recurrent glioblastoma
Conditions
Interventions
Single arm :All patients received treatment with VM-26 combined with bevacizumab regimen.
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and = 60, with an expected survival time of >= 3 months; 5. Laboratory test indicators, including complete blood count, hepatic and renal function, and coagulation function, meet the following requirements (tests must be performed within 7 days before treatment): - Absolute neutrophil count (ANC) >= 1.5 × 10?/L - Platelet count (PLT) >= 100 × 10?/L - Hemoglobin (Hb) >= 90 g/L - Serum total bilirubin (TBIL) = 60 mL/min (calculated using the Cockcroft-Gault formula) - International normalized ratio (INR) <= 1.5 - Activated partial thromboplastin time (APTT) <= 1.5 × ULN; 6. No severe dysfunction of vital organs such as the heart, lungs, or kidneys, and no uncontrolled infections (e.g., active pneumonia, sepsis, etc.); 7. No severe bleeding tendency or history of hemorrhagic diseases (such as intracranial hemorrhage or major gastrointestinal bleeding within the past 6 months), and no unhealed wounds or surgical incisions. 8. Female patients must be non-pregnant, non-lactating, and agree to use effective contraception during the study period and for 6 months after treatment. 9. The patient voluntarily participates in this study, signs the informed consent form, and is able to cooperate with the completion of treatment, follow-up, and all required examinations.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with VM-26 (teniposide). 2. Patients who have received other salvage therapies after recurrence (such as reoperation, re-irradiation, or other chemotherapy drugs) are excluded, except for those with an interval of >=4 weeks from tumor progression/relapse after initial treatment to enrollment in this study and whose related adverse reactions have recovered to NCI-CTCAE v5.0 grade =2 seizure episodes within the past month, or ineffective control despite the use of antiepileptic drugs). 4. Presence of severe cerebral edema or symptoms of increased intracranial pressure that remain uncontrolled despite dehydration therapy. 5. Arterial thromboembolic events (such as myocardial infarction, cerebral infarction, etc.) or venous thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.) have occurred within the past 6 months. 6. Hypertensive crisis or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg, still uncontrolled despite standard antihypertensive treatment). 7. History of active gastrointestinal ulcer, perforation, or fistula formation (within the past 6 months). 8. Concurrent with other malignant tumors (except for cured malignancies such as basal cell carcinoma of the skin or carcinoma in situ of the cervix), or a history of prior malignant tumors with a disease-free survival period of less than 5 years. 9. Presence of psychiatric disorders or cognitive impairment that would prevent cooperation with treatment and follow-up; 10. Other conditions deemed by the investigator as unsuitable for participation in this study (e.g., severe electrolyte disturbances, active autoimmune diseases, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;12-month event-free survival rate;progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactXiaoxu Lu
Henan Cancer Hospital
Outcome results
None listed