Glioma
Conditions
Interventions
Test Group:Vebreltinib Enteric-coated Capsules: 200 mg per dose, twice daily, orally administered. The treatment cycle is 28 days, with continuous administration
the dosage can be adjusted based on tolerability.
Temozolomide Capsules: 150 mg/m2, once daily, administered continuously from Day 1 to Day 5, followed by a 23-day rest period. The treatment cycle is
the dosage can be adjusted based on tolerability.
Bevacizumab: 3-5 mg/kg body weight, administered intravenously once every 2 weeks
the dosage can be adjusted according to the clinician's decision and tolerability.
Control Group:The optimal treatment plan determined by joint decision-making of clinicians and patients.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Confirmed as recurrent/progressive malignant glioma by imaging and pathological examinations; 3. The last surgical specimen, confirmed by molecular pathology and immunohistochemical tests, shows no MET gene abnormalities (fusion, mutation, splice variation, amplification) or MET protein overexpression (H-score = 75×10?/L; Absolute neutrophil count >= 1.5×10?/L; Hemoglobin > 90g/L; (2) Blood biochemistry: Aspartate transaminase (AST, SGOT) = 70, able to swallow drugs and maintain oral administration; 8. Women of childbearing age must undergo a pregnancy test within 7 days before the first dose with a negative result, and commit to using at least one acceptable contraceptive method (i.e., intrauterine device, barrier method with spermicide, condom, any form of hormonal contraceptive, or abstinence) throughout the study period and within 3 months after the last receipt of study treatment; 9. Voluntarily participate in the study, sign the informed consent form, and be able to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have received any other postoperative treatments except chemotherapy and tumor-treating fields after the last surgery (including but not limited to c-Met inhibitors, HGF-targeted drug therapy, antibody-based anti-tumor drug therapy, carmustine sustained-release implant therapy, or intracranial lesion implantation radiotherapy); 2. Patients who are unable to undergo cranial MRI examination; 3. Patients with active bleeding detected by cranial CT or MRI scan before enrollment; 4. Patients with uncontrolled hypertension, with systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after antihypertensive drug treatment; 5. Patients who have experienced decompensated heart failure (NYHA class ? and ?), unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmia within 3 months before enrollment; 6. Patients who have suffered severe trauma or infection affecting the current anti-tumor treatment within 4 weeks before enrollment; 7. Patients who have undergone major surgery within 4 weeks before enrollment; or those who have undergone bone marrow biopsy, open biopsy, or intracranial biopsy within 7 days before screening; 8. Patients with anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA > 1000 IU/ml. Patients who are HBsAg positive but have HBV-DNA levels between 1000-10000 IU/ml and are willing to receive antiviral treatment during the study can be enrolled; 9. Patients who require long-term continuous use of hematopoietic growth factors (including granulocyte colony-stimulating factor, macrophage colony-stimulating factor, interleukin-11) or platelet transfusion to maintain a platelet count >= 75×10?/L and an absolute neutrophil count >= 1.5×10?/L; 10. Pregnant or lactating women, or those planning to become pregnant during the study; 11. Patients who have used other investigational drugs within 30 days before the first administration of the study drug; 12. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Overall Survival Rate ;Duration of Response (DOR);Objective Response Rate (ORR);Karnofsky Performance Status Scale (KPS);Patient-Reported Outcomes Measurement;Disease Control Rate(DCR); | — |
Countries
China
Contacts
Public ContactBao Zhaoshi
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed