[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ctit-chemotherapy-induced-thrombocytopenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ctit-chemotherapy-induced-thrombocytopenia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,60,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100612345","phase-2-a-clinical-study-of-hetrombopag-for-prevention-of-thrombocytopenia-induced-by-gemcitabine-plus-cisplatin-in-the-treatment-of-nasopharyngeal-carcinoma-100612345",false,"NCT07252375","A Clinical Study of Hetrombopag for Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma","A Single-Arm, Exploratory, Self-Controlled Clinical Study of Hetrombopag for Secondary Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* 1\\. Aged 18 to 75 years old, regardless of gender;\n* 2\\. Patients with nasopharyngeal carcinoma confirmed by pathological or cytological examination;\n* 3\\. Currently receiving treatment with the Gemcitabine + Cisplatin (GP) regimen at a 21-day cycle, with the lowest platelet count \\\u003C 75×10⁹\u002FL in the previous chemotherapy cycle, and expected to maintain the same chemotherapy regimen for at least 2 more cycles;\n* 4\\. Estimated survival time ≥ 12 weeks;\n* 5\\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;\n* 6\\. Laboratory test indicators meeting the following requirements:\n\n  1. Absolute Neutrophil Count (ANC) \\> 1.0×10⁹\u002FL, Hemoglobin (Hb) \\> 80 g\u002FL;\n  2. Renal function: Creatinine (Cr) ≤ 1.5 × Upper Limit of Normal (ULN) or estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml\u002Fmin (calculated by the Cockcroft-Gault formula);\n  3. Liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; (If the patient has intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN);\n  4. Coagulation function: International Normalized Ratio (INR) of Prothrombin Time (PT) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) within the normal range;\n* 7\\. Females of childbearing potential must agree to use contraception during the study and for 6 months after the study ends; non-lactating females are eligible. Males must agree to use contraception during the study and for 6 months after the study ends;\n* 8\\. No participation in other clinical trials of drugs within 4 weeks prior to enrollment;\n* 9\\. Subjects must understand the study details and voluntarily sign the Informed Consent Form (ICF);\n* 10\\. No severe complications such as active massive gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or non-cancerous fever \\> 38℃;\n* 11\\. Expected to have good compliance and be able to complete follow-up for efficacy and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* 1\\. Thrombocytopenia not caused by cancer therapy occurring within 6 months prior to screening, including but not limited to hepatic cirrhosis with hypersplenism, infection, and bleeding;\n* 2\\. Having other hematopoietic system diseases besides chemotherapy-induced thrombocytopenia, including leukemia, primary immune thrombocytopenia (ITP), myeloproliferative diseases (MPDs), multiple myeloma (MM), myelodysplastic syndromes (MDS), etc.;\n* 3\\. Complicated with bone marrow involvement or bone marrow metastasis;\n* 4\\. Having received pelvic, spinal radiotherapy or large-field bone irradiation within 3 months prior to screening;\n* 5\\. History of any arterial or venous thrombosis occurring within 6 months prior to screening;\n* 6\\. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within 2 weeks prior to screening;\n* 7\\. Severe cardiovascular diseases (e.g., NYHA Cardiac Function Classification Grade III-IV) within 6 months prior to screening, or patients with arrhythmias known to increase thromboembolic risk (such as atrial fibrillation \\[AF\\]), history of coronary artery stenting, angioplasty, or coronary artery bypass grafting (CABG);\n* 8\\. Brain tumor or brain metastasis;\n* 9\\. Having received platelet transfusion within 2 days prior to enrollment;\n* 10\\. Having received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonist drugs (such as eltrombopag, avatrombopag) within 5 days prior to screening;\n* 11\\. Patients with known or anticipated allergy or intolerance to the active ingredient or excipients of Hetrombopag Ethanolamine Tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose \\[L-HPC\\], magnesium stearate, film-coating premix);\n* 12\\. Pregnant or lactating women;\n* 13\\. Patients deemed ineligible for enrollment by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a single-arm, exploratory, self-controlled clinical trial for the prevention of thrombocytopenia induced by gemcitabine plus cisplatin in the treatment of nasopharyngeal carcinoma. It aims to investigate the efficacy and safety of hetrombopag for the secondary prevention of thrombocytopenia caused by gemcitabine plus cisplatin in patients with nasopharyngeal carcinoma. The study protocol has been reviewed and approved by the Institutional Ethics Committee of Fujian Cancer Hospital, allowing the conduct of this clinical study.",[27,28],"Nasopharyngeal Carcinoma (NPC)","CTIT-Chemotherapy Induced