Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.
Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.: 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)
The percentage of patients who accomplish the recommended regimen for at least 1 course. — 24 months
Trial sites (1)
Facility
City
Region
Status
Beijing Tiantan Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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