Recurrent Glioblastoma
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.
Interventions
RADIATIONfractionated radiotherapy
fractionated radiotherapy (500cGy \*5F, 600cGy\*5F, 350cGy\*10F, according to the tumor volume)
DRUGcadonilimab
Cardunizumab (10mg/kg, Q3W, d1)
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. . Written and signed informed consent. 2. . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent. 3. Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence. 4. The maximum diameter of recurrent tumor is less than 6 cm. 5. Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past. 6. The interval from the last radiotherapy is more than 6 months. 7. KPS (Karnofsky function status score)\>60.
Exclusion criteria
1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment. 2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies. 3. Multiple malignant gliomas. 4. Subtentorial glioblastoma or Extracranial metastatic lesions. 5. Active autoimmune diseases. 6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) | 3 months after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control rate (LC) | from date of enrollment to date of first documented local progression. Assessed up to 6 months | The proportion of patients without tumor progression on imaging of brain glioma lesions was evaluated by RANO standard. |
| Objective Response Rate (ORR) | from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months | 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. |
| Disease control rate (DCR) | from date of enrollment to the date of progress. Assessed up to 6 months | The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1. |
| progression-free survival (PFS) | from date of enrollment to the date of first documented progression. Assessed up to 6 months | the probability of 6-month disease progression-free survival was evaluated by RANO standard after treatment. |
| survival (OS) rate | from date of enrollment to the date of death from any cause. Assessed up to 6months | Probability of survival for 6 months after treatment |
Contacts
Primary ContactWei Yu, MD
Outcome results
None listed