Radiofrequency Ablation + Pembrolizumab for Pancreatic Cancer
(PANCARDINAL-2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPutao Cen

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for individuals with advanced pancreatic cancer that can't be removed by surgery. Participants should have no prior treatments for metastatic disease, and must be able to undergo procedures like endoscopic ultrasound.

Inclusion Criteria

I finished my previous cancer treatment over 6 months ago.

ANC ≥1 x 10^9/L

My pancreatic cancer cannot be removed by surgery and has spread.

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Exclusion Criteria

My pancreatic cancer can possibly be removed with surgery.

I am unable to understand and agree to the study's details on my own.

Pregnant or breastfeeding patients or those not employing effective birth control

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Treatment Details

Interventions

Endoscopic Ultrasound Radiofrequency Ablation (Procedure)
Neoadjuvant Chemotherapy (NAC) (Chemotherapy)
Pembrolizumab (Immunotherapy)

Trial OverviewThe study tests a combination of therapies: first, using an endoscope to apply heat (radiofrequency ablation) directly to the tumor; then chemotherapy; followed by pembrolizumab, an immunotherapy drug.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Standard of care chemotherapy + immunotherapy + EUS-RFAExperimental Treatment3 Interventions