[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhou Chengzhi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":186},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,69,97,125,145,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100646924","phase-2-comparative-f-fdg-and-ga-my6349-petct-imaging-for-assessing-trop2-adc-therapeutic-efficacy-in-egfr-tki-resistant-advanced-nsclc-100646924",false,"NCT07685197","Comparative ¹⁸F-FDG and ⁶⁸Ga-MY6349 PET\u002FCT Imaging for Assessing TROP2 ADC Therapeutic Efficacy in EGFR-TKI Resistant Advanced NSCLC","Efficacy Evaluation of TROP2 ADC Therapy in Patients With Advanced\u002FMetastatic NSCLC Resistant to EGFR-TKIs: A Comparative Imaging Study of ¹⁸F-FDG and ⁶⁸Ga-MY6349 PET\u002FCT","Inclusion Criteria:\n\n* Aged ≥18 years at the time of signing the informed consent form, with no restriction on gender.\n* Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC), classified as locally advanced Stage IIIB\u002FIIIC or metastatic Stage IV NSCLC (per the 8th edition of UICC\u002FAJCC TNM staging system for lung cancer), and not eligible for curative resection and\u002For definitive radiotherapy (with or without concurrent chemotherapy).\n* Presence of EGFR sensitizing mutations (exon 19 deletion or exon 21 L858R point mutation).\n* Subjects who have received first-line third-generation EGFR-TKI therapy with documented treatment failure. For subjects previously treated with third-generation EGFR-TKIs in adjuvant, neoadjuvant or consolidation settings, such TKI therapy will be regarded as first-line treatment for locally advanced or metastatic disease if disease progression occurs within ≤6 months after the last dose.\n* At least one measurable lesion as defined by RECIST v1.1; previously irradiated lesions shall not be selected as target lesions. Subjects with only cutaneous or osseous lesions are not eligible for enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to study drug administration.\n* Estimated life expectancy ≥12 weeks.\n* Adequate organ and bone marrow function (no blood transfusion, recombinant thrombopoietin or colony-stimulating factor administered within 2 weeks before dosing), defined as follows:\n\n  1. Hematology: Absolute neutrophil count (NEUT#) ≥1.5×10⁹\u002FL; platelets (PLT) ≥100×10⁹\u002FL; hemoglobin ≥90 g\u002FL.\n  2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN; albumin ≥30 g\u002FL. For subjects with hepatic metastases at baseline, ALT and AST ≤5×ULN, TBIL ≤3×ULN.\n  3. Renal function: Creatinine clearance ≥50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula).\n  4. Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤1.5×ULN.\n* Females of childbearing potential and male subjects whose partners are of childbearing potential must agree to use effective medical contraception from the date of informed consent signature through 6 months after the last study drug administration.\n* The subject voluntarily participates in this study, signs the informed consent form, and is able to comply with all protocol-specified visits and relevant procedures.\n\nExclusion Criteria:\n\n* Tumor histology or cytology confirms mixed components including small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma.\n* Subjects with known leptomeningeal metastases, brainstem metastases, spinal cord metastases\u002Fcompression, or symptomatic unstable central nervous system (CNS) metastases are excluded unless they are off steroid therapy and maintain stable neurological status for at least two weeks after completion of definitive radiotherapy and steroid tapering.\n* Prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than third-generation EGFR-TKIs (e.g., chemotherapy, immunotherapy).\n* Previous treatment with any TROP2-targeted agents or therapeutics containing topoisomerase I inhibitors, including antibody-drug conjugates (ADCs), whether administered in adjuvant, neoadjuvant, or metastatic disease settings.\n* Thoracic radiotherapy with a cumulative dose \\>30 Gy delivered within 6 months prior to the first dose; non-thoracic or extended-field radiotherapy with a cumulative dose \\>30 Gy administered within 4 weeks prior to the first dose. Palliative radiotherapy for symptom control is permitted only if completed at least 2 weeks before study drug initiation.\n* History of another primary malignant tumor within 3 years before the first dose, excluding malignancies cured by local therapy such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and cervical carcinoma in situ.\n* Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors:\n\n  1. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) Class III\u002FIV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular\u002Fcerebrovascular events within 6 months before dosing.\n  2. Medical history of myocarditis, primary cardiomyopathy, or specific cardiomyopathies.\n  3. Deep vein thrombosis, peripheral arterial thromboembolism, pulmonary embolism, or other severe thromboembolic events within 3 months prior to dosing (subjects may be enrolled if stably treated with low-molecular-weight heparin or equivalent anticoagulants for ≥2 weeks).