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 (Jun 2026). This Phase 2 trial studies multiple treatments including Neoadjuvant Chemotherapy (NAC) and Immunotherapy (pembrolizumab) for pancreatic ductal adenocarcinoma.
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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06831136 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages