Recurrent High-grade GliomaPhase 2NCT04822805
A Study of Anlotinib in the Treatment of Recurrent High-grade Glioma
A Phase 2 study testing Anlotinib hydrochloride in people with Recurrent High-grade Glioma, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of anlotinib in treatment of recurrent high-grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent High-grade Glioma
- What is being tested?
- Anlotinib hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2020to 30 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old (calculated on the day of signing the informed consent), regardless of gender.
- Karnofsky score (KPS score) ≥60.
- According to Rano criteria, there are evaluable intracranial lesions, and recurrent high-grade gliomas have been confirmed.
- Patients have undergone surgery and relapsed after receiving standard radiotherapy and chemotherapy;
- The toxicity has returned to ≤1 grade If have received chemotherapy;
- Expected survival ≥ 3 months;
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- The patient has no major organ dysfunction. Specific laboratory indicators are required: white blood cells ≥3.0×109/L, platelets ≥75×109/L, hemoglobin ≥10g/dl, and serum bilirubin not greater than 1.5 times the maximum normal value; ALT and AST are not more than 2 times the maximum normal value; blood creatinine ≤ 1.5 mg/dl.
- Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period.
- The patient voluntarily joined the study and signed a written informed consent.
Who cannot join
- Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Patients with any severe and/or uncontrollable disease, including:
- 1) Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); 2) Patients with myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QTC ≥480ms), and grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification); 3) Active or uncontrolled serious infection (≥CTC AE Grade 2 infection); 4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7) Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L); 8) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein quantification is more than 1.0 g; 9) Patients who have seizures and need treatment; 3. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment; 4. Patients whose imaging shows that the tumor has invaded important blood vessels or the researcher judges that the tumor is likely to invade important blood vessels causing fatal hemorrhage during the follow-up study; 5. Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event ≥ CTCAE level 3, unhealed wounds, ulcers or fractures; 6. Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 7. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 8. Participated in clinical research of other anti-tumor drugs within four weeks; 9. Have received the treatment of small molecule anti-angiogenesis targeted drugs (such as regorafenib, perzopanib, apatinib, etc.); 10. Those considered by the researcher to be unsuitable for inclusion。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, 310000
Hui Dai, 13968855810 ext. 0574-56006326, 124186159@qq.com
About this study
Official title: Anlotinib in the Treatment of Recurrent High-grade Glioma： an Open-label Single-arm, Phase 2 Trials
This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of anlotinib in treatment of recurrent high-grade glioma.
Read the detailed description
Glioma is a common primary central nervous system malignant tumor that originates from glial cells. High grade glioma (HGG) refers to grade III and IV gliomas in the central nervous system tumor classification of the World Health Organization (WHO), accounting for approximately 67% of newly diagnosed cases. The maximum safety resection of the tumor followed by radiotherapy and chemotherapy is the HGG standard initial treatment strategy. However, glioma cells grow aggressively, and most patients will relapse after initial treatment. Recurrent high-grade glioma (r-HGG) is difficult to treat, lacking treatment standards and having a poor prognosis.
There is no standard treatment plan for patients with recurrent high-grade cancer. Studies have shown that gliomas highly express a variety of pro-angiogenic factors and have a large number of abnormally proliferated blood vessels, VEGF especially playing an important role in the formation of GBM neovascularization. VEGF is almost not expressed in normal tissues, but it is highly expressed (about 96%) in malignant gliomas and surrounding tissues, especially VEGF-A is highly expressed in glioblastomas. Therefore, VEGF It can be used as an effective target for anti-angiogenesis treatment of malignant glioma.
Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor that has significant inhibitory activity against angiogenesis related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor related kinases such as PDGFR /, C-Kit, Ret, etc. (e.g., Met, FGFR1/2/3).
Based on the above theory , the purpose of this study was to explore the efficacy and safety of anlotinib in treatment of recurrent high-grade glioma.
- Conditions
- Recurrent High-grade Glioma
- Being tested
- Anlotinib hydrochloride
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochlorideDrug
Also called Anlotinib
Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Anlotinib | Experimental | Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient. Receives: Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
The time interval from the randomization of the patient to the first disease progression or death from any cause
Measured: 5months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start13 Apr 2020
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent High-grade GliomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib , and being observed the disease-related outcomes of the patients.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hui Dai, Principal investigator, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822805
- Sponsor's protocol ID
- H2CH2020M504
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao S, Zhang M, Zhang Q, Wu J, Dai H. Anlotinib alone or in combination with bevacizumab in the treatment of recurrent high-grade glioma: a prospective single-arm, open-label phase II trial. BMC Cancer. 2024 Jan 2;24(1):6. doi: 10.1186/s12885-023-11776-4.
