GlioblastomaPhase 2NCT04157478
Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma
A Phase 2 study testing Anlotinib Hydrochloride, Radiation therapy and Temozolomide in people with Glioblastoma, run by People's Hospital of Guangxi Zhuang Autonomous Region at 7 sites in China.
Trial summary
For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. 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?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 7 sitesChina
- Study dates
- Jan 2020to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Newly diagnosed and histological proven glioblastoma
- Complete gross resection or subtotal resection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow, liver and renal function
- Written informed consent
Who cannot join
- Meningeal carcinomatosis or spinal compression
- Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis
- Active, known, or suspected autoimmune disease
- Severe allergy to anlotinib or temozolomide
- Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
- Uncontrolled mental disorders
Show all 11Show fewer
- High risk of bleeding
- Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms), according to NYHA criteria; grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%
- Contraindicated for MRI examination
- Recipient of live vaccine prior to the first dose of anlotinib
- Ready for or previously received organ transplantation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541002
Liuzhou Worker's Hospital
Liuzhou, Guangxi, 545005
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Heming Lu, MD, +86-771-218-6503, gxheminglu@sina.com
Heming Lu, MD
Yulin First Hospital
Yulin, Guangxi, 537000
About this study
Official title: Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study
For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.
- Conditions
- Glioblastoma
- Being tested
- Anlotinib Hydrochloride, Radiation therapy, Temozolomide
- Keywords
- Glioblastoma, Anlotinib hydrochloride, Stupp regimen, Temozolomide, Radiation therapy, Tyrosine kinase inhibitor
- 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
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 therapyRadiation
Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.
TemozolomideDrug
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 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy, Temozolomide and anlotinib | Experimental | Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). 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. Receives: Drug: Anlotinib Hydrochloride; Radiation: Radiation therapy; Drug: Temozolomide |
| Radiation therapy and temozolomide | Active comparator | Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Receives: 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
Measured: 3 years
Secondary outcomes (2)
Overall survival
Measured: 3 years
Objective response rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (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.
- 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
- None (open label)
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous Region
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, Cancer Hospital of Guangxi Medical University, Liuzhou Workers' Hospital, Nanxishan Hospital, LiuZhou People's Hospital, Affiliated Hospital of Guilin University
- Responsible party
- Principal investigator, Heming Lu, People's Hospital of Guangxi Zhuang Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157478
- Sponsor's protocol ID
- GXPH-19001
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. 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 Multicenter Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT04157478
- Acronym / sponsor ID
- GXPH-19001
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Anlotinib hydrochloride, Stupp regimen, Temozolomide, Radiation therapy, Tyrosine kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- People's Hospital of Guangxi Zhuang Autonomous RegionUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, Cancer Hospital of Guangxi Medical University, Liuzhou Workers' Hospital, Nanxishan Hospital, LiuZhou People's Hospital, Affiliated Hospital of Guilin University
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Nov 2019 (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.
For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy, Temozolomide and anlotinib | Experimental | Drug: Anlotinib Hydrochloride, Radiation: Radiation therapy, Drug: TemozolomidePatients will receive standard radiation therapy plus temozolomide (Stupp regimen). 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 and temozolomide | Active comparator | Radiation: Radiation therapy, Drug: TemozolomidePatients will receive standard radiation therapy plus temozolomide (Stupp regimen). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed and histological proven glioblastoma
- Complete gross resection or subtotal resection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow, liver and renal function
- Written informed consent
Key exclusion criteria (11 listed)
- Meningeal carcinomatosis or spinal compression
- Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis
- Active, known, or suspected autoimmune disease
- Severe allergy to anlotinib or temozolomide
- Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
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 HydrochlorideAnlotinib 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 | Radiation therapy, Temozolomide and anlotinib |
| Radiation therapyRadiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy. | Radiation | Radiation therapy and temozolomide, Radiation therapy, Temozolomide and anlotinib |
| TemozolomideTemozolomide 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 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles. | Drug | Radiation therapy and temozolomide, Radiation therapy, Temozolomide and anlotinib |
Primary outcome
Progression-free survival
Time frame: 3 years
2 secondary outcomes
Overall survival
Time frame: 3 years
Objective response rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
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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.
7 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 People's Hospital of Guangxi Zhuang Autonomous Region at 7 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heming Lu, MD (86-771-2186-504, gxheminglu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). 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 12 Nov 2019.