| Eligibility |
Inclusion Criteria:
1. Age 18~70, male or female
2. Primary supratentorial glioblastoma with first or second rogression/recurrence
3. IDH1/2 wildtype
4. KPS score =70 in patients with the first recurrence and =60 in patients with the
second recurrence
5. Expected survival =12 weeks.
6. The time interval from the last radiotherapy was =12 weeks, unless there was new tumor
enhancement in the radiological field or clear evidence of tumor hipathology.
7. Radiotherapy and at least one regimen of chemotherapy before recurrence (excluding
temozolomide chemotherapy during concurrent radiotherapy).
8. The patients were enrolled after the end of the previous chemotherapy interval and had
recovered from the related adverse reactions (except hair loss and pigmentation).
9. The tumor was confirmed to have definite recurrence by MRI, with enhanced lesion
diameter =1cm and =2 layers (layer spacing 5mm), or was confirmed to have recurrence
by pathology after re-biopsy or surgery.
10. The time interval between the last operation and the last biopsy was =4 weeks or =2
weeks at the time of enrollment.
11. The main organs function normally, no serious abnormal blood, heart, lung, liver,
kidney function and immune deficiency diseases
12. Women of childbearing age are required to have a negative pregnancy test (serum or
urine) within 7 days before enrolment and to voluntarily use contraception during
treatment and within 8 weeks after the last treatment;For men, they should be
surgically sterilized or agree to use contraception during treatment and for 8 weeks
after the last treatment.
13. Patients voluntarily enrolled in this study and signed informed consent (ICF).
14. Good compliance is expected, efficacy and adverse reactions can be followed up
according to protocol requirements
Exclusion Criteria:
1. Glioblastoma in the midline (thalamus, brainstem, sellar region, etc.).
2. Patients with initial recurrence had previously received long-term high-dose
antiangiogenic drugs (except those with amlotinib or apatinib for less than 1 month
and no progress during treatment, except those with intermittent bev dose intensity
=5mg/ week and =3 times) or immunocheckpoint inhibitors, TCR-T, CAR-T, etc.;Patients
with secondary recurrence had previously received long-term high-dose therapy of Bev
(except for intermittent Bev dose intensity =5mg/ week and =3 times) or
immunocheckpoint inhibitors, TCR-T, or CAR-T.
3. Other study drugs are being used.
4. An allergic reaction or intolerance to any component of the drug used in this study is
known.
5. Other malignant tumors in the past 3 years.
6. Subjects who had been systematically treated with corticosteroids (>4mg/day
dexamethasone or other equivalent hormone) or other immunosuppressants within 2 weeks
prior to first use of carrelizumab.In the absence of active autoimmune disease,
inhaled or topical corticosteroids and hormone replacement therapy with doses less
than or equal to 4mg/ day of dexamethasone are permitted.
7. The presence or history of any active autoimmune disease .
8. Uncontrolled hypertension.
9. Myocardial infarction occurred within 6 months prior to enrollment, New York Heart
Society Class II heart failure or above, uncontrolled angina pectoris, uncontrolled
severe arrhythmias, clinically significant pericardial disease, and electrocardiogram
indicating acute ischemia or abnormal active conduction system.
10. Abnormal coagulation function, bleeding tendency or receiving thrombolytic or
anticoagulant therapy.
11. Before entering the study 3 months there have been significant clinical significance
of bleeding symptoms or have definite bleeding tendency;Or arterial/venous thrombosis
events, such as cerebrovascular accidents, deep vein thrombosis and pulmonary
embolism, occurred within 6 months before the study.
12. Severe infection occurred within 4 weeks prior to initial administration;Or
unexplained fever >38.5? during screening/prior to first administration.
13. People who have a history of abuse of psychotropic substances and are unable to get
rid of them or have mental disorders.
14. Had major surgery or had an open wound or fracture within 4 weeks prior to first
administration.
15. Empty sinus passages or perforations were observed within 6 months prior to study
entry.
16. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome (AIDS), active hepatitis B (HBVDNA=500IU/ mL), hepatitis C (positive
hepatitis C antibody and HCV-RNA above the detection limit of the assay method) or
co-infection with hepatitis B and hepatitis C.
17. Patients who received anti-tumor vaccine or other immunomodulatory drugs within 4
weeks before enrolment;Patients who have received or will receive live attenuated or
recombinant vaccine within 4 weeks;Patients who received or will receive the
inactivated vaccine within 1 week.
18. Pregnancy and lactation.
19. Other conditions that the investigator considered inappropriate for inclusion.
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