Clinical trial · Interventional
Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors
Efficacy and Safety of Apatinib Combined With Dose-dense Temozolomide in Recurrent Glioblastoma
NCT03660761CI-TRIAL-00038163completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The patient was given a daily dose of apatinib 500mg (or based on weight). Individualized chemotherapy regimens were given based on molecular expression and prior chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Efficacy and Safety | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apatinib | Drug | — | UNRESOLVED |
| temodar | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib 500mg
- interventionNames
- Drug: apatinib
- Drug: temodar
Primary outcomes (1)
- measure
- Response to treatment
- timeFrame
- up to 3 months
- description
- Response were evaluatedevery 1-3 months with Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST 1.0) usingdynamic contrast enhancement magnetic resonance imaging (MRI) or computed tomography (CT). Complete response (CR) was defined as complete disappearance of target lesions and maintaining ≥ 4 weeks; partial response (PR): ≥ 30% reduction in maximum diameterof tumor and keepingstable ≥ 4 weeks; progressive disease (PD):\>20% increase in bidimensionalmeasurements of the lesions, or emerging one or more newlesions; stable disease (SD): criteria for CR, PR and PDnot met.PFS was defined as the initial treatment to the disease progression or the date of death.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * (1) 18 years \< the age of patients \> 70 years. (2) Karnofsky performance scale (KPS) ≥ 60. (2) Histologically confirmed diagnosis of GBM World Health Organization \[WHO\] Grade IV. (3) They were required to have measurable or evaluable disease by magnetic resonance imaging (MRI) confirmation and a minimum life expectancy of 8 weeks. (4) Definition of relapse: all patients must have progressive disease on MRI defined by Response Assessment in Neuro-Oncology (RANO) criteria after the standard Stupp protocol. The time interval for the start of treatment was at least 12 weeks from prior radiotherapy unless there was either histopathologic confirmation of recurrent tumor or new contrast enhancement on MRI outside of the radiotherapy treatment field. (5) Adequate bone marrow function (leukocyte count ≥ 4000/μL, neutrophil count ≥1500/µL, platelet count ≥100 000/µL, hemoglobin ≥8.0g/dL), adequate renal function (serum creatinine ≤ 150μmol/L, 24 hours urine protein ≤3.4g), and liver function (total bilirubin ≤34μmol/L and aspartate and alanine aminotransferase ≤120U/L). Exclusion Criteria: * (1) extracranial metastatic disease, (2) Gliadel wafer treatment, (3) severe cardiopulmonary insufficiency, (4) status epilepticus, (5) pregnancy, (6) gastrointestinal bleeding, (7) uncontrolled blood pressure with medication (\>140/90 mm Hg), (8) swallowing difficulties. (9) HIV positivity with a combination antiretroviral therapy.
References
Publications (2)
- RESULTKasper H. [The supplying of vitamin A after pancreatectomy]. Med Welt. 1968 Jan 20;3:178-80. No abstract available. German. PMID 5728925
- RESULTPotapova TV, Sharovskaia IuIu, Kovalev SA, Mittel'man LA, Chailakhian LM. [Effect of the ion composition of the surrounding medium on membrane potentials of L cells]. Tsitologiia. 1972 Nov;14(11):1335-41. No abstract available. Russian. PMID 4654530