\n  4. Life-threatening major vascular diseases including aortic aneurysm or aortic dissection requiring surgical intervention within 6 months before dosing.\n  5. Corrected QT interval (QTcF) \\>470 ms.\n* Uncontrolled systemic diseases as judged by the investigator:\n\n  1. Poorly controlled diabetes mellitus (two consecutive fasting blood glucose readings ≥10 mmol\u002FL).\n  2. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg).\n  3. Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once per week.\n* History of steroid-dependent non-infectious interstitial lung disease (ILD) or non-infectious pneumonitis; active ILD or non-infectious pneumonitis at screening; or suspicious ILD\u002Fpneumonitis that cannot be ruled out by screening imaging.\n* Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of severe corneal disorders that hinder or delay corneal wound healing.\n* Clinically significant severe pulmonary impairment secondary to concurrent lung disorders, including but not limited to underlying lung diseases (e.g., severe asthma, advanced chronic obstructive pulmonary disease, restrictive lung disease within 3 months prior to dosing); autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.); or prior pneumonectomy.\n* Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulceration, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage.\n* Active gastrointestinal disorders or other conditions that substantially alter the absorption, distribution, metabolism, or excretion of oral study drugs (e.g., refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow oral medication, history of extensive intestinal resection).\n* Risk of esophagotracheal or esophagopleural fistula; tumor invasion or compression of vital adjacent organs and vessels (heart, esophagus, superior vena cava, etc.) accompanied by relevant clinical manifestations such as superior vena cava syndrome.\n* Toxicities from prior anti-tumor therapy that have not resolved to Grade ≤1 per NCI CTCAE v5.0 or the thresholds specified in eligibility criteria (alopecia, fatigue, and other toxicities judged low-risk by the investigator are exempted).\n* Severe infection occurring within 4 weeks before dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic antimicrobial therapy within 2 weeks before dosing.\n* Confirmed active pulmonary tuberculosis. Subjects with suspected active tuberculosis must undergo clinical examinations to rule out infection before enrollment.\n* Active hepatitis B (HBsAg-positive with HBV-DNA ≥500 IU\u002FmL or above the lower limit of quantification, whichever is higher); active hepatitis C (anti-HCV positive with HCV-RNA above the lower limit of quantification); or concurrent HBV and HCV co-infection.\n* Positive human immunodeficiency virus (HIV) serology or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n* History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Major surgery performed within 4 weeks prior to dosing or major surgery planned during study participation.\n* Known hypersensitivity to the study drug or any of its excipients (including polysorbate 20); history of severe hypersensitivity reactions to other biologic agents.\n* Non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or proprietary Chinese medicines with approved anti-tumor indications administered within 2 weeks before dosing.\n* Current use (or inability to discontinue prior to the first study dose) of drugs or herbal supplements that are strong cytochrome P450 (CYP) 3A4 inducers, with a minimum 3-week washout period required. All subjects shall avoid concomitant use of any CYP3A4-inducing medications, herbal supplements, and\u002For relevant foods throughout the study.\n* Live vaccine administered within 30 days before dosing or planned live vaccination during study participation.\n* Rapid clinical deterioration during screening, such as marked decline in performance status.\n* Pregnant or breastfeeding women.\n* Local or systemic non-malignant diseases, or tumor-induced diseases\u002Fsymptoms that carry high medical risks and\u002For cause uncertainty in survival assessment, such as leukemoid reaction, cachexia, etc.\n* Any medical condition that, in the investigator's opinion, may confound the evaluation of the study drug, compromise subject safety, interfere with the interpretation of study results, or render the subject unsuitable for trial participation.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The primary objective is to evaluate the correlation between ⁶⁸Ga-MY6349 PET\u002FCT-derived metrics reflecting tumoral TROP2 expression activity (including SUVmax, SUVmean, MTV, TLG, etc.) and progression-free survival (PFS) assessed per RECIST v1.1. This study plans to enroll 100 EGFR-mutant patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance following first-line therapy with third-generation EGFR-TKIs.