[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Baohui Han\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100623636","noninvasive-detection-of-lung-nodule-malignancy-using-cfdna-fragmentomics-100623636",false,"NCT07399210","Noninvasive Detection of Lung Nodule Malignancy Using cfDNA Fragmentomics","A Prospective Clinical Study Evaluating the Noninvasive Use of Circulating Cell-Free DNA Fragmentomics to Differentiate Benign and Malignant Lung Nodules, With Emphasis on Small Nodules.","SHC2408","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Positive for lung nodules on low-dose spiral CT (LDCT) meeting one of the following criteria:\n\nSolid or part-solid nodules ≥ 5 mm and ≤ 20 mm; Pure ground-glass nodules ≥ 8 mm and ≤ 30 mm; In cases of multiple nodules, the largest nodule (by maximum diameter) must meet these criteria;\n\n* Participants whose lung nodule status (benign or malignant) can be clinically confirmed;\n* No cancer-directed therapy (e.g., chemotherapy, radiotherapy, immunotherapy, cell therapy) within the past 3 months;\n* Able to provide a 5 mL peripheral blood sample prior to any treatment;\n* Voluntary signing of informed consent after full explanation of the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding;\n* Current or past diagnosis (within the past 5 years) of malignant tumors (excluding patients with early-stage lung cancer who have undergone surgery but still have multiple evaluable nodules), or with severe heart disease, serious liver or kidney disorders, or significant bone marrow hematopoietic dysfunction;\n* History of organ transplantation or blood transfusion within the past 3 months;\n* History of seropositivity for human immunodeficiency virus (HIV);\n* Any other condition deemed inappropriate for study participation by the investigators.","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","1 Month","OBSERVATIONAL","The goal of this observational study is to learn if cfDNA fragmentomics can noninvasively diagnose whether lung nodules are benign or malignant in adults with imaging-detected lung nodules.",[26,27],"Lung Cancer (Diagnosis)","Fragmentomics",[27,29,30,31,32],"Lung Cancer(Diagnosis)","cfDNA","Small Nodule","Non-invasive","RECRUITING","2026-02-08",{"date":36,"type":37},"2026-02-10","ACTUAL",{"date":39,"type":37},"2024-08-21",{"date":41,"type":21},"2026-08-21",{"name":43,"class":44},"Baohui Han","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100581165","dream-study-dnarna-ngs-co-testing-in-driver-negative-treatment-resistant-nsclc-100581165","NCT06846762","DREAM Study: DNA\u002FRNA-NGS Co-Testing in Driver-Negative, Treatment-Resistant NSCLC","Real-world Study of DNA + RNA-NGS Co-testing in Patients with Driver Gene-negative, First-line Non-targeted Therapy-resistant Primary NSCLC (Dream Study)","Inclusion Criteria:\n\n1. Aged 18 and above, male or female\n2. Pathologically diagnosed with advanced or metastatic inoperable non-small cell lung cancer\n3. Prior genetic testing \\[DNA-NGS\\] results show no mutations in EGFR, BRAF, MET, HER2, KRAS, FGFR2\u002F3，no amplifications in MET and HER2 and no fusions in ALK, ROS1, RET, NTRK, NRG1, EGFR, MET, BRAF, FGFR2\u002F3\n4. Based on negative driver gene results, received first-line non-targeted therapy with rapid progression or intolerance, with a progression-free survival (PFS) of ≤6 months (regardless of drug exposure time, calculated from the first day of medication)\n5. Have retained tumor tissue samples prior to first-line treatment\n6. Patients are from medical centers that can ethically affiliate and have accessible clinical follow-up data.\n\nExclusion Criteria:\n\n1. Patients who do not meet any of the necessary inclusion criteria\n2. Presence of other pulmonary diseases that require treatment or are severe, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc.\n3. Presence of active infections that require systemic treatment\n4. History of drug abuse or alcohol abuse, or mental illness, or suspected allergy or intolerance to the study drug or any of its components\n5. Any other conditions deemed unsuitable for entry into this study by the investigator.",{"count":54,"type":21},508,"1 Year","The study is divided into two parts, Part A and Part B. The purpose of Part A is to reveal the proportion of NSCLC patients who are primarily resistant to first-line non-targeted therapy due to the omission of driver genes (especially fusion variations) by DNA-NGS, the median PFS of patients in the first line, and clinical characteristics through synchronous co-testing of DNA and RNA NGS. The purpose of Part B is to compare the difference in ORR between patients with driver gene positivity identified through synchronous co-testing of DNA and RNA NGS who receive and do not receive targeted therapy.",[58],"Non-Small Cell Lung Cancer",[60,61,62,63,64],"NSCLC","Primary Resistance","DNA+RNA-NGS","Driver Gene Testing","Targeted Therapy","2025-02-20",{"date":67,"type":37},"2025-02-26",{"date":69,"type":21},"2025-03-01",{"date":71,"type":21},"2027-01-01",{"name":43,"class":44},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100541675","phase-1-safety-and-efficacy-of-adebrelimab-plus-irinotecan-liposome-ii-with-or-without-famitinib-in-es-sclc-pre-treated-with-immunotherapy-100541675","NCT06332950","Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy","A Randomized, Multi-cohort, Multi-center Phase Ib\u002FII Study of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in Patients With ES-SCLC Pre-treated With Immune Checkpoint Inhibitor(s)","Inclusion Criteria:\n\n* Willing to participate and sign the informed consent form.\n* Age: 18-75 years old, male or female.\n* ECOG PS: 0-1 points.\n* Histologically or cytologically confirmed of extensive stage small cell lung cancer (according to the International Association for the Study of Lung Cancer, 8th Edition or VALG II staging system).