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Brain cancer hope: new drug combo shows promise in early trial

NCT ID NCT04959500

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding the drug anlotinib hydrochloride to the standard Stupp regimen (chemoradiation) can help people with newly diagnosed glioblastoma live longer without their cancer growing. About 150 adults aged 18-75 with this aggressive brain tumor are participating. The trial is double-blind, meaning neither patients nor doctors know who gets the extra drug, to ensure fair results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
anlotinib hydrochloride
What this could lead to
If successful, this could offer a new treatment option that slows the growth of glioblastoma, a fast-growing brain cancer.
What could go wrong
This is an early phase 2 trial with only 150 participants, so results may not apply to all patients. The drug also has side effects like high blood pressure and fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma

Contacts and locations

Locations

  • Beijing TianTan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100070, China

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000, China

  • Fudan University shabghai cancer center

    Shanghai, Shanghai Municipality, 200433, China

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Gansu Provincial Hospital

    Gansu, Lanzhou Province, 730000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029, China

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730000, China

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518000, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Fifth Affiliated Hospital Sun Yat-sen University

    Zhuhai, Guangdong, 519000, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330006, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000, China

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

    Beijing, Beijing Municipality, 100853, China

  • The Second Affiliated Hospital of PLA Air Force Medical University

    Xian, Shanxi, 710000, China

  • The Sixth Madical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100142, China

  • The affiliated hospital of xuzhou medical university

    Xuzhou, Jiangsu, 221000, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • West China Hospital，Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.