Clinical trial NCT05473923: PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas
Official title: Study on Precision Treatment Strategy Through PTCs (patient-derived Tumor-like Cell Clusters)-based Drug Screening for Recurrent High-grade Gliomas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Recurrent High Grade Glioma
Keywords: precision medicine
organoid-based drug screening
bioinformatic prediction for drug response
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing GeneX Health Technology Co., Ltd
First posted: 2022-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1 At the age of 18\~75, regardless the gender
* 2 The lesion of primary surgery was diagnosed as WHO II\~IV Glioma by histologic pathology
* 3 Received radiotherapy and Temozolomide-based chemotherapy within 5 years
* 4 Recurrent and respectable gliomas, and have been neurosurgically resected
* 5 The resected recurrent gliomas was identified as WHO III\~IV Glioma by histologic pathology
* 6 None postoperative standard therapeutic regimens can be followed when participating the recruitment
* 7 Can understand the trial's content and sign informed consent

Exclusion Criteria:

* 1 Having other untreated malignant tumors
* 2 The amount of resected tumors is not enough for genomic sequencing or PTCs drug screening
* 3 Received Carmustine implants within 6 months prior to enrollment
* 4 Subjects with active HBC, HCV or HIV infection
* 5 Subjects with uncontrolled cardio- or cerebro- vascular diseases
* 6 Subjects with uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes
* 7 Subjects with other conditions in their active phase that would interfere trial participation
* 8 Subjects receiving immunosuppressants after organ transplantation
* 9 Subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment, or receiving anticoagulant therapy
* 10 Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment
* 11 Subjects with other conditions that would interfere participating in the trial at the investigator's discretion
* 12 Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures

Primary outcomes:
measure: The percentage of patients who accomplish the recommended regimen for at least 1 course.
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (AEs)
timeFrame: From the first shot to 4 weeks after the last shot
measure: Ratio of 6 months overall survival (OS)
timeFrame: 6 months
measure: Ratio of 12months overall survival (OS)
timeFrame: 12 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: