Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
Study NCT ID:
NCT06406660
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient-derived Organoid Drug Sensitivity Guided Treatment for Recurrent Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '1-2 years', 'description': "Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1."}], 'secondaryOutcomes': [{'measure': 'Progressive free survival', 'timeFrame': '1-2 years', 'description': 'The time from initiation of treatment to the occurrence of disease progression or death.'}, {'measure': 'Overall survival time', 'timeFrame': '2 years', 'description': 'The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '11784881', 'type': 'BACKGROUND', 'citation': 'Carney 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': '34985935', 'type': 'BACKGROUND', 'citation': 'Bogart 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': '35603841', 'type': 'BACKGROUND', 'citation': 'Yang 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': '32055013', 'type': 'BACKGROUND', 'citation': 'Iams 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': '34985925', 'type': 'BACKGROUND', 'citation': 'Zugazagoitia 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': '36156007', 'type': 'BACKGROUND', 'citation': 'Muto 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': '29703791', 'type': 'BACKGROUND', 'citation': 'Seidlitz 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.'}, {'pmid': '30171177', 'type': 'BACKGROUND', 'citation': 'Romero-Calvo I, Weber CR, Ray M, Brown M, Kirby K, Nandi RK, Long TM, Sparrow SM, Ugolkov A, Qiang W, Zhang Y, Brunetti T, Kindler H, Segal JP, Rzhetsky A, Mazar AP, Buschmann MM, Weichselbaum R, Roggin K, White KP. Human Organoids Share Structural and Genetic Features with Primary Pancreatic Adenocarcinoma Tumors. Mol Cancer Res. 2019 Jan;17(1):70-83. doi: 10.1158/1541-7786.MCR-18-0531. Epub 2018 Aug 31.'}, {'pmid': '30726695', 'type': 'BACKGROUND', 'citation': 'Li M, Izpisua Belmonte JC. Organoids - Preclinical Models of Human Disease. N Engl J Med. 2019 Feb 7;380(6):569-579. doi: 10.1056/NEJMra1806175. No abstract available.'}, {'pmid': '34083237', 'type': 'BACKGROUND', 'citation': 'Kim SY, Kim SM, Lim S, Lee JY, Choi SJ, Yang SD, Yun MR, Kim CG, Gu SR, Park C, Park AY, Lim SM, Heo SG, Kim H, Cho BC. Modeling Clinical Responses to Targeted Therapies by Patient-Derived Organoids of Advanced Lung Adenocarcinoma. Clin Cancer Res. 2021 Aug 1;27(15):4397-4409. doi: 10.1158/1078-0432.CCR-20-5026. Epub 2021 Jun 3.'}, {'pmid': '36657446', 'type': 'BACKGROUND', 'citation': 'Wang HM, Zhang CY, Peng KC, Chen ZX, Su JW, Li YF, Li WF, Gao QY, Zhang SL, Chen YQ, Zhou Q, Xu C, Xu CR, Wang Z, Su J, Yan HH, Zhang XC, Chen HJ, Wu YL, Yang JJ. Using patient-derived organoids to predict locally advanced or metastatic lung cancer tumor response: A real-world study. Cell Rep Med. 2023 Feb 21;4(2):100911. doi: 10.1016/j.xcrm.2022.100911. Epub 2023 Jan 18.'}, {'pmid': '29692415', 'type': 'BACKGROUND', 'citation': 'Drost J, Clevers H. Organoids in cancer research. Nat Rev Cancer. 2018 Jul;18(7):407-418. doi: 10.1038/s41568-018-0007-6.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Twenty patients with recurrent small cell lung cancer who met the inclusion criteria were enrolled in the study after signing an informed consent form. Tumor samples were obtained through clinical puncture, and qualified samples were subjected to organoid modeling. Perform drug sensitivity test on the established lung cancer organoids. The drugs used are all that have been marketed and applied in clinical practice. According to the results of organoid drug sensitivity analysis, the patient received a treatment plan with relatively sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled patients, conduct statistical analysis on the consistency between drug sensitivity test results and patient treatment response, and evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years old (calculated based on the date of signing informed consent);\n2. Diagnosed as recurrent small cell lung cancer;\n3. After at least one systematic treatment and the disease progresses;\n4. 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;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;\n6. Expected survival time≥3 months;\n7. Before a tumor sample can be taken, there must be a record of disease progression on imaging after the previous treatment.;\n8. The patient has informed consent and signed a written consent form;\n9. The patients had good compliance and willingly followed the study plan, including scheduled visits, treatments, laboratory tests, and other research steps.\n\nExclusion Criteria:\n\n1. Extremely weakened overall condition, unable to tolerate bronchoscopy examination;\n2. Patients with acute suppurative inflammation of the respiratory tract accompanied by high fever, acute asthma attacks, and ongoing hemoptysis;\n3. Have a history of interstitial lung disease, non infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc\n4. Patients with active leptomeningeal disease or brain metastasis;\n5. 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);\n6. Have a history of immunodeficiency, including positive HIV serum tests;\n7. 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);\n8. The presence of any serious or uncontrollable systemic diseases;\n9. Pregnant or lactating female patients;\n10. The researchers believe that patients who are not suitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06406660', 'briefTitle': 'Patient-derived Organoid Drug Sensitivity Guided Treatment for Recurrent Small Cell Lung Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Patient-derived Organoid Drug Sensitivity Guided Treatment for Recurrent Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2024-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Organoid-Guided therapy', 'description': 'All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.', 'interventionNames': ['Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test']}], 'interventions': [{'name': 'Chemotherapy and targeted-therapy guided by organoid drug sensitivity test', 'type': 'OTHER', 'description': 'This study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment. This study aims to evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity tests.', 'armGroupLabels': ['Organoid-Guided therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiming Wang, PhD', 'role': 'CONTACT', 'email': 'qimingwang1006@126.com', 'phone': '+8613783590691'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Qiming Wang, PhD', 'role': 'CONTACT', 'email': 'qimingwang1006@126.com', 'phone': '+8613783590691'}], 'overallOfficials': [{'name': 'Qiming Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Kingbio Medical (Beijing) Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}