Clinical trialEarly Phase 1Active not recruiting
CEB-01 in Locally Resectable Pancreatic Cancer
Exploratory Clinical Trial to Assess Safety, Tolerability Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants With Pancreatic Cancer.
- Outcome
- Ongoing
- Phase
- Early Phase 1
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 20 August 2024
- Expected end
- September 2028
- Enrollment
- 39 participants
- Sites
- 4
- Primary outcomes
- Frequency of Adverse Events (AEs) (Safety); Frequency of surgical complications after pancreatic surgery
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 14 October 2026
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
The 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
Detailed description public domain (ClinicalTrials.gov)
Exploratory, multi-center, interventional, prospective, randomised, single-blind, controlled clinical trial in adult participants with locally resectable pancreatic cancer. Participants will be allocated in a 2:1 ratio to two treatment arms: (Arm 1, n=26 participants) standard surgery and CEB-01 implant after surgery, or (Arm 2, n=13 participants) standard surgery without implant. For measurement of primary safety and efficacy endpoints, follow-up will consist of shortterm evaluation at 365 ± 30 days and long-term evaluation at 1095 ± 30 days post-surgery as it is considered sufficient for the assessment of the therapeutic effect of CEB-01 regarding local recurrence. For pharmacokinetic assessment, blood samples will be collected at baseline and at 8 different time points until 60 ± 15 days post-surgery. For each participant the trial duration will be composed by a screening period for of up to 35 days, one day for surgery and 1095 ± 30 days of follow-up. The trial population will consist of 39 participants with a de novo pancreatic cancer who fulfil all the inclusion and exclusion criteria.