Glioblastoma
Conditions
Interventions
Experimental group:After diagnosis, the patient was given GTV 6-14Gy/1F. Camrelizumab was administered within 24 hours before and after radiotherapy (D1) and on day 15 (D15). Surgery was performed on
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Diagnosed glioblastoma that cannot be completely removed surgically as assessed; 3. Newly diagnosed glioblastoma that has not received any treatment; 4. KPS score higher than 60; 5. Expected survival >= 6 months; 6. Major organ function meets the following requirements: (1) Absolute neutrophil count (ANC) >= 1000/mcL; (2) Platelets >= 100,000/mcL; (3) Hemoglobin >= 9.0 g/dl or >= 5.6 mmol/L; (4) Serum creatinine or measured/calculated creatinine clearance (glomerular filtration rate [GFR] can also be used as a substitute for creatinine or creatinine clearance [CrCl]) = 40 mL/min CrCl, using the Cockcroft-Gault formula; (5) Total serum bilirubin 1.5 times ULN; (6) ALT and AST <= 3 times ULN; (7) Activated partial thromboplastin time (aPTT) <= 1.5 times ULN, unless the subject is receiving anticoagulation therapy, and PT or PTT is within the therapeutic range expected for the anticoagulant used; 7. Patient’s intracranial pressure is between 70–200 mmH2O; 8. No prior chemotherapy or radiotherapy; 9. Patient and partner are using effective contraceptive measures; 10. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Previous treatment for glioma with radiotherapy or chemotherapy. 2.Other clinically active malignant tumors within the past five years, except for those with no risk of metastasis or death, such as well-controlled papillary thyroid carcinoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and breast. 3.The patient has active cerebral hemorrhage. 4.The patient is pregnant or breastfeeding. 5.Individuals with severe or unstable health conditions, such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes, mental illnesses, arrhythmias that require medication for treatment (classified as grade 2 or higher according to the NCI CTCAE 4.03 version), or any other significant or unstable comorbidities. 6.Current or recent use of aspirin at a dose of >325 mg/day (within 10 days prior to randomization); 7.In cases where there is a risk of bleeding, coagulation disorders are present, or if anticoagulant coumarin derivatives (such as warfarin) are being administered at therapeutic doses within a week prior to the start of treatment, heparin can be used to prevent the development of deep vein thrombosis (DVT). 8.The patient suffers from Post-Traumatic Stress Disorder (PTSD) or has inflammatory bowel disease that carries a risk of perforation. 9.Systolic blood pressure above 150 mmHg, and diastolic blood pressure above 100 mmHg – levels that cannot be controlled by standard antihypertensive medications. 10.Presence of unsolvable scars, ulcers, or a recent fracture. 11.I am currently participating in a study involving a investigational drug. 12.Previously treated with PD1/PDL1 inhibitors or targeted therapies. 13.Patients with a known history of seropositivity for the human immunodeficiency virus, or those with other active viral, bacterial, or fungal infections, as well as patients with hepatitis B or C who are positive in antiviral treatment, can be included in the study. 14.There are other health conditions (such as mental illnesses, etc.), as well as results from physical examinations or laboratory tests that suggest that the patient may experience interruptions in the prescribed treatment, which could affect their compliance with the treatment regimen or put them at a high risk of treatment-related complications. 15.It is known that the patient is intolerant to radiotherapy. 16.Unwillingness or inability to comply with the agreement. 17.The subject had a known history of abuse of psychotropic drugs, alcoholism, or drug use. 18.In the judgment of the researchers, the subjects had other factors that could potentially lead to the forced termination of this study. These factors included other serious illnesses (including mental health disorders) that required concurrent treatment, significant abnormalities in laboratory test results, as well as family or social circumstances that could pose a risk to the safety of the subjects, or that could affect the collection of data and samples for the study. 19.Patients who have been diagnosed with severe active scleroderma, lupus, another rheumatic disease, or an autoimmune disease within the past 3 months; as well as those with a documented history of severe autoimmune diseases, or those suffering from syndromes that require the use of systemic steroids or immunosuppressive agents, are not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate (PFS6); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival;Objective Response Rate(Response Assessment in Neuro-Oncology criteria);Common Terminology Criteria for Adverse Events version 4.0;Local Tumor Control Rate;Quality of Life;Cognitive Function;Safety and Tolerability; | — |
Countries
China
Contacts
Public ContactChen Yuanyuan
Sun Yat-sen University Cancer Center
Outcome results
None listed