Actively Recruiting
Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
Led by Beijing Neurosurgical Institute · Updated on 2024-10-31
30
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant glioma will : * Be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy. * Be followed for 1 year after the injection to complete imaging studies, neurological function tests, and report adverse events. Using the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 65 years, male or female
- Patients who voluntarily signed informed consent
- Patients with recurrent supratentorial high-grade glioma confirmed by pathology (glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendro-astrocytoma, or subtentorial astrocytoma)
- Patients with no tumor recurrence within two months after initial surgery and conventional radiotherapy or chemotherapy
- Patients with tumor recurrence at distant sites after surgery and radiotherapy or chemotherapy
- Tumor recurrence confirmed by PET/MRS with enhanced lesion diameter between 1 cm and 3 cm
- Karnofsky Performance Status (KPS) score of 70 or higher before treatment
- Normal bone marrow, liver, and kidney function meeting specified laboratory values
- Women of childbearing age must have a negative pregnancy test within 7 days before treatment and agree to use effective contraception during the study and for 3 months after
You will not qualify if you...
- Pregnant or lactating patients
- Patients with encephalitis, multiple sclerosis, or other central nervous system infections
- Patients with history of or awaiting organ transplantation
- Patients with uncontrolled infections or serious diseases such as HIV
- Patients with unstable systemic illnesses including active infection, uncontrolled hypertension, recent angina, heart failure, recent myocardial infarction, severe arrhythmia, liver or kidney failure
- Patients with systemic autoimmune or immunodeficiency diseases
- Patients with severe allergies
- Patients requiring long-term immune or glucocorticoid therapy
- Patients with mental disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
F
Fusheng Liu, MD,PhD
CONTACT
J
Junwen Zhang, PhD
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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