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OncoMatch/Clinical Trials/NCT06538857

CEB-01 in Locally Resectable Pancreatic Cancer

Is NCT06538857 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies CEB-01 for pancreatic carcinoma.

Phase 2RecruitingCEBIOTEXNCT06538857Data as of May 2026

Treatment: CEB-01The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the pancreatic cancer tumor, CEB 01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of pancreatic cancer after surgery, while keeping a tolerable toxicity profile. The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in patients with locally resectable pancreatic cancer

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Excluded: UGT1A1 homozygous

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

haemoglobin (Hb) ≥10 g/dL (with preoperative transfusion), platelets ≥80,000/mm3 with intraoperative transfusion, WBC ≥3,000/mm3, neutrophil count ≥1,500/mm3

Kidney function

creatinine ≤2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2

Liver function

ALT and AST ≤ 4x ULN; recommended serum bilirubin ≤ 10 mg/dl (or equivalent value in μmol/L units); preoperative biliary drainage per clinical practice

Cardiac function

cardiac function as defined by biochemical and haematological parameters

Normal renal function as defined by biochemical parameters as follows: creatinine ≤2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2. Haematological and cardiac function as defined by biochemical and haematological parameters as follows: haemoglobin (Hb) ≥10 g/dL (with preoperative transfusion), platelets ≥80.000/mm3 with intraoperative transfusion, white blood cells (WBC) ≥3.000/mm3, neutrophil count ≥1.500/mm3. Liver function as defined by biochemical parameters as follows: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 times the upper limit of normality [ULN]. Recommended serum bilirubin for eligibility is bilirubin ≤ 10 mg/dl (or equivalent value in μmol/L units).

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

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