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

KY2022-069-02

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.

2022-08-12

2024-08-10

2024-12-31

Recruiting

Early phase I

30

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-02-15