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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05473923
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Beijing Tiantan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent High Grade Glioma
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing, 100070

Site Contact

Yang Zhang, Dr.

[email protected]

+861059976516

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