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Sonodynamic-Chemoradiotherapy Integration in Glioblastoma

NCT07130149 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-08-19

No results posted yet for this study

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.

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

  • Glioblastoma (GBM)

Interventions

PROCEDURE

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.

OTHER

Standard Treatment

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

Sponsors & Collaborators

  • Yingjuan Zheng

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2028-08-01
Completion
2028-10-01

Countries

  • China

Study Locations

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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 NCT07130149 on ClinicalTrials.gov