[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-malignancies-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-malignancies-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100607233","a-multicenter-open-label-randomized-controlled-trial-evaluating-the-efficacy-and-safety-of-romiplostim-n01-in-the-treatment-of-thrombocytopenia-associated-with-concurrentsequential-chemoradiotherapy-and-chemotherapy-combined-withwithout-immunotherapy-in-solid-tumors-100607233",false,"NCT07185893","A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent\u002FSequential Chemoradiotherapy and Chemotherapy Combined With\u002FWithout Immunotherapy in Solid Tumors","Inclusion Criteria:\n\n1. Age:18 to 80 years old (man or female);\n2. Confirmed with solid tumor by pathological histology or cytology examination;\n3. The patient is undergoing concurrent\u002Fsequential radiotherapy ± immunotherapy;\n4. During the treatment period, the patient experienced a decrease in platelets, and the platelet count within the last 3 days before enrollment was 25×10\\^9\u002FL \\\u003C platelet count ≤ 75×10\\^9\u002FL;\n5. The estimated survival period at screening is ≥ 3 months, and it is expected that the current chemotherapy cycle can be used for ≥ 2 cycles;\n6. ECOG 0 - 2;\n7. Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Platelet count ≤ 25×10\\^9\u002FL at baseline;\n2. The patient has previously received treatments for thrombocytopenia, such as thrombopoietin receptor agonists (TOP-RA), recombinant human thrombopoietin (rhTPO), or rhIL-11, etc.;\n3. Patients with hematological disorders, including lymphoma, leukemia, aplastic anemia, primary immune thrombocytopenia, myelodysplastic syndromes, multiple myeloma, and myelodysplastic syndrome, etc.;\n4. Have experienced thrombocytopenia due to non-tumor treatment within the past 6 months, including but not limited to EDTA-dependent pseudo-thrombocytopenia, splenomegaly, infection, bleeding, etc.;\n5. After red blood cell or erythropoietin (EPO) infusion, hemoglobin is still \\\u003C 50g\u002FL, or after granulocyte colony-stimulating factor (G-CSF) treatment, absolute neutrophil count is still \\\u003C 1.0×10\\^9\u002FL;\n6. Have experienced any arterial or venous thrombosis within the past 6 months;\n7. Have suffered from severe cardiovascular diseases (such as NYHA cardiac function class III-IV), increased risk of thrombosis-related arrhythmias (such as atrial fibrillation), coronary artery stent implantation, angioplasty, and coronary artery bypass grafting within the past 6 months;\n8. Have received platelet transfusion within 5 days before randomization or enrollment;\n9. Patients with positive hepatitis C antibody and excessive HCV-RNA detection, positive hepatitis B surface antigen and excessive HBV-DNA detection, patients with severe cirrhosis, positive HIV antibody, or positive syphilis antibody;\n10. During screening, for subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≥ 3 times ULN; for subjects with liver metastasis, ≥ 5 times ULN;\n11. Serum creatinine concentration ≥ 1.5 times ULN or eGFR ≤ 60ml\u002Fmin;\n12. Patients who are allergic or intolerant to the active ingredient or excipients of Romiplostim N01 for injection;\n13. Planning to get pregnant or in the lactation period;\n14. The investigator determines that the patient is not suitable to participate in this trial.","ALL","18 Years","80 Years",{"count":19,"type":20},106,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical trial is to evaluate the safety and efficacy of Romiplostim N01 in patients with solid tumors who are undergoing concurrent\u002Fsequential radiotherapy and chemotherapy（combined with\u002Fwithout immunotherapy）-related thrombocytopenia.\n\nAll eligible patients will be stratified and randomly assigned based on baseline platelet count（Stratification factors: whether the baseline platelet count of the patients is greater than 50×10\\^9\u002FL. ） . All patients will be randomly assigned in a 1:1 ratio to experimental group or control group:\n\nExperimental group: Romiplostim N01 (N=53) Control group：Human Interleukin-11(rhlL-11) (N=53) The main questions this trial aims to answer are: 1. The proportion of patients who received platelet transfusion due to thrombocytopenia during the treatment process, as well as the adjustment, delay and discontinuation of radiotherapy and chemotherapy doses； 2. Can patients treated with Romiplostim N01 restore their platelet count to ≥ 100×10\\^9\u002FL and what is the response rate of patients during the treatment (response criteria: no need for platelet transfusion and PLT increase ≥ 50×10\\^9\u002FL or at least twice the baseline or PLT increase to ≥ 100×10\\^9\u002FL)；3. The safety and tolerance of Romiplostim N01 in