brain stem tumor, brain stem glioma and recurrent glioblastoma
Conditions
Interventions
Experimental group:Sonodynamic therapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
No minimum to 75 Years
Inclusion criteria
Inclusion criteria: 1. All subjects or their legal representatives must voluntarily sign an informed consent form approved by the Ethics Committee in person prior to the commencement of any screening procedure; 2. Aged = 3 months; 6. The subject has sufficient organ and bone marrow function, without serious hematopoietic dysfunction, heart, lung, liver, kidney dysfunction and immune deficiency. Laboratory examination results before enrollment were consistent with: hematological indicators were basically normal: white blood cell count >= 4 x 10^9/L; Neutrophil absolute number >= 1.5 x 10^9/L; Platelets >= 100 x 10^9/L; Hemoglobin >= 90 g/L; Normal renal function: serum creatinine = 60 ml/min; The liver function was basically normal: serum total bilirubin <= 1.5 x ULN (if there was liver metastasis, serum total bilirubin <= 3.0 x ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.0 x ULN (<= 5.0 x ULN if liver metastases are present); The coagulation function was basically normal: the international normalized ratio (INR) of prothrombin time was <= 2.0, and PT, APTT and TT were all within the normal range; 7. The toxicity of antitumor therapy prior to the administration of the trial drug decreased to grade 1 or below, or fully recovered from previous surgery (as determined by the investigator); 8. Women of childbearing age and all male subjects must agree to use efficient contraceptive methods (condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) during the trial period and within 12 months after the last use of Xipofen, and the pregnancy test results of women of childbearing age must be negative within 7 days or less before the administration.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to hematoporphyrin or other photosensitive drugs; 2. Subjects who participated in any other drug clinical trial or other interventional clinical trial within 4 weeks prior to the administration of the study drug, except those who participated in an observational (non-interventional) clinical study or were already in the follow-up period of an interventional study; 3. Previous sonodynamic therapy; 4. Use of other photosensitive drugs (tetracyclic antibiotics, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics, griseofulfomycin, etc.) within 4 weeks before study drug administration; 5. Subjects with gliomas in an oxoid state or who are not expected to tolerate sonodynamic therapy; 6. Subject has an uncontrolled infection or clinically significant active infectious disease; 7. Subjects with a positive test result for any or more of the hepatitis C virus (HCV) antibody, treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody, or active hepatitis B (defined as HBV DNA >= 2,000 IU/mL or HBV DNA>= 104 copies); 8. Uncontrollable seizures and/or high intracranial pressure and/or hypertension and/or hyperglycemia; 9. Severe or uncontrolled cardiovascular and cerebrovascular disease and pulmonary disease (including myocardial infarction, grade III-IV heart failure, cardiac insufficiency, grade 2 or more heart block, severe arrhythmia, brain infarction, cerebral hemorrhage, asthma attack, or severe respiratory failure); 10. Patients with other malignant tumors that have not been effectively controlled in the past 5 years; 11. Have uncontrolled mental illness/social conditions that are expected to limit compliance with study requirements or impair the subject's ability to sign informed consent in person; 12. Pregnant or lactating women; 13. Other reasons for ineligibility to participate in the trial, such as large brain tumor lesions, were judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactYingjuan Zheng
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed