NCT06353360

TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.

Tumor-Treating Fields (TTFields) in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma: A Safety and Efficacy Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is To investigate the safety and efficacy of Tumor-Treating Fields (TTFields) in combined with temozolomide (TMZ) and tislelizumab in the treatment of newly diagnosed glioblastoma (GBM).

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DEVICE	Tumor Treating Fields	Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day, starting on the Day 1 of cycle 1 (C1D1), throughout the entire course of treatment.
DRUG	Tislelizumab	Tislelizumab will be given 300 mg intravenously every 4 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. The Tislelizumab treatment should be continued until confirmed PD, unacceptable toxicity, or finished Tislelizumab treatment for other reasons.
DRUG	Temozolomide (TMZ)	The patients will carry out 6 cycles of TMZ adjuvant chemotherapy according to the instructions. The dosage of TMZ is 150-200 mg/(m2·d), daily for 5 days followed by 23 days without treatment, the treatment cycle is 28 days. The initial dose of cycle 1 is 150 mg/(m2·d), if patients do not experience TMZ chemotherapy toxicity, the dose should be increased to 200 mg/(m2·d) in subsequent treatment cycles. After 6 cycles of TMZ adjuvant chemotherapy, if the patients do not experience disease progression, it is recommended to continue TMZ adjuvant chemotherapy, or treated according to investigators' recommendations. The TMZ treatment should be continued until confirmed progressive disease (PD), unacceptable toxicity, or finished TMZ treatment for other reasons.

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-07-15
• Completion: 2026-03-09
• First posted: 2024-04-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: China