RecruitingPhase 2NCT06353360

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


Sponsor

Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

Enrollment

30 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-part treatment for newly diagnosed glioblastoma — a serious type of brain tumor. After surgery and standard radiation plus chemotherapy, patients would receive electrical field therapy (a wearable device that disrupts cancer cell growth), an ongoing chemotherapy drug called temozolomide, and an immunotherapy drug called tislelizumab. **You may be eligible if...** - You are 18 or older and have been diagnosed with glioblastoma (confirmed by biopsy) that sits above the brainstem - Your brain tumor does not have the IDH mutation (wild-type) - You have already completed surgery and radiation with temozolomide, and are now planning maintenance chemotherapy - You are in reasonably good physical condition (Karnofsky score ≥70) with an expected survival of at least 3 months **You may NOT be eligible if...** - Your cancer progressed early during radiation and chemotherapy - You have cancer that has spread to the fluid around the brain and spinal cord - You have had other cancer treatment in the past 5 years (with some exceptions) - You have an implanted device like a pacemaker, deep brain stimulator, or cardiac defibrillator - You are pregnant, breastfeeding, or trying to become pregnant - You have skin wounds, ulcers, or infections where the device electrodes would be placed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETumor 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.

DRUGTislelizumab

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.

DRUGTemozolomide (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.


Locations(1)

Huashan Hospital affiliated to Fudan University

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06353360


Related Trials