Study on Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy for Advanced Pancreatic Cancer
Sponsor: The University of Texas Health Science Center, Houston
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Texas Health Science Center at Houston | 77030 | Houston | Texas |
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