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OncoMatch/Clinical Trials/NCT06831136

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

Is NCT06831136 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Neoadjuvant Chemotherapy (NAC) and Immunotherapy (pembrolizumab) for pancreatic ductal adenocarcinoma.

Phase 2RecruitingThe University of Texas Health Science Center, HoustonNCT06831136Data as of May 2026

Treatment: Neoadjuvant Chemotherapy (NAC) · Immunotherapy (pembrolizumab) · Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)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).

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Disease stage

Excluded: Stage RESECTABLE, BORDERLINE RESECTABLE

Biopsy-proven locally advanced unresectable or metastatic PDAC; At least one measurable metastatic lesion on axial imaging per RECIST v1

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: systemic therapy

Exception: Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if standard of care neoadjuvant or adjuvant therapy was completed at least 3 months prior to study enrollment. Prior adjuvant therapy may include mFFX, NALIRIFOX, GA or Capecitabine (Xeloda). Patients who had prior treatment and stable disease up to 3 months and confirmed radiographically by our radiology investigators, then patients can proceed with EUS-RFA within 6-8 weeks of enrollment of study. Patients who have started chemotherapy within a 3-month timeframe are allowed.

No prior systemic therapy, including chemotherapy or chemoradiation is permitted with the following exceptions: Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if standard of care neoadjuvant or adjuvant therapy was completed at least 3 months prior to study enrollment. Prior adjuvant therapy may include mFFX, NALIRIFOX, GA or Capecitabine (Xeloda). If started on first-line treatment for mPDAC elsewhere (i.e., not at our study site), eligible participants can have undergone 3 months of chemotherapy with stable disease before study entry. Patients who had prior treatment and stable disease up to 3 months and confirmed radiographically by our radiology investigators, then patients can proceed with EUS-RFA within 6-8 weeks of enrollment of study. Patients who have started chemotherapy within a 3-month timeframe are allowed.

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1 x 10^9/L; Platelet count ≥75 x 10^9/L

Kidney function

Serum creatinine clearance must be ≥30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula

Liver function

Total serum bilirubin <2× ULN unless secondary to Gilbert's Syndrome; patients with a declining bilirubin status post stent placement are eligible with serum bilirubin ≤2.5 x ULN; ALT, AST, and ALP ≤3× ULN, or ≤5× ULN in cases of documented liver involvement; albumin levels ≥3 g/dL

Absolute neutrophil count (ANC) ≥1 x 10^9/L; Platelet count ≥75 x 10^9/L; Albumin levels ≥3 g/dL; Total serum bilirubin <2× ULN unless secondary to Gilbert's Syndrome; ALT, AST, and ALP ≤3× ULN, or ≤5× ULN in cases of documented liver involvement; Serum creatinine clearance must be ≥30 mL/minute

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The University of Texas Health Science Center at Houston · Houston, Texas

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