PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas

Last updated: February 9, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neurofibromatosis

Brain Cancer

Brain Tumor

Treatment

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

Clinical Study ID

NCT05473923
KY2022-069-02
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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 histologicpathology

  • 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 histologicpathology

  • 6 None postoperative standard therapeutic regimens can be followed whenparticipating the recruitment

  • 7 Can understand the trial's content and sign informed consent

Exclusion

Exclusion Criteria:

  • 1 Having other untreated malignant tumors

  • 2 The amount of resected tumors is not enough for genomic sequencing or PTCs drugscreening

  • 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 increaseadverse events or interfere the evaluation of outcomes

  • 7 Subjects with other conditions in their active phase that would interfere trialparticipation

  • 8 Subjects receiving immunosuppressants after organ transplantation

  • 9 Subjects with unstable pulmonary embolism, deep venous embolism, or other majorarterial and venous thromboembolic events that occur within 30 days before theenrollment, or receiving anticoagulant therapy

  • 10 Subjects in pregnancy or breastfeeding, or those who plan to become pregnantduring treatment or within 2 months after the end of treatment

  • 11 Subjects with other conditions that would interfere participating in the trial atthe investigator's discretion

  • 12 Subjects with medical conditions that affect signing the written informed consentor complying with the research procedures; or patients who are unwilling or unableto comply with the research procedures

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.
Phase: 1
Study Start date:
August 12, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100070
    China

    Site Not Available

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