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

Study on Precision Treatment Strategy Through PTCs (patient-derived Tumor-like Cell Clusters)-based Drug Screening for Recurrent High-grade Gliomas

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent High Grade Glioma
• Intervention / Treatment: Drug: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of patients who accomplish the recommended regimen for at least 1 course.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (AEs)	AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	From the first shot to 4 weeks after the last shot
Ratio of 6 months overall survival (OS)	Percentage of patients who survived more than 6 months from the date of surgery to death	6 months
Ratio of 12months overall survival (OS)	Percentage of patients who survived more than 12 months from the date of surgery to death	12 months
Progression-free survival (PFS)	Progression-free survival, time from the date of surgery to any types of progression	24 months
Overall survival (OS)	Overall survival, time from the date of surgery to death for whatever reason	24 months

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing GeneX Health Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: precision medicine; organoid-based drug screening; bioinformatic prediction for drug response
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Recurrence; Glioma
• Other Study ID Numbers: KY2022-069-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No