[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chipscreen Biosciences, Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":331},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,44,66,89,111,130,152,173,193,215,239,263,289,310],{"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":43},"100639830","phase-1-a-phase--study-of-cs08399-in-participants-with-mtap-deleted-solid-tumors-and-lymphoma-100639830",false,"NCT07583771","A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic and Preliminary Efficacy of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","Inclusion Criteria:\n\n1. Understand and sign the informed consent form voluntarily.\n2. ≥18 years old when signing the informed consent, regardless of sex.\n3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed\u002Frefractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing.\n4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria.\n5. For glioblastoma: KPS score ≥60. For other solid tumors and lymphoma: ECOG performance status of 0 or 1.\n6. Adequate organ function.\n7. Life expectancy ≥3 months.\n8. Able to swallow and retain oral study medication.\n\nExclusion Criteria:\n\n1. Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs\u002Fdevices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).\n2. Previously received MAT2A or PRMT5 inhibitors.\n3. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.\n4. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1.\n5. History of other primary malignancies within 5 years prior to the first dose.\n6. For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.\n7. Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.\n8. Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.\n9. Active infection requiring systemic anti-infective treatment at screening.\n10. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms.\n11. Uncontrolled or significant cardiovascular disease.\n12. Poorly controlled diabetes.\n13. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption.\n14. History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose.\n15. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening.\n16. Serious thromboembolic events within 6 months prior to the first dose.\n17. Active tuberculosis at screening.\n18. Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening.\n19. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.\n20. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. History of alcohol abuse or drug abuse.\n22. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.\n23. Pregnant or breastfeeding women.\n24. Other conditions deemed unsuitable for participation in this trial by the investigator.","ALL","18 Years",{"count":19,"type":20},186,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).",[26,27,28,29,30],"Pancreatic Adenocarcinoma","Non Small Cell Lung Cancer","Advanced Solid Tumors","Lymphoma","Diffuse Large B-Cell Lymphoma (DLBCL)","NOT_YET_RECRUITING","2026-05-07",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":20},"2026-06",{"date":39,"type":20},"2030-01",{"name":41,"class":42},"Chipscreen Biosciences, Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100638530","chiglitazar-added-to-sglt-2-inhibitors-for-type-2-diabetes-100638530","NCT07580638","Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes","Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive.\n* Diagnosis of Type 2 Diabetes Mellitus (T2DM) .\n* Receiving stable-dose SGLT-2 inhibitor monotherapy or in combination with one other oral antidiabetic drug for at least one month prior to screening, but with inadequate glycemic control, defined as HbA1c ≥ 7.5%.\n* Must be willing to participate and have provided written informed consent.\n\nExclusion Criteria:\n\n* Current or routine use of insulin therapy.\n* Use of three or more antidiabetic drugs within one month prior to screening.\n* Current treatment with a thiazolidinedione (TZD) or a GLP-1 receptor agonist (GLP-1 RA).\n* Prior treatment with Chiglitazar Sodium.\n* Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C).\n* Laboratory findings meeting any of the following criteria: a) Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN); b) Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².","75 Years",{"count":53,"type":20},3550,"OBSERVATIONAL","The goal of this observational study is to evaluate the comprehensive clinical efficacy, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with Type 2 Diabetes Mellitus (T2DM) . The main questions it aims to answer are:\n\nWhat is the real-world effectiveness of Chiglitazar, when added to an SGLT-2 inhibitor, on glycemic control? What are the effects of this combination therapy on cardiovascular, renal, and hepatic outcomes? What is the overall safety of this treatment regimen?\n\nThis is a non-interventional study. Participants will be prescribed Chiglitazar or other oral antidiabetic drugs by their treating physician as part of their routine clinical care. For the purpose of this registry study, data will be collected from their regular medical follow-ups. Participants will:\n\nAttend regular follow-up visits as part of their standard diabetes care. Have data collected from their routine clinical assessments.",[57],"T2DM (Type 2 Diabetes Mellitus)","2026-05-05",{"date":60,"type":35},"2026-05-12",{"date":62,"type":20},"2026-07-18",{"date":64,"type":20},"2028-07-18",{"name":41,"class":42},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100632867","bioequivalence-study-of-chiglitazarmetformin-extended-release-tablets-100632867","NCT07519265","Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Tablets","Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions","Inclusion Criteria:\n\n* Healthy male or female participants；\n* Age from 18 to 45 years, inclusive；\n* Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；\n* From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；\n* Voluntarily agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine\u002Fmetabolic disorders;\n* Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;\n* Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;\n* Surgery within 3 months prior to screening or planned surgery during the study period;\n* Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;\n* History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;\n* Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;\n* Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;\n* History of drug or substance abuse, or a positive alcohol or urine drug screening test;\n* Intolerance to venipuncture, or a history of fainting in response to needles or blood;\n* Fasting blood glucose \\> 6.1 mmol\u002FL or \\\u003C 3.9 mmol\u002FL at screening, and\u002For a history of hypoglycemia\u002Fsyncope;\n* Participation in any interventional clinical trial within 3 months prior to screening;\n* Blood donation or significant blood loss (\\> 200 mL) within 3 months prior to screening;\n* Pregnant or lactating women;\n* Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;\n* Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;\n* Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;\n* Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;\n* Glomerular Filtration Rate (GFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m²;\n* Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \\\u003C 50 mmHg or ≥ 90 mmHg at screening;\n* A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody;\n* Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;\n* Plans to or is required to engage in strenuous physical activity or exercise during the study period;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.",true,"45 Years",{"count":76,"type":20},64,[78],"NA","This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.",[57],"2026-04-07",{"date":83,"type":35},"2026-04-09",{"date":85,"type":20},"2026-07-09",{"date":87,"type":20},"2026-08-10",{"name":41,"class":42},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":43},"100534922","phase-1-a-study-of-cs23546-in-subjects-with-advanced-tumors-100534922","NCT06245122","A Study of CS23546 in Subjects With Advanced Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CS23546 in Subjects With Advanced Tumors","Key Inclusion Criteria:\n\n1. Male or female and ≥18 years of age on day of signing informed consent.\n2. Histologically or cytologically confirmed unresectable advanced recurrent\u002Frefractory solid tumor or lymphoma that is failure or or intolerant of all standard therapy or for which no standard therapy is available.\n3. Individuals are required to provide tumor tissue samples for prospective detection of Programmed cell death 1 ligand 1 (PD-L1) expression and\u002For Microsatellite instability (MSI) \u002F the DNA mismatch repair (MMR) status. Subjects who cannot be provided during the dose escalation phase will be evaluated by the researchers and sponsors before deciding whether to enroll.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n5. Adequate organ function.\n6. Life expectancy ≥12 weeks.\n7. Dose expansion phase: Cohort 1, Subjects with urothelial carcinoma. Cohort 2, Subjects with Extranodal NK\u002FT-cell lymphoma (NKTCL). Cohort 3, Subjects with soft tissue sarcoma. Cohort 4, Subjects with PD-L1 expression positive and\u002For microsatellite-instability-high (MSI-H) \u002F mismatch-repair-deficient (dMMR) advanced solid tumors or lymphoma\n\nKey Exclusion Criteria:\n\n1. Received anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs\u002Fdevices that have not been approved for marketing within 28 days before the first medication.\n2. History of ≥ Grade 3 immune related Adverse Events (irAEs) or termination of treatment due to irAEs during prior treatment with Programmed death 1 (PD-1) \u002FPD-L1 antibody.\n3. Active autoimmune diseases present during the screening period and systemic treatment was received within 2 years before the first medication. Individuals who only require hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids used for adrenal or pituitary insufficiency) can be enrolled.\n4. Presence of central nervous system metastasis and\u002For meningeal metastasis.