Apatinib, Carilizumab, Neoadjuvant Therapy, Recurrent High-Grade Glioma
Conditions
Brief summary
GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.
Interventions
BIOLOGICALPD-1
Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent. 2. Age 18-70 years old, both male and female. 3. After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma. 4. 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. 5. KPS score ≥60； 6. Life expectancy \>12 weeks. 7. Adequate organ function defined by: 1. HGB≥110g/L； 2. WBC≥3.0×109/L；NEUT≥1.5×109/L； 3. PLT ≥75×109/L； <!-- --> 1. BIL≤1.5ULN； 2. ALT and AST≤2.0×ULN； 3. creatinine \< 1.5 x ULN or estimated creatinine clearance≥50ml/min（using the Cockcroft-Gault formula）
Exclusion criteria
1. Presence of extracranial disease. 2. Previous treatment with a PD-1, PDL-1 or CTLA-4，VEGFR targeted therapy. 3. Pregnant or breastfeeding patients. 4. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required. 5. Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. 6. History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies. 7. Known drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | 18 months | Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment |
Countries
China
Contacts
Primary ContactChen Zhong ping, PHD
Backup ContactKe Chao, PHD
Outcome results
None listed