Clinical trial NCT04725214: Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma
Official title: Anlotinib Combined With STUPP Protocol as First-line Regimen for MGMT Nonmethylated Glioblastoma: a Multicenter, Open-label, Single-arm, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: MGMT-Unmethylated Glioblastoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adjuvant therapy with Anlotinib and Temozolomide for MGMT nonmethylated glioblastoma after concurrent chemo-radiotherapy
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Aged 18-70 years,
2. Histologically proven diagnosis of glioblastoma (WHO grade IV),
3. Have received standard STUPP treatment plan,
4. Gross resection or partial resection of the tumor (confirmed by MRI)\> 50%,
5. The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60,
6. 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:

1. Recurrent or multiple malignant gliomas
2. Subtentorial glioblastoma or metastatic lesions outside the skull
3. Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery
4. Previously received radiation therapy for the head and neck cancer
5. Have received any antibody treatment before
6. 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
7. Evidence of bleeding diathesis or coagulopathy
8. Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)

Primary outcomes:
measure: 1-year OS
timeFrame: from enrollment to death (for any reason).assessed up to 12 months
Secondary outcomes:
measure: PFS
timeFrame: from enrollment to progression or death (for any reason),assessed up to 24months
measure: OS
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
measure: adverse event
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
measure: Health-related quality of life
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
measure: Neurocognitive function
timeFrame: from enrollment to death (for any reason).assessed up to 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Qichun Wei, MD
role: STUDY_CHAIR
References: