Patient-derived Organoid Drug Sensitivity Guided Treatment for Recurrent Small Cell Lung Cancer

Launched by HENAN CANCER HOSPITAL · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat patients with recurrent small cell lung cancer, a type of lung cancer that comes back after treatment. The study aims to enroll 20 patients who are between 18 and 75 years old and have had at least one previous treatment for their cancer that did not work. Researchers will create small lab-grown versions of the patients' tumors, called organoids, to test how well different drugs work against them. This information will help doctors choose the best treatment for each patient based on their unique cancer.

To be eligible for the trial, patients must have a confirmed diagnosis of recurrent small cell lung cancer, show signs that their disease is getting worse, and be in relatively good health to tolerate the necessary tests and treatments. Participants can expect to undergo imaging tests and possibly bronchoscopy (a procedure to look inside the lungs) to collect tumor samples. By participating, they may contribute to developing personalized treatment options that could improve outcomes for others with similar conditions. It's also important for potential participants to know that those with certain serious health issues or other types of cancer may not qualify for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);
• • 2. Diagnosed as recurrent small cell lung cancer;
• • 3. After at least one systematic treatment and the disease progresses;
• • 4. According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least one lesion that has not received radiation therapy, has not received other local therapies, and can obtain tumor tissue (can be from a single lesion source or multiple lesions combined) is used for organoid establishment;
• • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
• • 6. Expected survival time≥3 months;
• • 7. Before a tumor sample can be taken, there must be a record of disease progression on imaging after the previous treatment.;
• • 8. The patient has informed consent and signed a written consent form;
• • 9. The patients had good compliance and willingly followed the study plan, including scheduled visits, treatments, laboratory tests, and other research steps.
• Exclusion Criteria:
• • 1. Extremely weakened overall condition, unable to tolerate bronchoscopy examination;
• • 2. Patients with acute suppurative inflammation of the respiratory tract accompanied by high fever, acute asthma attacks, and ongoing hemoptysis;
• • 3. Have a history of interstitial lung disease, non infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
• • 4. Patients with active leptomeningeal disease or brain metastasis;
• • 5. Diagnosed with other malignant diseases other than NSCLC within 5 years prior to initial administration (excluding curative basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curative resection of carcinoma in situ);
• • 6. Have a history of immunodeficiency, including positive HIV serum tests;
• • 7. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);
• • 8. The presence of any serious or uncontrollable systemic diseases;
• • 9. Pregnant or lactating female patients;
• • 10. The researchers believe that patients who are not suitable to participate in this study.