\n\nScreening assessments will be completed within 28 days after patients sign the informed consent form. Eligible subjects will undergo a baseline ⁶⁸Ga-MY6349 PET\u002FCT scan prior to study drug administration, with imaging coverage from mid-thighs to the vertex of the skull. All subjects will receive a ¹⁸F-FDG PET\u002FCT scan within 14 days after the ⁶⁸Ga-MY6349 PET\u002FCT. For patients who have undergone ¹⁸F-FDG PET\u002FCT within 14 days before the ⁶⁸Ga-MY6349 scan, the existing imaging data can be used for diagnostic performance evaluation, and repeat ¹⁸F-FDG PET\u002FCT is not required.\n\nSubsequently, subjects will receive monotherapy with sacituzumab govitecan at a dose of 5 mg\u002Fkg via intravenous infusion (IV) on Day 1 of each cycle, administered every 2 weeks (Q2W). Treatment will continue until investigator-confirmed radiological disease progression, intolerable adverse toxicity, voluntary treatment discontinuation by the subject, or any other protocol-specified treatment discontinuation criterion, whichever occurs first.\n\nAt 3 months after initiation of sacituzumab govitecan treatment, subjects will repeat the ⁶⁸Ga-MY6349 PET\u002FCT scan (coverage: mid-thighs to vertex), followed by a ¹⁸F-FDG PET\u002FCT examination within 14 days thereafter.\n\nEligible subjects will receive regular tumor assessments in accordance with RECIST v1.1. Within 48 weeks after the first dose, imaging-based tumor assessments will be performed every 6 weeks (±7 days). At Week 12 (±1 week), paired ⁶⁸Ga-MY6349 and ¹⁸F-FDG PET\u002FCT scans will be conducted without routine diagnostic CT. After Week 48, tumor assessments will be scheduled every 12 weeks (±7 days) until radiological disease progression, initiation of subsequent anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination by the sponsor, whichever comes first. Imaging assessments will follow the predetermined schedule regardless of dose delays or dose modifications.\n\nAfter the first documented complete response (CR) or partial response (PR), response confirmation imaging must be conducted no less than 4 weeks (28 days) later. For subjects discontinuing treatment for reasons other than radiological progression, death or loss to follow-up, if more than 4 weeks have passed since the last imaging evaluation, repeat imaging will be performed at the End-of-Treatment (EOT) visit. Subsequent imaging assessments will be conducted per schedule to the greatest extent feasible until radiological disease progression, initiation of new anti-tumor therapy, consent withdrawal, loss to follow-up, death, or sponsor-initiated study termination, whichever occurs earliest.\n\nAll ⁶⁸Ga-MY6349 PET\u002FCT images will be blindly and independently reviewed by two experienced nuclear medicine physicians who are not involved in this clinical trial (without access to any clinical data) to identify positive NSCLC lesions, as well as lesion location and count. In case of disagreement between the two independent readers regarding the presence of positive lesions, a blinded arbitration review by a senior nuclear medicine expert will be activated, and the arbitrator's reading results will serve as the final conclusion. All ¹⁸F-FDG PET\u002FCT images will undergo single blinded independent review by one nuclear medicine physician.\n\nUpon completion of treatment, all subjects will complete safety follow-up regardless of whether they receive subsequent anti-tumor therapy. Telephone-based survival follow-up visits will be conducted every 3 months (±14 days) after the last dose of study treatment to collect survival status and information on subsequent anti-tumor treatments, until subject withdrawal, loss to follow-up, death, or study closure, whichever occurs first.",[26,27,28,29,30],"NSCLC","EGFR Activating Mutation","EGFR-TKI-resistant Non-Small Cell Lung Cancer","Trop2","PET\u002FCT Imaging","NOT_YET_RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-06","ACTUAL",{"date":37,"type":20},"2026-07",{"date":39,"type":20},"2028-07",{"name":41,"class":42},"Zhou Chengzhi","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100637502","phase-1-exploratory-study-on-the-efficacy-and-safety-of-nebulized-huc-msc-derived-exosomes-for-non-acute-cip-100637502","NCT07599111","Exploratory Study on the Efficacy and Safety of Nebulized hUC-MSC-Derived Exosomes for Non-Acute CIP","Exploratory Study on the Efficacy and Safety of Nebulized Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Non-Acute Immune Checkpoint Inhibitor-Related Pneumonitis","Inclusion Criteria:\n\n* Informed consent: Signed written informed consent.\n* Age and diagnosis: Aged 18-75 years with histologically confirmed malignant tumor.\n* Treatment history: Received at least one cycle of immune checkpoint inhibitor therapy and developed immune checkpoint inhibitor-related pneumonitis.