Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ENROLLING BY INVITATION

NCT07130149

PHASE2

Sonodynamic-Chemoradiotherapy Integration in Glioblastoma

Sponsor: Yingjuan Zheng

View on ClinicalTrials.gov

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.

Official title: Clinical Investigation of Sonodynamic Therapy in Conjunction With Chemoradiotherapy for Glioblastoma Management

Key Details

Gender

All

Age Range

Any - 75 Years

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2024-10-01

Completion Date

2028-10-01

Last Updated

2025-08-19

Healthy Volunteers

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

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.

Locations (1)

First H A Zhengzhou U

Zhengzhou, Henan, China