Condition: Locally Resectable Paediatric Tumours · Sponsor: CEBIOTEX
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
This description comes directly from the study's public registry record.
A Responsible Person Designated by the Sponsor · +34 93 434 44 12 · investigacion@mfar.net
Anna Huguet, Ph.D. · ahuguet@cebiotex.com
Always discuss trial participation with your own doctor first.
| Hospital Sant Joan de Déu | Esplugues de Llobregat, Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06986811