\n* Confirmed Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP) by clinical evaluation (diagnosis and grading in accordance with the NCCN Guidelines for Management of Immunotherapy-Related Toxicities Version 1.2025), having received standard glucocorticoid therapy for ≥4 weeks, with glucocorticoids either discontinued or tapered to a prednisone-equivalent dose of \\\u003C20 mg\u002Fday.\n* Recent HRCT imaging: Persistent residual CIP-related lesions in both lungs, including ground-glass opacity, consolidation, reticular opacity, traction bronchiectasis, and\u002For honeycombing, involving a large extent of the lung fields; no significant resolution or improvement of these residual lesions on repeated HRCT within the past 4 weeks.\n* General condition: ECOG PS score 0-1, with stable control of the primary tumor for ≥6 months.\n* Contraception: Fertile subjects agree to use effective contraception during the study period and for 360 days after the last dose.\n\nExclusion Criteria:\n\n* Concomitant medication: Current use of antifibrotic agents such as pirfenidone and nintedanib.\n* Operational limitation: Inability to cooperate with pulmonary function testing or nebulized inhalation.\n* History of other pulmonary diseases: Presence of unresolved interstitial lung disease or pulmonary fibrosis induced by targeted therapy, radiotherapy, or other causes.\n* Severe comorbidities: Including severe cardiac, hepatic, or renal insufficiency, or severe hematological abnormalities.\n* Specific medical history: Severe neuromuscular disease, history of organ transplantation, active epilepsy, primary or severe acquired\u002Fsecondary immunodeficiency.\n* Other factors: Severe allergic constitution, psychiatric disorders, use of other investigational products within 28 days, or any other condition deemed inappropriate by the investigator.","75 Years",{"count":52,"type":20},40,[54,23],"PHASE1","Study Objectives The primary objective of Phase II is to evaluate the percentage of lesion resolution on high-resolution computed tomography (HRCT) as assessed by independent blinded reviewers. Secondary objectives include evaluating effects on pulmonary function, exercise capacity, dyspnea, quality of life, and oxygenation, as well as comprehensively assessing safety and tolerability. Phase I focuses on determining safety, dose-limiting toxicities (DLT), and recommended Phase II dose.\n\nStudy Population\n\nThe target population is patients with non-acute CIP aged 18-75 years with histologically confirmed malignancy. Key inclusion criteria include:\n\nAt least one cycle of immune checkpoint inhibitor (ICI) therapy and development of Grade 3-4 CIP per NCCN Guidelines V1.2025 Standard glucocorticoid treatment for ≥4 weeks, with current dose \\\u003C20 mg\u002Fday prednisone equivalent or discontinued Persistent residual CIP lesions on HRCT without significant improvement in the past 4 weeks ECOG PS 0-1 and stable primary tumor for ≥6 months Effective contraception during the study and for 360 days after last dosing\n\nKey exclusion criteria include:\n\nConcomitant use of pirfenidone, nintedanib, or other antifibrotic agents Inability to perform pulmonary function tests or tolerate nebulization Unresolved interstitial lung disease from radiotherapy or targeted therapy Severe cardiac, hepatic, renal, or hematological dysfunction Organ transplantation, severe immunodeficiency, active epilepsy, or severe allergic status Other investigational drug use within 28 days Study Design and Sample Size Phase I: 9-18 subjects, open-label, dose-escalation design to evaluate DLT and safety Phase II: 40 subjects, randomized, double-blind, placebo-controlled design Study Endpoints Phase I Primary Endpoints Incidence of DLT Incidence of adverse events (AE) and serious adverse events (SAE) Phase II Primary Endpoint Percentage of HRCT lesion resolution at Weeks 4, 12, and 24, assessed by independent blinded reviewers Secondary Endpoints Pulmonary function: FVC%, TLC, RV, FRC, DLCO Functional and symptomatic measures: 6MWD, mMRC dyspnea score, SGRQ, LCQ Oxygenation: PaO₂, A-aDO₂, oxygenation index Exploratory Endpoints Dynamic changes in serum biomarkers: KL-6, cytokines (IL-1β, IL-6, IL-10), immune cell subsets (Tregs, Th1\u002FTh17) Safety Assessments Monitoring of AEs\u002FSAEs graded by CTCAE v5.0 and causality assessment Physical examination, vital signs, SpO₂, 12-lead ECG Laboratory tests: CBC, biochemistry, coagulation, urinalysis, CRP, ESR Study Termination Rules Overall Study Termination Successful completion after all 40 subjects finish 24-week follow-up and database lock Occurrence of unexpected serious or unacceptable safety risks Demonstration of overwhelming efficacy or futility Sponsor termination due to slow enrollment, funding, or major protocol deviations Regulatory or ethics committee requirements Individual Subject Discontinuation Development of DLT or severe hypersensitivity Rapid CIP progression (e.g., \\>50% radiological worsening) Tumor progression or clinical deterioration Withdrawal of informed consent Poor compliance unresponsive to intervention Loss to follow-up or death Investigator judgment of inappropriateness for continued participation