GlioblastomaNCT05811793
Efficacy and Safety of SCAI of Bevacizumab Combined With IC of Tislelizumab in the Treatment of Recurrent Glioblastoma.
A study testing Tislelizumab and Bevacizumab in people with Glioblastoma, run by Second Affiliated Hospital of Nanchang University.
Trial summary
To investigate the efficacy, safety and tolerability of superselective cerebral arterial infusion of Bevacizumab combined with intrathecal injection of Tislelizumab in the treatment of recurrent glioblastoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Tislelizumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2023to 30 Dec 2025
- Phase
- Interventional
- 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
- 1, 18 ≤ age ≤ 75 years. 2. Recurrent glioblastoma who failed first-line therapy, with no more than 3 prior episodes of disease progression and at least one confirmed and evaluable lesion.
- 3. ECOG score 0-2 points, expected survival time ≥ 3 months; 4. Stable neurological symptoms for more than 7 days; 5. If the previous surgical resection interval is at least 4 weeks, after receiving chemotherapy for 3 weeks, after receiving radiotherapy including whole brain radiotherapy, stereotactic radiotherapy and other radiotherapy for 3 months, if receiving other intrathecal treatment drugs washout period of 7 days.
- 6. Neutrophil count ≥ 1.5 × 10 ^ 9/L, hemoglobin ≥ 80 g/L, platelets ≥ 75 × 10 ^ 9/L.
- 7. Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 × upper limit of normal; 8. Total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×ULN, albumin ≥ 30 g/L, creatinine ≤ 2 × ULN, calculated creatinine clearance ≥ 50 mL/min, 24-hour urine creatinine clearance ≥ 50 mL/min; 9. subjects should agree to use adequate contraception from the first dose until 3 months after the last dose.
Who cannot join
- 1. Pregnant or lactating women. 2. Active infection requiring intravenous antibiotics requiring therapeutic anticoagulation with warfarin.
- 3. History of allergy to monoclonal antibodies; 4. Use of non-tumor vaccines containing live viruses to prevent infectious diseases within 12 weeks before the study drug; 5. Subjects with serious medical, neurological or psychiatric disorders and judged to be unable to fully comply with study treatment or assessments; 6. Active infectious diseases within 7 days before starting the study drug; 7. Severe liver dysfunction (persistent grade 3 or greater liver adverse events) or known active chronic hepatitis, human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) test positive; 8. Patients with active autoimmune diseases requiring systemic treatment (i.e., the use of corticosteroids or immunosuppressive agents), except replacement therapy (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency), allowing inhalation or local steroids and adrenal replacement dose > 10 mg daily prednisone equivalent, requiring long-term systemic corticosteroid therapy (> 10 mg prednisone or equivalent per day) or any other immunosuppressive therapy (including anti-TNF-a therapy); 9. Investigate the allergic history of drug ingredients; 10. Inadequate control of hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg (using antihypertensive drugs); 11. Any past history of hypertensive crisis or hypertensive encephalopathy; 12. New York Heart Association (NYHA) Class II or greater congestive heart failure; 13. History of myocardial infarction or unstable angina within 6 months prior to enrollment; 14. History of stroke or transient ischemic attack within 6 months prior to enrollment; 15. Severe vascular diseases (such as aortic aneurysm, aortic dissection); 16. Symptomatic peripheral vascular disease. 17. Evidence of bleeding diathesis or coagulopathy. 18. Major surgery, open biopsy or severe traumatic injury within 28 days prior to study enrollment, or major surgery is expected to be required during the course of the study.
- 19. Core biopsy or other minor surgical procedures, excluding placement of vascular access devices, within 7 days prior to study enrollment.
- 20. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study entry; 21. Severe, non-healing wounds, ulcers or fractures. 22. Urine protein to creatinine ratio ≥ 1.0 or urine protein ≥ 2 +. 23. Subjects with high intracranial pressure who are not suitable for lumbar puncture, and the researchers believe that they are not suitable for inclusion in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Superselective Cerebral Arterial Infusion of Bevacizumab Combined With Intrathecal Injection of Tislelizumab in the Treatment of Recurrent Glioblastoma
To investigate the efficacy, safety and tolerability of superselective cerebral arterial infusion of Bevacizumab combined with intrathecal injection of Tislelizumab in the treatment of recurrent glioblastoma
Read the detailed description
Glioblastoma multiforme (GBM) is a highly malignant intracranial tumor with a median survival of only about 15-17 months after standard treatment. Patients with GBM often experience disease recurrence, and once recurrence occurs, treatment options are very limited, with a median overall survival of only about 6 months. Results of a phase II clinical trial of nivolumab combined with standard or reduced-dose bevacizumab iv therapy for recurrent GBM showed that the median PFS for the two groups was 5.6 months vs. 4.6 months, respectively. The aim of this study is to improve the outcome of recurrent GBM patients by changing the route of administration of the two drugs, such as delivering Bevacizumab via intra-arterial infusion and administering PD-1 monoclonal antibodies via intrathecal injection.
