Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Recurrent Glioblastoma Clinical Trial

Official title:

Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05737368
• Other study ID #: 2022-0995
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 28, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wei Yu, MD
• Phone: +8657187783521
• Email: 11418282[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 11
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glioblastoma
• Recurrence
• Recurrent Glioblastoma

Intervention

Radiation:
• fractionated radiotherapy
fractionated radiotherapy (500cGy *5F, 600cGy*5F, 350cGy*10F, according to the tumor volume)

Drug:
• cadonilimab
Cardunizumab (10mg/kg, Q3W, d1)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AEs)		3 months after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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