GlioblastomaNCT04814329
Glioblastoma Response Prediction to Apatinib
An observational study of Glioblastoma, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial summary
Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- genetic characteristic
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2021to 30 Jun 2023
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University
Who may be able to join
- Age 18-70 years old
- recurrent glioblastoma
- received apatinib plus temozolomide treatment，response and survival data were available
- tumor tissues were acquired
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Predicting Response of Recurrent Glioblastoma to Apatinib
Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. Some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients. However, a subset of patients progressed in 2 months. There is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy. In this study, whole genome sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.
- Conditions
- Glioblastoma
- Being tested
- genetic characteristic
- Keywords
- Vascular Endothelial Growth Factor Receptor 2, Biomarkers, glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic characteristicOther
the underlying genetic characteristics that prodicting response
| Study group | Role | What they receive |
|---|---|---|
| effective group | After treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months. Receives: Other: genetic characteristic | |
| stable group | After treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months. Receives: Other: genetic characteristic | |
| Early progressed group | After treatment, tumor got progressed and the progression-free survival time was no more than 1 month. Receives: Other: genetic characteristic |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic outcome
response prodicting biomarker
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start22 Apr 2021
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junping Zhang, Beijing Sanbo Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814329
- Sponsor's protocol ID
- 2021ZZLX03
- Status last verified
- Jul 2023
- First submitted
- 22 Mar 2021
- Last updated
- 21 Jul 2023
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Predicting Response of Recurrent Glioblastoma to Apatinib
- ClinicalTrials.gov ID
- NCT04814329
- Acronym / sponsor ID
- 2021ZZLX03
- Conditions
- Glioblastoma
- Keywords
- Vascular Endothelial Growth Factor Receptor 2, Biomarkers, glioblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Mar 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.
Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. Some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients. However, a subset of patients progressed in 2 months. There is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy. In this study, whole genome sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| effective group | – | Other: genetic characteristicAfter treatment, tumor achieved complete response or partial response and the progression-free survival time was ≥6 months. |
| stable group | – | Other: genetic characteristicAfter treatment, tumor remains stable and the progression-free survival time was more than 1 month and less than 6 months. |
| Early progressed group | – | Other: genetic characteristicAfter treatment, tumor got progressed and the progression-free survival time was no more than 1 month. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University
Key inclusion criteria (4 listed)
- Age 18-70 years old
- recurrent glioblastoma
- received apatinib plus temozolomide treatment，response and survival data were available
- tumor tissues were acquired
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| genetic characteristicthe underlying genetic characteristics that prodicting response | Other | Early progressed group, effective group, stable group |
Primary outcome
genetic outcome
Time frame: up to 2 years
response prodicting biomarker
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Beijing Sanbo Brain Hospital at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
genetic outcome (time frame: up to 2 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 21 Jul 2023.