Glioblastoma (GBM)Phase 2NCT07130149
Sonodynamic-Chemoradiotherapy Integration in Glioblastoma
A Phase 2 study testing Sonodynamic Therapy (SDT) and Standard Treatment in people with Glioblastoma (GBM), run by Yingjuan Zheng at 1 site in China.
Trial summary
This Phase II trial tests if sonodynamic therapy (SDT)-a non-invasive treatment using ultrasound to activate a cancer-killing drug-improves outcomes for newly diagnosed glioblastoma patients. Who? 230 adults (<75 years) with confirmed glioblastoma, adequate organ function, no major health issues. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Sonodynamic Therapy (SDT) and Standard Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Age < 75 years;
- Newly diagnosed postoperative glioblastoma patients pathologically confirmed as glioblastoma;
- Absence of severe hematopoietic dysfunction or cardiac, pulmonary, hepatic, renal abnormalities, or immunodeficiency. Pre-enrollment laboratory results must meet the following:
- Hematology:
- White blood cell count ≥4×10⁹/L
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- Absolute neutrophil count ≥1.5×10⁹/L
- Platelets ≥100×10⁹/L
- Hemoglobin ≥90g/L
- Renal function:
- Serum creatinine ≤1.2mg/dL or creatinine clearance ≥60mL/min
- Hepatic function:
- Total bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastasis present)
- AST/ALT ≤2.0×ULN (≤5.0×ULN if liver metastasis present)
- Coagulation:
- INR ≤2.0, with PT, APTT, and TT within normal ranges;
- Life expectancy ≥3 months;
- Adverse reactions from prior anti-tumor therapy recovered to ≤ Grade 1, or complete recovery from surgery (Investigator's judgment);
- Fertile females and all male subjects must agree to use highly effective contraception (condoms, sponges, gels, diaphragms, IUDs, oral/injectable contraceptives, or implants) during the trial and for 12 months after last Hematoporphyrin use. Fertile females must have negative pregnancy test within ≤7 days before investigational product administration.
Who cannot join
- Recurrent glioblastoma, brainstem tumors, or glioblastoma patients having received postoperative chemoradiotherapy;
- Hypersensitivity to photosensitizers;
- Uncontrolled infections, refractory epilepsy, and/or intracranial hypertension, and/or hypertension, and/or hyperglycemia;
- HIV infection, active hepatitis B (HBsAg positive with HBV DNA positive), or hepatitis C (HCV antibody positive);
- Other malignancies within 5 years without effective control (excluding cervical carcinoma in situ, cutaneous squamous cell carcinoma, or localized basal cell skin cancer);
- Other Investigator-assessed contraindications for trial participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Investigation of Sonodynamic Therapy in Conjunction With Chemoradiotherapy for Glioblastoma Management
This Phase II trial tests if sonodynamic therapy (SDT)-a non-invasive treatment using ultrasound to activate a cancer-killing drug-improves outcomes for newly diagnosed glioblastoma patients.
Who? 230 adults (<75 years) with confirmed glioblastoma, adequate organ function, no major health issues.
Read more
Groups:
Test Group: SDT + standard therapy (radiation, chemo, bevacizumab). Control Group: Standard therapy alone.
Procedure:
SDT uses the drug Hiporfin® followed by focused ultrasound sessions. Patients avoid sunlight for 1 month.
Study Duration:
Treatment: ~6-8 weeks. Follow-up: 24 months (monthly MRIs).
Key Goal:
Compare progression-free survival (time until tumor worsens) between groups. Secondary goals: overall survival, safety.
Read the detailed description
Detailed Description
This single-center, randomized, open-label Phase II trial evaluates the synergistic efficacy and safety of sonodynamic therapy (SDT) combined with standard chemoradiotherapy in newly diagnosed glioblastoma (GBM). While the Brief Summary outlines the trial's scope, this section elaborates on mechanistic, methodological, and analytical nuances not captured elsewhere.
