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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-30

Study Completion Date

2021-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group-1

NSCLC patients receiving chemotherapy or target therapy treatment.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No