NSCLC
Conditions
Keywords
Tumor Organoids, Drug Sensitivity, NSCLC
Brief summary
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.
Detailed description
Methods - Open label single arm observatory comparison experiment 1. Enrolled patients (before or after surgery) were treated with chemotherapy or target therapy. The medication regime and treatment cycle were decided based on the clinical guideline and evidence-based medicine. This clinical study will not affect the treatment plan of the patients. 2. The resection tissue or biopsy tissue of NSCLC will be collected, and subject to ex vivo 3-D culture to establish patient-derived tumor organoid models, which will be used for drug sensitivity test. 3. The patient-derived organoid-based drug sensitivity test will be compared with clinical treatment data of chemotherapy or target therapy, followed by correlation analysis.
Interventions
None listed
Sponsors
K2 Oncology, Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of ex vivo sensitivity test on patient derived organoid models | 12 months | The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment. |
Countries
China
Contacts
Primary ContactZhijian Sun, Dr.
Backup ContactChenggang Zhu, Dr.
Outcome results
None listed