Recurrent GlioblastomaPhase 2NCT05638451
Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients
A Phase 2 study testing Sintilimab plus Bevacizumab and Temozolomide in people with Recurrent Glioblastoma, run by Zhujiang Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Sintilimab plus Bevacizumab and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Molecular pathological diagnosis was high-grade glioma (2016 World Health Organization (WHO） Grade Ⅲ or Ⅳ);
- Age 18 - 70 years old, Karnofsky performance status （KPS） score ≥ 70, and the expected survival period is more than 3 months;
- Primary supratentorial glioblastoma with first or second recurrence
- Imaging confirmed recurrence (according to RANO criteria);
- The time of the first medication after enrollment should be more than 4 weeks away from the surgery or the last radiotherapy;
- Confirmed progression time is ≥4 weeks from the last drug treatment (including adjuvant temozolomide chemotherapy after the completion of concurrent chemoradiotherapy);
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- If the patient is on hormone therapy, the hormone dose must be stable or reduced for at least 7 days before the baseline MRI examination;
- Major organ function within 7 days prior to treatment, meeting the following criteria:
- Routine blood test standards (without blood transfusion within 14 days):
- Hemoglobin (HB) ≥90 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
- Platelet (PLT) ≥ 90×10^9/L; (2) Biochemical examination shall meet the following standards:
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 ULN, if with liver metastasis, ALT and AST ≤ 5ULN;
- Serum creatinine (Cr) ≤1.5 ULN and creatinine clearance rate (CCr) ≥ 60 ml/min; (3) Echocardiography: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); (4) International normalized ratio (INR), partial thromboplastin time (APTT), prothrombin time (PT) ≤1.5 ULN; 9. Patients voluntarily joined the study and signed informed consent.
Who cannot join
- Prior treatment with immunotherapy;
- Patients who have had or are currently suffering from other malignant tumors or solid organ or bone marrow transplantation within 5 years. Excludes cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors;
- Baseline MRI indicates the risk of cerebral hemorrhage or hernia in the past or recent;
- Pulmonary embolism or deep vein thrombosis within 2 months
- Unstable angina pectoris, myocardial infarction within past 12 months. Grade 2 or greater congestive heart failure
- Peptic ulcer, abdominal fistula, gastrointestinal perforation, or abdominal abscess within past 6 months
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- Patients with any physical signs or history of bleeding, regardless of severity;
- Uncontrollable high blood pressure
- Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis;
- Renal failure requires hemodialysis or peritoneal dialysis;
- Known history of active infectious pneumonia and active tuberculosis.
- Requiring escalating or chronic supraphysiologic doses of corticosteroids (> 4 mg dexamethasone daily) for control of disease
- Allergic reaction to bevacizumab or any of its excipients
- Diagnosis of immunodeficiency, including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- Active autoimmune disease requiring systemic treatment (i.e., disease modifiers, corticosteroids, or immunosuppressive drugs) within past 2 years. Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, etc.) is not considered a systemic form of therapy.
- Pregnancy or breastfeeding, or pregnancy or birth during the expected test period, from the pre-screening or screening visit until 120 days after the last dose of test treatment.
- Unable to undergo brain MRI (i.e., pacemaker or any other MRI contraindications).
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
southern medical university affiliated Zhujiang Hospital
Guangzhou
Junde Zhang, Doctor, 13002087575, 13002087575@163.com
Yujing Tan, Doctor, +8662782356, tanyujing-1981@163.com
About this study
Official title: Phase 2 Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma.
Read the detailed description
This is a phase 2,open-label, multicenter, single-arm study designed to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma.
