diffuse midline glioma
Conditions
Interventions
Experimental Group:Cardonilizumab combined with bevacizumab was administered every 3 weeks until 1 year or disease progression or unacceptable toxicities, or withdrew consent.
Sponsors
Sanbo Brain Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The age of signing the informed consent is not less than 3 years old, no gender limit; 2. Diffuse midline glioma was confirmed pathologically (the diagnostic criteria refer to WHO2021 5th Edition Classification criteria for tumors of the central nervous system); 3. Tumor recurrence/progression with measurable enhancement or nonenhancement (two maximum vertical diameters >=1cm, or >=2 layer thickness; 4. At least prior radiation treatment; 5. The time interval between enrollment and the last radiotherapy >=12 weeks, unless there is a new tumor lesion or clear evidence of tumor histopathology in the radiation field; 6. At the time of enrollment, patients had recovered from related adverse reactions (except hair loss and pigmentation) after the interval of previous chemotherapy; 7. KPS>=50 (aged >12 years) or Lansky>=50 (aged =12 weeks; 9. Enrollment was >=4 weeks from the last operation or >=2 weeks from the last biopsy; 10. Hormone dose stable or down-regulated for at least 3 days from baseline screening; 11. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : (1) Routine blood examination, which must meet (no blood transfusion within 14 days) : 1) HGB>=90g/L; 2) WBC>=3.0x10^9/L; NEUT>=1.5x10^9/L; 3) PLT>=75x10^9/L; (2) Biochemical examination shall meet the following standards: 1) BIL=60ml/min; (3) Fecal occult blood (-); (4) Normal urine routine, or urine protein <(++), or 24-hour urine protein volume <1.0g; (5) The ECG showed that the heart rate was in the normal range and the QT interval was normal or slightly prolonged (QTc<480ms); (6) Normal coagulation function, no active bleeding and thrombosis disease. 1) International normalized ratio INR<=1.5xULN; 2) Partial thrombin time APTT<=1.5xULN; 3) Prothrombin time PT<=1.5ULN; 12. Patients of childbearing age must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment; 13. The patient voluntarily joined the clinical study and signed the informed consent. The patient had good compliance and could cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Other investigational drugs are being used. 2. Known or suspected allergy to the study drug or any drug associated with this study. 3. Other malignant tumors within the past 3 years or at the same time. 4. Present with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). 5. Uncontrolled hypertension (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg, despite optimal medical treatment). 6. Myocardial infarction, New York Heart Society Class II or above heart failure, uncontrolled angina, and clinically significant pericardial disease within 6 months prior to enrollment. 7. Bleeding symptoms of significant clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, have occurred within 3 months before entering the study; Or arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months prior to study entry. 8. Severe infections (such as intravenous antibiotics, antifungal or antiviral drugs) occurring within 4 weeks prior to initial medication, including but not limited to infection complications, bacteremia, severe pneumonia, etc., requiring hospitalization; Or unexplained fever >38.5? during screening/prior to initial administration. 9. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders. 10. Major surgical procedures or open wounds or fractures within 4 weeks prior to initial dosing. 11. There was a cavity or perforation of the viscera sinus within 6 months prior to study entry. 12. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA>=500 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of the assay), or co-infection with hepatitis B and hepatitis C. 13. Patients who received anti-tumor vaccine or other immunomodulatory drugs (such as interleukin-2, thymosin, lentinan, etc.) within 4 weeks prior to enrollment; Patients who have received or will receive live attenuated or recombinant vaccine within 4 weeks; Patients who have received or will receive inactivated vaccine within 1 week. 14. Patients who have previously received solid organ transplants. 15. Pregnant and lactating patients. 16. Other situations considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival;overall survival;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactZhang Junping
Sanbo Brain Hospital Capital Medical University
Outcome results
None listed