RecruitingPhase 2NCT06831136

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

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

24 participants

Start Date

Mar 26, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two treatments — a procedure called endoscopic ultrasound radiofrequency ablation (EUS-RFA, which uses heat delivered through a scope to destroy tumor tissue) and the immunotherapy drug pembrolizumab — can help treat advanced pancreatic cancer that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with pancreatic ductal cancer (confirmed by biopsy) that is either locally advanced or has spread to other organs and cannot be surgically removed - You are capable of understanding and consenting to the study - Your overall health and functional status are adequate **You may NOT be eligible if...** - You have previously had pancreatic cancer surgery and do not have a recurrent tumor that can be treated with the ablation procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant Chemotherapy (NAC)

Participant will undergo 8 weeks of NAC (treating physician's choice). Possible regimens are either mFOLFIRINOX or NALIRIFOX or Gemcitabine Nab-Paclitaxel ± Cisplatin (GA+/-Cisplatin) or Capecitabine (Xeloda).

DRUGImmunotherapy (pembrolizumab)

2-12 weeks after initial chemotherapy and after the first EUS-RFA treatment, patients will receive 400 mg every 6 weeks of pembrolizumab via infusion. Participants will be administered standard of care chemotherapy and pembrolizumab every 6 weeks.

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

After 2-12 weeks of chemotherapy, patients will undergo EUS-RFA treatment 1 session every 6 weeks. Each RFA treatment will be for up to 5 cycles at 30W for 20 seconds or until there is an increase in measured impedance. After the 5th EUS-RFA, if there is clinical benefit, then patients will continue with EUS-RFA treatments until no active tumor is seen. During each session, the therapeutic gastroenterologist will evaluate if there is any tumor to undergo RFA. If no active tumor seen, then will abort RFA

Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT06831136

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