NSCLC Clinical Trial
Official title:
The Correlation Study of the Drug Sensitivity Between Ex Vivo Model of Non-Small Cell Lung Cancer (NSCLC) Patient-Derived Organoids and Clinical Response in NSCLC Patients
This clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 30, 2021 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Aged 18 years old or more; - Late stage NSCLC patients, with tumor invasion confirmed by histopathology analysis. Metastasis of axillary lymph nodes and other region lymph nodes are confirmed with histopathologic or cytopathologic analysis; - Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumor; - No clinical evidence of other malignancy, unstable complication or uncontrolled infection; - Life expectancy > 12 months. - Informed and signed consent by the patient. Exclusion Criteria: - Not accessible to biopsy and/or surgery sample; - Patient already enrolled in another clinical trial with another first line of chemotherapy; - Unmeasurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria; - Women who are pregnant, plan to become pregnant or are lactating during the study; - Elevation of carcinoembryonic antigen (CEA) observed without distal metastases found; - Have some kind of contraindications for chemotherapy and targeted therapy: cardiovascular and cerebrovascular diseases; liver and kidney function deficiency; hematological system diseases; clinician consider the patients are not suitable for chemotherapies or target therapies; - Have other malignant tumor previously; - Have surgical contraindications: anesthesia taboo; surgery unresectable extensive lesions; - State of health can't finish the study; - Patient already enrolled in another clinical trial with another anti-cancer therapy or plan to participate in other clinical study. - No self-determination or refuse to participant. - With unlisted exclusion criteria but are considered not suitable for the clinical study by researchers. |
Country | Name | City | State |
---|---|---|---|
China | People's Hospital of Hebei Province | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
K2 Oncology, Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of ex vivo sensitivity test on patient derived organoid models | The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment. | 12 months |
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