Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * The patient signed the informed consent voluntarily. * Age ≥18 years and ≤65 years, male or female. * After the initial surgery, the imaging showed that the tumor was completely removed, followed by conventional radiotherapy or (and) chemotherapy, and no recurrence was observed within two months after the end of radiotherapy. The patient had a recurrence of supratentorial high-grade glioma. The pathological diagnosis was glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendro-astrocytoma, or subtentorial astrocytoma recurrence. * After conventional surgery, radiotherapy (or) chemotherapy was performed, and there was no recurrence at the primary site of the tumor, but there was tumor recurrence at the distant site. * With PET/MRS, tumor recurrence was considered, and the enhanced lesion diameter was greater than 1cm, but less than 3cm. * KPS score ≥70 before treatment. * Normal bone marrow reserve function and normal liver and kid