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New treatment option for Pancreatic Carcinoma
Official title CEB-01 in Locally Resectable Pancreatic Cancer
ClinicalTrials.gov ID: NCT06538857
What this study is testing
What is CEB-01?
CEB-01 is an investigational medicine, being studied as a potential treatment for pancreatic carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Histopathological confirmation of the diagnosis can be done during surgery by means of intraoperative biopsy as per clinical practice. No need of...
- Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment.
You likely can't join 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...
- Impossibility of ensuring adequate follow-up.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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 people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Catalonia, Spain
- Madrid, Madrid, Spain
- Seville, Sevilla, Spain
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Catalonia, Spain; Madrid, Madrid, Spain; Seville, Sevilla, Spain; Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.