CEB-01 in Locally Resectable Pancreatic Cancer

Launched by CEBIOTEX · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CEB-01 for patients with locally resectable pancreatic cancer, which means the cancer can be surgically removed. After the tumor is taken out, the CEB-01 implant, which contains a form of chemotherapy, will be placed in the area where the tumor was. This implant is designed to slowly release the chemotherapy to help prevent the cancer from returning locally. The study will look at how safe this treatment is, how well it works, and how the body handles the medication.

To participate in this trial, you need to be at least 18 years old and have a specific type of pancreatic cancer that can be surgically removed. You must also have good overall health and meet certain criteria regarding your blood counts and organ function. Participants will undergo surgery and then receive the CEB-01 implant, with regular check-ups to monitor their health and the effectiveness of the treatment. It's important to note that women who can become pregnant will need to take a pregnancy test and use contraception during the study. This trial aims to offer a potential new option for patients looking for better ways to manage their pancreatic cancer after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years.
• 2. Participants must have a diagnosis of:
• • 1. 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.
• • 2. Histopathological confirmation of the diagnosis can be done during surgery by means of intraoperative biopsy as per clinical practice.
• • No need of preoperative biopsy.
• • 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, PET scan, ultrasounds or others) that can be accurately measured.
• • 5. Participants should have surgically removable lesion/s for what they will be submitted to a pancreatoduodenectomy.
• • 6. Normal renal function as defined by biochemical parameters as follows: creatinine ≤2 mg/dl or creatinine clearance ≥ 60 ml/min/1.73 m2.
• • 7. 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.
• • 8. 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).
• • 9. 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.
• • 10. Neoadjuvant chemotherapy is allowed in borderline and/or locally advanced cases borderline completed at least 4 weeks before surgery.
• • 11. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• • 12. Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.
• • 13. Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.
• • 14. 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 tumour 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.