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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• After brain surgery (patients with total resection, partial resection and biopsy were acceptable), the pathological examination confirmed glioblastoma with isocitrate dehydrogenase (IDH) wild-type according to the 2021 World Health Organization (WHO) classification of tumors of the central nervous system.

• The age of the subjects was ≥18 years old;

• Supratentorial tumors;

• Patients who had undergone maximal surgical resection (biopsy) and completed TMZ concurrent chemoradiotherapy were planned for adjuvant TMZ treatment.

• Karnofsky performance status (KPS) score ≥70;

• The predicted survival time was ≥3 months.

• Voluntarily signed informed consent;

• Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial.

Locations
Other Locations
China
Huashan Hospital affiliated to Fudan University
RECRUITING
Shanghai
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-03-09
Participants
Target number of participants: 30
Treatments
Experimental: Tumor Treating Fields + Temozolomide + Tislelizumab
Sponsors
Leads: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

This content was sourced from clinicaltrials.gov