Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

Study Overview
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Brief Summary
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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.

Detailed Description
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For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).

Official Title
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Anlotinib Combined With STUPP Protocol as First-line Regimen for MGMT Nonmethylated Glioblastoma: a Multicenter, Open-label, Single-arm, Phase II Clinical Trial

Conditions
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MGMT-Unmethylated Glioblastoma

Intervention / Treatment
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* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-70 years, Histologically proven diagnosis of glioblastoma (WHO grade IV), Have received standard STUPP treatment plan, Gross resection or partial resection of the tumor (confirmed by MRI)> 50%, The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60, No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 7.Adequate bone marrow function: Hemoglobin ≥ 100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L 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: Recurrent or multiple malignant gliomas Subtentorial glioblastoma or metastatic lesions outside the skull Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery Previously received radiation therapy for the head and neck cancer Have received any antibody treatment before Contraindication of radiotherapy and chemotherapy defined as follows: Acute bacterial or fungal infection，Unstable angina and/or congestive heart failure within the last 6 months，co-morbidity with immunosuppressive therapy Evidence of bleeding diathesis or coagulopathy Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Adjuvant therapy with Anlotinib and Temozolomide for MGMT nonmethylated glioblastoma after concurrent chemo-radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>For MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14) | Drug: Anlotinib<br>* Anlotinib With STUPP Regimen<br>* Other names: temozolomide capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year OS | 1-year overall survival | from enrollment to death (for any reason).assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-Free Survival | from enrollment to progression or death (for any reason),assessed up to 24months | 
| OS | Overall Survival | 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 |