Study on The Sensitizing Effect of Sonodynamic Therapy on The Treatment of Brainstem Glioma With Radiotherapy and Chemotherapy and Survival Analysis

Korábbi kezelés

• 2) Subjects who participated in any other drug clinical trials or other interventional clinical trials within 4 weeks before the administration of the test drug, except for those who participated in observational (non-interventional) clinical studies or those who are in the follow-up period of interventional studies;
• 3) Subjects who have previously received SDT treatment;
• 4) Subjects who used other photosensitive drugs (tetracycline antibiotics, sulfonamides, phenothiazines, sulfonylurea hypoglycemic drugs, thiazide diuretics, and griseofulvin, etc.) within 4 weeks before the administration of the test drug

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• 1) Subjects known to be allergic to hematoporphyrin or other photosensitive drugs;
• 6) Subjects with uncontrolled infections or clinically significant active infectious diseases;
• 7) Subjects with positive test results for any one or more of hepatitis C virus (HCV) antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody, or subjects with active hepatitis B (defined as HBV DNA ≥ 2000 IU/mL or HBV DNA ≥ 10⁴ copies);
• 8) Difficult-to-control epilepsy and/or increased intracranial pressure and/or hypertension and/or hyperglycemia;
• 9) Subjects with severe or uncontrolled cardiovascular and cerebrovascular diseases and lung diseases (including myocardial infarction, Class III - IV heart failure, cardiac insufficiency, Grade 2 or above heart block, severe arrhythmia, cerebral infarction, cerebral hemorrhage, asthma attack, or severe respiratory failure);
• 10) Subjects who have had other malignant tumors in the past 5 years and have not been effectively controlled;
• 11) Subjects with uncontrolled mental illnesses/social situations that are expected to limit their compliance with the research requirements or impair the subject's ability to sign the informed consent form in writing;

Egyéb

• 5) Subjects with brainstem gliomas in a cachectic state or who are expected to be unable to tolerate SDT treatment;
• 12) Pregnant or lactating women;
• 13) Subjects with other reasons judged by the researcher to be unsuitable for participating in this trial, such as those with large brain tumor lesions.

• 1) All subjects or their legal representatives must voluntarily and in writing sign the informed consent form approved by the ethics committee before starting the screening process;
• 2) Age < 75 years old, gender is not limited.;
• 3) Newly diagnosed patients with brainstem DIPG. It is confirmed as brainstem DIPG by histology or cytology (referring to the WHO Classification of Tumors of the Central Nervous System 2016), and there are radiologically evaluable lesions;
• 4) ECOG score is 0 - 2;
• 5) The expected survival period is ≥ 3 months;
• 6) The subjects have sufficient organ and bone marrow functions, without severe hematopoietic dysfunction and abnormal heart, lung, liver, kidney functions or immunodeficiency. The hematological indicators before enrollment are basically normal: white blood cell count ≥ 4×10⁹/L, absolute neutrophil count ≥ 1.5×10⁹/L, platelet ≥ 100×10⁹/L, hemoglobin ≥ 90 g/L. The renal function is basically normal: serum creatinine ≤ 1.2 mg/dL or creatinine clearance rate ≥ 60 ml/min. The liver function is basically normal: serum total bilirubin ≤ 1.5 × ULN (if there is liver metastasis, then serum total bilirubin should ≤ 3.0 × ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN (if there is liver metastasis ≤ 5.0 × ULN). The coagulation function is basically normal: the international normalized ratio of prothrombin time (INR) ≤ 2.0, and PT, APTT, and TT are all within the normal range;
• 7) The toxic reactions of anti-tumor treatment before the administration of the test drug have decreased to Grade 1 or below, or the subjects have fully recovered from previous surgeries (judged by the researcher). 8) Women of childbearing age and all male subjects must agree to use highly effective contraceptive methods during the trial period and within 12 months after the last use of hematoporphyrin injection (such as condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.), and the pregnancy test results of women of childbearing age must be negative within ≤ 7 days before the administration of the test drug.