Recurrent High Grade GliomaEarly Phase 1NCT05473923
PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas
A Early Phase 1 study testing Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. in people with Recurrent High Grade Glioma, run by Beijing Tiantan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent High Grade Glioma
- What is being tested?
- Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2022to 30 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent High Grade Glioma
- Being tested
- Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.
- Keywords
- precision medicine, organoid-based drug screening, bioinformatic prediction for drug response
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. | Experimental | 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. Receives: Drug: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who accomplish the recommended regimen for at least 1 course.
Measured: 24 months
Secondary outcomes (5)
Incidence of Treatment-Emergent Adverse Events (AEs)
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 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
Measured: 6 months
Ratio of 12months overall survival (OS)
Percentage of patients who survived more than 12 months from the date of surgery to death
Measured: 12 months
Progression-free survival (PFS)
Progression-free survival, time from the date of surgery to any types of progression
Measured: 24 months
Overall survival (OS)
Overall survival, time from the date of surgery to death for whatever reason
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start12 Aug 2022
- Primary completion31 Dec 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing GeneX Health Technology Co., Ltd
- Responsible party
- Principal investigator, Yang Zhang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473923
- Sponsor's protocol ID
- KY2022-069-02
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Precision Treatment Strategy Through PTCs (patient-derived Tumor-like Cell Clusters)-based Drug Screening for Recurrent High-grade Gliomas
- ClinicalTrials.gov ID
- NCT05473923
- Acronym / sponsor ID
- KY2022-069-02
- Conditions
- Recurrent High Grade Glioma
- Keywords
- precision medicine, organoid-based drug screening, bioinformatic prediction for drug response
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing GeneX Health Technology Co., Ltd
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. |
Primary outcome
The percentage of patients who accomplish the recommended regimen for at least 1 course.
Time frame: 24 months
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (AEs)
Time frame: From the first shot to 4 weeks after the last shot
Ratio of 6 months overall survival (OS)
Time frame: 6 months
Ratio of 12months overall survival (OS)
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. in people with Recurrent High Grade Glioma, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who accomplish the recommended regimen for at least 1 course. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.