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Apatinib mesylate tablets in the treatment of recurrent glioblastoma, open II single arm clinical study

Apatinib mesylate tablets in the treatment of recurrent glioblastoma, open II single arm clinical study

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014395
Enrollment
Unknown
Registered
2018-01-10
Start date
2017-11-01
Completion date
Unknown
Last updated
2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioblastoma

Interventions

single arm:Taking apatinib

Sponsors

Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. age greater than 18 years, less than 75 years; 2. pathological diagnosis of glioblastoma; 3. patients who were not willing to receive chemotherapy after surgery or the patients who had relapsed in the course of treatment of STUPP regimen or after treatment; 4. ECOG score: 0-2 points; 5. more than the expected survival time in March; 6. the main organ function is normal, which is in accordance with the following criteria: (1)the standard of blood routine examination should be conformed (no blood transfusion and blood products within 14 days, no correction of G-CSF and other hematopoietic stimulators): HB = 90 g/L; ANC = 1.5 * 10^9/L; PLT = 80*10^9/L; (2)biochemical examination should comply with the following criteria: TBIL 45 ml/min (Cockcroft-Gault formula); 7. subjects volunteered to join the study and signed informed consent. The compliance was good and followed up.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women 2. with high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (systolic pressure >140 diastolic mmHg >90 mmHg) with I at or above the level of myocardial ischemia or myocardial infarction arrhythmia (including QT interval = 440 MS) and II heart function insufficiency 3. factors that have an obvious influence on the absorption of oral drugs such as inability to swallow chronic diarrhea and intestinal obstruction, etc. 4. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 sec or APTT >1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy 5. uncontrolled epilepsy 6. severe uncontrolled recurrent infection or other serious uncontrolled accompanying diseases 7. researchers judge other possible effects on clinical studies and findings

Design outcomes

Primary

MeasureTime frame
6 months of disease free survival rate;Objective remission rate;

Secondary

MeasureTime frame
Total survival for 2 yearsTotal survival for 2 years;Disease control rate;

Countries

China

Contacts

Public ContactMei Shi

Xijing Hospital

m15109224579@163.com+86 15109224579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026