Status:
UNKNOWN
Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients
Lead Sponsor:
K2 Oncology, Inc.
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03453307
Start Date
January 30 2018
End Date
July 30 2021
Last Update
March 5 2018
Active Locations (1)
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1
People's Hospital of Hebei Province
Shijiazhuang, Hebei, China, 050051