Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Amino Acids

Endothelial Growth Factors

Mitogens

Tyrosine Kinase Inhibitors

Tyrosine

12 mg daily from day 1 to 14 of a 21-day cycle

Anlotinib is a multitarget receptor tyrosine kinase inhibitor which inhibits vascular endothelial growth factor receptor (VEGFR) 1-3, fibroblast growth factor receptor (FGFR) 1-4, platelet-derived growth factor receptors (PDGFR) α/β, c-Kit, and Met.

Anlotinib

Rongjie Tao, Dr.

Jun Xu, Dr.

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);

Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib

Phase II Clinical Trials on Anlotinib for the Treatment of Recurrent Glioblastoma.

PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

OS is defined as the time until death due to any cause.

ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.

Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib	NCT04004975	Recurrent Gliob...	Anlotinib	18 Years - 80 Years	Shandong Cancer Hospital and Institute
Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib	NCT04004975	Recurrent Gliob...	Anlotinib	18 Years - 80 Years	Shandong Cancer Hospital and Institute
Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib	NCT04004975	Recurrent Gliob...	Anlotinib	18 Years - 80 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for anlotinib recurrent glioblastoma