To hear about similar clinical trials, please enter your email below
Trial Title:
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
NCT ID:
NCT05737368
Condition:
Recurrent Glioblastoma
Conditions: Official terms:
Glioblastoma
Recurrence
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
fractionated radiotherapy
Description:
fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor
volume)
Arm group label:
Patients will receive the treatment of fractionated radiotherapy and Cadonilimab
Intervention type:
Drug
Intervention name:
cadonilimab
Description:
Cardunizumab (10mg/kg, Q3W, d1)
Arm group label:
Patients will receive the treatment of fractionated radiotherapy and Cadonilimab
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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
February 28, 2023
Completion date:
February 28, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737368
