NCT05589961

Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Second Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety of an innovative integrated treatment regimen for recurrent glioblastoma , including patients with recurrent glioblastoma multiforme.

Detailed description

This study is a single-center, prospective, open-label, single-arm clinical study of an innovative integrated treatment regimen for recurrent glioblastoma multiforme. The main outcome measurement of the study is to evaluate the safety of the integrated treatment regimen for glioblastoma multiforme. Secondary outcome measurement are OS, PFS, ORR, and quality of life. Safety is evaluated by monitoring adverse events, physical examination results, vital signs, ECG, hematology, and clinical biochemistry. Imaging was performed at the end of every 3 sessions to assess treatment outcome and disease progression. The whole treatment and efficacy will be observed for two years.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	TMZ	After enrollment, temozolomide 50mg/m2 was given orally for QD until progression, and radiotherapy and PF 0.2g/ time for TID were started one week later until progression. Pembrolizumab 200mg once every 3 weeks until progression; The radiotherapy regimen depends on the patient's recurrence and initial treatment.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-10-21
• Last updated: 2022-10-21

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study