Clinical Study on the Treatment of Recurrent Glioblastoma With Anlotinib
Ključne riječi
Sažetak
Opis
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);
Datumi
| Posljednja provjera: | 06/30/2019 |
| Prvo podneseno: | 06/30/2019 |
| Predviđena prijava poslana: | 06/30/2019 |
| Prvo objavljeno: | 07/01/2019 |
| Posljednje ažuriranje poslano: | 06/30/2019 |
| Posljednje ažuriranje objavljeno: | 07/01/2019 |
| Stvarni datum početka studija: | 06/24/2019 |
| Procijenjeni datum primarnog završetka: | 07/24/2020 |
| Procijenjeni datum završetka studije: | 07/24/2021 |
Stanje ili bolest
Intervencija / liječenje
Drug: anlotinib
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Experimental: anlotinib 12 mg daily from day 1 to 14 of a 21-day cycle | Drug: anlotinib 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. |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | 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); |
Ishod
Primarne mjere ishoda
1. Progress free survival (PFS) [each 42 days up to PD or death(up to 24 months)]
Sekundarne mjere ishoda
1. Overall Survival (OS) [From randomization until death (up to 24 months)]
2. Objective Response Rate (ORR) [each 42 days up to intolerance the toxicity or PD (up to 24 months)]
3. Disease Control Rate (DCR) [each 42 days up to intolerance the toxicity or PD (up to 24 months)]
4. Quality of Life score (QoL) [each 42 days up to intolerance the toxicity or PD (up to 24 months)]
