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OncoMatch/Clinical Trials/NCT06538857

CEB-01 in Locally Resectable Pancreatic Cancer

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

Phase 2RecruitingCEBIOTEXNCT06538857Data as of Jun 2026Location: Spain

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

Treatments studied

Other

CEB-01

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.

Frequently asked questions

Is NCT06538857 currently recruiting?

Yes, this trial is currently recruiting patients.

Are patients with UGT1A1 alterations eligible?

No. UGT1A1 homozygous is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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