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Summary of Clinical Trial Findings
Purpose
- Glioblastoma (GBM) treatment limitations due to systemic toxicity and blood-brain barrier (BBB) permeability
- Use of vascularized flaps to bypass BBB and improve access of immune cells to tumor microenvironment
Methods
- 12 patients with newly diagnosed GBM underwent surgical resection followed by lining of the cavity with autologous TPFF or PCF
- Safety and efficacy assessed through monitoring adverse events, progression-free disease (PFS), and overall survival (OS)
Results
- Median age of patients: 57 years
- All patients were Isocitrate dehydrogenase (IDH) wildtype
- 70% of patients had 6-month PFS
- Median PFS: 9.10 months; OS: 17.6 months
- 33% of patients have been alive for more than two years
Conclusions
- Insertion of autologous TPFF/PCF along GBM resection cavity is safe and feasible
- Encouraging response rate warrants larger phase II studies to assess safety, feasibility, and efficacy
Trial Registration
- ClinicalTrials.gov ID NCT03630289, dated: 08/02/2018
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