Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05737368
Collaborator
(none)
11
1
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

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

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

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of adverse events (AEs) [3 months after treatment]

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Qichun Wei, MD/PhD, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05737368
Other Study ID Numbers:
  • 2022-0995
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023