Sonodynamic-Chemoradiotherapy Integration in Glioblastoma

Prior treatment

• Recurrent glioblastoma, brainstem tumors, or glioblastoma patients having received postoperative chemoradiotherapy;

Other illness

• 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

• Other Investigator-assessed contraindications for trial participation.

• 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.