Scientific Rationale SDT leverages low-intensity, low-frequency focused ultrasound (LILFU) (800 kHz-1 MHz, 1-1.25 W/cm²) to activate the sonosensitizer Hiporfin® (5 mg/kg), generating cytotoxic reactive oxygen species (ROS) selectively within tumor cells. Preclinical data demonstrate SDT disrupts mitochondrial function, enhances DNA damage from temozolomide, and promotes immunogenic cell death. This trial builds on Phase I results (unpublished) showing SDT induced tumor shrinkage in recurrent GBM with minimal toxicity.
Intervention Specifics
SDT Protocol:
Timing: Initiated 40 hours post-Hiporfin® administration to optimize tumor drug accumulation.
Ultrasound Parameters:
Frequency: 800 kHz-1 MHz (adjustable for tumor depth). Intensity: 1-1.25 W/cm² (below cavitation threshold to minimize tissue damage). Duration: 15 minutes/session, repeated at 24h, 48h, and 72h. Localized Delivery: Adults receive Hiporfin® via intra-arterial infusion (maximizing tumor uptake); children receive intravenous dosing (safety precaution).
Standard Therapy:
Radiation: 50-54 Gy in 1.8-2 Gy fractions (25 sessions). Temozolomide: 75 mg/m²/day concurrent with radiation; escalated to 150-200 mg/m²/day post-radiation.
Bevacizumab: 7.5-10 mg/kg every 3 weeks (angiogenesis inhibition). Methodological Rigor Stratified Randomization: Patients are stratified by tumor location (supratentorial vs. deep midline), size (<4 cm vs. ≥4 cm), and residual post-surgical volume to balance prognostic factors.
Imaging Protocol: MRI scans (T1-weighted with contrast, FLAIR) are standardized across timepoints (baseline, monthly post-treatment) and analyzed centrally using 3D volumetric segmentation to reduce inter-rater variability.
Safety Monitoring:
Phototoxicity Mitigation: Strict 30-day light avoidance protocol with ambient light levels monitored.
Real-Time AE Tracking: Adverse events (e.g., skin reactions, CNS edema) are graded per WHO criteria and managed via a pre-specified escalation algorithm.
Statistical Analysis Primary Endpoint: Progression-free survival (PFS) analyzed via stratified log-rank test (α=0.05, two-sided), adjusting for stratification factors.
Secondary Endpoints:
Overall survival (OS) analyzed using Weibull parametric survival models. Tumor control rate (CR+PR+SD) assessed via RECIST 1.1 with RANO criteria for neurologic tumors.
Exploratory Analysis: Biomarker correlation (EGFR expression, ROS levels) with SDT response using multiplex IHC and RNA sequencing.
Innovation \& Impact
This trial is the first to integrate SDT with standard GBM therapy in a randomized design. If successful, SDT could address critical unmet needs:
Non-invasive targeting of deep/inoperable tumors. ROS-mediated chemo/radio-sensitization to overcome treatment resistance. Reduced neurotoxicity vs. traditional therapies.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Sonodynamic Therapy (SDT), Standard Treatment
- Keywords
- Glioblastoma (GBM), Sonodynamic Therapy (SDT), Chemoradiotherapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonodynamic Therapy (SDT)Procedure or surgery
SDT: Hematoporphyrin 5 mg/kg.Sonodynamic therapy is administered 40 hours later, twice a day with an interval of 10-12 hours, for 5 consecutive days. One cycle lasts 28 days, and a total of 4-6 cycles are conducted.
