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

Early Phase 1

Active, not recruiting

• Conditions: Recurrent High Grade Glioma
• Interventions: Drug: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

• Registration Number: NCT05473923
• Lead Sponsor: Beijing Tiantan Hospital

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.

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 Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-26
• Study Start: 2022-08-12
• Primary Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.	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.

Primary Outcome Measures

Name	Time	Method
The percentage of patients who accomplish the recommended regimen for at least 1 course.	24 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China