- Conditions
- Glioblastoma
- Being tested
- Tislelizumab and Bevacizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab and BevacizumabDrug
Tislelizumab is a drug material authorized for marketing in China. Tislelizumab will be administered off-label in this study. Subjects with recurrent GBM will receive intrathecal tislelizumab every 3 weeks for six times. Intrathecal administration of Bevacizumab will be performed via Ommaya reservoir or intraventricular catheter.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab arterial infusion combined with Tislelizumab intrathecal injection | Experimental | This is a prospective, interventional, multicenter Phase 2 trial for the treatment of patients with recurrent GBM who will receive Bevacizumab arterial infusion combined with Tislelizumab intrathecal injection. The study consists of two parts: the "arterial infusion part" in part 1, where each subject will receive 15 mg/Kg of Bevacizumab by cerebral arterial infusion over 15 minutes at a fixed time (d0, d30, d60); the infusion of 20% mannitol 12.5 ml over 120 seconds prior to the infusion of Bevacizumab; and the "intrathecal injection part" in part 2, where the subject will receive a fixed dose of intrathecal PD1 therapy (Tislelizumab 20 mg, d1, Q3W) intrathecal injection every 3 weeks for 6 cycles. Receives: Drug: Tislelizumab and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
PFS was defined as the time from random assignment until objective tumor progression (independent image committee assessment) or death (any cause)
Measured: Up to 10 approximately months
Secondary outcomes (4)
Objective Response Rate
ORR is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set.
Measured: Up to 10 approximately months
Overall Survival
OS was defined as the time from random assignment until death (any cause) or censored at the last date of known survival.
Measured: Up to 10 approximately months
Duration of Response
Time from the patient 's first assessment of clinical response to the first assessment of disease progression or death from any cause.
Measured: Up to 10 approximately months
Safety and Tolerability
The safety endpoints will be assessed by a review of adverse events and serious adverse events according to CTCAE up to 10 approximately months after last dose
Measured: Up to 10 approximately months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start15 Apr 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completion30 Dec 2025 (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 Second Affiliated Hospital of Nanchang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Xingen Zhu, Dr., Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811793
- Sponsor's protocol ID
- IIT-I-2023-016
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Superselective Cerebral Arterial Infusion of Bevacizumab Combined With Intrathecal Injection of Tislelizumab in the Treatment of Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT05811793
- Acronym / sponsor ID
- IIT-I-2023-016
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Apr 2023 (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.
To investigate the efficacy, safety and tolerability of superselective cerebral arterial infusion of Bevacizumab combined with intrathecal injection of Tislelizumab in the treatment of recurrent glioblastoma
Detailed description
Glioblastoma multiforme (GBM) is a highly malignant intracranial tumor with a median survival of only about 15-17 months after standard treatment. Patients with GBM often experience disease recurrence, and once recurrence occurs, treatment options are very limited, with a median overall survival of only about 6 months. Results of a phase II clinical trial of nivolumab combined with standard or reduced-dose bevacizumab iv therapy for recurrent GBM showed that the median PFS for the two groups was 5.6 months vs. 4.6 months, respectively. The aim of this study is to improve the outcome of recurrent GBM patients by changing the route of administration of the two drugs, such as delivering Bevacizumab via intra-arterial infusion and administering PD-1 monoclonal antibodies via intrathecal injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab arterial infusion combined with Tislelizumab intrathecal injection | Experimental | Drug: Tislelizumab and BevacizumabThis is a prospective, interventional, multicenter Phase 2 trial for the treatment of patients with recurrent GBM who will receive Bevacizumab arterial infusion combined with Tislelizumab intrathecal injection. The study consists of two parts: the "arterial infusion part" in part 1, where each subject will receive 15 mg/Kg of Bevacizumab by cerebral arterial infusion over 15 minutes at a fixed time (d0, d30, d60); the infusion of 20% mannitol 12.5 ml over 120 seconds prior to the infusion of Bevacizumab; and the "intrathecal injection part" in part 2, where the subject will receive a fixed dose of intrathecal PD1 therapy (Tislelizumab 20 mg, d1, Q3W) intrathecal injection every 3 weeks for 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1, 18 ≤ age ≤ 75 years. 2. Recurrent glioblastoma who failed first-line therapy, with no more than 3 prior episodes of disease progression and at least one confirmed and evaluable lesion.
