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

NCT06353360 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-07-15
Completion
2026-03-09

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353360 on ClinicalTrials.gov