[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565997":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":77,"collaborators":32,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":32,"enrollmentInfo":90,"targetDuration":32,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":105,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Small cell lung cancer (SCLC) patients receiving ICI combined with chemotherapy (etoposide + carboplatin\u002Fcisplatin).",[13,14],"Drug: Efbemalenograstim alfa Injection","Drug: carboplatin\u002Fcisplatin-etoposide",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2","Non-small cell lung cancer (NSCLC) patients receiving ICI combined with chemotherapy (platinum-based\u002Ftaxane, pemetrexed\u002Fplatinum).",[13,19,20],"Drug: Carboplatin plus Paclitaxel","Drug: Cisplatin\u002Fpemetrexed or Carboplatin\u002Fpemetrexed",{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort 3","Esophageal squamous cell carcinoma (ESCC) patients receiving ICI combined with chemotherapy (TP, which stands for cisplatin + taxane).",[13,25],"Drug: TP regimen",[27,33,37,41,45],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Efbemalenograstim alfa Injection","This product should be administered subcutaneously 48 hours after the completion of anti-tumor drug administration in each chemotherapy cycle. The recommended dose for adults is 20mg administered subcutaneously once per chemotherapy cycle. Please do not administer this product within 14 days before and 24 hours after the administration of cytotoxic chemotherapy drugs.",[9,16,22],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"carboplatin\u002Fcisplatin-etoposide","one of the following chemotherapy regimens can be selected: EC, Q3W: Carboplatin AUC = 5\\~6 on Day 1; Etoposide 80\\~100 mg\u002Fm² on Days 1-3. EP, Q3W: Cisplatin 75\\~80 mg\u002Fm² on Day 1; Etoposide 80\\~100 mg\u002Fm² on Days 1-3.",[9],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Carboplatin plus Paclitaxel","For non-small cell lung cancer (squamous cell carcinoma), one of the following chemotherapy regimens can be selected:\n\nCarboplatin AUC = 5\\~6 on Day 1 + Taxane: Paclitaxel 175-200 mg\u002Fm² on Day 1; or Albumin-bound Paclitaxel 200-260 mg\u002Fm² on Day 1, administered every 3 weeks (Q3W); Cisplatin\u002FCarboplatin 75 mg\u002Fm²\u002FAUC = 5\\~6 on Day 1 + Gemcitabine 1000 mg\u002Fm² on Days 1 and 8, administered every 3 weeks (Q3W).",[16],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Cisplatin\u002Fpemetrexed or Carboplatin\u002Fpemetrexed","For non-small cell lung cancer (non-squamous cell carcinoma), one of the following chemotherapy regimens can be selected:\n\nCisplatin 75 mg\u002Fm² on Day 1 + Pemetrexed 500 mg\u002Fm² on Day 1, administered every 3 weeks (Q3W).\n\nCarboplatin AUC = 5\\~6 on Day 1 + Pemetrexed 500 mg\u002Fm² on Day 1, administered every 3 weeks (Q3W).",[16],{"type":28,"name":46,"description":47,"armGroupLabels":48,"otherNames":32},"TP regimen","The chemotherapy regimen options include:\n\nTP regimen: Cisplatin 60-80 mg\u002Fm² administered via intravenous drip on Day 1 + Taxane: Paclitaxel 175 mg\u002Fm² on Day 1; or Albumin-bound Paclitaxel 200-260 mg\u002Fm² on Day 1, with a treatment cycle of every 3 weeks (Q3W).",[22],[50],{"name":51,"affiliation":5,"role":52},"JinMing Yu, Phd","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":32,"email":58},"JinMing Yu, PhD","CONTACT","86+13806406293","jn7984729@public.jn.sd.cn",[60],{"facility":5,"status":32,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Jinan","Shandong","250117","China","CN",{"type":67,"coordinates":68},"Point",[69,70],116.99722,36.66833,{"lat":70,"lon":69},[73],{"name":74,"role":56,"phone":75,"phoneExt":32,"email":76},"Linlin Wang","0086+13793187739","wanglinlinatjn@163.com",{"type":52,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Jinming Yu","Investigator Official Title President of Shandong Cancer Hospital and Institute","100565997","a-multi-cohort-study-of-efbemalenograstim-alfa-injection-for-preventing-anc-reduction-in-solid-tumor-patients-post-immune-chemotherapy-100565997",false,"NCT06649448","A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy.","A Multi-cohort, Open-label, Multi-center Exploratory Study of Efbemalenograstim Alfa Injection for Preventing Absolute Neutrophil Count (ANC) Reduction in Solid Tumor Patients Undergoing Immune-chemotherapy Regimen.","EF-001","Inclusion Criteria:\n\n* Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-ups;\n* Aged 18 years or older, regardless of gender;\n* Patients with histologically or cytologically confirmed stage IV small cell lung cancer (SCLC) (as per the 8th edition of the American Joint Committee on Cancer (AJCC)) or T3-4 SCLC with multiple pulmonary nodules or tumors\u002Fnodules too large to be included in a tolerable radiotherapy plan, stage IV non-small cell lung cancer (NSCLC) (as per the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Thoracic Oncology Staging Manual), or stage IV esophageal squamous cell carcinoma (excluding adenosquamous carcinoma) who are not eligible for radical therapy;\n* Patients who have not previously received systemic