Clinical trial · Interventional
Sonodynamic-Chemoradiotherapy Integration in Glioblastoma
Clinical Investigation of Sonodynamic Therapy in Conjunction With Chemoradiotherapy for Glioblastoma Management
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sonodynamic Therapy (SDT) | Procedure | — | UNRESOLVED |
| Standard Treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SDT + Standard Therapy
- description
- 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
- interventionNames
- Procedure: Sonodynamic Therapy (SDT)
- Other: Standard Treatment
- type
- ACTIVE_COMPARATOR
- label
- Standard Therapy
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. Signed informed consent form;
2. Age \< 75 years;
3. Newly diagnosed postoperative glioblastoma patients pathologically confirmed as glioblastoma;
4. 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
* 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;
5. Life expectancy ≥3 months;
6. Adverse reactions from prior anti-tumor therapy recovered to ≤ Grade 1, or complete recovery from surgery (Investigator's judgment);
7. 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.
Exclusion Criteria:
1. Recurrent glioblastoma, brainstem tumors, or glioblastoma patients having received postoperative chemoradiotherapy;
2. Hypersensitivity to photosensitizers;
3. Uncontrolled infections, refractory epilepsy, and/or intracranial hypertension, and/or hypertension, and/or hyperglycemia;
4. HIV infection, active hepatitis B (HBsAg positive with HBV DNA positive), or hepatitis C (HCV antibody positive);
5. Other malignancies within 5 years without effective control (excluding cervical carcinoma in situ, cutaneous squamous cell carcinoma, or localized basal cell skin cancer);
6. Other Investigator-assessed contraindications for trial participation.References
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