Newly Diagnosed Glioblastoma

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Temozolomide; Radiation: Radiation Therapy; Drug: Anlotinib Hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04959500

ALTN-Ⅱ-01

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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.

Treatment:

Drug: Anlotinib Hydrochloride

Drug: Temozolomide

Radiation: Radiation Therapy

control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Temozolomide

Radiation: Radiation Therapy