Secondary glioblastoma
Conditions
Interventions
Test group(60= KPS score <80):Vebreltinib was administrated orally 300mg twice a day every 28 days
Test group(KPS score =80):Vebreltinib was administrated orally 300mg twice a day every 28 days
Control group(60= KPS score <80):Temozolomide dose density regimen: 7 days of administration, 7 days of rest, every 28 days as a cycle, the dose is based on tolerance, 100-150 mg/m2/d
or cisplatin combined with etoposide regimen: cisplatin 80 -100mg/m2, administered in 3 days, the dose is determined according to tolerance, etoposide 100mg/m2/d, administered continuously for 3 days
every 28 days is a cycle
Control group(KPS score =80):Temozolomide dose density regimen: 7 days of administration, 7 days of rest, every 28 days as a cycle, the dose is based on tolerance, 100-150 mg/m2/d
Sponsors
Beijing Tiantan Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female with 18 = Age = 65 years; 2. Histologically confirmed secondary glioblastoma (progression from lower-grade glioma to glioblastoma) or IDH-mutant glioblastoma (Histology and IDH test reports from other hospitals are acceptable); 3. The latest surgical sample was confirmed to be positive for the ZM fusion gene through molecular pathological testing in the central laboratory; 4. Those who had previously received radio-therapy (including gamma knife, cyberknife, etc.) and temozolomide treatment and had tumor recurrence, or who had received temozolomide but were not suitable for radiotherapy, or who had received radiotherapy but were intolerant to temozolomide (ANC 90g/L; (2) Blood biochemistry: aspartate aminotransferase (AST, SGOT) =3×ULN; Alanine aminotransferase (ALT, SGPT) =3×ULN; Total bilirubin =2×ULN; serum creatinine =1.5×ULN; Urea nitrogen =1.5×ULN; serum amylase = 1.5×ULN or 1.5×ULN <serum amylase =2×ULN without evidence of pancreatic disease; serum lipase =1.5×ULN or 1.5×ULN <serum lipase =2×ULN without evidence of pancreatic disease; Fasting serum triglyceride level= 2.5×ULN; (3) Coagulation function: prothrombin time international standardized ratio (INR) = 2.0; 7. Karnofsky Performance Status (KPS) = 60, be able to swallow the drug and keep it orally; 8. Life expectancy of =3 months; 9. Female participants must have a negative serum beta-human choronic gonadotropin pregnancy test within 7 days prior to enrollment if of child-bearing potential, and are required to use adequate contraception (i.e., IUD, spermicidal barrier, condom, hormonal contraceptives, or abstinence), during their participation in the study and for 3 months following the last dose administration; 10. Voluntarily participate in this study and sign the informed consent form, and be able to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Previously received c-met inhibitors or HGF-targeted drugs; 2. Antibody oncology drugs received within 30 days prior to study enrollment; 3. Previously received carmustine extended-release implants or intralesional radiotherapy; 4. Patients who could not have brain MRI; 5. Active bleeding detected by transcranial CT or MRI scan before enrollment; 6. Uncompensated hypertension with systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg after treatment with anti-hypertension drugs; 7. Negligent decompensated heart failure (NYHA graded III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmias within 3 months prior to enrollment; 8. Severe trauma or infection affecting current antitumor therapy within 4 weeks prior to enrollment; 9. = Grade 3 chronic toxic reactions (excluding hair loss) according to the National Cancer Institute Common Adverse Event Evaluation Criteria (NCI-CTCAE 5.0); 10. Major surgery (excluding glioma surgery) performed within 4 weeks prior to enrollment; individuals who have undergone bone marrow biopsy, open biopsy, or intracranial biopsy within 7 days prior to screening; 11. Anti HIV (+), or both anti HCV and HCV-RNA (+), or HBsAg (+) and HBV DNA >1000IU/ml. If HBsAg (+) but HBV-DNA level between 1000~10000 IU/ml, patients who were willing to use anti-viral therapy during the study period have been enrolled; 12. Other malignancies within the past 5 years that have not been effectively controlled, except for carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or localized basal cell skin cancer; 13. Long-term continuous use of hematopoietic growth factor (including granulocyte colony-stimulating factor, macrophage knockdown-stimulating factor, or interleukin-11) or platelet transfusion is required to maintain platelet count =75×10^9/L and absolute neutrophil count =1.5×10^9/L; 14. Pregnancy or breastfeeding, or plan to be pregnant during the study period; 15. Other study drugs used within 30 days prior to the first administration of the investigational drug; 16. Unsuitable to participate in this clinical trial judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;ORR, Objective Response Rate;Karnofsky Performance Status Scale, KPS;Quality of life; | — |
Countries
China
Contacts
Public ContactQiu Xiaoguang; Li Wenbin
Bejing Tiantan Hospital, Capital Medical University
Outcome results
None listed