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CEB-01 in Locally Resectable Pancreatic Cancer

ConditionPancreatic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCEBIOTEX

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

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.

Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard surgery

    Procedure/Surgery

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

  • 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.

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 2 interventions
Group B: Arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame
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).

Time frame
Through study completion, after surgery average 3 years

Secondary outcomes

1

Local recurrence-free survival (LRFS)

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

Time frame
Through study completion, average 3 years
2

Progression-free survival (PFS)

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

Time frame
Through study completion, average 3 years
3

Overall survival (OS)

Time from surgery to death from any cause

Time frame
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

Time frame
During 60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CEBIOTEX

Lead sponsor

MFAR

Collaborator

Source ClinicalTrials.gov
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