confirm stable disease.
+10 more criteria

Exclusion Criteria

•No telephone number and permanent street address
•Pregnant or breastfeeding patients; or is a male or female patient of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose
•Inmates or prisoners
•Unable to provide informed consent
•Resectable, borderline resectable PDAC.
•Known history of central nervous system (CNS) metastases
•Has a history of another primary malignancy. Patients having the following are still eligible:
•1. No active stage 4 cancer
•2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•3. Adequately treated carcinoma in situ without evidence of disease
+17 more criteria

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

March 26, 2025

Primary Completion Date

January 20, 2028

Completion Date

January 20, 2030

Last Updated

September 10, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Neoadjuvant Chemotherapy (NAC)

DRUG

Immunotherapy (pembrolizumab)

DRUG

Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)

DEVICE

Contacts

Putao Cen, MD

CONTACT

(832) 325-7705 pancreasresearch@uth.tmc.edu

Ayodeji Adeniji

CONTACT

(713) 500-5377 Ayodeji.Adeniji@uth.tmc.edu

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

RECRUITINGPHASE1/PHASE2

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

NCT06445062

Colorectal CancerCRC+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors