This is a single-center, single-arm, open and exploratory clinical study. The purpose of this study was to evaluate the consistency and accuracy of the organogenic (PDO) model for patients with lung cancer, to predict the clinical efficacy of anticancer drugs, and to speculate and select personalized treatment regiments for patients with lung cancer who are resistant to multi-line standard therapies.
As for the difficult problem of drug resistance in lung cancer after multi-line therapy, there is no standard consensus in clinical diagnosis and treatment, and relevant treatment plans are still being explored and the efficacy is unknown. Patient-derived organoid cells (PDOs) have become a reliable tumor model for drugs in vitro. PDOs is a personalized tumor model with similar characteristics to the original tumor. This model can maintain the molecular and cellular composition of the original tumor, reflect the heterogeneity of the original tumor, and realize in vitro high-throughput rapid screening of drug sensitivity, accurately predict the drug response of patients, so as to provide rapid clinical drug feedback. In recent years, lung cancer organoids have also been rapidly established to reproduce the tissue structure of primary lung tumors, screen the sensitivity of therapeutic drugs, formulate lung cancer treatment programs, and realize individualized tumor treatment of lung cancer. Patients were highly matched to their PDO responses, with 84.43% accuracy, 78.01% sensitivity and 91.97% specificity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Antitumor therapy guided by organoid will be given to Multi-line Drug-resistant Non-small Cell Lung Cancer patients.
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
RECRUITINGProgression-free survival
Time from randomization to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. Lesion will be assessed in comparison to baseline measurements.
Time frame: 1 year
Overall survival
Randomize time to date of death or last known alive date calculation.
Time frame: 72 weeks
Disease control rate
The proportion of patients with a best response grade of complete response, partial response, or stable disease that has shrunk or stabilized for a period of time.
Time frame: an average of 1 year
Changes in tumor volume shrinking
Change in tumor volume reduction from randomization to 6 months
Time frame: 6 months
Prediction of the response to treatment by the patient-derived organoids
The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment.
Time frame: 2 years
The rate of successful generation of lung cancer organoids
Successful generation of lung cancer organoids (growth of lung tumoral cells).
Time frame: 2 years
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