Malignant Brain Stem TumorPhase 2NCT04668508
Anlotinib to Malignant Brainstem Glioma
A Phase 2 study testing Anlotinib in people with Malignant Brain Stem Tumor and Glioma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study is a single-arm, open-label, phase II study of anlotinib combined with radiation in the treatment of patients with malignant brainstem glioma. Twenty five patients will be enrolled in the study who is diagonsis with malignant brainstem glioma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Brain Stem Tumor, Glioma
- What is being tested?
- Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2020to 1 Jan 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign written informed consent before any trial-related processes are implemented;
- Age ≥ 18 years old and ≤ 70 years old;
- Life expectancy exceeds 3 months;
- The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if it is confirmed to have progressed;
- Patients with WHO Ⅲ - Ⅳ brain stem glioma confirmed by histology or radiology;
- The Karnofsky score has to >40;
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- For subjects who had undergone surgical biopsy or treatment, the surgical incision has to be healed well;
- No prior radiotherapy, chemotherapy, immunotherapy or biotherapy has been performed;
- Hematological function is sufficient, defined as absolute neutrophil count
- ≥1.5×109 /L, platelet count ≥100 ×109 /L, hemoglobin ≥90g/L (no history of blood transfusion within 7 days);
- Hepatic function is adequate, defined as all patients with total bilirubin levels ≤ 1.5 times normal upper limit (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases , AST and ALT levels ≤ 5 times ULN;
- adequate renal function, defined as creatinine clearance ≥ 45 ml / min (Cockcroft-Gault formula);
- Coagulation function is adequate, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as the INR or PT is within the range of anticoagulant drugs can;
- Female subjects of childbearing age should be negative for urine or serum pregnancy test within 3 days prior to receiving the first study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required;
- If there is a risk of conception, male and female patients need to use high-efficiency contraception (ie, an annual failure rate of less than 1%) and continue until at least 180 days after stopping the trial treatment; Note: If abstinence is normal for the subject Lifestyle and preferred methods of contraception can be used as a method of contraception.
Who cannot join
- WHO grade I-II glioma or imaging diagnosis of low-level brainstem glioma;
- Supratentorial gliomas in adults involve the brain stem;
- Patients with contraindications for MRI;
- Patients with any signs or history of bleeding physique;
- Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose;
- Severe intracranial infection;
- Any arterial thrombosis, embolism or ischemia occurred within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to enrollment (implanted IV port or catheter-derived thrombosis, or superficial vein thrombosis is not considered a "serious" thrombosis embolism);
- Prior or concurrent malignancies excepting for adequately treated skin cancer (non-melanoma), in situ cervical carcinoma or cured malignant disease≥5 years;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yuanyuan Chen, Professor, +86 13738103808, chenyy@zjcc.org.cn
About this study
Official title: A Phase II Study of Anlotinib Combined With Radiation in Patients With Malignant Brainstem Glioma
This study is a single-arm, open-label, phase II study of anlotinib combined with radiation in the treatment of patients with malignant brainstem glioma. Twenty five patients will be enrolled in the study who is diagonsis with malignant brainstem glioma. The primary objective includes disease control rate (DCR), the role of antinib combined with radiotherapy in improving quality of life and 6-month progression-free survival rate. The secondary objective include overall survival (OS), toxicity profile. Exploratory objectives include the use of plasma specimens and cerebrospinal fluid (if possible) to detect biomarkers predicting the efficacy of anlotinib.
- Conditions
- Malignant Brain Stem Tumor, Glioma
- Being tested
- Anlotinib
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
concurrent using anlotinib combined with radiation plus adjuvant anlotinib after radiotherapy until disease progress or develop into serious adverse events.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib combined with radiation | Experimental | Not described Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate
based on RECIST1.1
Measured: through study completion, an average of 1 year
6-month progression-free survival rate
proportion of patients with progression-free survival longer than 6 months.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
6-month quality of life deterioration-free survival
quality of life
Measured: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
Secondary outcomes (1)
overall survival
overall survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start24 Nov 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain Stem TumorStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Anlotinib combined with radiation
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668508
- Sponsor's protocol ID
- IRB-2020-217
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Anlotinib Combined With Radiation in Patients With Malignant Brainstem Glioma
- ClinicalTrials.gov ID
- NCT04668508
- Acronym / sponsor ID
- IRB-2020-217
- Conditions
- Malignant Brain Stem Tumor, Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 16 Dec 2020 (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.
This study is a single-arm, open-label, phase II study of anlotinib combined with radiation in the treatment of patients with malignant brainstem glioma. Twenty five patients will be enrolled in the study who is diagonsis with malignant brainstem glioma. The primary objective includes disease control rate (DCR), the role of antinib combined with radiotherapy in improving quality of life and 6-month progression-free survival rate. The secondary objective include overall survival (OS), toxicity profile. Exploratory objectives include the use of plasma specimens and cerebrospinal fluid (if possible) to detect biomarkers predicting the efficacy of anlotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Anlotinib combined with radiation
| Arm | Type | Receives |
|---|---|---|
| anlotinib combined with radiation | Experimental | Drug: Anlotinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sign written informed consent before any trial-related processes are implemented;
- Age ≥ 18 years old and ≤ 70 years old;
- Life expectancy exceeds 3 months;
- The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if it is confirmed to have progressed;
- Patients with WHO Ⅲ - Ⅳ brain stem glioma confirmed by histology or radiology;
Key exclusion criteria (8 listed)
- WHO grade I-II glioma or imaging diagnosis of low-level brainstem glioma;
- Supratentorial gliomas in adults involve the brain stem;
- Patients with contraindications for MRI;
- Patients with any signs or history of bleeding physique;
- Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose;
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 |
|---|---|---|
| Anlotinibconcurrent using anlotinib combined with radiation plus adjuvant anlotinib after radiotherapy until disease progress or develop into serious adverse events. | Drug | anlotinib combined with radiation |
Primary outcome
disease control rate
Time frame: through study completion, an average of 1 year
based on RECIST1.1
6-month progression-free survival rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
proportion of patients with progression-free survival longer than 6 months.
6-month quality of life deterioration-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
quality of life
1 secondary outcome
overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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 in people with Malignant Brain Stem Tumor and Glioma, run by Zhejiang Cancer 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 15 inclusion and 8 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 16 Dec 2020. 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.
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 Yuanyuan Chen, Professor (+8613738103808, chenyy@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control rate (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 16 Dec 2020.