Clinical trial · Interventional
PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas
Study on Precision Treatment Strategy Through PTCs (patient-derived Tumor-like Cell Clusters)-based Drug Screening for Recurrent High-grade Gliomas
NCT05473923CI-TRIAL-00085800active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent High Grade Glioma | High-Grade Glioma, NOS | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.
- 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.
- interventionNames
- Drug: Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board.
Primary outcomes (1)
- measure
- The percentage of patients who accomplish the recommended regimen for at least 1 course.
- timeFrame
- 24 months
Secondary outcomes (5)
- measure
- Incidence of Treatment-Emergent Adverse Events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.