Patients with recurrent high-grade glioma
Conditions
Interventions
Test group: Obitazine fumarate enteric-coated pellet capsule (SM-1) combined with temozolomide:Obitazine fumarate enteric-coated pellet capsule (SM-1) in combination with temozolomide
Control group 1: Temozolomide capsules:Temozolomide capsules
Control group 2: Temozolomide capsule + cisplatin:Temozolomide capsule + cisplatin
Exploratory group: SM-1 monotherapy group:SM-1 monotherapy group
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age>=18 years old, gender is not limited; 3. Patients with high-grade gliomas (including grade III and IV, except brainstem tumors, diffuse midline glioma and gliosarcoma) diagnosed by MRI after standard treatment (surgery, Stupp regimen treatment) and evaluated by RANO criteria (see Appendix 1 for details) to support the initial recurrence; The STUPP program needs to be completed for at least 6 cycles; 4. The methylation status of the MGMT promoter is positive; 5. The first clinical recurrence must be completed within 3 months after the end of radiotherapy; 6. Estimated survival time> 3 months; 7. KPS score (see Appendix 2 for details) >=60; 8. Within 5 days before administration, the dose of corticosteroids used is stable or gradually reduced; 9. Have sufficient organ function and meet all of the following indicators: Liver function: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), =60 mL/min (calculated by the Cockcroft-Gault equation, see Annex 3 for details); Hematology: absolute neutrophil count (ANC) >=1.5×10³/µL; platelet >=100×10³/µL; hemoglobin >=9.0 g/dL; Echocardiography: left ventricular ejection fraction (LVEF) >=50%; 10. Patients enrolled in the study are able to take effective contraceptive measures from the beginning of the screening period to 6 months after the end of this study; Within 7 days before receiving the study drug for the first time, the blood pregnancy test of female patients of childbearing age was negative; 11. The patient has a full understanding of the test process, content and possible adverse reactions, and can complete the test in accordance with the clinical trial plan.
Exclusion criteria
Exclusion criteria: 1?Patients with other malignancies, unless they have survived progression-free for 5 years and are considered to have a low risk of recurrence or in situ cancer; 2?had major organ surgery (excluding glioma biopsy or excision) within 4 weeks prior to initial use of the study drug or required elective surgery during the trial period; 3?Receiving other investigational drugs or treatments that are not on the market within the 4 weeks prior to the first use of the investigational drug; 4?Anti-tumor therapy such as biologic agents (antibodies, immunomodulators, cytokines, etc.), chemotherapy drugs (nitrosourea drugs used within 42 days before receiving the study drug for the first time are not allowed to be included in the group) or Chinese patent drugs with anti-tumor indications; 5?A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 6?Have a variety of factors that affect oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 7?Patients with definite bleeding tendencies, such as gastrointestinal bleeding and hemorrhagic gastric ulcer; Patients with history of black stool and hematemesis within 2 months before administration; Patients with possible internal bleeding; 8?Use of hematopoietic cytokines (granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), or erythropoietin) within 7 days before first receiving the investigational drug; 9?Patients known to be allergic to the investigational drug (SM-1, temozolomide, or cisplatin) or its excipients or dacarbazine; 10?Patients with a known history of psychotropic substance abuse, alcohol abuse or drug use; 11?Hepatitis B surface antigen (HbsAg) positive, and hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer in peripheral blood was higher than the upper limit of the normal value of the research center; Subjects with positive hepatitis C virus (HCV) antibody test results should be further tested for HCV RNA, and HCV RNA quantitative test is positive. Human immunodeficiency virus (HIV), syphilis positive test; 12?Patients who had any of the following conditions in the 6 months before first receiving the study drug: severe or unstable angina pectoris, myocardial infarction, coronary artery reconstruction, congestive heart failure, cerebrovascular events (including transient ischemic attacks); 13?Pulmonary embolism within 6 months before first receiving the study drug; A history of blood clots, pulmonary embolism, or deep vein thrombosis (unless controlled by anticoagulant therapy, the patient must take a stable dose of medication for more than 2 weeks); 14?Have any clinically significant infection, i.e. any acute viral, bacterial or fungal infection that requires specific treatment (anti-infective treatment must be completed =7 days before the start of the study); 15?any unhealed wounds, fractures, or ulcers in the 28 days prior to first taking the trial drug; Have other severe, uncontrolled conditions, including uncontrolled diabetes (HBA1c =9% in patients with a history of diabetes at 28 days prior to enrollment) or clinical symptoms of unstable congestive heart failure; 16?Patients who use antiepileptic drugs prior to first use of the investigational drug (other than non-enzyme-induced antiepileptic drugs with stable dose levels within 14 days prior to first use of the investigational drug) or have a grand ma
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, overall survival/and safety assessment.;Security assessment; | — |
Primary
| Measure | Time frame |
|---|---|
| Brain glioma lesion measurement; | — |
Countries
China
Contacts
Public ContactWeibinLi
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed