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Pancreatic CarcinomaEarly Phase 1NCT06538857

CEB-01 in Locally Resectable Pancreatic Cancer

A Early Phase 1 study testing Standard surgery and CEB-01 in people with Pancreatic Carcinoma, run by CEBIOTEX at 4 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Carcinoma
What is being tested?
Standard surgery and CEB-01
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
4 sitesSpain
Study dates
20 Aug 2024to Sep 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • H. Clínico San Carlos

    Madrid, Madrid, 28040

  • H.U. Virgen del Rocío

    Seville, Sevilla, 41013

  • H. Clínico Univ. de Valencia

    Valencia, Valencia, 46010

Other trials in Spain

About this study

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

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

Read the 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, n=26 participants) standard surgery and CEB-01 implant after surgery, or (Arm 2, n=13 participants) 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 60 ± 15 days post-surgery. For each participant the trial duration will be composed by a screening period for of up to 35 days, one day for surgery and 1095 ± 30 days of follow-up.

The trial population will consist of 39 participants with a de novo pancreatic cancer who fulfil all the inclusion and exclusion criteria.

Being tested
Standard surgery, CEB-01
Keywords
Locally advanced disease, Resectable pancreatic cancer, Borderline resectable pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard surgeryProcedure or surgery

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

  • CEB-01Drug

    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.

Study groups in NCT06538857
Study groupRoleWhat they receive
Arm 1Experimentalstandard surgery and CEB-01 implant after surgery
Receives: Procedure: Standard surgery; Drug: CEB-01
Arm 2Active comparatorstandard surgery
Receives: Procedure: Standard surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 v5.0). In addition to CTCAE, the severity of postoperative complications will also be graded according to Clavien-Dindo's classification (Clavien et al., 2009) and will be included in the assessment of AEs.

    Measured: Through study completion, average 3 years

  2. Frequency of surgical complications after pancreatic surgery

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

    Measured: Through study completion, after surgery average 3 years

Secondary outcomes (7)

  1. Local recurrence-free survival (LRFS)

    Time from surgery until the progression of the disease in the area of implanted CEB-01

    Measured: Through study completion, average 3 years

  2. Progression-free survival (PFS)

    Time from surgery to objective tumour progression or death from any cause

    Measured: Through study completion, average 3 years

  3. Overall survival (OS)

    Time from surgery to death from any cause

    Measured: Through study completion, average 3 years

  4. Maximum concentration (Cmax) of SN-38

    The highest concentration of SN-38 in the peripheral blood samples taken at sequential timepoints

    Measured: During 60 days

  5. Time of maximum plasma concentration (Tmax) of SN-38

    Time from the surgery to the momento with the highest concentration of SN-38 in the peripheral blood samples taken at sequential timepoints

    Measured: During 60 days

  6. Terminal half-life (t1/2) of SN-38

    The time required for the plasma concentration of SN-38 to fall by 50% from the Cmax

    Measured: During 60 days

  7. Area under the concentration-time curve (AUC0-inf) of SN-38

    Represents the total SN-38 exposure in the peripheral blood across time

    Measured: During 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start20 Aug 2024
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538857
Sponsor's protocol ID
CEB-01-RLPC01-CT
Other IDs
2024-512742-42-00
Status last verified
Sep 2026
First submitted
1 Aug 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data (IPD) will be provided.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Standard surgery and CEB-01 in people with Pancreatic Carcinoma, run by CEBIOTEX at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Adverse Events (AEs) (Safety) (time frame: Through study completion, average 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06538857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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