Clinical trial NCT04959500: Newly Diagnosed Glioblastoma
Official title: Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Double-blind Multicenter Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioblastoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Progression Free Survival (PFS) assessed by IRC
timeFrame: 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
Secondary outcomes:
measure: The progression free survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: 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
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing TianTan Hospital,Capital Medical University
state: Beijing Province
city: Beijing
country: China
facility: The Sixth Madical Center of PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army (PLAGH)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing Province
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Xuzhou
country: China
facility: The affiliated hospital of xuzhou medical university
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Gansu
country: China
facility: Gansu Provincial Hospital
state: Lanzhou Province
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Shanghai
country: China
facility: Fudan University shabghai cancer center
state: Shanghai
city: Xian
country: China
facility: The Second Affiliated Hospital of PLA Air Force Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Sun Yat-sen University
name: Zhongping Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: