Actively Recruiting
Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma
Led by The University of Texas Health Science Center, Houston · Updated on 2025-09-10
24
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to follow the study protocol, including treatment and scheduled visits
- Biopsy-confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma
- Mental capacity to provide informed consent and comply with study requirements
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- At least one measurable metastatic lesion on imaging per RECIST v1 criteria
- No prior systemic therapy except prior adjuvant therapy completed at least 3 months before enrollment or up to 3 months of stable first-line chemotherapy
- Absolute neutrophil count (ANC) of at least 1 x 10^9/L
- Platelet count of at least 75 x 10^9/L
- Albumin level of at least 3 g/dL
- Total serum bilirubin less than 2 times upper limit of normal unless due to Gilbert's Syndrome
- Patients with biliary stents or drainage are allowed if bilirubin is improving and below 2.5 times upper limit of normal
- Liver enzymes (ALT, AST, ALP) less than 3 times upper limit of normal or less than 5 times with liver involvement
- Serum creatinine clearance of at least 30 mL/min
- Prior major surgery completed at least 4 weeks before starting immunotherapy
You will not qualify if you...
- No telephone number or permanent address
- Pregnant or breastfeeding, or unwilling to use effective birth control during study and 90 days after last dose
- Prisoners or inmates
- Unable to provide informed consent
- Resectable or borderline resectable pancreatic ductal adenocarcinoma
- Known central nervous system metastases
- History of another primary cancer except adequately treated non-melanoma skin cancer or carcinoma in situ without active disease
- Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
- Use of strong inhibitors or inducers of certain liver enzymes (CYP3A, CYP2C8, UGT1A1)
- Significant uncontrolled cardiovascular, central nervous system, or systemic diseases
- History of HIV or active tuberculosis (latent TB allowed)
- Medical conditions making pembrolizumab unsafe (e.g., interstitial lung disease, active infections needing antibiotics)
- Psychiatric or substance abuse disorders interfering with study participation
- Active autoimmune diseases or history requiring systemic steroids or immunosuppressants except certain controlled conditions
- Current or recent use of immunosuppressive medications within 14 days before pembrolizumab except certain topical or low-dose steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Putao Cen, MD
CONTACT
A
Ayodeji Adeniji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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