Actively Recruiting
CEB-01 in Locally Resectable Pancreatic Cancer
Led by CEBIOTEX · Updated on 2025-05-23
39
Participants Needed
4
Research Sites
210 weeks
Total Duration
On this page
Sponsors
C
CEBIOTEX
Lead Sponsor
M
MFAR
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CEB-01 in Locally Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of de novo carcinoma, adenocarcinoma, or ductal adenocarcinoma of the pancreas with locally advanced, resectable, or borderline resectable disease
- Histopathological confirmation can be done during surgery; preoperative biopsy not required
- Prior chemotherapy allowed if no disease progression during treatment
- Radiographically measurable disease by validated imaging
- Surgically removable lesions planned for pancreatoduodenectomy
- Normal renal function: creatinine ≤2 mg/dl or creatinine clearance ≥60 ml/min/1.73 m2
- Adequate hematological function: hemoglobin ≥10 g/dL (with preoperative transfusion), platelets ≥80,000/mm3 (with intraoperative transfusion), WBC ≥3,000/mm3, neutrophils ≥1,500/mm3
- Liver function: ALT and AST ≤4 times upper limit of normal; bilirubin ≤10 mg/dl (preoperative biliary drainage as per practice)
- Fully recovered from acute toxic effects (Grade 3 or above) of prior therapies
- Neoadjuvant chemotherapy allowed if completed at least 4 weeks before surgery
- ECOG Performance Status 0 or 1
- Negative pregnancy test for females of childbearing potential
- Willingness to use contraception during study and for 6 months after surgery
- Signed informed consent
You will not qualify if you...
- Other malignancies within past 2 years
- R2 resections with macroscopic disease remaining after surgery
- Homozygous UGT1A1 genotype due to toxicity risk with irinotecan and SN-38
- Active bacterial, viral, or fungal infections
- Known active HIV, hepatitis B or C, or chronic liver disease
- Inability to ensure adequate follow-up
- Inability to comply with safety monitoring
- Contraindication to CT scan
- Major surgery within 14 days before study drug or ongoing recovery from surgical complications
- Other significant concurrent illnesses
- Prior allogeneic stem cell transplant
- Disease of major organ systems compromising therapy tolerance
- Pregnancy or lactation; breastfeeding must be discontinued
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Hospital Clínico y Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
2
H. Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
3
H.U. Virgen del Rocío
Seville, Sevilla, Spain, 41013
Actively Recruiting
4
H. Clínico Univ. de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
A
A Responsible Person Designated by the Sponsor
CONTACT
A
Anna Huguet, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here