Sonodynamic-Chemoradiotherapy Integration in Glioblastoma

NCT07130149 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: ZZU-1stH-GBM-SDTCRT-2025
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Glioblastoma (GBM); Sonodynamic Therapy (SDT); Chemoradiotherapy; Temozolomide

Outcome Measures

Primary Outcomes (1)

• Progression - free survival (PFS)

  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

  It is evaluated for up to 5 years from the date of randomization to the date of death from any cause.

Study Arms (2)

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

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

Other: Standard Treatment

Interventions

Sonodynamic Therapy (SDT) PROCEDURE

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.

SDT + Standard Therapy

Standard Treatment OTHER

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

SDT + Standard Therapy; Standard Therapy

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yingjuan Zheng: lead

Study Sites (1)

First H A Zhengzhou U

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (1)