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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

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Tiantan Hospital,Capital Medical University
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BeijingChinaUnknown status
The General Hospital of the People's Liberation Army (PLAGH)
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BeijingChinaUnknown status
The Sixth Madical Center of PLA General Hospital
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Fujian Provincial Cancer Hospital
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FuzhouChinaUnknown status
Gansu Provincial Hospital
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GansuChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
The First Hospital of Lanzhou University
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LanzhouChinaUnknown status
Lanzhou University Second Hospital
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LanzhouChinaUnknown status
Jiangxi Cancer Hospital
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NanchangChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Fudan University shabghai cancer center
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital & Institute
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ShenyangChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
The Second Affiliated Hospital of PLA Air Force Medical University
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XianChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
The Fifth Affiliated Hospital Sun Yat-sen University
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ZhuhaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.