Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Conditions
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Recurrent Glioblastoma

Intervention / Treatment
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* Radiation: fractionated radiotherapy
* Drug: cadonilimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . Written and signed informed consent. . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent. Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence. The maximum diameter of recurrent tumor is less than 6 cm. Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past. The interval from the last radiotherapy is more than 6 months. KPS (Karnofsky function status score)>60. Exclusion Criteria: Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies. Multiple malignant gliomas. Subtentorial glioblastoma or Extracranial metastatic lesions. Active autoimmune diseases. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients will receive the treatment of fractionated radiotherapy and Cadonilimab<br>fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1) | Radiation: fractionated radiotherapy<br>* fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume)<br>Drug: cadonilimab<br>* Cardunizumab (10mg/kg, Q3W, d1)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events (AEs) |  | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |