glioblastoma
Conditions
Interventions
experimental group:Camelizumab
Apatinib
SBRT
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients with advanced malignant glioblastoma diagnosed by pathology/ cytology; 2.More than three months from the last radiotherapy; 3.According to RECIST1.1 criteria, clinically assessable lesions; 4.The age at which informed consent is signed is 18-70 years, Male or female; 5.ECOG score 0-1; 6.Estimated lifetime >= 6 months; 7.Normal functioning of vital organs; 8.Ability and willingness to follow research and follow-up procedures; 9.Men and women of childbearing age must agree to adequate contraception throughout the study period and within 6 months after treatment; 10.The patient volunteered to join the clinical study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Meningeal metastasis, other intracranial disseminated, multiple intracranial metastases; 2.Patients who have previously received small-molecule TKI class of antiangiogenic drugs (including but not limited to bevacizumab, pazopanib, sorafenib, regofenib, sildenib, etc.), and who have used immunotherapies such as PD-1 antibodies, CTLA-4 antibodies, TCR-TCAR-T, etc; 3.Have a clear history of allergies and may have potential allergies or intolerance to biological agents such as apatinib and camelizumab; 4.Participated in clinical trials of other anti-tumor drugs within 4 weeks prior to first administration; or received live attenuated vaccine within 4 weeks prior to first administration or planned during study; 5.Other malignancies have occurred within 5 years (with the exception of adequately treated carcinoma of the cervix in situ or cutaneous squamous cell carcinoma basal cell carcinoma); 6.Immunosuppressive drugs were used within 14 days of first use of Camrelizumab; 7.Late patients with symptoms, spread to the viscera and risk of life-threatening complications in the short term; 8.Any active autoimmune disease or history of autoimmune disease; 9.Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite best medication); 10.Myocardial ischemia or myocardial infarction above grade II, arrhythmia with poor control (including QTc men >= 450 women >= 470 ms); 11.Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) INR>ULN 4 seconds or APTTINR > 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 12.A significant amount of hemoptysis (2.5 ml) or more occurred within 2 months prior to entry into the study a significant clinical bleeding symptom or a definite bleeding tendency occurred within 3 months prior to the study; 13.Severe infection within 4 weeks prior to first administration, or unexplained fever > 38.5 degrees C during screening /before first administration; 14.Persons with a history of substance abuse and who are unable to abstain or who have mental disorders; 15.Major surgery or open wound or fracture within 4 weeks prior to initial administration; 16.Significant factors affecting oral drug absorption, such as dysphagia, chronic diarrhea and intestinal obstruction, or the presence of sinus or perforation in the cavity within 6 months; 17.Urine routine indicates >= urine protein, or confirmed 24 h hour urine protein >= 1.0 g; 18.HIV infection or known AIDS, active hepatitis B, hepatitis C or co-infection with hepatitis B and C; 19.Subjects had untreated central nervous system metastases and had received previous systemic, radical brain or meningeal metastases. Patients who have been shown to be stable for at least 1 month and who have stopped systemic hormone therapy for more than 2 weeks without clinical evidence may be included; 20.Other circumstances that the researchers determined were unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival; | — |
Countries
China
Contacts
Public ContactTian Suqing
Peking University Third Hospital
Outcome results
None listed