CEB-01 in Locally Resectable Pancreatic Cancer

NCT06538857 | Recruiting Phase 2

• 2 other identifiers: CEB-01-RLPC01-CT2024-512742-42-00
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Pancreatic Carcinoma

Keywords

Locally advanced disease; Resectable pancreatic cancer; Borderline resectable pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Frequency of Adverse Events (AEs) (Safety)

  Frequency of adverse events reported classified by type and severity according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE).

  Through study completion, average 3 years

• Frequency of surgical complications after pancreatic surgery

  Frequency of surgical complications according to the International Patient Safety Goals (IPSG).

  Through study completion, after surgery average 3 years

Secondary Outcomes (7)

• Local recurrence-free survival (LRFS)

  Through study completion, average 3 years

• Progression-free survival (PFS)

  Through study completion, average 3 years

• Overall survival (OS)

  Through study completion, average 3 years

• Maximum concentration (Cmax) of SN-38

  During 60 days

• Time of maximum plasma concentration (Tmax) of SN-38

  During 60 days

Study Arms (2)

Arm 1

EXPERIMENTAL

standard surgery and CEB-01 implant after surgery

Procedure: Standard surgery; Drug: CEB-01

Arm 2

ACTIVE COMPARATOR

standard surgery

Procedure: Standard surgery

Interventions

Standard surgery PROCEDURE

The location and size of the tumor determine the type of surgery.

Arm 1; Arm 2

CEB-01 DRUG

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 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Participants must have a diagnosis of:
• 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.
• No need of preoperative biopsy.
• Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment.
• 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.
• Participants should have surgically removable lesion/s for what they will be submitted to a pancreatoduodenectomy.
• Normal renal function as defined by biochemical parameters as follows: creatinine ≤2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2.
• 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.
• 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).
• 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.
• Neoadjuvant chemotherapy is allowed in borderline and/or locally advanced cases borderline completed at least 4 weeks before surgery.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.

You may not qualify if:

• 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.
• 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.
• Impossibility of ensuring adequate follow-up.
• Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
• Contraindication to computed tomography scan (CT).
• 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.
• Other relevant concomitant illnesses.
• Participants' status post-allogeneic stem cell transplant are not eligible.
• Participants with disease of any major organ system that would compromise their ability to withstand therapy.
• Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.

Sponsors & Collaborators

• CEBIOTEX: lead
• MFAR: collaborator

Study Sites (4)

Hospital Clínico y Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

H. Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

H.U. Virgen del Rocío

Seville, Sevilla, 41013, Spain

RECRUITING

H. Clínico Univ. de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Javier Padillo Ruiz, M.D.; Ph.D.

  H.U. Virgen del Rocío (Sevilla)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A Responsible Person Designated by the Sponsor

CONTACT

+34 93 434 44 12; investigacion@mfar.net

Anna Huguet, Ph.D.

CONTACT

+34 93 434 44 12; ahuguet@cebiotex.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind trial in which investigators, and investigators' staff, will be aware of the treatment allocation (CEB-01 or not, but only once the tumour/s removal has/have been completed). The participants, medical staff of the sponsor or data analysts will remain blinded to each participant's assigned study treatment from the time of randomisation until database lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)