A total of 30 patients will be enrolled in the study and administered Sintilimab in combination with Bevacizumab and Temozolomide. The study treatment will be continued for up to 4 cycles and Sintilimab was maintained until a progression of disease or unacceptable toxicity is confirmed.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Sintilimab plus Bevacizumab and Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab plus Bevacizumab and TemozolomideDrug
200mg Sintilimab plus 10mg/kg Bevacizumab very 3 weeks 200 mg/m2/day Temozolomide on days 1-5 out of a 28 days schedule
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab and Bevacizumab and Temozolomide | Experimental | single arm study Receives: Drug: Sintilimab plus Bevacizumab and Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate at 6 months
Progression free survival by iRANO criteria
Measured: Up to two years
Secondary outcomes (8)
Progression free survival
the time interval from entry to tumor progression, Progression free survival (PFS) by iRANO criteria
Measured: Up to two years
Overall survival
the time interval from entry to death from any cause
Measured: Up to two years
Objective response rate
rate of Complete Response +Partial Response
Measured: Up to two years
Disease control rate
rate of Complete Response +Partial Response+Stable Disease
Measured: Up to two years
Median duration of Karnofsky Performance Status(KPS) ≥ 70
Median duration of KPS ≥ 70 during progression-free survival
Measured: Up to two years
Frequency and severity of treatment-related adverse events
Frequency and severity of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to two years
Median duration of stable/improved quality of life assessed by EORTC QLQ-C30
the time interval from entry to change of ≥10 points on the EORTC QLQ-C30 without further improvement or disease progression or death
Measured: Up to two years
Absolute counts and ratios of immune cell subtypes
Changes of absolute counts and ratios of immune cell subtypes
Measured: Day 1 and Day 29 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 May 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junde Zhang, MD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638451
- Sponsor's protocol ID
- Junde Zhang
- Status last verified
- Jun 2023
- First submitted
- 27 Nov 2022
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients
- ClinicalTrials.gov ID
- NCT05638451
- Acronym / sponsor ID
- Junde Zhang
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Dec 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma.
Detailed description
This is a phase 2,open-label, multicenter, single-arm study designed to evaluate the efficacy and safety of Sintilimab in combination with Bevacizumab and Temozolomide in subjects with recurrent glioblastoma.
A total of 30 patients will be enrolled in the study and administered Sintilimab in combination with Bevacizumab and Temozolomide. The study treatment will be continued for up to 4 cycles and Sintilimab was maintained until a progression of disease or unacceptable toxicity is confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab and Bevacizumab and Temozolomide | Experimental | Drug: Sintilimab plus Bevacizumab and Temozolomidesingle arm study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Molecular pathological diagnosis was high-grade glioma (2016 World Health Organization (WHO） Grade Ⅲ or Ⅳ);
- Age 18 - 70 years old, Karnofsky performance status （KPS） score ≥ 70, and the expected survival period is more than 3 months;
- Primary supratentorial glioblastoma with first or second recurrence
- Imaging confirmed recurrence (according to RANO criteria);
- The time of the first medication after enrollment should be more than 4 weeks away from the surgery or the last radiotherapy;
Key exclusion criteria (18 listed)
- Prior treatment with immunotherapy;
- Patients who have had or are currently suffering from other malignant tumors or solid organ or bone marrow transplantation within 5 years. Excludes cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors;
- Baseline MRI indicates the risk of cerebral hemorrhage or hernia in the past or recent;
- Pulmonary embolism or deep vein thrombosis within 2 months
- Unstable angina pectoris, myocardial infarction within past 12 months. Grade 2 or greater congestive heart failure
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 |
|---|---|---|
| Sintilimab plus Bevacizumab and Temozolomide200mg Sintilimab plus 10mg/kg Bevacizumab very 3 weeks 200 mg/m2/day Temozolomide on days 1-5 out of a 28 days schedule | Drug | Sintilimab and Bevacizumab and Temozolomide |
Primary outcome
Progression free survival rate at 6 months
Time frame: Up to two years
Progression free survival by iRANO criteria
8 secondary outcomes
Progression free survival
Time frame: Up to two years
Overall survival
Time frame: Up to two years
Objective response rate
Time frame: Up to two years
Disease control rate
Time frame: Up to two years
Median duration of Karnofsky Performance Status(KPS) ≥ 70
Time frame: Up to two years
Frequency and severity of treatment-related adverse events
Time frame: Up to two years
Median duration of stable/improved quality of life assessed by EORTC QLQ-C30
Time frame: Up to two years
Absolute counts and ratios of immune cell subtypes
Time frame: Day 1 and Day 29 of each cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- 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.
Junde Zhang, MD principal investigator
Zhujiang 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 Sintilimab plus Bevacizumab and Temozolomide in people with Recurrent Glioblastoma, run by Zhujiang 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 18 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 5 Jun 2024. 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 Junde Zhang, MD (13002087575, 13002087575@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 rate at 6 months (time frame: Up to two 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 5 Jun 2024.