Actively Recruiting
Exploratory Clinical Trial to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants With Pancreatic Cancer
Led by CEBIOTEX · Updated on 2025-05-23
39
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
C
CEBIOTEX
Lead Sponsor
M
MFAR
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of the CEB-01 implant in adults with locally resectable pancreatic cancer. CEB-01 is a membrane containing SN-38, an active chemotherapy metabolite, designed to be placed in the surgical bed after tumor removal to provide local and sustained chemotherapy release. The study is an exploratory, multi-center, randomized, single-blind clinical trial aiming to delay or prevent local cancer recurrence while maintaining manageable toxicity. Participants will be randomly assigned in a 2:1 ratio to receive either standard surgery plus the CEB-01 implant or standard surgery alone. The implant is a biocompatible and biodegradable nanofiber membrane made of PLGA loaded with SN-38, placed after tumor removal. The trial includes a screening period up to 35 days, one day for surgery, and approximately three years of follow-up for safety and efficacy assessments. Blood samples will be collected at baseline and multiple times up to about 43 days post-surgery to assess pharmacokinetics. During the study, participants will be monitored for adverse events, surgical complications, and cancer recurrence through assessments over an average of three years. Researchers will measure local recurrence-free survival, progression-free survival, overall survival, and pharmacokinetic parameters such as drug concentration and half-life. Follow-up visits will evaluate the long-term therapeutic effect of CEB-01, with detailed safety monitoring throughout the trial duration.
CONDITIONS
Brief 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 of diagnosis during surgery is acceptable
- Measurable disease by imaging techniques such as MRI, CT scan, PET scan, or ultrasound
- Surgically removable lesions suitable for pancreatoduodenectomy
- Normal renal function: creatinine 2 mg/dl or creatinine clearance 60 ml/min/1.73 m2
- Adequate hematological and cardiac function with specified blood count thresholds
- Liver function with ALT and AST 4 times upper limit of normal and bilirubin 10 mg/dl
- Fully recovered from acute toxic effects (Grade 3 or above) of prior chemotherapy, immunotherapy, or radiotherapy
- Neoadjuvant chemotherapy allowed if completed at least 4 weeks before surgery
- ECOG Performance Status 0 or 1
- Negative pregnancy test for women of childbearing potential at screening
- Willingness to use contraception during the study and for 6 months after surgery
- Written informed consent obtained prior to screening procedures
You will not qualify if you...
- Other cancers diagnosed within the past 2 years
- R2 resections with remaining macroscopic disease after surgery
- Homozygous UGT1A1 genotype increasing risk of irinotecan toxicity
- 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 requirements
- Contraindication to CT scan
- Major surgery within 14 days before starting study treatment or ongoing recovery from surgical complications
- Other significant concurrent illnesses
- History of allogeneic stem cell transplant
- Disease of major organ systems compromising therapy tolerance
- Pregnancy or breastfeeding; breastfeeding must be discontinued for lactating mothers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 35 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 day
Participants undergo standard surgery to remove the pancreatic tumor. In the experimental arm, the CEB-01 implant is placed after surgery to locally release chemotherapy.
1 surgery day visit
Duration - Up to 1095 ± 30 days (approximately 3 years)
Participants are monitored for safety, efficacy, and pharmacokinetics after surgery and treatment. Blood samples are collected at baseline and at 8 time points up to approximately 43 days post-surgery for pharmacokinetic assessment.
Visits at baseline and 8 additional time points within 60 days post-surgery; additional follow-up visits up to 3 years
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
A
Anna Huguet, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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