Glioblastoma MultiformePhase 2NCT06353360
TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.
A Phase 2 study testing Tumor Treating Fields, Tislelizumab and Temozolomide (TMZ) in people with Glioblastoma Multiforme, run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Tumor Treating Fields, Tislelizumab and Temozolomide (TMZ)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 9 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Early progression of GBM occurred after TMZ+radiation therapy (RT) treatment (except pseudoprogression, imaging examination should be supplemented to further exclude if necessary).
- The subject had received any other cytotoxic or biologic antineoplastic therapy before enrollment;
- Distant leptomeningeal metastasis;
- Patients had a diagnosis of cancer other than glioblastoma and received antineoplastic therapy within 5 years before enrollment, excluding cured stage I prostate cancer, cervical or uterine cancer in situ, breast cancer in situ, and nonmelanoma skin cancer.
- Previous treatment with anti-PD-1 antibody/anti-PD-L1 antibody and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody;
- Participants who had received systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or antineoplastic factor agents) within 2 weeks before enrollment. Excluding nasal sprays and inhaled corticosteroids;
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- The presence of an active, known, or suspected autoimmune disease that was judged by the investigator to be unsuitable for this study. The following exclusions may be made: vitiligo, alopecia, Graves' disease, psoriasis, or eczema that did not require systemic treatment within the previous 2 years; Hypothyroidism (due to autoimmune thyroiditis) that is asymptomatic or requires only stable doses of hormone-replacement therapy or type I diabetes that requires only stable doses of insulin-replacement therapy, or childhood asthma that has resolved completely without intervention or recurrence in adulthood without an external trigger.
- Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following:
- Thrombocytopenia (platelet count < 100×103/μL)
- Neutropenia (absolute neutrophil count < 1.5×103/μL)
- National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) 4 grade non-hematologic toxicity (except alopecia, nausea and vomiting)
- Significant liver function impairment -aspartate aminotransferase (AST) or alanine transaminase (ALT) exceeding 3 times the upper limit of normal
- Total bilirubin more than 1.5 times the upper limit of the normal range
- Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L).
- The subject had an active implanted device (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, cardiac defibrillator, etc.).
- Infratentorial tumors;
- Documented increased intracranial pressure (clinically manifested as severe papilledema, vomiting, nausea, or decreased consciousness);
- There were infection, ulcer and unhealed wound in the skin where the electrode was applied.
- A known history of allergy to TMZ or tislelizumab;
- Skull defects or residual metal fragments in the skull (except titanium plates or nails used for skull surgery);
- Patients allergic to conductive hydrogels or medical adhesives;
- Those who are pregnant or preparing to become pregnant or who are breastfeeding;
- Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital affiliated to Fudan University
Shanghai
Liang Chen, +86 21 5460 1999, chenlianghs@126.com
About this study
Official title: Tumor-Treating Fields (TTFields) in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma: A Safety and Efficacy Clinical Study
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
- Glioblastoma Multiforme
- Being tested
- Tumor Treating Fields, Tislelizumab, Temozolomide (TMZ)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Treating FieldsDevice
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.
TislelizumabDrug
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.
Temozolomide (TMZ)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tumor Treating Fields + Temozolomide + Tislelizumab | Experimental | Not described Receives: Device: Tumor Treating Fields; Drug: Tislelizumab; Drug: Temozolomide (TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-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
Measured: Up to 18 months
Secondary outcomes (7)
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
Measured: 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).
Measured: 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)
Measured: Up to 18 months
Overall Survival (OS)
OS is defined as the time from the date of treatment until death due to any cause
Measured: 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
Measured: 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
Measured: Up to12 months
OS rate at 1-year
The analysis will be estimated proportions of patients who are survival at 1 year following the time of enrollment
Measured: Up to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start30 Apr 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion9 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353360
- Sponsor's protocol ID
- HL-06
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor-Treating Fields (TTFields) in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma: A Safety and Efficacy Clinical Study
- ClinicalTrials.gov ID
- NCT06353360
- Acronym / sponsor ID
- HL-06
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 9 Mar 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Treating Fields + Temozolomide + Tislelizumab | Experimental | Device: Tumor Treating Fields, Drug: Tislelizumab, Drug: Temozolomide (TMZ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (23 listed)
- Early progression of GBM occurred after TMZ+radiation therapy (RT) treatment (except pseudoprogression, imaging examination should be supplemented to further exclude if necessary).
- The subject had received any other cytotoxic or biologic antineoplastic therapy before enrollment;
- Distant leptomeningeal metastasis;
- Patients had a diagnosis of cancer other than glioblastoma and received antineoplastic therapy within 5 years before enrollment, excluding cured stage I prostate cancer, cervical or uterine cancer in situ, breast cancer in situ, and nonmelanoma skin cancer.
- Previous treatment with anti-PD-1 antibody/anti-PD-L1 antibody and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor Treating FieldsTumor 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. | Device | Tumor Treating Fields + Temozolomide + Tislelizumab |
| TislelizumabTislelizumab 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 | Tumor Treating Fields + Temozolomide + Tislelizumab |
| 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. | Drug | Tumor Treating Fields + Temozolomide + Tislelizumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 18 months
PFS is defined as the time from the start of treatment until disease progression or death due to any cause, whichever occurs first
7 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 18 months
Objective response rate (ORR)
Time frame: Up to 18 months
Disease control rate (DCR)
Time frame: Up to 18 months
Overall Survival (OS)
Time frame: Up to 18 months
PFS rate at 6 months
Time frame: Up to 6 months
PFS rate at 1 year
Time frame: Up to12 months
OS rate at 1-year
Time frame: Up to12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tumor Treating Fields, Tislelizumab and Temozolomide (TMZ) in people with Glioblastoma Multiforme, run by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.