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Trial Title:
Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients
NCT ID:
NCT05638451
Condition:
Recurrent Glioblastoma
Conditions: Official terms:
Glioblastoma
Recurrence
Bevacizumab
Temozolomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab plus Bevacizumab and Temozolomide
Description:
200mg Sintilimab plus 10mg/kg Bevacizumab very 3 weeks 200 mg/m2/day Temozolomide on days
1-5 out of a 28 days schedule
Arm group label:
Sintilimab and Bevacizumab and Temozolomide
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Molecular pathological diagnosis was high-grade glioma (2016 World Health
Organization (WHO） Grade Ⅲ or Ⅳ);
2. Age 18 - 70 years old, Karnofsky performance status （KPS） score ≥ 70, and the
expected survival period is more than 3 months;
3. Primary supratentorial glioblastoma with first or second recurrence
4. Imaging confirmed recurrence (according to RANO criteria);
5. The time of the first medication after enrollment should be more than 4 weeks away
from the surgery or the last radiotherapy;
6. Confirmed progression time is ≥4 weeks from the last drug treatment (including
adjuvant temozolomide chemotherapy after the completion of concurrent
chemoradiotherapy);
7. 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;
8. Major organ function within 7 days prior to treatment, meeting the following
criteria:
(1) Routine blood test standards (without blood transfusion within 14 days):
1. Hemoglobin (HB) ≥90 g/L;
2. Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
3. Platelet (PLT) ≥ 90×10^9/L; (2) Biochemical examination shall meet the following
standards:
4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
5. Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 ULN, if with
liver metastasis, ALT and AST ≤ 5ULN;
6. 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.
Exclusion Criteria:
1. Prior treatment with immunotherapy;
2. 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;
3. Baseline MRI indicates the risk of cerebral hemorrhage or hernia in the past or
recent;
4. Pulmonary embolism or deep vein thrombosis within 2 months
5. Unstable angina pectoris, myocardial infarction within past 12 months. Grade 2 or
greater congestive heart failure
6. Peptic ulcer, abdominal fistula, gastrointestinal perforation, or abdominal abscess
within past 6 months
7. Patients with any physical signs or history of bleeding, regardless of severity;
8. Uncontrollable high blood pressure
9. Patients with liver cirrhosis, decompensated liver disease, active hepatitis or
chronic hepatitis;
10. Renal failure requires hemodialysis or peritoneal dialysis;
11. Known history of active infectious pneumonia and active tuberculosis.
12. Requiring escalating or chronic supraphysiologic doses of corticosteroids (> 4 mg
dexamethasone daily) for control of disease
13. Allergic reaction to bevacizumab or any of its excipients
14. Diagnosis of immunodeficiency, including human immunodeficiency virus (HIV) or
acquired immunodeficiency syndrome (AIDS)
15. 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.
16. 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.
17. Unable to undergo brain MRI (i.e., pacemaker or any other MRI contraindications).
18. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
southern medical university affiliated Zhujiang Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Junde Zhang, Doctor
Phone:
13002087575
Email:
13002087575@163.com
Contact backup:
Last name:
Yujing Tan, Doctor
Phone:
+8662782356
Email:
tanyujing-1981@163.com
Start date:
May 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05638451
