Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Phase 1

Not yet recruiting

• Conditions: Recurrent Glioblastoma
• Interventions: Radiation: fractionated radiotherapy; Drug: cadonilimab

• Registration Number: NCT05737368
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Study Start: 2023-02-28
• Primary Completion: 2024-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 11

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients will receive the treatment of fractionated radiotherapy and Cadonilimab	fractionated radiotherapy	fractionated radiotherapy (500cGy \*5F, 600cGy\*5F, 350cGy\*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1)
Patients will receive the treatment of fractionated radiotherapy and Cadonilimab	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)

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	3 months after treatment

Secondary Outcome Measures

Name	Time	Method
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