Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT05473923
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.
This study is active but is not currently recruiting participants.
18 year–75 year
All sexes
Interventional
Early Phase 1
Beijing, Beijing Municipality, 100070, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 months
Time frame: From the first shot to 4 weeks after the last shot
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 6 months
Percentage of patients who survived more than 6 months from the date of surgery to death
Time frame: 12 months
Percentage of patients who survived more than 12 months from the date of surgery to death
Time frame: 24 months
Progression-free survival, time from the date of surgery to any types of progression
Time frame: 24 months
Overall survival, time from the date of surgery to death for whatever reason
Beijing Tiantan Hospital
Other
Study on Precision Treatment Strategy Through PTCs (patient-derived Tumor-like Cell Clusters)-based Drug Screening for Recurrent High-grade Gliomas
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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