Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients
Drug Sensitivity Correlation Between Patient-Derived Organoid Model 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.
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.
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.