Standard TreatmentOther
Radiotherapy: The dose is 50-54 Gy, 1.8-2 Gy per day, 5 times a week, for a total of 25 sessions Chemotherapy: When temozolomide is administered concurrently with radiotherapy, the dose is 75 mg/m² per day, taken daily until the end of radiotherapy. For adjuvant chemotherapy with temozolomide, the dose is 150 mg/m² per day from day 1 to day 5, followed by a 23 - day rest period. Each cycle lasts 28 days. If well - tolerated, the dose should be adjusted to 200 mg/m² per day for the 2nd - 6th cycles Targeted Therapy: Bevacizumab 7.5-10 mg/kg, once every 3 weeks, for a total of 4-6 courses
| Study group | Role | What they receive |
|---|---|---|
| SDT + Standard Therapy | Experimental | Hematoporphyrin 5 mg/kg.Sonodynamic therapy is administered 40 hours later, twice a day with an interval of 10-12 hours, for 5 consecutive days. One cycle lasts 28 days, and a total of 4-6 cycles are conducted Radiotherapy: The dose is 50-54 Gy, 1.8-2 Gy per day, 5 times a week, for a total of 25 sessions Chemotherapy: When temozolomide is administered concurrently with radiotherapy, the dose is 75 mg/m² per day, taken daily until the end of radiotherapy. For adjuvant chemotherapy with temozolomide, the dose is 150 mg/m² per day from day1to day 5, followed by a 23-day rest period. Each cycle lasts 28 days. If well-tolerated, the dose should be adjusted to 200 mg/m² per day for the 2nd - 6th cycles Targeted Therapy: Bevacizumab 7.5-10 mg/kg, once every 3 weeks, for a total of 4-6 courses Receives: Procedure: Sonodynamic Therapy (SDT); Other: Standard Treatment |
| Standard Therapy | Active comparator | Radiotherapy: The dose is 50-54 Gy, 1.8-2 Gy per day, 5 times a week, for a total of 25 sessions Chemotherapy: When temozolomide is administered concurrently with radiotherapy, the dose is 75 mg/m² per day, taken daily until the end of radiotherapy. For adjuvant chemotherapy with temozolomide, the dose is 150 mg/m² per day from day 1 to day 5, followed by a 23 - day rest period. Each cycle lasts 28 days. If well - tolerated, the dose should be adjusted to 200 mg/m² per day for the 2nd - 6th cycles Targeted Therapy: Bevacizumab 7.5-10 mg/kg, once every 3 weeks, for a total of 4-6 courses Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression - free survival (PFS)
Measured: It is evaluated for up to 5 years from the date of randomization to the date of first documented progression or death from any cause, whichever comes first
Secondary outcomes (1)
Overall survival time
Measured: It is evaluated for up to 5 years from the date of randomization to the date of death from any cause.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Oct 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yingjuan Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yingjuan Zheng, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130149
- Sponsor's protocol ID
- ZZU-1stH-GBM-SDTCRT-2025
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Sonodynamic Therapy in Conjunction With Chemoradiotherapy for Glioblastoma Management
- ClinicalTrials.gov ID
- NCT07130149
- Acronym / sponsor ID
- ZZU-1stH-GBM-SDTCRT-2025
- Conditions
- Glioblastoma (GBM)
- Keywords
- Glioblastoma (GBM), Sonodynamic Therapy (SDT), Chemoradiotherapy, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Yingjuan ZhengUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Aug 2025 (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.
This Phase II trial tests if sonodynamic therapy (SDT)-a non-invasive treatment using ultrasound to activate a cancer-killing drug-improves outcomes for newly diagnosed glioblastoma patients.
Who? 230 adults (<75 years) with confirmed glioblastoma, adequate organ function, no major health issues.
Groups:
Test Group: SDT + standard therapy (radiation, chemo, bevacizumab). Control Group: Standard therapy alone.
Procedure:
SDT uses the drug Hiporfin® followed by focused ultrasound sessions. Patients avoid sunlight for 1 month.
Study Duration:
Treatment: ~6-8 weeks. Follow-up: 24 months (monthly MRIs).
Key Goal:
Compare progression-free survival (time until tumor worsens) between groups. Secondary goals: overall survival, safety.
