Actively Recruiting
Clinical Study on the Application of Oncolytic Virus in Recurrent Glioblastoma
Led by Mianyang Central Hospital · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an oncolytic viral agent for treating recurrent glioblastoma, a type of brain cancer. This clinical trial aims to assess the safety, tolerability, and medical effects experienced by participants injected with the oncolytic virus. The study focuses on understanding the medical problems that may occur after administration of this investigational treatment. Participants will receive the oncolytic virus via intratumoral injection initially, followed by additional injections every 2 to 4 weeks, totaling 6 injections. During the study, physical examinations and various tests will be conducted every 2 to 4 weeks to monitor symptoms, blood test results, and imaging findings. The primary outcome measured is the maximum tolerated dose at 4 hours, 2 days, 7 days, and 14 days after administration. Throughout the trial, participants will undergo regular assessments including physical exams, hematological tests, and imaging scans to track their health and response to the treatment. Researchers will closely monitor safety and tolerability, recording symptoms and laboratory results. The total participation period includes the injection phase and follow-up assessments to evaluate treatment effects and side effects up to the study end date in 2026.
CONDITIONS
Brief Title
Clinical Study of Oncolytic Virus in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with recurrent glioblastoma considered ineffective for standard treatment by medical commission
- Histologically confirmed recurrent glioblastoma
- MRI showing recurrent lesion larger than 1.0 cm in maximum diameter
- Prior therapy including radiotherapy or surgery completed more than 28 days ago
- Stable or declining corticosteroid regimen for at least 7 days before study
- Most recent antitumor therapy completed within specified timeframes (vincristine 2 weeks, nitrosoureas 4 weeks, bevacizumab 4 weeks, temozolomide 6 weeks)
- Age between 18 and 70 years
- Normal blood counts, kidney and liver function
- Agreement to use acceptable contraception during study and for 180 days after treatment
- Ability to perform study procedures and provide informed consent according to regulations
You will not qualify if you...
- Not meeting inclusion criteria
- Participation in other drug trials within 4 weeks
- Bleeding risk or use of anticoagulants
- Presence of extracranial metastases
- Poorly controlled liver disease or bilirubin over twice normal limit
- Pregnancy or lactation in females
- Uncontrolled infection or severe concomitant disease
- Immunodeficiency, autoimmune diseases, or active viral infections (HBV, HCV, HIV)
- History of psychotropic substance abuse or mental disorders
- Active or history of autoimmune disease
- Use of antiviral drugs within 1 week
- Receiving immunosuppressive therapy, chemotherapy, radiation, or biotherapy
- MRI contraindications such as pacemakers or metal implants
- Substance abuse or psychological/social conditions affecting participation
- Allergy or intolerance to oncolytic virus or its components
- Vaccination within 30 days before administration
- Previous gene transfer or oncolytic virus therapy
- History of encephalitis, multiple sclerosis, CNS infections, or primary CNS diseases
- Refusal of contraception during study and six months after dosing
- Serious concurrent disease endangering safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 14 days after administration
Participants receive intratumoral injection of the oncolytic virus.
Visits approximately at 4 hours, 2 days, 7 days, and 14 days after administration
Trial Site Locations
Total: 1 location
1
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
Actively Recruiting
Research Team
L
Liang xue Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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