Study Timeline Preparation and initiation: January 2026 - May 2026 Phase I\u002FII enrollment: June 2026 - May 2027 Treatment and follow-up (overlapping with enrollment): through June 2028 Database lock and statistical analysis: July 2028 - August 2028 Study closeout: August 2028 - December 2028",[57,58,59,60],"Pneumonitis, Interstitial","Immune Checkpoint Inhibitors (ICIs)","Mesenchymal Stem Cells","Exosomes","2026-05-13",{"date":63,"type":35},"2026-05-20",{"date":65,"type":20},"2026-04",{"date":67,"type":20},"2028-10",{"name":41,"class":42},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":78,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100619151","diagnostic-biomarkers-for-checkpoint-inhibitor-related-pneumonitis-100619151","NCT07340892","Diagnostic Biomarkers for Checkpoint Inhibitor-related Pneumonitis","Prospective Study of NMR-based Serum Metabolic Profiles for the Diagnosis of Checkpoint Inhibitor-related Pneumonitis","Inclusion Criteria:\n\n1. Patients with a pathological diagnosis of lung cancer;\n2. The subject has received at least one course of immune checkpoint inhibitor treatment;\n3. Capable of understanding and voluntarily signing an informed consent form.\n\n   For the CIP group, the following additional criteria must be met:\n4. Highly suspected of having checkpoint inhibitor pneumonitis based on radiological abnormalities and\u002For pulmonary symptoms (including fever, cough, and dyspnea).\n\n   For the Control group, the following additional criteria must be met:\n5. Has had no clinical symptoms or radiographic evidence suggestive of pneumonitis at enrollment or prior to enrollment.\n\nExclusion Criteria:\n\n1. Pulmonary lesions were definitively diagnosed as tumor progression, bacterial pneumonia, or pulmonary edema;\n2. Incomplete or missing follow-up data.",{"count":77,"type":20},60,"1 Year","OBSERVATIONAL","Checkpoint inhibitor-related pneumonitis (CIP) is a common fatal immune-related adverse events of PD-1\u002FPD-L1 inhibitors. Early diagnosis of CIP is crucial for timely intervention and improved prognosis; however, the absence of precise and effective diagnostic techniques often leads to underdiagnosis and misdiagnosis. The investigators conducted a prospective clinical study to evaluate the effectiveness of ¹H-nuclear magnetic resonance (NMR)-based lipoprotein and metabolite analysis in diagnosing checkpoint inhibitor-related pneumonitis (CIP), aiming to improve its early diagnosis rate.",[82],"Checkpoint Inhibitor-related Pneumonitis",[84,85,86],"Checkpoint inhibitor-related pneumonitis","¹H-nuclear magnetic resonance","Metabolism","RECRUITING","2026-02-02",{"date":90,"type":35},"2026-02-04",{"date":92,"type":20},"2026-01-10",{"date":94,"type":20},"2028-01-10",{"name":41,"class":42},1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100562003","phase-1-auto-hsct-supported-dose-dense-chemotherapy-with-adebrelimab-as-first-line-treatment-for-es-sclc-100562003","NCT06597513","Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC","A Single-Arm Trial of Hematopoietic Stem Cell Transplantation-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer","Inclusion Criteria:\n\n1. Pathologically confirmed small cell lung cancer (SCLC) staged as extensive-stage (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) classification.\n2. ES-SCLC dose not received prior systemic treatment.\n3. History of localized-stage SCLC with prior radiotherapy and chemotherapy, with the requirement for definitive treatment, and a minimum of 6 months interval from the last treatment to diagnosis of ES-SCLC.\n4. CT or MRI scan ≤28 days prior to the first dose of study medication, with at least one target lesion that has not been irradiated (RECIST v1.1 criteria).\n5. Male or female patients aged ≥18 and ≤70 years.\n6. ECOG Performance Status of 0 or 1.\n7. Life expectancy ≥12 weeks.\n8. Adequate organ system function (excluding use of any blood components or growth factors during screening).\n9. Male or female participants must agree to use appropriate contraception (e.g., intrauterine device, contraceptive pills, or condoms) from the start of the study treatment until 6 months after the last study treatment; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n10. Subjects voluntarily participate in this study and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed SCLC and NSCLC.\n2. Prior treatment with any T-cell co-stimulatory or immune checkpoint inhibitors, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1\u002F2 inhibitors, or other T-cell targeted agents.\n3. Prior treatment with vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) inhibitors.\n4. Symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. For treated brain metastases, the following criteria must be met: no progression on MRI ≥4 weeks post-treatment, completion of treatment ≥28 days before the first dose of study drug, and no need for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) ≤14 days before the first dose.