Glioma
Conditions
Interventions
experimental group:Two weeks before surgery, the patient was treated with Carrillizumab neoadjuvant therapy once (200mg iv) and then underwent glioma resection
and the drug continued to be administered every three weeks after surgery.
control group:Carrillizumab was administered once every three weeks after surgery (200mg iv)
Sponsors
Shanghai Cancer Center, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Patients who are willing and able to comply with and perform follow-up and treatment plans; 3. Patients with GBM at the initial diagnosis who can undergo one-stage resection; 4. Patients with GBM that are candidates to primary resection surgery, according to the following criteria; 5. Patients who are newly diagnosed with GBM by biopsy, MRS (magnetic resonance spectroscopy), or other means; 6. Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator; 7. Eastern Cancer Oncology Group (ECOG) performance status of 0-1. Patients with ECOG > 1 due to neurological symptoms considered to be reversible following surgery, according to investigator's criteria will be eligible; 8. Life expectancy > 12 weeks; 9. Adequate organ function defined by: (1) Bone Marrow Reserve: white blood cells (WBC) >= 2 x 10^9/L, absolute neutrophil count (ANC) >= 1.5x 10^9/L; platelet count >= 100 x 10^9/L; hemoglobin >= 9.0 g/dL. (2) Hepatic: bilirubin 40 ml/min, using the Cockcroft-Gault formula.
Exclusion criteria
Exclusion criteria: 1. Presence of extracranial disease. 2. With any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive the planned therapy (including brain surgery), or interfere with the interpretation of study results. 3. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 4. Previous treatment with a PD-1, PDL1 or CTLA-4 targeted therapy. 5. Treatment with any anti-cancer drug or radiation therapy. 6. Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents), except for control of cerebral edema, or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 7. Pregnant or breastfeeding patients. 8. With known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required. 9. Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. 10. With history of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies. 11. Prisoners or subjects who are involuntarily incarcerated or who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. 12. Subjects unable (due to existent medical condition, e.g, pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast enhanced MRI and/or a CT scan of the brain. 13. Concomitant or prior malignancy that, in the opinion of the investigator contraindicates GBM surgery or can interfere with the results of the study, in the opinion of the investigator. 14. Known drug or alcohol abuse. 15. Other conditions that might affect the conduct of clinical studies or the interpretation of study results, evaluated by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactCao Yiqun
Shanghai Cancer Center, Fudan University
Outcome results
None listed