Study on Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy for Advanced Pancreatic Cancer

Sponsor: The University of Texas Health Science Center, Houston

Sponsor score: 0

ClinicalTrials ID:NCT06831136

This clinical trial is exploring a new treatment approach for patients with advanced pancreatic cancer that cannot be surgically removed. The study combines endoscopic ultrasound radiofrequency ablation (EUS-RFA) with chemotherapy and the immunotherapy drug pembrolizumab to evaluate its safety and effectiveness.

Patient Parameters

Program Overview

The aim of this study is to test a new treatment method for patients with advanced pancreatic cancer that cannot be removed by surgery. The treatment combines endoscopic ultrasound radiofrequency ablation (EUS-RFA), chemotherapy, and the immunotherapy drug pembrolizumab. Researchers want to see if this combination is safe and can help control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to follow the study plan, including treatments and scheduled visits.
  • Diagnosed with advanced pancreatic cancer that cannot be surgically removed or has spread to other parts of the body.
    • Patients who had surgery before are not eligible unless the cancer has returned and can be treated with EUS-RFA.
    • If a metal stent is in place, it will be replaced with a plastic one during the procedure.
  • Able to understand and agree to the study requirements.
  • In good general health with an ECOG performance status of 0 to 2.
  • Have at least one measurable cancer lesion based on imaging tests.
  • Previous chemotherapy or radiation therapy is allowed if completed at least 6 months before joining the study.
  • Meet specific blood test requirements for neutrophil and platelet counts, liver function, and kidney function.
  • Any major surgery must have been completed at least 4 weeks before starting immunotherapy.

Exclusion Criteria

  • No permanent address or phone number.
  • Pregnant or breastfeeding, or not willing to use birth control during the study and for 90 days after the last dose.
  • Incarcerated individuals.
  • Unable to provide informed consent.
  • Cancer that can be surgically removed or is borderline resectable.
  • History of cancer spread to the brain or central nervous system.
  • History of another primary cancer, unless it is not active or was treated successfully.
  • Known low or absent enzyme activity affecting drug metabolism.
  • Use of certain medications that affect liver enzymes.
  • Significant or uncontrolled health conditions that could interfere with the study.
  • History of HIV or active tuberculosis.
  • Medical conditions that make pembrolizumab treatment risky.
  • Psychiatric or substance abuse issues that could affect participation.
  • Active autoimmune diseases or history of such diseases requiring treatment, except for certain conditions like stable hypothyroidism or controlled celiac disease.
  • Recent use of immunosuppressive medications, with some exceptions for low-dose or specific types of steroids.

Locations

FACILITYZIPCITYSTATE
The University of Texas Health Science Center at Houston77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.