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Active, Not Recruiting

NCT Number: NCT04959500

Newly Diagnosed Glioblastoma

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Progression Free Survival (PFS) assessed by IRC

    Time frame: 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

    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.

Secondary outcomes

  1. The progression free survival (PFS)

    Time frame: 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

    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.

  2. Overall survival (OS)

    Time frame: 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

    OS was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2021
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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