CEB-01 in Locally Resectable Pancreatic Cancer

Trial Title: CEB-01 in Locally Resectable Pancreatic Cancer

NCT ID: NCT06538857

Condition: Pancreatic Carcinoma

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
Locally advanced disease
Resectable pancreatic cancer
Borderline resectable pancreatic cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants will be allocated in a 2:1 ratio to two treatment arms: (Arm 1) standard surgery and CEB-01 implant after surgery, or (Arm 2) standard surgery without implant.

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking description: This is a single-blind trial where only the participant will be blinded to the treatment group assignment. The investigator (surgeons and oncologist) will not be blinded.

Intervention:

Intervention type: Procedure
Intervention name: Standard surgery
Description: The location and size of the tumor determine the type of surgery.
Arm group label: Arm 1
Arm group label: Arm 2

Intervention type: Drug
Intervention name: CEB-01
Description: It is novel formulation for local release of chemotherapy. It consists of a biocompatible and biodegradable nanofiber membrane made of poly(lactic-co-glycolic acid) (PLGA), which is loaded with the anti-tumor drug SN-38 and implanted in the surgical bed after tumor removal.
Arm group label: Arm 1

Summary: 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: 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) standard surgery and CEB-01 implant after surgery, or (Arm 2) 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 43 ± 7 days post-surgery. For each participant the trial duration will be composed by a screening period for of up to 28 days, one day for surgery and 1095 ± 30 days of follow-up. The trial population will consist of 21 participants with a de novo pancreatic cancer who fulfil all the inclusion and exclusion criteria.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age ≥18 years. 2. Participants diagnosed with a single lesion of histologically or cytologically confirmed de novo carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas with only locally advanced disease, resectable or borderline resectable. 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, positron emission tomography (PET) scan, ultrasounds or others) that can be accurately measured. 5. Participants should have a single surgically removable lesion. 6. Normal liver, renal, hematological, and cardiac function as defined by biochemical and hematological parameters as follows: hemoglobin (Hb) >11 g/dL (with preoperative transfusion), platelets >80.000/mm3 with intraoperative transfusion, white blood cells (WBC) >3.000/mm3, neutrophil count >1.500/mm3, albumin >3.0 g/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2,5 times the upper limit of normality (ULN), bilirubin <2 times the ULN, creatinine <1,5 mg/dl or creatinine clearance > 60 ml/min. 7. 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. 8. Neoadjuvant chemotherapy is allowed in borderline and/or locally advanced cases borderline completed at least 4 weeks before surgery. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. 10. Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening. 11. Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.. 12. 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 tumor 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: H.U. Virgen del Rocío

Address:
City: Sevilla
Country: Spain

Status: Recruiting

Contact:
Last name: A Responsible Person Designated by the Sponsor

Phone: +34 93 434 44 12
Email: investigacion@mfar.net

Contact backup:
Last name: Principal Investigator Designated by the Sponsor, M.D.;Ph.D.

Start date: August 9, 2024

Completion date: September 2028

Lead sponsor:
Agency: CEBIOTEX
Agency class: Industry

Collaborator:
Agency: MFAR
Agency class: Other

Source: CEBIOTEX

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06538857