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
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.
• Male or female patients: ≥18 years old.
• For non-small cell lung cancer confirmed by histology or cytology, there is no standard protocol recommendation in the guidelines for disease progression after multiline standard therapy.
• Expected survival ≥3 months.
• Sign informed consent.
• The patient is willing and able to adhere to the protocol during the study, including receiving treatment and scheduled visits and examinations, including follow-up.
• Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour
• At least one previously unirradiated lesion that can be accurately measured at baseline with longest diameter ≥ 10 mm (must have a short lymph node excluding axis ≥ 15 mm) according to RECIST criteria with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination for accurate repeated measures. Or an unevaluable lesion, including but not limited to pleural and ascites, bone metastasis, etc.