Thrombocytopenia","NOT_YET_RECRUITING","2025-11-19",{"date":32,"type":33},"2025-11-26","ACTUAL",{"date":35,"type":21},"2025-11-30",{"date":37,"type":21},"2028-11-30",{"name":39,"class":40},"Fujian Cancer Hospital","OTHER_GOV",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":4},"100611656","phase-2-hetrombopag-for-the-prevention-of-adc-induced-thrombocytopenia-in-breast-cancer-an-exploratory-dual-cohort-phase-2-study-100611656","NCT07243418","Hetrombopag for the Prevention of ADC-Induced Thrombocytopenia in Breast Cancer: An Exploratory, Dual-Cohort, Phase 2 Study","Dual-cohort, Single-arm, Exploratory Phase II Clinical Study of Hetrombopag for Primary\u002FSecondary Prevention of Thrombocytopenia Induced by ADC Drugs in Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age: 18 -75 years old, gender not limited.\n* 2\\. Breast cancer patients diagnosed by histopathological or cytological examination;\n* 3\\. Cohort 1: Planned to receive ADC drug treatment; Cohort 2: Patients who received ADC drug treatment in the previous chemotherapy cycle and had a minimum PLT value of less than 75\\*109\u002FL are expected to maintain the same chemotherapy regimen for ≥2 cycles.\n* 4\\. Expected survival period ≥12 weeks;\n* 5\\. Physical condition ECOG PS score: 0-2 points;\n* 6\\. The laboratory inspection indicators meet the following requirements:\n\n  1. Renal function: Cr≤UNL (upper limit of normal) ×1.5, endogenous creatinine clearance rate (Ccr) ≥55 ml\u002Fmin;\n  2. Liver function: Total bilirubin ≤ULN×1.5; ALT and AST≤ULN×3; If it is intrahepatic cholangiocarcinoma or liver metastasis, the total bilirubin shall not exceed three times the upper limit of normal, and the transaminase shall not exceed five times the upper limit of normal.\n  3. Coagulation function: The international normalized ratio of prothrombin time is ≤ULN×1.5, and some prothrombin times are within the normal range.\n* 7\\. Women of childbearing age agree to use contraception during the study period and for six months after the end of the study. And not a lactating patient; Male patients who agreed to contraception during the study period and for 6 months after the end of the study;\n* 8\\. Those who have not participated in other drug clinical trials within 4 weeks prior to enrollment;\n* 9\\. The subjects can understand the situation of this study and voluntarily sign the informed consent form.\n* 10\\. No serious complications such as active massive gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or non-cancerous fever \\> 38℃;\n* 11\\. Those with good expected compliance can follow up on the therapeutic effect and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* 1\\. Screening or baseline platelet value ≤10×109\u002FL;\n* 2\\. Patients who are currently taking pyrotinib, dalciclib or other CDK4\u002F6 class drugs\n* 3\\. Thrombocytopenia caused by non-tumor treatment occurred within 6 months before screening, including but not limited to liver cirrhosis with hypersplenism, infection and bleeding, etc.\n* 4\\. Suffering from other hematopoietic system diseases except for thrombocytopenia caused by anti-tumor therapy, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma and myelodysplastic syndrome, etc.\n* 5\\. Combined bone marrow invasion or bone marrow metastasis;\n* 6\\. Had received radiotherapy for the pelvis, spine and bone irradiation within 3 months before screening:\n* 7\\. Any history of arterial or venous thrombosis within 6 months prior to the screening;\n* 8\\. There were severe clinical manifestations of bleeding (such as gastrointestinal bleeding, etc.) within 2 weeks before screening;\n* 9\\. Patients with severe cardiovascular diseases (such as NYHA cardiac function score III-IV), arrhythmias known to increase the risk of thromboembolism such as atrial fibrillation, after coronary stent implantation, angioplasty, and after coronary artery bypass grafting within 6 months prior to screening;\n* 10\\. Brain tumors or brain metastases;\n* 11\\. When the absolute value of neutrophils is less than 1.0×109\u002FL and hemoglobin is less than 80g\u002FL, the use of granulocyte colony-stimulating factor and red blood cell, EPO infusion therapy that conforms to clinical routine is allowed.\n* 12\\. Significantly abnormal liver function: For patients without liver metastasis, ALT\u002FAST \\> 3ULN (upper limit of normal value), and TBIL \\> 3ULN; Patients with liver metastasis have ALT\u002FAST≥5ULN and TBIL≥5ULN.