Detailed description
Detailed Description
This single-center, randomized, open-label Phase II trial evaluates the synergistic efficacy and safety of sonodynamic therapy (SDT) combined with standard chemoradiotherapy in newly diagnosed glioblastoma (GBM). While the Brief Summary outlines the trial's scope, this section elaborates on mechanistic, methodological, and analytical nuances not captured elsewhere.
Scientific Rationale SDT leverages low-intensity, low-frequency focused ultrasound (LILFU) (800 kHz-1 MHz, 1-1.25 W/cm²) to activate the sonosensitizer Hiporfin® (5 mg/kg), generating cytotoxic reactive oxygen species (ROS) selectively within tumor cells. Preclinical data demonstrate SDT disrupts mitochondrial function, enhances DNA damage from temozolomide, and promotes immunogenic cell death. This trial builds on Phase I results (unpublished) showing SDT induced tumor shrinkage in recurrent GBM with minimal toxicity.
Intervention Specifics
SDT Protocol:
Timing: Initiated 40 hours post-Hiporfin® administration to optimize tumor drug accumulation.
Ultrasound Parameters:
Frequency: 800 kHz-1 MHz (adjustable for tumor depth). Intensity: 1-1.25 W/cm² (below cavitation threshold to minimize tissue damage). Duration: 15 minutes/session, repeated at 24h, 48h, and 72h. Localized Delivery: Adults receive Hiporfin® via intra-arterial infusion (maximizing tumor uptake); children receive intravenous dosing (safety precaution).
Standard Therapy:
Radiation: 50-54 Gy in 1.8-2 Gy fractions (25 sessions). Temozolomide: 75 mg/m²/day concurrent with radiation; escalated to 150-200 mg/m²/day post-radiation.
Bevacizumab: 7.5-10 mg/kg every 3 weeks (angiogenesis inhibition). Methodological Rigor Stratified Randomization: Patients are stratified by tumor location (supratentorial vs. deep midline), size (<4 cm vs. ≥4 cm), and residual post-surgical volume to balance prognostic factors.
Imaging Protocol: MRI scans (T1-weighted with contrast, FLAIR) are standardized across timepoints (baseline, monthly post-treatment) and analyzed centrally using 3D volumetric segmentation to reduce inter-rater variability.
Safety Monitoring:
Phototoxicity Mitigation: Strict 30-day light avoidance protocol with ambient light levels monitored.
Real-Time AE Tracking: Adverse events (e.g., skin reactions, CNS edema) are graded per WHO criteria and managed via a pre-specified escalation algorithm.
Statistical Analysis Primary Endpoint: Progression-free survival (PFS) analyzed via stratified log-rank test (α=0.05, two-sided), adjusting for stratification factors.
Secondary Endpoints:
Overall survival (OS) analyzed using Weibull parametric survival models. Tumor control rate (CR+PR+SD) assessed via RECIST 1.1 with RANO criteria for neurologic tumors.
Exploratory Analysis: Biomarker correlation (EGFR expression, ROS levels) with SDT response using multiplex IHC and RNA sequencing.
