Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

February 20, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events (AEs)
Time Frame: 3 months after treatment
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate (LC)
Time Frame: 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.
from date of enrollment to date of first documented local progression. Assessed up to 6 months
Objective Response Rate (ORR)
Time Frame: 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.
from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months
Disease control rate (DCR)
Time Frame: 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.
from date of enrollment to the date of progress. Assessed up to 6 months
progression-free survival (PFS)
Time Frame: 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.
from date of enrollment to the date of first documented progression. Assessed up to 6 months
survival (OS) rate
Time Frame: from date of enrollment to the date of death from any cause. Assessed up to 6months
Probability of survival for 6 months after treatment
from date of enrollment to the date of death from any cause. Assessed up to 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 28, 2023

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Estimate)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0995

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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