Tests ultrasound-activated sonodynamic therapy alongside standard treatment for glioblastoma
Tests sonodynamic therapy with standard treatment in adults newly diagnosed with glioblastoma.
Plain-language title generated from the registry record
Registry title: Sonodynamic-Chemoradiotherapy Integration in Glioblastoma
Key facts
- Where
- Zhengzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults under 75 with newly diagnosed glioblastoma after surgery. It tests ultrasound-activated drug treatment (sonodynamic therapy) added to standard treatment.
- Age
- Under 75 years
- Sex
- All sexes can join
- Disease stage
- Newly diagnosed glioblastoma after surgery, confirmed by pathology (tissue examination)
- Earlier treatment
- No chemoradiotherapy after surgery. Side effects from earlier cancer treatment must have recovered to Grade 1 or less, or the person must have fully recovered from surgery.
Main reasons for not taking part
- Recurrent glioblastoma, brainstem tumor, or chemoradiotherapy already given after surgery
- Allergy to photosensitizer drugs
- Uncontrolled infection, hard-to-control epilepsy, raised pressure in the head, high blood pressure or high blood sugar
- HIV infection, active hepatitis B or hepatitis C
- Another cancer within the past 5 years that is not under effective control
Read by machine on 9 November 2026.
Where in China
- First H A Zhengzhou UZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yingjuan Zheng
- Trial code
- NCT07130149
- Record updated
- 19 August 2025
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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; 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.
Exclusion: 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.