NCT05669586

Organoids Predict Therapeutic Response in Patients With Multi-line Drug-resistant Lung Cancer

A Single-arm, Single-center Clinical Trial of Patient-derived Lung Cancer Organoids for Predicting Therapeutic Response in Patients With Multiline Drug-resistant Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Affiliated Hospital of Jiangnan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer
• Organoid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-05-31
• Completion: 2026-05-31
• First posted: 2023-01-03
• Last updated: 2024-03-19

Locations

1 site across 1 country: China