Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Safety and Efficiency of Using the Neoadjuvant Therapy With Carilizumab and Apatinib in Patients With Recurrent High-Grade Glioma ：A Prospective, Randomized Study

Conditions
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Neoadjuvant Therapy, Carilizumab, Apatinib, Recurrent High-Grade Glioma

Intervention / Treatment
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* Biological: PD-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Age 18-70 years old, both male and female. After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma. 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. KPS score ≥60； Life expectancy >12 weeks. Adequate organ function defined by: HGB≥110g/L； WBC≥3.0×109/L；NEUT≥1.5×109/L； PLT ≥75×109/L； BIL≤1.5ULN； ALT and AST≤2.0×ULN； creatinine < 1.5 x ULN or estimated creatinine clearance≥50ml/min（using the Cockcroft-Gault formula） Exclusion Criteria: Presence of extracranial disease. Previous treatment with a PD-1, PDL-1 or CTLA-4，VEGFR targeted therapy. Pregnant or breastfeeding patients. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required. Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies. Known drug or alcohol abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant group<br>Patients need to treat with PD-1 and apatinib before surgery. Sequential therapy with PD-1 and apatinib when patients accepted surgery. | Biological: PD-1<br>* Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG<br>* Other names: apatinib;|
| Experimental: Adjuvant group<br>Before surgery, patients no need to treat with PD-1 and apatinib. Sequential therapy with PD-1 and apatinib when patients accepted surgery. | Biological: PD-1<br>* Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG<br>* Other names: apatinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) | Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment | 18 months |