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

Primary Purpose

Recurrent High Grade Glioma

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

About this trial

This is an interventional treatment trial for Recurrent High Grade Glioma focused on measuring precision medicine, organoid-based drug screening, bioinformatic prediction for drug response

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (AEs)

AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Ratio of 6 months overall survival (OS)

Percentage of patients who survived more than 6 months from the date of surgery to death

Ratio of 12months overall survival (OS)

Percentage of patients who survived more than 12 months from the date of surgery to death

Progression-free survival (PFS)

Progression-free survival, time from the date of surgery to any types of progression

Overall survival (OS)

Overall survival, time from the date of surgery to death for whatever reason

Full Information

NCT ID

NCT05473923

First Posted

July 19, 2022

Last Updated

February 13, 2023

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing GeneX Health Technology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05473923

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 12, 2022 (Actual)

Primary Completion Date

August 10, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing GeneX Health Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent High Grade Glioma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events (AEs)

Description

AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame

From the first shot to 4 weeks after the last shot

Title

Ratio of 6 months overall survival (OS)

Description

Percentage of patients who survived more than 6 months from the date of surgery to death

Time Frame

6 months

Title

Ratio of 12months overall survival (OS)

Description

Percentage of patients who survived more than 12 months from the date of surgery to death

Time Frame

12 months

Title

Progression-free survival (PFS)

Description

Progression-free survival, time from the date of surgery to any types of progression

Time Frame

24 months

Title

Overall survival (OS)

Description

Overall survival, time from the date of surgery to death for whatever reason

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yang T Zhang, M.D. & Ph.D.

Phone

+861059976516

zhangyang8025@yeah.net

Facility Information:

Facility Name

Beijing Tiantan Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100070

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yang Zhang, Dr.

Phone

+861059976516

zhangyang8025@163.com

12. IPD Sharing Statement

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

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