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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

July 15, 2025

Study Completion Date

March 9, 2026

Conditions
Glioblastoma Multiforme
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

Huashan Hospital affiliated to Fudan University, Shanghai

All Listed Sponsors
lead

Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

INDUSTRY