Actively Recruiting
CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours
Led by CEBIOTEX · Updated on 2025-05-31
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 abdominal 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 abdominal tumors after surgery, while keeping a tolerable toxicity profile. The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in pediatric patients with locally resectable abdominal tumors including Soft Tissue Sarcoma (STS), high-risk Neuroblastoma (NB), Wilms tumour (WT), germ cell tumors (GCT), extracranial malignant rhabdoid tumour (eMRT), synovial sarcoma (SS), desmoplastic small round cell tumour (DSRCT) and fibrolamellar hepatocellular carcinoma (FL-HCC
CONDITIONS
Official Title
CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than or equal to 18 years
- Diagnosis of de novo or recurrent abdominal soft-tissue sarcoma, high-risk neuroblastoma, or other specified abdominal tumors
- Histology assessment required for new cases; tumor histology must be confirmed
- Previous irinotecan treatment allowed if no disease progression occurred
- May have more than one surgically removable lesion
- Adequate liver, kidney, blood, and heart function
- Fully recovered from severe toxic effects of prior therapy
- Functional performance status score of 50 or higher
- Negative pregnancy test for females of childbearing potential
- Willingness to use contraception during study and for 6 months post-surgery
- Life expectancy greater than 6 months
- Informed consent obtained from legally authorized guardian
You will not qualify if you...
- Presence of metastatic lesions
- Other cancers within past 2 years except certain skin cancers or disease-free for at least 24 months
- Active bacterial, viral, or fungal infection
- Known HIV, hepatitis B, hepatitis C, or chronic liver disease
- Unable to ensure adequate follow-up
- Inability to comply with safety monitoring
- Contraindication to CT scan
- Major surgery within 14 days before study drug implant or still recovering from surgical complications
- Other significant illnesses
- History of allogeneic stem cell transplant
- Disease affecting major organs that would limit therapy
- Tumor size too large for implant based on body surface area
- Known allergy to SN-38 or implant components
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
Research Team
A
A Responsible Person Designated by the Sponsor
CONTACT
A
Anna Huguet, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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