Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

• Status: Unknown status
• Trial end date: 2021-07-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute

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);