CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours

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

NCT Number	NCT06986811
Lead Sponsor	CEBIOTEX
Conditions	Locally Resectable Paediatric Tumours
Enrollment	60 participants
Start Date	2025-05-06
Primary Completion	2029-05 (estimated)
Study Completion	2029-05 (estimated)
Updated on ClinicalTrials.gov	2025-05-31