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The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients will receive the treatment of fractionated radiotherapy and Cadonilimab | Experimental | fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractionated radiotherapy | Radiation | fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate (LC) | The proportion of patients without tumor progression on imaging of brain glioma lesions was evaluated by RANO standard. | from date of enrollment to date of first documented local progression. Assessed up to 6 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Yu, MD | Contact | +8657187783521 | 11418282@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qichun Wei, MD/PhD | Zhejiang University | Study Director |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| cadonilimab | Drug | Cardunizumab (10mg/kg, Q3W, d1) |
|
The ORR is defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1. |
| from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months |
| Disease control rate (DCR) | The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1. | from date of enrollment to the date of progress. Assessed up to 6 months |
| progression-free survival (PFS) | the probability of 6-month disease progression-free survival was evaluated by RANO standard after treatment. | from date of enrollment to the date of first documented progression. Assessed up to 6 months |
| survival (OS) rate | Probability of survival for 6 months after treatment | from date of enrollment to the date of death from any cause. Assessed up to 6months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |