High-Grade Glioma
Conditions
Interventions
Case series:Hypofractionated Stereotactic Radiotherapy + Durvalumab+ Bevacizumab
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Karnofsky performance status (KPS) >= 70; 3. Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma; 4. Underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol) after initial diagnosis, recurrent based on the Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathologically proven; 5. Measurable disease; 6. Estimated survival of at least 3 months; 7. Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/µl; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value; 8. Signed informed consent form; 9. Agreed to participate the follow-up.
Exclusion criteria
Exclusion criteria: 1. With other malignant tumors except recovered tumors; 2. Received >=2 times radiotherapies on same tumor lesion; 3. More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter; 4. Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR; 5. Pregnancy or or nursing mothers; 6. Participated in other trials after diagnosis of recurrent; 7. Influence factors toward oral medications; 8. Patients with CTCAE5.0 grade 3+ bleeding; 9. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval >= 450 ms, women >= 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%; 10. Long-term unhealed wounds or fractures; 11. History of organ transplantation; 12. Serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival after salvage treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Objective response rate (ORR);Quality of Life score (QoL);Cognitive function;Treatment-related toxicity rate; | — |
Countries
China
Contacts
Public ContactYun Guan
Huashan Hospital, Fudan University
Outcome results
None listed