Newly Diagnosed Glioblastoma

NCT04959500 | Active Not Recruiting Phase 2

• 1 other identifier: ALTN-Ⅱ-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 22

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

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) assessed by IRC

  PFS was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause.

  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 (2)

• The progression free survival (PFS)

  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

• Overall survival (OS)

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Anlotinib Hydrochloride; Radiation: Radiation Therapy; Drug: Temozolomide

control group

PLACEBO COMPARATOR

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.

Drug: Placebo; Radiation: Radiation Therapy; Drug: Temozolomide

Interventions

Anlotinib Hydrochloride DRUG

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.

Experimental group

Placebo DRUG

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.

control group

Radiation Therapy RADIATION

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.

Experimental group; control group

Temozolomide DRUG

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.

Experimental group; control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (22)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Beijing TianTan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

The Sixth Madical Center of PLA General Hospital

Beijing, Beijing Municipality, 100142, China

Location

The General Hospital of the People's Liberation Army (PLAGH)

Beijing, Beijing Municipality, 100853, China

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730000, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China

Location

The Fifth Affiliated Hospital Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

The affiliated hospital of xuzhou medical university

Xuzhou, Jiangsu, 221000, China

Location

The First Affiliated Hospital of NanChang University

Nanchang, Jiangxi, 330006, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

Gansu Provincial Hospital

Gansu, Lanzhou Province, 730000, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

Location

Fudan University shabghai cancer center

Shanghai, Shanghai Municipality, 200433, China

Location

The Second Affiliated Hospital of PLA Air Force Medical University

Xian, Shanxi, 710000, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhongping Chen, Doctor

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 13, 2021
• Study Start: July 21, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (22)