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Newly Diagnosed Glioblastoma

Study Purpose

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma.Take PFS as the main evaluation index, the purpose is to evaluate its effectiveness

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:

- Understood and Signed an informed consent form.

, with good compliance.

- Age: 18-75 years old；.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2；Life expectancy of at least 3 months.

- Glioblastoma confirmed by histology ; - Random time is 4-6 weeks from the last operation , and the investigator judges that the surgical wound has healed well; - Within 5 days before administration, the dosage of corticosteroids was stable or gradually decreased; - Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study ；Not Pregnant or breastfeeding women,Pregnancy before pregnancy screening, the women who blood / urine results were positivetherapy.

Exclusion Criteria:

- Have previously received systemic radiotherapy and chemotherapy for GBM; - IDH1/2 mutations are present.

- Contraindicated for MRI examination.

- The tumor only occurs in the brain stem.

- Radiologically obvious diffuse meningeal dissemination.

- Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage, cerebrovascular malformations or other bleeding tendency during the subsequent study period; - Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident , deep vein thrombosis and pulmonary embolism； - Other malignant tumors have occurred or are currently present at the same time within 3 years.

- There are many factors that affect oral medications ; - Received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the start of the study.

- A clear history of neurological or psychiatric diseases, moderate or higher epilepsy , moderate or higher aphasia or dementia.

- Participated in other anti-tumor drug clinical trials within 4 weeks before grouping; - Other conditions which are not fit for this study assessed by investigator.

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.	NCT04959500
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.	Sun Yat-sen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhongping Chen, Doctor
Principal Investigator Affiliation	Sun Yat-sen University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: Experimental group

Experimental: Radiation therapy, Temozolomide and anlotinib Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Anlotinib hydrochloride will be given with a daily dose of 10 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.

Placebo Comparator: control group

Experimental: Radiation therapy, Temozolomide and Placebo Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Placebo will be given with a daily dose of 0 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.

Interventions

Drug: - Anlotinib Hydrochloride

Drug: Anlotinib Hydrochloride Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.

Drug: - Placebo

Drug: Placebo Placebo will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.

Radiation: - Radiation Therapy

Radiation: Radiation therapy Radiation therapy will be delivered in daily fractions of 1.8-2.0 Gy given 5 days a week for a total of 54-60 Gy.

Drug: - Temozolomide

Drug: Temozolomide Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bengbu, Anhui, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004

Site Contact

Hao Jiang, Master

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