Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2021-07-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group
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.
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.
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.
control group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Zhongping Chen
clinical professor
Principal Investigators
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Zhongping Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing TianTan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The Sixth Madical Center of PLA General Hospital
Beijing, Beijing Municipality, China
The General Hospital of the People's Liberation Army (PLAGH)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The affiliated hospital of xuzhou medical university
Xuzhou, Jiangsu, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Gansu Provincial Hospital
Gansu, Lanzhou Province, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Fudan University shabghai cancer center
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of PLA Air Force Medical University
Xian, Shanxi, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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ALTN-Ⅱ-01
Identifier Type: -
Identifier Source: org_study_id
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