NCT04959500Active, not recruitingPhase 2
Newly Diagnosed Glioblastoma
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
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 23 Jun 2021
- Start date
- 21 Jul 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Glioblastoma
- NCT number
- NCT04959500
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 21 Jul 2021 to the primary completion date, 31 Dec 2026
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have previously received systemic radiotherapy and chemotherapy for GBM;
- 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.
- Participated in other anti-tumor drug clinical trials within 4 weeks before grouping;
Other illness
- 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.
- A clear history of neurological or psychiatric diseases, moderate or higher epilepsy , moderate or higher aphasia or dementia
- Other conditions which are not fit for this study assessed by investigator.
Other
- IDH1/2 mutations are present
- Contraindicated for MRI examination
- The tumor only occurs in the brain stem
- Radiologically obvious diffuse meningeal dissemination
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The General Hospital of the People's Liberation Army (PLAGH) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Sixth Madical Center of PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Provincial Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Gansu Provincial Hospital Coordinator of this site? Confirm its status | Gansu | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Jiangxi Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Fudan University shabghai cancer center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Second Affiliated Hospital of PLA Air Force Medical University Coordinator of this site? Confirm its status | Xian | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The Fifth Affiliated Hospital Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.