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Study of EUS-RFA and Pembrolizumab for Pancreatic Cancer

This study is looking at a new way to treat locally advanced or metastatic pancreatic ductal adenocarcinoma (a type of pancreatic cancer). It combines standard chemotherapy (like mFOLFIRINOX or Gemcitabine Nab-Paclitaxel) with two other treatments: Endoscopic Ultrasound (EUS)-guided radiofrequency ablation (RFA), which uses heat to destroy cancer cells, and pembrolizumab, an immunotherapy that helps your body's immune system fight cancer. You would first receive chemotherapy, then have EUS-RFA treatments every six weeks, and also receive pembrolizumab infusions every six weeks. The study aims to see how safe and effective this combined approach is. We are looking for 24 participants who have biopsy-proven pancreatic cancer that is locally advanced or has spread.

Study design
This is an interventional study, meaning participants receive specific treatments. It is a pilot phase II trial, enrolling 24 participants.
What's involved
You would undergo 8 weeks of chemotherapy, followed by EUS-RFA treatments every 6 weeks for up to 5 cycles, and pembrolizumab infusions every 6 weeks. You will also have scheduled visits and examinations.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be assessed from diagnosis until the first sign of progression or death, for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06831136

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~24 participants
Updated 2025-09-10 on ClinicalTrials.gov
What's tested:Neoadjuvant Chemotherapy (NAC)Immunotherapy (pembrolizumab)Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy as assessed by the Overall response rate using RECIST v1.1 guidelines
Measured over From date of diagnosis to the initial date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.

Conditions

Pancreatic Ductal Adenocarcinoma

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Pancreatic Ductal Adenocarcinoma

NCT06831136

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas Health Science Center at Houston

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Putao Cen · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Putao Cen, MD
[email protected]
(832) 325-7705
Email the study team

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Eligibility criteria

Inclusion

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
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:
Absolute neutrophil count (ANC) ≥1 x 109/L
Platelet count ≥75 x 109/L
Albumin levels ≥3 g/dL
Total serum bilirubin \<2× upper limit of normal (ULN) unless secondary to Gilbert's Syndrome
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤3× ULN, or ≤5× ULN in cases of documented liver involvement
Serum creatinine clearance must be ≥30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula
Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before immunotherapy.

Exclusion

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:
Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
Use of strong inhibitors or inducers of Cytochrome P450 3A (CYP3A), CYP2C8 and UGT1A1
History or evidence of clinically significant or uncontrolled cardiovascular, CNS,and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent
History of HIV or active tuberculosis (TB) (PPD response without active TB is allowed)
Underlying medical conditions that, in the Investigator's opinion, will make the administration of pembrolizumab hazardous (e.g., interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms)
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy and the following scenarios below:
Is currently using or previously used immunosuppressive medication within 14 days before the first dose of pembrolizumab. The following medications are exceptions to this criterion:

What this trial measures

  • Efficacy as assessed by the Overall response rate using RECIST v1.1 guidelinesFrom date of diagnosis to the initial date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.

    (ORR) is defined as proportion of patients with complete response (CR) or partial response (PR)