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

This study plans to enroll 20 patients with recurrent small cell lung cancer. Patient-derived Organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

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.

• BACKGROUNDCarney DN. Lung cancer--time to move on from chemotherapy. N Engl J Med. 2002 Jan 10;346(2):126-8. doi: 10.1056/NEJM200201103460211. No abstract available. PMID 11784881
• BACKGROUNDBogart JA, Waqar SN, Mix MD. Radiation and Systemic Therapy for Limited-Stage Small-Cell Lung Cancer. J Clin Oncol. 2022 Feb 20;40(6):661-670. doi: 10.1200/JCO.21.01639. Epub 2022 Jan 5. PMID 34985935
• BACKGROUNDYang JJ, Yu D, White E, Lee DH, Blot W, Robien K, Sinha R, Park Y, Takata Y, Gao YT, Smith-Byrne K, Monninkhof EM, Kaaks R, Langhammer A, Borch KB, Al-Shaar L, Lan Q, Sorgjerd EP, Zhang X, Zhu C, Chirlaque MD, Severi G, Overvad K, Sacerdote C, Aune D, Johansson M, Smith-Warner SA, Zheng W, Shu XO. Prediagnosis Leisure-Time Physical Activity and Lung Cancer Survival: A Pooled Analysis of 11 Cohorts. JNCI Cancer Spectr. 2022 Mar 2;6(2):pkac009. doi: 10.1093/jncics/pkac009. PMID 35603841
• BACKGROUNDIams WT, Porter J, Horn L. Immunotherapeutic approaches for small-cell lung cancer. Nat Rev Clin Oncol. 2020 May;17(5):300-312. doi: 10.1038/s41571-019-0316-z. Epub 2020 Feb 13. PMID 32055013
• BACKGROUNDZugazagoitia J, Paz-Ares L. Extensive-Stage Small-Cell Lung Cancer: First-Line and Second-Line Treatment Options. J Clin Oncol. 2022 Feb 20;40(6):671-680. doi: 10.1200/JCO.21.01881. Epub 2022 Jan 5. PMID 34985925
• BACKGROUNDMuto S, Inomata S, Yamaguchi H, Mine H, Takagi H, Watanabe M, Ozaki Y, Inoue T, Yamaura T, Fukuhara M, Okabe N, Matsumura Y, Hasegawa T, Osugi J, Hoshino M, Higuchi M, Shio Y, Suzuki H. [Resistance Mechanisms to Immune Checkpoint Inhibitor and Its Overcome with Focus on beta-Catenin in Lung Cancer]. Gan To Kagaku Ryoho. 2022 Sep;49(9):928-931. Japanese. PMID 36156007
• BACKGROUNDSeidlitz T, Merker SR, Rothe A, Zakrzewski F, von Neubeck C, Grutzmann K, Sommer U, Schweitzer C, Scholch S, Uhlemann H, Gaebler AM, Werner K, Krause M, Baretton GB, Welsch T, Koo BK, Aust DE, Klink B, Weitz J, Stange DE. Human gastric cancer modelling using organoids. Gut. 2019 Feb;68(2):207-217. doi: 10.1136/gutjnl-2017-314549. Epub 2018 Apr 27.