anti-tumor therapy for advanced\u002Fmetastatic disease. For patients who have received neoadjuvant\u002Fadjuvant and radical concurrent chemoradiotherapy, screening is allowed if the time from the last chemotherapy to recurrence or progression exceeds 6 months. For patients who have received radiotherapy alone, screening is allowed after disease progression;\n* Patients planned to receive immunotherapy combined with at least 2 cycles of chemotherapy regimens with a high risk of severe neutropenia complicated by febrile neutropenia (FN) or medium FN risk regimens combined with ≥ 1 patient-specific risk factor. According to the \\"Chinese Expert Consensus on Diagnosis and Treatment of Neutropenia Induced by Chemotherapy for Cancer (2023 Version)\\", patient-specific factors are also crucial in influencing the risk of FN. The patient factors that increase the risk of FN mainly include: (1) Age \\> 65 years and receiving full-dose chemotherapy; (2) Prior chemotherapy or radiotherapy; (3) Persistent neutropenia (\\>10 days); (4) Bone marrow invasion by tumor; (5) Recent surgery and\u002For open trauma; (6) Poor overall physical condition with comorbidities such as liver (serum bilirubin \\> 2 times the upper limit of normal (ULN)), kidney (creatinine clearance ≤ 50 ml\u002Fmin), heart, lung, endocrine, and other underlying diseases; (7) Poor nutritional status; (8) Chronic immunosuppression, such as human immunodeficiency virus infection, organ transplantation, and long-term immunosuppression after transplantation; (9) Advanced disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-1;\n* Adequate organ and bone marrow function:\n\n  1. Blood routine examination criteria (without blood transfusion or blood products and without using G-CSF or other hematopoietic stimulating factors within 14 days to correct):\n\n     Hemoglobin (HB) ≥ 80g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet count (PLT) ≥ 100×109\u002FL;\n  2. Biochemical examination criteria:\n\n     Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5´ ULN; if there is liver metastasis, then ALT and AST ≤ 5´ ULN; Serum creatinine ≤ 1.5´ ULN;\n  3. Left ventricular ejection fraction \\> 50%;\n* The investigator judges that the patient can tolerate the treatment with Abegrimacostat Alpha.\n\nExclusion Criteria:\n\n* Patients diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction through clinical examination, electrocardiogram, or other means;\n* Individuals with a history of rubber allergy;\n* Patients who have received radiotherapy for bone lesions (patients who have received radiotherapy for lesions other than bone lesions can be enrolled 4 weeks after treatment);\n* Patients who have undergone bone marrow transplantation or stem cell transplantation;\n* Pregnant or lactating women;\n* Patients with alcoholism or drug abuse that affects their compliance in participating in the study;\n* Known allergy to granulocyte colony-stimulating factors or excipients in the study drug;\n* Use of other investigational drugs within 1 month prior to enrollment in this study;\n* Received treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment;\n* Presence of other primary malignancies, with the following exceptions: 1) Malignancies in complete remission for at least 2 years prior to enrollment and requiring no additional treatment during the study; 2) Non-melanoma skin cancer or malignant lentigo maligna that has been adequately treated and shows no evidence of disease recurrence; 3) Carcinoma in situ that has been adequately treated and shows no evidence of disease recurrence;\n* The investigator believes that the patient has a disease or symptom that makes them unsuitable for participation in this study, or that the study drug may harm the patient\\'s health or affect the assessment of adverse events.","ALL","18 Years",{"count":91,"type":92},200,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study is a multi-cohort, open-label, multi-center exploratory clinical research designed to evaluate the efficacy and safety of Efbemalenograstim alfa Injection in preventing neutropenia (reduction in absolute neutrophil count, ANC) in solid tumor patients undergoing immune checkpoint inhibitor (ICI) combined chemotherapy. A total of 200 solid tumor patients who are scheduled to receive at least 2 cycles of ICI combined chemotherapy will be enrolled. The study is divided into three cohorts:\n\nCohort 1: Small cell lung cancer (SCLC) patients receiving ICI combined with chemotherapy (etoposide + carboplatin\u002Fcisplatin).\n\nCohort 2: Non-small cell lung cancer (NSCLC) patients receiving ICI combined with chemotherapy (platinum-based\u002Ftaxane, pemetrexed\u002Fplatinum).\n\nCohort 3: Esophageal squamous cell carcinoma (ESCC) patients receiving ICI combined with chemotherapy (TP, which stands for cisplatin + taxane).",[98,99,100],"Solid Tumor Cancer","Chemotherapy Induced Neutropenia","G-CSF",[102,103,100,104],"ICI combined with chemotherapy","ANC","Solid Tumor","NOT_YET_RECRUITING","2024-10-17",{"date":108,"type":109},"2024-10-18","ACTUAL",{"date":111,"type":92},"2024-10-10",{"date":113,"type":92},"2026-05-31",{"name":5,"class":6},1]