GlioblastomaPhase 2NCT04959500
Newly Diagnosed Glioblastoma
A Phase 2 study testing Anlotinib Hydrochloride, Radiation Therapy and Temozolomide in people with Glioblastoma, run by Sun Yat-sen University at 22 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Anlotinib Hydrochloride, Radiation Therapy and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 22 sitesChina
- Study dates
- 21 Jul 2021to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Beijing TianTan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100070
The Sixth Madical Center of PLA General Hospital
Beijing, Beijing Municipality, 100142
The General Hospital of the People's Liberation Army (PLAGH)
Beijing, Beijing Municipality, 100853
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
West China Hospital，Sichuan University
Chengdu, Sichuan, 610041
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
Gansu Provincial Hospital
Gansu, Lanzhou Province, 730000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Fudan University shabghai cancer center
Shanghai, Shanghai Municipality, 200433
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
The Second Affiliated Hospital of PLA Air Force Medical University
Xian, Shanxi, 710000
The affiliated hospital of xuzhou medical university
Xuzhou, Jiangsu, 221000
Henan Cancer Hospital
Zhengzhou, Henan, 450008
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, Guangdong, 519000
About this study
Official 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
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
- Being tested
- Anlotinib Hydrochloride, Placebo, Radiation Therapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
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.
PlaceboDrug
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 TherapyRadiation
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.
TemozolomideDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Radiation: Radiation Therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start21 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongping Chen, Sun Yat-sen University
- Investigators
- Zhongping Chen, Doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959500
- Sponsor's protocol ID
- ALTN-Ⅱ-01
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2021
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04959500
- Acronym / sponsor ID
- ALTN-Ⅱ-01
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Anlotinib Hydrochloride, Radiation: Radiation Therapy, Drug: TemozolomideExperimental: 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. |
| control group | Placebo comparator | Drug: Placebo, Radiation: Radiation Therapy, Drug: TemozolomideExperimental: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib HydrochlorideDrug: 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. | Drug | Experimental group |
| PlaceboDrug: 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. | Drug | control group |
| Radiation TherapyRadiation: 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. | Radiation | Experimental group, control group |
| TemozolomideDrug: 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. | Drug | Experimental group, control group |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongping Chen, Doctor principal investigator
Sun Yat-Sen University Cancer Center
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Hydrochloride, Radiation Therapy and Temozolomide in people with Glioblastoma, run by Sun Yat-sen University at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.