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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant group | Experimental | Patients need to treat with PD-1 and apatinib before surgery. Sequential therapy with PD-1 and apatinib when patients accepted surgery. |
|
| Adjuvant group | Experimental | Before surgery, patients no need to treat with PD-1 and apatinib. Sequential therapy with PD-1 and apatinib when patients accepted surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 | Biological | Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Zhong ping, PHD | Contact | 020-8734009 | chenzhp@sysucc.org.cn | |
| Ke Chao, PHD | Contact | kechao@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer center of Sun Yat sen University | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |