Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: MGMT-Unmethylated Glioblastoma

Treatments: Drug: Anlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04725214

2020-780

Details and patient eligibility

About

The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.

Full description

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

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Experimental

Experimental group

Description:

For MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14)

Treatment:

Drug: Anlotinib