CEB-01 in Locally Resectable Pancreatic Cancer
ConditionPancreatic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCEBIOTEX
About this trial
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
Eligibility criteria
Qualifiers
Age ≥18 years.
Lesion/s of histologically or cytologically confirmed de novo carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas with only locally advanced disease, resectable or borderline resectable.
Histopathological confirmation of the diagnosis can be done during surgery by means of intraoperative biopsy as per clinical practice.
Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment.
Disqualifiers
Other malignancies within past 2 years.
R2 resections (macroscopic disease remains after surgery).
Patients with homozygous UGT1A1 known to be at risk of increased toxicity with irinotecan and SN-38.
Active bacterial, viral or fungal infection.
Trial design
Treatments tested in this trial
- Standard surgery
- CEB-01
Treatment groups
39 Participants
are divided into 2 treatment groupsSponsors and collaborators
CEBIOTEX
Lead sponsor
MFAR
Collaborator
Source ClinicalTrials.gov