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

Recurrent High Grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473923
• Other study ID #: KY2022-069-02
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 12, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Beijing Tiantan Hospital
• Contact: Yang T Zhang, M.D. & Ph.D.
• Phone: +861059976516
• Email: zhangyang8025[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Recurrence
• Recurrent High Grade Glioma

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing GeneX Health Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who accomplish the recommended regimen for at least 1 course.		24 months
Secondary	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
Secondary	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
Secondary	Ratio of 12months overall survival (OS)	Percentage of patients who survived more than 12 months from the date of surgery to death	12 months
Secondary	Progression-free survival (PFS)	Progression-free survival, time from the date of surgery to any types of progression	24 months
Secondary	Overall survival (OS)	Overall survival, time from the date of surgery to death for whatever reason	24 months