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The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.
For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | For MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib With STUPP Regimen |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year OS | 1-year overall survival | from enrollment to death (for any reason).assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-Free Survival | from enrollment to progression or death (for any reason),assessed up to 24months |
| OS | Overall Survival |
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Inclusion Criteria:
8.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 9.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL,ALP≤5x UNL 10.For females of child-bearing potential, negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential and male participants must practice adequate contraception during participation in the study and within 8 weeks after the last administration of the drug 11.Able to provide written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qichun Wei, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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Adjuvant therapy with Anlotinib and Temozolomide for MGMT nonmethylated glioblastoma after concurrent chemo-radiotherapy
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| from enrollment to death (for any reason).assessed up to 24 months |
| adverse event | Adverse events are described in terms of CTC AE 5.0 | from enrollment to death (for any reason).assessed up to 24 months |
| Health-related quality of life | Health-related quality of life are measured by the EORTC-QL30/BN20 | from enrollment to death (for any reason).assessed up to 24 months |
| Neurocognitive function | Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE) | from enrollment to death (for any reason).assessed up to 24 months |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |