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

Capital Medical University

Status and phase: Enrolling; Early Phase 1

Conditions: Recurrent High Grade Glioma

Treatments: Drug: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

Study type: Interventional

Funder types: Other

Identifiers

NCT05473923

KY2022-069-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

Experimental group

Description:

These drugs included all the FDA-approved drugs that have been used in treating gliomas. A single drug or a drug combination for a specific patient will be recommended by the molecular tumor board, comprising neurooncologists, neurosurgeons, pharmacologists, cancer biologists, radiologists and bioinformaticians, will recommend , based on their expertise, patients willingness as well as evidences from PTCs-drug screening and bioinformatic prediction for drug response.

Treatment:

Drug: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.