Innovation \& Impact
This trial is the first to integrate SDT with standard GBM therapy in a randomized design. If successful, SDT could address critical unmet needs:
Non-invasive targeting of deep/inoperable tumors. ROS-mediated chemo/radio-sensitization to overcome treatment resistance. Reduced neurotoxicity vs. traditional therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDT + Standard Therapy | Experimental | Procedure: Sonodynamic Therapy (SDT), Other: Standard TreatmentHematoporphyrin 5 mg/kg.Sonodynamic therapy is administered 40 hours later, twice a day with an interval of 10-12 hours, for 5 consecutive days. One cycle lasts 28 days, and a total of 4-6 cycles are conducted Radiotherapy: The dose is 50-54 Gy, 1.8-2 Gy per day, 5 times a week, for a total of 25 sessions Chemotherapy: When temozolomide is administered concurrently with radiotherapy, the dose is 75 mg/m² per day, taken daily until the end of radiotherapy. For adjuvant chemotherapy with temozolomide, the dose is 150 mg/m² per day from day1to day 5, followed by a 23-day rest period. Each cycle lasts 28 days. If well-tolerated, the dose should be adjusted to 200 mg/m² per day for the 2nd - 6th cycles Targeted Therapy: Bevacizumab 7.5-10 mg/kg, once every 3 weeks, for a total of 4-6 courses |
| Standard Therapy | Active comparator | Other: Standard TreatmentRadiotherapy: The dose is 50-54 Gy, 1.8-2 Gy per day, 5 times a week, for a total of 25 sessions Chemotherapy: When temozolomide is administered concurrently with radiotherapy, the dose is 75 mg/m² per day, taken daily until the end of radiotherapy. For adjuvant chemotherapy with temozolomide, the dose is 150 mg/m² per day from day 1 to day 5, followed by a 23 - day rest period. Each cycle lasts 28 days. If well - tolerated, the dose should be adjusted to 200 mg/m² per day for the 2nd - 6th cycles Targeted Therapy: Bevacizumab 7.5-10 mg/kg, once every 3 weeks, for a total of 4-6 courses |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent form;
- Age < 75 years;
- Newly diagnosed postoperative glioblastoma patients pathologically confirmed as glioblastoma;
- Absence of severe hematopoietic dysfunction or cardiac, pulmonary, hepatic, renal abnormalities, or immunodeficiency. Pre-enrollment laboratory results must meet the following:
- Life expectancy ≥3 months;
Key exclusion criteria (6 listed)
- Recurrent glioblastoma, brainstem tumors, or glioblastoma patients having received postoperative chemoradiotherapy;
- Hypersensitivity to photosensitizers;
- Uncontrolled infections, refractory epilepsy, and/or intracranial hypertension, and/or hypertension, and/or hyperglycemia;
- HIV infection, active hepatitis B (HBsAg positive with HBV DNA positive), or hepatitis C (HCV antibody positive);
- Other malignancies within 5 years without effective control (excluding cervical carcinoma in situ, cutaneous squamous cell carcinoma, or localized basal cell skin cancer);
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 |
|---|---|---|
| Sonodynamic Therapy (SDT)SDT: Hematoporphyrin 5 mg/kg.Sonodynamic therapy is administered 40 hours later, twice a day with an interval of 10-12 hours, for 5 consecutive days. One cycle lasts 28 days, and a total of 4-6 cycles are conducted. | Procedure or surgery | SDT + Standard Therapy |
| Standard TreatmentRadiotherapy: The dose is 50-54 Gy, 1.8-2 Gy per day, 5 times a week, for a total of 25 sessions Chemotherapy: When temozolomide is administered concurrently with radiotherapy, the dose is 75 mg/m² per day, taken daily until the end of radiotherapy. For adjuvant chemotherapy with temozolomide, the dose is 150 mg/m² per day from day 1 to day 5, followed by a 23 - day rest period. Each cycle lasts 28 days. If well - tolerated, the dose should be adjusted to 200 mg/m² per day for the 2nd - 6th cycles Targeted Therapy: Bevacizumab 7.5-10 mg/kg, once every 3 weeks, for a total of 4-6 courses | Other | SDT + Standard Therapy, Standard Therapy |
Primary outcome
Progression - free survival (PFS)
Time frame: It is evaluated for up to 5 years from the date of randomization to the date of first documented progression or death from any cause, whichever comes first
1 secondary outcome
Overall survival time
Time frame: It is evaluated for up to 5 years from the date of randomization to the date of death from any cause.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sonodynamic Therapy (SDT) and Standard Treatment in people with Glioblastoma (GBM), run by Yingjuan Zheng 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 19 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression - free survival (PFS) (time frame: It is evaluated for up to 5 years from the date of randomization to the date of first documented progression or death from any cause, whichever comes first). 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 19 Aug 2025.