\n* Progression after first-line immunotherapy combined with platinum-based system therapy more than 90 days.\n* At least one measurable lesion (RECIST 1.1 criteria) was assessed by imaging evaluation (enhanced CT or MRI) within 4 weeks prior to enrollment.\n* Patients with asymptomatic or treatment-stabilized central nervous system (CNS) metastases must meet the following conditions: (1) No imaging progress for at least 4 weeks after the end of treatment; (2) completion of treatment 4 weeks before enrollment; (3) no treatment with systemic corticosteroids (\\>10mg\u002F day prednisone or other equivalent dose) within the first 2 weeks before enrollment.\n* Expected survival time ≥12 weeks.\n* Adequate hematology and organ function (No blood transfusion or blood products, no correction with G-CSF and other hematopoietic stimulating factors within 14 days), including:\n\n  1. Complete blood count: White blood cell count WBC≥3.0×109\u002FL; Absolute neutrophil count ANC≥1.5×109\u002F L; Platelet count≥100×109\u002F L; Hemoglobin≥90 g\u002FL.\n  2. Liver function: AST≤2.5× upper limit of normal(ULN); ALT≤2.5×ULN (Patients with liver metastasis, AST and ALT≤5×ULN); TBIL≤1.5×ULN (Except for Gilbert syndrome ≤3×ULN); ALB≥30.0 g\u002FL.\n  3. Renal function: Serum creatinine≤1.5×ULN or creatinine clearance≥50ml\u002Fmin (Cockcroft-Gault formula).\n  4. Normal coagulation function: INR and APTT≤1.5×ULN.\n  5. TSH≤ULN.\n  6. Other: Lipase≤1.5×ULN (Patients with lipase\\>1.5×ULN but no clinical or imaging evidence of pancreatitis could be enrolled); Amylase≤1.5×ULN (Patients with amylase \\>1.5×ULN but no clinical or imaging evidence of pancreatitis could be enrolled); ALP≤2.5×ULN (Patients with bone metastasis, ALP≤5×ULN).\n  7. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)≥50%.\n* Women of childbearing potential must undergo a negative pregnancy test (HCG) 7 days prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 3 months after the administration of the last therapeutic dose.\n\nExclusion Criteria:\n\n* Non-small cell lung cancer or non-small cell lung cancer admixed with components of small cell lung cancer, as confirmed by histology or cytology.\n* With \\> 2 lines of prior chemotherapy.\n* Patients previously treated with topoisomerase I inhibitors.\n* With primary resistance, defined as patients who do not respond to first-line treatment or progress within 90 days after the end of treatment.\n* Patients previously treated with antiangiogenic drugs, such as bevacizumab, recombinant human endostatin, anlotinib, apatinib, etc.\n* Radiotherapy for the chest and whole brain was completed within 4 weeks prior to enrollment (enrollment was allowed if palliative radiotherapy for bone lesions could complete before the first dose).\n* Except for alopecia and fatigue, toxicity due to previous antitumor therapy did not recover to CTCAE 5.0≤1 level before enrollment. Other toxicities due to previous antitumor therapy are not expected to resolve and have long-lasting sequelae.\n* With active brain metastasis or meningeal metastasis. Compressive myelopathy that has not been cured or alleviated after surgery and\u002For radiotherapy, or present with compressive paraplegia or paraplegia after treatment in patients previously diagnosed with compressive myelopathy. Patients with liver metastases had significant clinical symptoms and abnormal liver function after cryotherapy and radiofrequency ablation treatment within the first 4 weeks of enrollment. Patients with uncontrolled mass pleural effusion, pericardial effusion, or ascites. Patients with cardiovascular disease.\n* Patients previously treated with systemic immunosuppressive medications within 4 weeks before enrollment.\n* Presence or history of active autoimmune disease. Interstitial pneumonia, drug-induced pneumonia, radiation pneumonia requiring steroid treatment (greater than 10 mg\u002Fday prednisone or its equivalent), or active pneumonia with clinical symptoms.\n* Patients with an active or uncontrolled severe infection (CTCAE 5.0≥2) within 2 weeks prior to the first dose.\n* With active tuberculosis or tuberculosis under treatment.\n* Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection. Untreated active hepatitis B (HBsAg positive or HBV DNA≥500 IU\u002Fml with abnormal liver function), hepatitis C (hepatitis C antibody positive, with higher HCV-RNA than the lower detection limit of the assay method and abnormal liver function) or hepatitis B and C co-infection.\n* Hypertension that cannot be controlled with medications (systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg). History of hypertensive crisis or hypertensive encephalopathy.\n* Arteriovenous thrombosis events occurred within 24 weeks prior to signing the ICF, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n* With factors influencing absorption of drug, such as refractory nausea and vomiting, chronic gastrointestinal diseases, or inability to swallow the formulated product.\n* With mental illness, alcoholism, inability to quit smoking, drug or substance abuse.\n* With known allergic history of the drug components of this program, or allergic to other monoclonal antibodies.\n* Received any other investigational treatment or participated in any other interventional clinical trials within 4 weeks prior to signing the ICF.","75 Years",{"count":82,"type":21},80,"INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This is an open-label, randomized, multi-cohort, multi-center, phase Ib\u002FII study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).",[89],"Extensive-stage Small-cell Lung Cancer","NOT_YET_RECRUITING","2024-03-20",{"date":93,"type":37},"2024-03-27",{"date":95,"type":21},"2024-04-01",{"date":97,"type":21},"2027-04-01",{"name":43,"class":44},""]