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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
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.
Huashan Hospital affiliated to Fudan University
Shanghai, China
RECRUITINGProgression-Free Survival (PFS)
PFS is defined as the time from the start of treatment until disease progression or death due to any cause, whichever occurs first
Time frame: Up to 18 months
Number of participants with adverse events (AEs)
Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments
Time frame: Up to 18 months
Objective response rate (ORR)
ORR is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).
Time frame: Up to 18 months
Disease control rate (DCR)
DCR is defined as the rate of best objective response of CR, PR, or stable disease (SD)
Time frame: Up to 18 months
Overall Survival (OS)
OS is defined as the time from the date of treatment until death due to any cause
Time frame: Up to 18 months
PFS rate at 6 months
The analysis will be estimated proportions of patients who are progression-free at 6 months following the time of enrollment
Time frame: Up to 6 months
PFS rate at 1 year
The analysis will be estimated proportions of patients who are progression-free at 1 year following the time of enrollment
Time frame: Up to12 months
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OS rate at 1-year
The analysis will be estimated proportions of patients who are survival at 1 year following the time of enrollment
Time frame: Up to12 months