A Clinical Study of the Safety and Efficacy of Third-generation Oncolytic TS-2021 in the Treatment of Recurrent Malignant Gliomas

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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 kidney function: Neutrophil absolute value ≥ 1,500/mm3, hemoglobin ≥10 g/dL, platelet count ≥100,000/mm3, total bilirubin level ≤1.5×ULN, glutamic pyruvic transaminase/glutamic oxalacetic transaminase ≤ 2.5× ULN, serum creatinine ≤1.5×ULN, The heart function was normal and the follow-up compliance was good.

• Women of childbearing age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Fusheng Liu, MD,PhD
liufushengs@hotmail.com
861059975630
Backup
Junwen Zhang, PhD
jewzhang@hotmail.com
861059975630
Time Frame
Start Date: 2024-08-29
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 30
Treatments
Experimental: TS-2021
30 eligible participants with recurrent malignant glioma will be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.
Sponsors
Leads: Beijing Neurosurgical Institute

This content was sourced from clinicaltrials.gov

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