Actively Recruiting
Clinical Study of Oncolytic Virus in Glioblastoma
Led by Mianyang Central Hospital · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial aims to evaluate whether an oncolytic viral agent can treat recurrent glioblastoma. It will also assess the safety and tolerability of the oncolytic viral agent. The primary question it seeks to answer is: What medical problems do participants experience when injected with the oncolytic viral agent? Researchers will administer the oncolytic viral agent via intratumoral injection to determine its efficacy in treating recurrent glioblastoma. Participant Procedures: Receive the initial injection, followed by additional injections every 2-4 weeks for a total of 6 injections. Undergo physical examinations and tests every 2 to 4 weeks. Record their symptoms, hematological test results, and imaging findings.
CONDITIONS
Official Title
Clinical Study of Oncolytic Virus in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with recurrent glioblastoma for whom standard treatments are considered ineffective
- Histologically confirmed recurrent glioblastoma
- MRI showing recurrent lesions larger than 1.0 cm in maximum diameter
- At least one prior therapy completed with specified timing: radiotherapy/surgery more than 28 days ago; stable or declining corticosteroid use for at least 7 days; recent antitumor therapy completed within specified timeframes
- Age between 18 and 70 years
- Normal hematological, kidney, and liver function
- Agreement to use acceptable contraception from consent until 180 days after treatment
- Ability to perform study procedures and provide written informed consent according to GCP and local laws
You will not qualify if you...
- Not meeting the inclusion criteria
- Participation in other drug trials within 4 weeks
- Preoperative bleeding risk or use of anticoagulants or medications increasing bleeding risk
- Presence of extracranial metastases
- Poorly controlled clinical diseases with liver enzyme or bilirubin levels above twice normal
- Pregnancy or lactation for female subjects
- Uncontrolled active infections or severe concomitant infectious diseases
- Immunodeficiency, autoimmune diseases, active HBV, HCV, or HIV infections
- History of psychotropic substance abuse or mental disorders
- Active or history of autoimmune disease
- Antiviral drug use within 1 week
- Receiving immunosuppressive therapy, chemotherapy, radiation, or biotherapy concurrently
- Presence of MRI-prohibited devices or metal implants
- History of substance abuse or relevant medical, psychological, or social conditions
- Allergy or intolerance to study oncolytic viruses or excipients
- Vaccination within 30 days before administration
- Prior gene transfer therapy or treatment with oncolytic viruses
- History of encephalitis, multiple sclerosis, CNS infections, or primary CNS disease
- Refusal to use contraception during and 6 months after dosing
- Serious concomitant disease that endangers safety or interferes with study completion as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
Actively Recruiting
Research Team
L
Liang xue Zhou
CONTACT
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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