Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

NCT ID: NCT05737368

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-02-28

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.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients will receive the treatment of fractionated radiotherapy and Cadonilimab

fractionated radiotherapy (500cGy \*5F, 600cGy\*5F, 350cGy\*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1)

Group Type: EXPERIMENTAL

fractionated radiotherapy

Intervention Type: RADIATION

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

cadonilimab

Intervention Type: DRUG

Cardunizumab (10mg/kg, Q3W, d1)

Interventions

fractionated radiotherapy

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

Intervention Type: RADIATION

cadonilimab

Cardunizumab (10mg/kg, Q3W, d1)

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qichun Wei, MD/PhD

Role: STUDY_DIRECTOR

Zhejiang University

Central Contacts

Wei Yu, MD

Role: CONTACT

11418282@zju.edu.cn

+8657187783521

Other Identifiers

2022-0995

Identifier Type: -

Identifier Source: org_study_id