treating CTIT.",[26,27,28],"Solid Tumor Malignancies, Cancer","CTIT-Chemotherapy Induced Thrombocytopenia","Thrombocytopenia",[30,31,32,33,34],"Romiplostim N01","Human Interleukin-11","solid tumor","thrombocytopenia","CTIT","NOT_YET_RECRUITING","2025-09-15",{"date":38,"type":39},"2025-09-22","ACTUAL",{"date":41,"type":20},"2025-09",{"date":43,"type":20},"2028-12-31",{"name":45,"class":46},"Jun wang","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":69,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":5},"100583992","phase-1-a-phase-i-study-of-lxp1788-injection-with-advanced-solid-tumors-100583992","NCT06883539","A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.","A Phase I Open-label Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LXP1788 Injection in Patients with Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Written (signed) Informed Consent.\n2. Male or female ≥ 18 years old.\n3. Life expectancy \\> 8 weeks.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available.\n6. Measurable disease per RECIST 1.1.\n7. Willing to have a tumor biopsy or having tissue sample from a previous biopsy available in the tissue bank for analysis that had been collected in the past 3 years.\n\nExclusion Criteria:\n\n1. Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (\\\u003C 6 months before enrollment), COPD with frequent exacerbations, uncontrolled hypertension (systemic blood pressure \\>= 160 mmHg and\u002For diastolic blood pressure \\>= 100 mmHg with or without anti-hypertensive medication), recent CVA (\\\u003C 6 months before enrollment), or active infection which requires treatment withintravenous antibiotics.\n2. Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of steroids to control their CNS disease.\n\n   Asymptomatic patients with metastatic brain disease who have been on a stable dose of steroids for less than 14 days prior to screening.\n3. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n   Bone marrow:\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL\n   * Platelet count \\\u003C 100 x 10\\^9\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Having had a blood transfusion within 2 weeks of screening date is also not allowed.\n\n   Hepatic:\n   * Total bilirubin \\> 1.5 x ULN\n   * AST and ALT \\> 3 x ULN if no liver metastases\n   * AST and ALT \\> 5 x ULN in the presence of liver metastases\n\n   Renal:\n\n   ⚫ Estimated creatinine clearance (CrCL) \\\u003C 60 mL\u002Fmin per the Cockcroft and Gault formula\n4. Known history of human immunodeficiency virus (HIV)-1 or -2 infection.\n5. Psychiatric disorders that would compromise the patient's compliance or ability to give consent.\n6. Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.\n7. Toxicities from any prior therapy, surgery, or radiotherapy that did not resolve to grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, with the exception of alopecia, skin hyperpigmentation or hypopigmentation.\n8. Underlying medical conditions that, in the investigator's opinion, will make the administration of LXP1788 Injection hazardous or obscure the interpretation of toxicities or adverse events.\n9. Exposure to any other investigational or commercial anti-cancer agents or curative therapies within 28 days or 5 half-lives (whichever is shorter), before the first dose of LXP1788 Injection. Exposure to radiation therapy for non-curative purposes or pain control may be permitted under the judgement of the investigator.\n10. Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions, or requirements.\n11. Pregnancy or breast feeding.\n12. Women or men of childbearing potential not willing to use effective means of contraception.\n13. Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).\n14. History of allergic reactions to any component of LXP1788 Injection.",{"count":56,"type":20},24,[58],"PHASE1","A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor.\n\nPatients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected.\n\nThe main questions it aims to answer are:\n\n1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection\n2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection",[26,61,62,63,64,65,66,67,68],"Solid Cancers","Solid Tumor Cancer","Solid Tumor, Unspecified, Adult","Solid Tumour","Solid Tumors Refractory to Standard Therapy","HCC - Hepatocellular Carcinoma","RCC, Renal Cell Cancer","Pancreas Cancer",[70,71,72,73,32,74,75,76,77,78],"Phase 1","LXP1788","LAUNXP","DBPR114-101","cancer","Hepatocellular carcinoma","Pancrease Cancer","Renal Cell Carcinoma","Tyrosine kinase inhibitor","RECRUITING","2025-03-12",{"date":82,"type":39},"2025-03-19",{"date":84,"type":39},"2024-12-31",{"date":86,"type":20},"2028-06-30",{"name":88,"class":89},"LaunXP Biomedical Co., Ltd.","INDUSTRY"]