Back to resultsTreatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
Primary Purpose
Recurrent Glioblastoma
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
fractionated radiotherapy
cadonilimab
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Glioblastoma
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients will receive the treatment of fractionated radiotherapy and Cadonilimab
Arm Description
fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1)
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events (AEs)
Secondary Outcome Measures
Local control rate (LC)
The proportion of patients without tumor progression on imaging of brain glioma lesions was evaluated by RANO standard.
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.
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.
progression-free survival (PFS)
the probability of 6-month disease progression-free survival was evaluated by RANO standard after treatment.
survival (OS) rate
Probability of survival for 6 months after treatment
Full Information
NCT ID
NCT05737368
First Posted
February 10, 2023
Last Updated
February 20, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05737368
Brief Title
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
Official Title
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 28, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients will receive the treatment of fractionated radiotherapy and Cadonilimab
Arm Type
Experimental
Arm Description
fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1)
Intervention Type
Radiation
Intervention Name(s)
fractionated radiotherapy
Intervention Description
fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume)
Intervention Type
Drug
Intervention Name(s)
cadonilimab
Intervention Description
Cardunizumab (10mg/kg, Q3W, d1)
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events (AEs)
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Local control rate (LC)
Description
The proportion of patients without tumor progression on imaging of brain glioma lesions was evaluated by RANO standard.
Time Frame
from date of enrollment to date of first documented local progression. Assessed up to 6 months
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months
Title
Disease control rate (DCR)
Description
The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.
Time Frame
from date of enrollment to the date of progress. Assessed up to 6 months
Title
progression-free survival (PFS)
Description
the probability of 6-month disease progression-free survival was evaluated by RANO standard after treatment.
Time Frame
from date of enrollment to the date of first documented progression. Assessed up to 6 months
Title
survival (OS) rate
Description
Probability of survival for 6 months after treatment
Time Frame
from date of enrollment to the date of death from any cause. Assessed up to 6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Yu, MD
Phone
+8657187783521
Email
11418282@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qichun Wei, MD/PhD
Organizational Affiliation
Zhejiang University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
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