clinical study on the treatment of recurrent glioblastoma with anlotinib

Conditions: Recurrent Glioblastoma

Summary: anlotinib is a novel small molecule multi-target tyrosine kinase inhibitor that can inhibit tumor angiogenesis and inhibit tumor cell growth. we performed second-generation gene sequencing on pathological specimens and cerebrospinal fluid of patients with recurrent glioblastoma.if patients have a genetic mutation （vegfr，kit，pdgfr，fgfr）and meet other eligibility criteria, they will be treated with antroinib. the initial observation targets were progression-free survival and adverse reactions. the secondary objective was overal survival.

inclusion criteria: 1. histologically confirmed world health organization (who) grade iv glioblastoma.; 2. radiographic evidence of tumour progression or recurrence; 3. 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); 4. ≥ 18 years of age; 5. karnofsky performance status (kps) ≥ 70; 6. corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. 7. a new baseline scan is required 1.7 measurable disease as per response assessment in neuro-oncology (rano) criteria; 8. estimated survival of at least 3 months; 9. signed informed consent form; 10. 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; exclusion criteria: exclusion criteria: 1. subjects with newly diagnosed gbm 2. 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; 3. abnormal hematological results at inclusion with: neutrophils \< 1,500/mm3; blood-platelets \< 100,000/mm3 4. severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min); 5. patient unable to follow procedures, visits, examinations described in the study; 6. any usual formal indication against imaging examinations (important claustrophobia, pacemaker);

Eligibility criteria:
inclusion criteria: 1. histologically confirmed world health organization (who) grade iv glioblastoma.; 2. radiographic evidence of tumour progression or recurrence; 3. 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); 4. ≥ 18 years of age; 5. karnofsky performance status (kps) ≥ 70; 6. corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. 7. a new baseline scan is required 1.7 measurable disease as per response assessment in neuro-oncology (rano) criteria; 8. estimated survival of at least 3 months; 9. signed informed consent form; 10. 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; exclusion criteria: 1. subjects with newly diagnosed gbm 2. 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; 3. abnormal hematological results at inclusion with: neutrophils \< 1,500/mm3; blood-platelets \< 100,000/mm3 4. severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min); 5. patient unable to follow procedures, visits, examinations described in the study; 6. any usual formal indication against imaging examinations (important claustrophobia, pacemaker);

Keywords: anlotinib recurrent glioblastoma