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

Last updated: February 27, 2018
Sponsor: K2 Oncology, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergies & Asthma

Non-small Cell Lung Cancer

Allergy

Treatment

N/A

Clinical Study ID

NCT03453307
K2OLC-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withhistopathologic 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 uncontrolledinfection;

  • Life expectancy > 12 months.

  • Informed and signed consent by the patient.

Exclusion

Exclusion Criteria:

  • Not accessible to biopsy and/or surgery sample;

  • Patient already enrolled in another clinical trial with another first line ofchemotherapy;

  • 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 forchemotherapies or target therapies;

  • Have other malignant tumor previously;

  • Have surgical contraindications: anesthesia taboo; surgery unresectable extensivelesions;

  • State of health can't finish the study;

  • Patient already enrolled in another clinical trial with another anti-cancer therapy orplan to participate in other clinical study.

  • No self-determination or refuse to participant.

  • With unlisted exclusion criteria but are considered not suitable for the clinicalstudy by researchers.

Study Design

Total Participants: 100
Study Start date:
January 30, 2018
Estimated Completion Date:
July 30, 2021

Study 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.

Connect with a study center

  • People's Hospital of Hebei Province

    Shijiazhuang, Hebei 050051
    China

    Active - Recruiting

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