\n* 13\\. Abnormal renal function: Serum creatinine ≥1.5ULN or eGFR≤60 ml\u002Fmin (Cockcroft-Gault formula)\n* 14\\. Platelet transfusion was received within 2 days before enrollment;\n* 15\\. Received treatment with human recombinant thrombopoietin (rhTPO), human recombinant interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatracopag) within 10 days before screening;\n* 16\\. Patients who are known or expected to be allergic to or intolerant to the active ingredients or excipients of heltrombopag ethanolamine tablets (excipients include: cellulose-lactose, low-substitution hydroxypropyl cellulose, magnesium stearate, film-coated premixes);\n* 17\\. Pregnant or lactating women;\n* 18\\. Those who were considered unsuitable for inclusion by the researchers.",{"count":49,"type":21},72,[24],"The title of this study is: A two-cohort, single-arm, exploratory Phase II clinical study on the primary\u002Fsecondary prevention ADC drug of heltrombopag for thrombocytopenia caused by breast cancer. This study is a two-cohort, single-arm, open-label, exploratory clinical trial for the prevention of thrombocytopenia caused by ADC drug treatment for breast cancer. This research was supported by Fujian Cancer Hospital. The protocol has been reviewed by the Ethics Committee of Fujian Cancer Hospital, which has agreed to conduct this clinical study.",[28,53],"Breast Cancer",{"date":55,"type":33},"2025-11-21",{"date":35,"type":21},{"date":58,"type":21},"2028-05-30",{"name":39,"class":40},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"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","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.","80 Years",{"count":68,"type":21},106,[70],"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.",[73,28,74],"Solid Tumor Malignancies, Cancer","Thrombocytopenia",[76,77,78,79,80],"Romiplostim N01","Human Interleukin-11","solid tumor","thrombocytopenia","CTIT","2025-09-15",{"date":83,"type":33},"2025-09-22",{"date":85,"type":21},"2025-09",{"date":87,"type":21},"2028-12-31",{"name":89,"class":90},"Jun wang","OTHER",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":96,"conditions":102,"keywords":103,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":4},"100549958","phase-3-a-multicenter-randomized-controlled-study-on-the-treatment-of-refractory-ctit-with-romiplostim-n01-compared-to-recombinant-human-thrombopoietin-100549958","NCT06440824","A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin","Inclusion Criteria:\n\n1. Sign a written informed consent form before enrollment;\n2. Age range from 18 to 75 years old;\n3. Solid tumors or hematological tumors confirmed by tissue or pathology;\n4. CTIT patients caused by anti-tumor therapy;\n5. At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA)\n6. Have not received treatment with Roptistine\u002FRoptistine N01;\n7. ECOG PS score: 0-2;\n8. Platelet value\\\u003C30 × 109\u002FL;\n9. Estimated survival time during screening is ≥ 12 weeks;\n10. Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and the placement of intrauterine devices, etc.) throughout the study period; Excluding female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year after menopause, as well as male participants who have undergone bilateral salpingectomy or ligation;\n11. Voluntarily participate in this study, sign an informed consent form, and have good compliance.\n\nExclusion Criteria:\n\n\\-\n\nPatients with any of the following conditions are not eligible for inclusion in this study:\n\n1. Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;\n2. Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding;\n3. Bone marrow invasion or metastasis;\n4. Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently\u002Fexpected to receive radiation therapy within the three months prior to screening;\n5. Screening for a history of severe cardiovascular disease within the first 6 months, such as congestive heart failure (NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, after coronary stent implantation, angioplasty, and coronary artery bypass grafting;\n6. Any history of arterial or venous thrombosis occurring within the first 6 months of screening;\n7. Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;\n8. Brain tumors or brain metastases;\n9. Urgent treatment is required, such as vena cava syndrome and spinal cord compression syndrome;\n10. Neutrophil absolute value \\\u003C 1.0 × 109\u002FL, hemoglobin \\\u003C 80g\u002FL, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy;\n11. Significant abnormalities in liver function: patients without liver metastasis, ALT\u002FAST\\>3ULN (upper limit of normal value), TBIL\\>3ULN； Patients with liver metastasis are present, ALT\u002FAST≥5ULN，TBIL≥5ULN；\n12. Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml\u002Fmin (Cockcroft Gault formula);\n13. Within the first month prior to screening, patients who have received treatment with loperstine\u002Floperstine N01 or recombinant human thrombopoietin (rhTPO);\n14. Received platelet transfusion within the first 3 days of randomization;\n15. Patients who are known or expected to be allergic or intolerant to Roxetine N01 or rhTPO excipients\n16. HIV infected individuals;\n17. Pregnant or lactating women;\n18. Participated in any clinical study of any other investigational drug or device three months prior to screening;\n19. The researchers believe that participating in the trial poses a significant risk to the health or safety of the subjects, or other circumstances that may affect the efficacy evaluation.",{"count":99,"type":21},60,[101],"PHASE3",[28],[104],"Romiplostim N01，Recombinant Human Thrombopoietin，CTIT","2024-06-03",{"date":107,"type":33},"2024-06-04",{"date":109,"type":21},"2024-06-01",{"date":35,"type":21},{"name":112,"class":90},"Shandong University"]