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

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    100
  • sponsor
    K2 Oncology, Inc.
Updated on 22 January 2021
metastasis
cancer chemotherapy

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.

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.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Clinical Study IdentifierNCT03453307
SponsorK2 Oncology, Inc.
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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