Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04725214
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Qichun Wei, MD
Principal Investigator Affiliation	Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	MGMT-Unmethylated Glioblastoma

Additional Details

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

Arms & Interventions

Arms

Experimental: Experimental

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

Interventions

Drug: - Anlotinib

Anlotinib With STUPP Regimen

Contact a Trial Team

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International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009

Site Contact

qichun wei, MD

qichun_wei@zju.edu.cn

086-0571-87783521

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