\n5. Hematologic disorders including, but not limited to, lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, or myelodysplastic syndromes.\n6. Symptomatic third-space fluid accumulation, such as uncontrolled pericardial effusion, pleural effusion, or ascites despite drainage or other treatments.\n7. Active, known, or suspected autoimmune diseases. Exceptions include vitiligo, type 1 diabetes, autoimmune thyroiditis with only hormone replacement therapy, or conditions unlikely to relapse without external stimuli.\n8. Use of systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressants ≤14 days before the first dose of study drug. Inhaled or topical corticosteroids and adrenal replacement therapy are allowed if no active autoimmune disease.\n9. Receipt of or planned vaccination with live vaccines ≤4 weeks before the first dose of study drug.\n10. Interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis requiring corticosteroids, active pneumonia, or severe pulmonary dysfunction.\n11. Active tuberculosis or history of active tuberculosis ≤48 weeks before screening, regardless of treatment status.\n12. Toxicities from prior anticancer treatment other than alopecia and fatigue must have resolved to CTCAE v4.03 ≤ Grade 1 before the first dose. Long-term sequelae such as platinum-based neurotoxicity are allowed if anticipated to be stable.\n13. Imaging (CT or MRI) showing tumor invasion of major vessels, hemoptysis symptoms within 3 months before screening, or daily hemoptysis ≥2.5 mL.\n14. Minor surgery (including catheter placement) ≤48 hours before the first dose of study drug.\n15. Current or recent use of aspirin (\\>325 mg\u002Fday) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function ≤10 days before the first dose.\n16. Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytics ≤10 days before the first dose. Preventive anticoagulation is allowed.\n17. Known hereditary bleeding disorders or coagulation dysfunction. Significant bleeding symptoms or clear bleeding tendencies (e.g., gastrointestinal bleeding, bleeding ulcers, baseline stool occult blood ++ or more) within 12 weeks before screening.\n18. History of thromboembolic events within 24 weeks before signing the ICF, including stroke (including transient ischemic attack, hemorrhagic stroke, or infarction), deep vein thrombosis, or pulmonary embolism.\n19. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg), hypertensive crises, or history of hypertensive encephalopathy.\n20. History of gastrointestinal ulcers, perforation, corrosive esophagitis or gastritis, inflammatory bowel disease, diverticulitis, abdominal fistula, tracheoesophageal fistula, or intra-abdominal abscess within 24 weeks before signing the ICF.\n21. Uncontrolled cardiac symptoms or diseases, including: (1) NYHA Class ≥II heart failure; (2) unstable angina; (3) myocardial infarction within 24 weeks; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n22. Known allergy to study drug or excipients, or a history of severe allergic reactions to any monoclonal antibody.\n23. Other malignancies within 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell carcinoma, squamous cell carcinoma of the skin, locally excised prostate cancer, or ductal carcinoma in situ with minimal risk of metastasis and expected cure.\n24. Known psychiatric disorders, alcohol abuse, drug abuse, or substance misuse.\n25. Positive HBsAg with HBV DNA levels exceeding normal limits (1000 copies\u002Fml or 500 IU\u002Fml), or positive HCV (HCV RNA or HCV Ab indicating acute or chronic infection); known HIV positive or acquired immunodeficiency syndrome (AIDS).\n26. Uncontrolled or symptomatic hypercalcemia.\n27. Receipt of any investigational drug or participation in another interventional clinical trial ≤4 weeks before signing the ICF.\n28. History of allogeneic bone marrow transplantation or solid organ transplantation.\n29. Use of systemic immunosuppressive drugs ≤2 weeks before randomization.\n30. History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin, or etoposide.\n31. Any other factors that, in the investigator\\'s judgment, may lead to premature discontinuation of the study, including non-compliance, severe concurrent illness (including psychiatric illness), significant laboratory abnormalities, or factors affecting the safety or data collection.","70 Years",{"count":106,"type":20},10,[54,23],"The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach.\n\nThe main questions it aims to answer are:\n\nDoes hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment?\n\nParticipants will:\n\nComplete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization.\n\nReceive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles.\n\nIf eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles.\n\nFinally, participants may enter a maintenance phase with adebrelimab.