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

NCT05473923 | Active Not Recruiting Early Phase 1

• 1 other identifier: KY2022-069-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent High Grade Glioma

Keywords

precision medicine; organoid-based drug screening; bioinformatic prediction for drug response

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who accomplish the recommended regimen for at least 1 course.

  24 months

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events (AEs)

  From the first shot to 4 weeks after the last shot

• Ratio of 6 months overall survival (OS)

  6 months

• Ratio of 12months overall survival (OS)

  12 months

• Progression-free survival (PFS)

  24 months

• Overall survival (OS)

  24 months

Study Arms (1)

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

EXPERIMENTAL

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.

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

Interventions

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. DRUG

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.

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Having other untreated malignant tumors
• The amount of resected tumors is not enough for genomic sequencing or PTCs drug screening
• Received Carmustine implants within 6 months prior to enrollment
• Subjects with active HBC, HCV or HIV infection
• Subjects with uncontrolled cardio- or cerebro- vascular diseases
• Subjects with uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes
• Subjects with other conditions in their active phase that would interfere trial participation
• Subjects receiving immunosuppressants after organ transplantation
• 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
• Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment
• Subjects with other conditions that would interfere participating in the trial at the investigator's discretion
• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing GeneX Health Technology Co., Ltd: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. & M.D.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: August 12, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

CN (1)