This trial is an open-label, single-arm, phase 0/1 study of high-grade glioma that aims to evaluate the feasibility, preliminary efficacy and safety of the precision treatment strategy.
The investigators have established a precision treatment strategy, that select chemotherapeutic drugs or targeted drugs based on information from PTCs drug-screening or/and bioinformatic prediction. In this study, the investigators are going to exploit this strategy for the precision treatment of recurrent high-grade gliomas. The investigators will evaluate the feasibility, safety and preliminary efficacy via collecting the indexes comprising clinical presentation, results of imaging examination, clinical assays, KPS, neurological score, etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients will be treated with FDA-approved chemotherapeutic or targeted drugs which were recommended by the molecular tumor board (MTB), based on their expertise, patients willingness as well as evidences from PTCs-drug screening and bioinformatic prediction for drug response.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The percentage of patients who accomplish the recommended regimen for at least 1 course.
Time frame: 24 months
Incidence of Treatment-Emergent Adverse Events (AEs)
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From the first shot to 4 weeks after the last shot
Ratio of 6 months overall survival (OS)
Percentage of patients who survived more than 6 months from the date of surgery to death
Time frame: 6 months
Ratio of 12months overall survival (OS)
Percentage of patients who survived more than 12 months from the date of surgery to death
Time frame: 12 months
Progression-free survival (PFS)
Progression-free survival, time from the date of surgery to any types of progression
Time frame: 24 months
Overall survival (OS)
Overall survival, time from the date of surgery to death for whatever reason
Time frame: 24 months
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