Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

NCT05737368 | Unknown Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 2022-0995
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  3 months after treatment

Secondary Outcomes (5)

• Local control rate (LC)

  from date of enrollment to date of first documented local progression. Assessed up to 6 months

• Objective Response Rate (ORR)

  from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months

• Disease control rate (DCR)

  from date of enrollment to the date of progress. Assessed up to 6 months

• progression-free survival (PFS)

  from date of enrollment to the date of first documented progression. Assessed up to 6 months

• survival (OS) rate

  from date of enrollment to the date of death from any cause. Assessed up to 6months

Study Arms (1)

Patients will receive the treatment of fractionated radiotherapy and Cadonilimab

EXPERIMENTAL

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; Drug: cadonilimab

Interventions

fractionated radiotherapy RADIATION

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

Patients will receive the treatment of fractionated radiotherapy and Cadonilimab

cadonilimab DRUG

Cardunizumab (10mg/kg, Q3W, d1)

Patients will receive the treatment of fractionated radiotherapy and Cadonilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and signed informed consent.
• Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent.
• Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence.
• The maximum diameter of recurrent tumor is less than 6 cm.
• Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past.
• The interval from the last radiotherapy is more than 6 months.
• KPS (Karnofsky function status score)\>60.

You may not qualify if:

• Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
• Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
• Multiple malignant gliomas.
• Subtentorial glioblastoma or Extracranial metastatic lesions.
• Active autoimmune diseases.
• Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Qichun Wei, MD/PhD

  Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Wei Yu, MD

CONTACT

+8657187783521; 11418282@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: February 28, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2025
• Last Updated: February 21, 2023

Record last verified: 2023-02