\n\nThroughout the trial, participants will:\n\nVisit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months",[110],"Extensive Stage Small Cell Lung Cancer",[112,113,114,115,116],"Auto-HSCT","Adebrelimab","Dose-Dense Chemotherapy","Etoposide","Carboplatin","2024-10-11",{"date":119,"type":35},"2024-10-15",{"date":121,"type":20},"2024-12",{"date":123,"type":20},"2026-12",{"name":41,"class":42},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":96},"100562792","phase-1-safety-and-efficacy-of-cryoablation-with-karelizumab-and-apatinib-for-multiple-lung-cancers-100562792","NCT06607770","Safety and Efficacy of Cryoablation With Karelizumab and Apatinib for Multiple Lung Cancers","An Exploratory Study of the Safety and Efficacy of Cryoablation in Combination With Karelizumab and Apatinib for the Treatment of Multiple Primary Lung Cancers Without Known Driver Genes","Inclusion Criteria:\n\n1. Clinical and pathological diagnosis of multiple primary lung cancers；\n2. There were 3 intrapulmonary nodules ≥ the initial diagnosis or preoperative, and there was no lymph node metastasis；\n3. The maximum lesion diameter ≤ 3 cm；\n4. At most, patients has undergone surgical resection treatment, and there are ≥ 2 remaining intrapulmonary nodules, and the postoperative pathology confirms that it is MIA or AIS；\n5. It is estimated that at least 1 measurable lesion meeting RECIST v1.1 criteria will remain after cryotherapy；\n6. Male or female≥ 18 years old and ≤ 75 years old；\n7. United States Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1；\n8. Expected survival ≥ 12 weeks；\n9. Vital organ and bone marrow function meets the following requirements:a.Blood routine: absolute neutrophil count (ANC) ≥1.5× 109\u002FL, platelet (PLT) ≥100× 109\u002FL, hemoglobin (HGB) ≥9 g\u002FdL;b.Liver function: serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤2.5 times the ULN, serum albumin (ALB) ≥2.8 g\u002FdL;c.Renal function: serum creatinine (Cr) ≤ 1.5 x ULN, or creatinine clearance ≥ 40 mL\u002Fmin;\n10. Subject with subject sexual partner needs to use one medically approved contraceptive measure (such as intrauterine device, birth control pill or condom, etc.) during study treatment and for 6 months after the end of the study treatment period;\n11. Subjects must have signed an IRB\u002FIEC-approved written informed consent form in accordance with competent authority and study site guidelines and be able to comply with protocol-specified visits, treatment protocols, laboratory tests, and related procedures.\n\nExclusion Criteria:\n\n1. Patients with known EGFR mutations, ALK rearrangements;\n2. Conditions that cannot be treated with cryoablation: diffuse lesions in both lungs, extensive pleural metastases with large pleural effusions, tumors adjacent to or encircling large mediastinal vessels, etc;\n3. Prior receipt of anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or any other antibody or drug targeting T cell co-stimulation or immune checkpoint pathways;\n4. Received the following treatments:a.Received systemic anti-tumor therapy such as chemotherapy, targeted therapy, immunotherapy, etc. within 4 weeks prior to randomization;b.Treatment with any investigational drug within 4 weeks prior to randomization;c.Receipt of high-dose immunosuppressive medications (systemic glucocorticoids greater than 10 mg\u002Fday of prednisone or its equivalent) within 4 weeks prior to randomization;d.Major surgery (such as open, thoracotomy, or laparotomy, etc.), or unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to randomization.\n5. Known or suspected active autoimmune disease (congenital or acquired);\n6. Known allogeneic organ transplantation (other than corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n7. Hypersensitivity to any component of the monoclonal antibody preparation;\n8. With interstitial lung disease;\n9. With other uncontrolled serious medical conditions;\n10. Other acute or chronic illness, psychiatric illness, or abnormal laboratory test values that may result in an increase in the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and the patient is listed as ineligible for this study in the judgment of the investigator.",{"count":133,"type":20},20,[54,23],"The goal of this clinical trial is to explore the safety and efficacy of cryoablation combined with carlizumab and apatinib in multiple primary lung cancer without known driver genes.Main included population criteria:Clinical and pathological diagnosis of multiple primary lung cancer;Three pulmonary nodules were diagnosed initially or before surgery, without lymph node metastasis;Male or female is 18 years old, and 75 years old;Up to one surgical resection treatment with 2 remaining pulmonary nodules, and postoperative pathology confirmed MIA or AIS and so on.The main questions it aims to answer is safety of cryoablation combined with carilizumab and apatinib in multiple primary lung cancer.Participants will take carplus with apatinib started 2-3 weeks after cryoablation. Carelizumab 200mg, q3w, apatinib 250mg, qd. Every 3 weeks is for one treatment cycle. Until PD, intolerable toxicity, death, patient withdrawal or investigator discretion requires termination.",[137],"Lung Cancer","2024-10-09",{"date":119,"type":35},{"date":141,"type":35},"2024-09-01",{"date":143,"type":20},"2027-08",{"name":41,"class":42},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":96},"100562794","phase-3-efficacy-and-safety-of-intratumoral-toluenesulfonamide-pts-injection-in-stage-iv-driver-gene-negative-nsclc-withwithout-chemoimmunotherapy-100562794","NCT06607796","Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With\u002FWithout Chemoimmunotherapy","A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures；\n2. Age ≥18 years and ≤75 years at the time of signing the ICF；\n3. Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；\n4. At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection；\n5. Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment；\n6. ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；\n7. Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；\n8. Life expectancy ≥ 3 months；\n9. Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.\n\nExclusion Criteria:\n\n1. Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;\n2. Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;\n3. Have severe bleeding, clotting disorders, infections, dehydration, etc;\n4. Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;\n5. History of severe emphysema and pulmonary alveoli;\n6. History of drug allergy or contraindication to toluene sulfonamide;\n7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;\n8. The investigators determined that the patients had other conditions that made them unsuitable for enrollment.",{"count":153,"type":20},180,[155],"PHASE3","The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.",[137],"2024-09-23",{"date":160,"type":35},"2024-09-25",{"date":162,"type":35},"2024-03-01",{"date":123,"type":20},{"name":41,"class":42},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":4},"100551593","liposomal-irinotecan-combination-regimen-for-first-line-treatment-of-small-cell-lung-cancer-100551593","NCT06462105","Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung Cancer","Randomized Phase II Clinical Study of Liposomal Irinotecan or Etoposide Combined With Carboplatin and Serplulimab as First-line Treatment for Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)；\n* Age ≥18 years；\n* Patients with pathologically or histologically confirmed extensive stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging system)；\n* The patient had not previously received any form of antitumor therapy；\n* According to RECIST1.1 criteria, the patient had at least one measurable target lesion；\n* Eastern Cooperative Oncology Group（ECOG）Physical status score: 0-2；\n* The expected survival time is ≥3 months；\n* Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, and hemoglobin ≥90 g\u002FL (no blood transfusion, blood products, correction with granulocyte colony stimulating factor or other hematopoietic stimulating factor within 14 days prior to laboratory examination)；\n* Serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with liver invasion)；\n* Women of childbearing age must have had a pregnancy test (serological) negative within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial period and for 6 months after the last dose of the test drug.\n\nExclusion Criteria:\n\n* Patients with large cell neuroendocrine tumor and mixed small cell carcinoma；\n* Patients with active brain metastases or central nervous system invasion； confirmed by imaging evaluation and\u002For biopsy (prednisone equivalent dose ≥10mg)；\n* Allergic reaction to any investigational drug or its ingredients；\n* The patient has previously received other antibodies\u002Fdrugs that target immune checkpoints, such as PD-1, PD-L1, CTLA4, etc；\n* Serious, uncontrolled comorbidities that could affect the study results, including but not limited to serious infections, diabetes, or cardiovascular and cerebrovascular disease, were identified；\n* Imaging confirmed intestinal obstruction；\n* It has uncontrollable ascites, abdominal infection and pyloric obstruction；\n* Cardiac function and disease: a history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities in the 6 months prior to recruitment；\n* Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x103 copies \u002FmL; more than 1x103 copies \u002FmL of HCV RNA)；\n* Human immunodeficiency virus (HIV) infection (HIV antibody positive);\n* Previous or current co-occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast\u002Fcervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years);\n* Pregnant and lactating women and patients of childbearing age who do not want to use contraception;\n* The investigators determined that patients were not suitable to participate in this study.",{"count":77,"type":20},[174],"NA","Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.",[177],"Small Cell Lung Cancer","2024-06-26",{"date":180,"type":35},"2024-06-28",{"date":182,"type":20},"2024-07-05",{"date":184,"type":20},"2027-06-30",{"name":41,"class":42},""]