- 3. ECOG score 0-2 points, expected survival time ≥ 3 months; 4. Stable neurological symptoms for more than 7 days; 5. If the previous surgical resection interval is at least 4 weeks, after receiving chemotherapy for 3 weeks, after receiving radiotherapy including whole brain radiotherapy, stereotactic radiotherapy and other radiotherapy for 3 months, if receiving other intrathecal treatment drugs washout period of 7 days.
- 6. Neutrophil count ≥ 1.5 × 10 ^ 9/L, hemoglobin ≥ 80 g/L, platelets ≥ 75 × 10 ^ 9/L.
- 7. Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 × upper limit of normal; 8. Total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×ULN, albumin ≥ 30 g/L, creatinine ≤ 2 × ULN, calculated creatinine clearance ≥ 50 mL/min, 24-hour urine creatinine clearance ≥ 50 mL/min; 9. subjects should agree to use adequate contraception from the first dose until 3 months after the last dose.
Key exclusion criteria (4 listed)
- 1. Pregnant or lactating women. 2. Active infection requiring intravenous antibiotics requiring therapeutic anticoagulation with warfarin.
- 3. History of allergy to monoclonal antibodies; 4. Use of non-tumor vaccines containing live viruses to prevent infectious diseases within 12 weeks before the study drug; 5. Subjects with serious medical, neurological or psychiatric disorders and judged to be unable to fully comply with study treatment or assessments; 6. Active infectious diseases within 7 days before starting the study drug; 7. Severe liver dysfunction (persistent grade 3 or greater liver adverse events) or known active chronic hepatitis, human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) test positive; 8. Patients with active autoimmune diseases requiring systemic treatment (i.e., the use of corticosteroids or immunosuppressive agents), except replacement therapy (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency), allowing inhalation or local steroids and adrenal replacement dose > 10 mg daily prednisone equivalent, requiring long-term systemic corticosteroid therapy (> 10 mg prednisone or equivalent per day) or any other immunosuppressive therapy (including anti-TNF-a therapy); 9. Investigate the allergic history of drug ingredients; 10. Inadequate control of hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg (using antihypertensive drugs); 11. Any past history of hypertensive crisis or hypertensive encephalopathy; 12. New York Heart Association (NYHA) Class II or greater congestive heart failure; 13. History of myocardial infarction or unstable angina within 6 months prior to enrollment; 14. History of stroke or transient ischemic attack within 6 months prior to enrollment; 15. Severe vascular diseases (such as aortic aneurysm, aortic dissection); 16. Symptomatic peripheral vascular disease. 17. Evidence of bleeding diathesis or coagulopathy. 18. Major surgery, open biopsy or severe traumatic injury within 28 days prior to study enrollment, or major surgery is expected to be required during the course of the study.
- 19. Core biopsy or other minor surgical procedures, excluding placement of vascular access devices, within 7 days prior to study enrollment.
- 20. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study entry; 21. Severe, non-healing wounds, ulcers or fractures. 22. Urine protein to creatinine ratio ≥ 1.0 or urine protein ≥ 2 +. 23. Subjects with high intracranial pressure who are not suitable for lumbar puncture, and the researchers believe that they are not suitable for inclusion in the study.
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 |
|---|---|---|
| Tislelizumab and BevacizumabTislelizumab is a drug material authorized for marketing in China. Tislelizumab will be administered off-label in this study. Subjects with recurrent GBM will receive intrathecal tislelizumab every 3 weeks for six times. Intrathecal administration of Bevacizumab will be performed via Ommaya reservoir or intraventricular catheter. | Drug | Bevacizumab arterial infusion combined with Tislelizumab intrathecal injection |
Primary outcome
Progression-Free Survival
Time frame: Up to 10 approximately months
PFS was defined as the time from random assignment until objective tumor progression (independent image committee assessment) or death (any cause)
4 secondary outcomes
Objective Response Rate
Time frame: Up to 10 approximately months
Overall Survival
Time frame: Up to 10 approximately months
Duration of Response
Time frame: Up to 10 approximately months
Safety and Tolerability
Time frame: Up to 10 approximately months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Xingen Zhu, Dr. principal investigator
Second Affiliated Hospital of Nanchang University
Questions about this trial
What is this clinical trial studying?
A study testing Tislelizumab and Bevacizumab in people with Glioblastoma, run by Second Affiliated Hospital of Nanchang University.
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 4 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingen Zhu, Dr. (18679136068, zxg2008vip@163.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: Up to 10 approximately 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 13 Apr 2023.