CEB-01 implant for pancreatic cancer treatment after surgery

Exploratory Clinical Trial to Assess Safety, Tolerability Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants With Pancreatic Cancer.

This study is testing a new implant that releases a chemotherapy drug after surgery for pancreatic cancer to see if it helps prevent the cancer from coming back compared to standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cebiotex (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 4 sites (Barcelona, Catalonia and 3 other locations)
• Trial ID: NCT06538857 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the CEB-01 implant, which releases SN-38, a chemotherapy agent, locally after surgical removal of pancreatic cancer tumors. It is a multi-center, randomized, single-blind trial involving adult participants with locally resectable pancreatic cancer. Participants will be divided into two groups: one receiving the CEB-01 implant post-surgery and the other receiving standard surgery without the implant. The study will assess outcomes over a follow-up period of up to three years to determine the impact on local recurrence rates and overall safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed locally advanced or borderline resectable pancreatic cancer.

Not a fit: Patients with metastatic pancreatic cancer or those who are not candidates for surgical resection will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of local recurrence of pancreatic cancer after surgery.

How similar studies have performed: While local chemotherapy delivery methods have been explored, this specific approach with CEB-01 is novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years.
2. Participants must have a diagnosis of:

   1. 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.
   2. Histopathological confirmation of the diagnosis can be done during surgery by means of intraoperative biopsy as per clinical practice.

   No need of preoperative biopsy.
3. Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment.
4. Participants must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion obtained by a validate imaging technique (i.e., magnetic resonance imaging (MRI), computed tomography (CT) scan, PET scan, ultrasounds or others) that can be accurately measured.
5. Participants should have surgically removable lesion/s for what they will be submitted to a pancreatoduodenectomy.
6. Normal renal function as defined by biochemical parameters as follows: creatinine ≤2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2.
7. 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.
8. 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). Preoperative biliary drainage to be done according to regular practice in each center. Patients in whom preoperative biliary drainage cannot be performed or biliary drainage was not completely effective, individualized decision to be made when bilirubin is ≥ 10 mg/dl (or equivalent value in μmol/L units).
9. Participants must have fully recovered from the acute toxic effects (Grade 3 or above) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this trial.
10. Neoadjuvant chemotherapy is allowed in borderline and/or locally advanced cases borderline completed at least 4 weeks before surgery.
11. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
12. Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.
13. Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.
14. The participant or a legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures.

Exclusion Criteria:

1. Other malignancies within past 2 years.
2. R2 resections (macroscopic disease remains after surgery).
3. Patients with homozygous UGT1A1 known to be at risk of increased toxicity with irinotecan and SN-38.
4. Active bacterial, viral or fungal infection.
5. Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion.
6. Impossibility of ensuring adequate follow-up.
7. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
8. Contraindication to computed tomography scan (CT).
9. Major surgery within 14 days prior to starting study drug or still in recovery after experiencing surgical complications; neither tumour biopsy nor central line insertion are considered a major surgery.
10. Other relevant concomitant illnesses.
11. Participants' status post-allogeneic stem cell transplant are not eligible.
12. Participants with disease of any major organ system that would compromise their ability to withstand therapy.
13. Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.

Where this trial is running

Barcelona, Catalonia and 3 other locations

• Hospital Clínico y Provincial de Barcelona — Barcelona, Catalonia, Spain (Recruiting)
• H. Clínico San Carlos — Madrid, Madrid, Spain (Recruiting)
• H.U. Virgen del Rocío — Seville, Sevilla, Spain (Recruiting)
• H. Clínico Univ. de Valencia — Valencia, Valencia, Spain (Recruiting)

Study contacts

• Principal investigator: Javier Padillo Ruiz, M.D.; Ph.D. — H.U. Virgen del Rocío (Sevilla)
• Study coordinator: A Responsible Person Designated by the Sponsor

Conditions Pancreatic Carcinoma; Locally advanced disease; Resectable pancreatic cancer; Borderline resectable pancreatic cancer