PubMed 38166698
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib in the Treatment of Recurrent High-grade Glioma： an Open-label Single-arm, Phase 2 Trials
- ClinicalTrials.gov ID
- NCT04822805
- Acronym / sponsor ID
- H2CH2020M504
- Conditions
- Recurrent High-grade Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 30 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.
This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of anlotinib in treatment of recurrent high-grade glioma.
Detailed description
Glioma is a common primary central nervous system malignant tumor that originates from glial cells. High grade glioma (HGG) refers to grade III and IV gliomas in the central nervous system tumor classification of the World Health Organization (WHO), accounting for approximately 67% of newly diagnosed cases. The maximum safety resection of the tumor followed by radiotherapy and chemotherapy is the HGG standard initial treatment strategy. However, glioma cells grow aggressively, and most patients will relapse after initial treatment. Recurrent high-grade glioma (r-HGG) is difficult to treat, lacking treatment standards and having a poor prognosis.
There is no standard treatment plan for patients with recurrent high-grade cancer. Studies have shown that gliomas highly express a variety of pro-angiogenic factors and have a large number of abnormally proliferated blood vessels, VEGF especially playing an important role in the formation of GBM neovascularization. VEGF is almost not expressed in normal tissues, but it is highly expressed (about 96%) in malignant gliomas and surrounding tissues, especially VEGF-A is highly expressed in glioblastomas. Therefore, VEGF It can be used as an effective target for anti-angiogenesis treatment of malignant glioma.
Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor that has significant inhibitory activity against angiogenesis related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor related kinases such as PDGFR /, C-Kit, Ret, etc. (e.g., Met, FGFR1/2/3).
Based on the above theory , the purpose of this study was to explore the efficacy and safety of anlotinib in treatment of recurrent high-grade glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib , and being observed the disease-related outcomes of the patients.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Anlotinib | Experimental | Drug: Anlotinib hydrochloridePatients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years old (calculated on the day of signing the informed consent), regardless of gender.
- Karnofsky score (KPS score) ≥60.
- According to Rano criteria, there are evaluable intracranial lesions, and recurrent high-grade gliomas have been confirmed.
- Patients have undergone surgery and relapsed after receiving standard radiotherapy and chemotherapy;
- The toxicity has returned to ≤1 grade If have received chemotherapy;
Key exclusion criteria (3 listed)
- Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Patients with any severe and/or uncontrollable disease, including:
- 1) Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); 2) Patients with myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QTC ≥480ms), and grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification); 3) Active or uncontrolled serious infection (≥CTC AE Grade 2 infection); 4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7) Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L); 8) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein quantification is more than 1.0 g; 9) Patients who have seizures and need treatment; 3. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment; 4. Patients whose imaging shows that the tumor has invaded important blood vessels or the researcher judges that the tumor is likely to invade important blood vessels causing fatal hemorrhage during the follow-up study; 5. Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event ≥ CTCAE level 3, unhealed wounds, ulcers or fractures; 6. Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 7. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 8. Participated in clinical research of other anti-tumor drugs within four weeks; 9. Have received the treatment of small molecule anti-angiogenesis targeted drugs (such as regorafenib, perzopanib, apatinib, etc.); 10. Those considered by the researcher to be unsuitable for inclusion。
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 hydrochlorideAlso: AnlotinibPatients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient. | Drug | Treatment with Anlotinib |
Primary outcome
progression-free survival
Time frame: 5months
The time interval from the randomization of the patient to the first disease progression or death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 38166698Zhao S, Zhang M, Zhang Q, Wu J, Dai H. Anlotinib alone or in combination with bevacizumab in the treatment of recurrent high-grade glioma: a prospective single-arm, open-label phase II trial. BMC Cancer. 2024 Jan 2;24(1):6. doi: 10.1186/s12885-023-11776-4.
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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.
Hui Dai principal investigator
Hangzhou Cancer Hospital
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 hydrochloride in people with Recurrent High-grade Glioma, run by First People's Hospital of Hangzhou 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 9 inclusion and 3 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 30 Mar 2021. 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 Hui Dai (13968855810 ext. 0571-56006322, 124186159@qq.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: 5months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822805, which also lists 1 linked publication.
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 30 Mar 2021.