Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Summary

Participation Requirements

Description

INCLUSION CRITERIA: Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma.; Radiographic evidence of tumour progression or recurrence; The second-generation gene sequencing on pathological specimens and cerebrospinal fluid show at least one genetic mutation of the four genes...

INCLUSION CRITERIA: Histologically confirmed World Health Organization (WHO) Grade IV glioblastoma.; Radiographic evidence of tumour progression or recurrence; The second-generation gene sequencing on pathological specimens and cerebrospinal fluid show at least one genetic mutation of the four genes (VEGFR?Kit?PDGFR?FGFR); ? 18 years of age; Karnofsky performance status (KPS) ? 70; Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. a new baseline scan is required 1.7 Measurable disease as per Response Assessment in Neuro-Oncology (RANO) criteria; Estimated survival of at least 3 months; signed informed consent form; Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/?l; 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; EXCLUSION CRITERIA: Exclusion Criteria: Subjects with newly diagnosed GBM Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. Women of childbearing potential must practice medically approved contraceptive precautions; Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3 Severe or chronic renal insufficiency (creatinine clearance ? 30 ml/min); Patient unable to follow procedures, visits, examinations described in the study; Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);

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