Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Registration Number
- NCT04959500
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Anlotinib Hydrochloride 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. control group Placebo 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. Experimental group Radiation Therapy 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. control group Radiation Therapy 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. Experimental group Temozolomide 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. control group Temozolomide 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) assessed by IRC From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months PFS was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.
- Secondary Outcome Measures
Name Time Method The progression free survival (PFS) From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months PFS was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.
Overall survival (OS) From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months OS was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Trial Locations
- Locations (21)
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing Province, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
The affiliated hospital of xuzhou medical university
🇨🇳Xuzhou, Jiangsu, China
Gansu Provincial Hospital
🇨🇳Gansu, Lanzhou Province, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Fudan University shabghai cancer center
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The Fifth Affiliated Hospital Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The General Hospital of the People's Liberation Army (PLAGH)
🇨🇳Beijing, Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of PLA Air Force Medical University
🇨🇳Xian, Shanxi, China
Beijing TianTan Hospital,Capital Medical University
🇨🇳Beijing, Beijing Province, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The Sixth Madical Center of PLA General Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of NanChang University
🇨🇳Nanchang, Jiangxi, China
West China Hospital，Sichuan University
🇨🇳Chengdu, Sichuan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China