Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Neurosurgical Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant or lactating patients.
Patients with encephalitis disease, multiple sclerosis, or other CNS (Central Nervous System) infection.
Patients with a history of organ transplantation or waiting for organ transplantation.
Patients with uncontrolled infectious diseases or other serious diseases, such as HIV positive.
Trial design
Design model
Single group
Treatments tested in this trial
TS-2021
Biological/VaccineThe participants meeting the criteria will undergo TS-2021 oncolytic virus (5×1011PFU/ml) intratumoral injection using stereotactic technique under MR Localization.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TS-2021Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events.
All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to TS-2021.
Time frame
Up to 8 weeks2
Overall survival
The overall survival for each patient receiving TS-2021 will be calculated.
Time frame
Up to 12 monthsSecondary outcomes
1
Objective response rate (ORR) determined by MRI scan review.
Interval tumor size change will be measured.
Time frame
Up to 12 months2
Progression Free Survival.
Time after TS-2021 administration to clinical and radiographic disease progression
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov