Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

Study Purpose

The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05737368
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Qichun Wei, MD/PhD
Principal Investigator Affiliation	Zhejiang University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma

Arms & Interventions

Arms

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)

Interventions

Radiation: - fractionated radiotherapy

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

Drug: - cadonilimab

Cardunizumab (10mg/kg, Q3W, d1)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Wei Yu, MD

11418282@zju.edu.cn

+8657187783521

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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