OncoMatch/Clinical Trials/NCT05132504
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
Is NCT05132504 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Folfirinox for pancreatic ductal adenocarcinoma.
Treatment: Pembrolizumab · Folfirinox — Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage LOCALIZED, POTENTIALLY RESECTABLE
Excluded: Stage BORDERLINE RESECTABLE, III, ADVANCED METASTATIC
localized adenocarcinoma of the pancreas that is potentially resectable
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Patient must not have received prior chemotherapy or radiation for pancreatic cancer.
Cannot have received: radiation therapy
Patient must not have received prior chemotherapy or radiation for pancreatic cancer.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Lab requirements
Blood counts
absolute neutrophil count (anc) ≥1500/μl; platelets ≥100 000/μl; hemoglobin ≥9.0 g/dl or ≥5.6 mmol/l
Kidney function
creatinine ≤1.5 × uln or ≥30 ml/min for participant with creatinine levels >1.5 × institutional uln
Liver function
total bilirubin ≤1.5 ×uln or direct bilirubin ≤uln for participants with total bilirubin levels >1.5 × uln; ast (sgot) and alt (sgpt) ≤2.5 × uln (≤5 × uln for participants with liver metastases)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baylor College of Medicine · Houston, Texas
- Baylor St. Luke's Medical Center (BSLMC). · Houston, Texas
- Houston Methodist Hospital · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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