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Clinical Trials in China / NCT04959500
Active, not recruiting Phase 2

Newly Diagnosed Glioblastoma

NCT04959500 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2021-07-21
Last updated
2026-01-02

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Anlotinib HydrochloridePlaceboRadiation TherapyTemozolomide

Anlotinib Hydrochloride: Drug: Anlotinib Hydrochloride Anlotinib hydrochloride will be given with a daily dose of 12 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.

Placebo: Drug: Placebo Placebo will be given with a daily dose of 12 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.

Radiation Therapy: Radiation: Radiation therapy Radiation therapy will be delivered in daily fractions of 1.8-2.0 Gy given 5 days a week for a total of 54-60 Gy.

Temozolomide: Drug: Temozolomide Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
Beijing TianTan Hospital,Capital Medical University Beijing Beijing Municipality
The Sixth Madical Center of PLA General Hospital Beijing Beijing Municipality
The General Hospital of the People's Liberation Army (PLAGH) Beijing Beijing Municipality
Chongqing University Cancer Hospital Chongqing Chongqing Municipality
Fujian Provincial Cancer Hospital Fuzhou Fujian
Lanzhou University Second Hospital Lanzhou Gansu
The First Hospital of Lanzhou University Lanzhou Gansu
Sun Yat-sen University Cancer Center Guangzhou Guangdong
Shenzhen People's Hospital Shenzhen Guangdong
The Fifth Affiliated Hospital Sun Yat-sen University Zhuhai Guangdong
Henan Cancer Hospital Zhengzhou Henan
The affiliated hospital of xuzhou medical university Xuzhou Jiangsu
The First Affiliated Hospital of NanChang University Nanchang Jiangxi
Jiangxi Cancer Hospital Nanchang Jiangxi
Gansu Provincial Hospital Gansu Lanzhou Province
Liaoning Cancer Hospital & Institute Shenyang Liaoning
Fudan University shabghai cancer center Shanghai Shanghai Municipality
The Second Affiliated Hospital of PLA Air Force Medical University Xian Shanxi
West China Hospital,Sichuan University Chengdu Sichuan
Tianjin Medical University General Hospital Tianjin Tianjin Municipality
Zhejiang Cancer Hospital Hangzhou Zhejiang

More Sun Yat-sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04959500 on ClinicalTrials.gov ↗ ← All trials in China