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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05669586
Other study ID # 136286
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 1, 2023
Est. completion date May 31, 2026

Study information

Verified date March 2024
Source Affiliated Hospital of Jiangnan University
Contact quan liu, doctor
Phone 15995299079
Email quanliu@jiangnan.edu.cn; quanliu.lq@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antitumor therapy guided by organoid drug sensitivity test
Antitumor therapy guided by organoid will be given to Multi-line Drug-resistant Non-small Cell Lung Cancer patients.

Locations

Country Name City State
China Affiliated Hospital of Jiangnan University Wuxi Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-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. 1 year
Secondary Overall survival Randomize time to date of death or last known alive date calculation. 72 weeks
Secondary 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. an average of 1 year
Secondary Changes in tumor volume shrinking Change in tumor volume reduction from randomization to 6 months 6 months
Secondary 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. 2 years
Secondary The rate of successful generation of lung cancer organoids Successful generation of lung cancer organoids (growth of lung tumoral cells). 2 years
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