A Phase II Study of Hypofractionated Stereotactic Radiotherapy Combined With Anlotinib in Patients With Recurrent High-Grade Glioma

KY2019-525

A Phase II Study of Hypofractionated Stereotactic Radiotherapy (HSRT) With Anlotinib in Patients With Recurrent High-Grade Glioma. The primary endpoint is overall survival after radiotherapy. Secondary endpoints included progress-free survival, objective response rate, cognitive function, quality of life, toxicity.

2019-12-16

2023-12-31

2024-12-31

Active (not recruiting)

Early phase I

22

Inclusion Criteria: 1. 18-70 years of age; 2. Karnofsky performance status (KPS) ≥ 60; 3. Original histopathologically proven diagnosis World Health Organization (WHO) Grade 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: 1. Prior invasive malignancy unless disease free; 2. Received re-irradiation; 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ESTIMATED'}}

2024-01-05