\n5. Dose expansion phase: Subjects with solid tumors or lymphoma who have previously received PD-L1 inhibitors and belong to primary resistance.",{"count":97,"type":20},156,[23],"The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced tumors.",[101],"Advanced Tumors","RECRUITING","2026-04-03",{"date":105,"type":35},"2026-04-06",{"date":107,"type":35},"2024-03-27",{"date":109,"type":20},"2027-05-31",{"name":41,"class":42},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":73,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100632232","phase-1-food-effect-and-multiple-dose-study-of-chiglitazarmetformin-extended-release-tablets-100632232","NCT07511010","Food Effect and Multiple-Dose Study of Chiglitazar\u002FMetformin Extended-Release Tablets","A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets","Inclusion Criteria:\n\n* Healthy male or female participants；\n* Age from 18 to 45 years, inclusive；\n* Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；\n* From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；\n* Voluntarily agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine\u002Fmetabolic disorders;\n* Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;\n* Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;\n* Surgery within 3 months prior to screening or planned surgery during the study period;\n* Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;\n* History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;\n* Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;\n* Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;\n* History of drug or substance abuse, or a positive alcohol or urine drug screening test;\n* Intolerance to venipuncture, or a history of fainting in response to needles or blood;\n* Fasting blood glucose \\> 6.1 mmol\u002FL or \\\u003C 3.9 mmol\u002FL at screening, and\u002For a history of hypoglycemia\u002Fsyncope;\n* Participation in any interventional clinical trial within 3 months prior to screening;\n* Blood donation or significant blood loss (\\> 200 mL) within 3 months prior to screening;\n* Pregnant or lactating women;\n* Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;\n* Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;\n* Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;\n* Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;\n* Glomerular Filtration Rate (GFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m²;\n* Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \\\u003C 50 mmHg or ≥ 90 mmHg at screening;\n* Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;\n* Plans to or is required to engage in strenuous physical activity or exercise during the study period;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.",{"count":119,"type":20},28,[23],"This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study.\n\nThe FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar\u002FMetformin extended-release tablets in healthy adult Chinese participants.\n\nThe multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar\u002FMetformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.",[57],"2026-04-01",{"date":105,"type":35},{"date":126,"type":20},"2026-10-08",{"date":128,"type":20},"2026-10-26",{"name":41,"class":42},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":43},"100554353","phase-3-a-study-of-tucidinostat-in-combination-with-sintilimab-and-bevacizumab-in-msspmmr-colorectal-cancer-patients-100554353","NCT06497985","A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS\u002FpMMR Colorectal Cancer Patients","A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS\u002FpMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies","Inclusion Criteria:\n\n1. Provide written informed consent for the study.\n2. Age ≥18 years and ≤75 years.\n3. Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.\n4. Has been previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) .\n5. Have confirmed MSS or MSI-L, or pMMR.\n6. KRAS status must have been previously determined (mutant or wild-type) .\n7. Measurable disease per RECIST v1.1.\n8. ECOG PS 0 or 1.\n9. Adequate organ function.\n10. Expected survival \\>12 weeks.\n\nExclusion Criteria:\n\n1. Prior use of HDAC inhibitor.\n2. Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.\n3. Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.\n4. Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.\n5. Received radiotherapy within 28 days before the first dose of study treatment.\n6. If randomized into the control group, it is planned to use the combination of tucidinostat with PD-1 inhibitor and bevacizumab after the end of study treatment.\n7. History of autoimmune diseases requiring systemic treatment within 2 years before the first dose of study treatment.\n8. Known history of primary immunodeficiency.\n9. Received systemic immunosuppressive drugs within 28 days before the first dose of study treatment.\n10. Received systemic immunostimulatory drugs within 28 days before the first dose of study treatment.\n11. Received major surgery within 28 days before the first dose of study treatment.\n12. Received a live vaccine within 28 days before the first dose of study treatment or planned to receive during the study period.\n13. Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.\n14. Has uncontrolled diabetes assessed by investigators within 7 days before the first dose of study treatment.\n15. Has symptomatic and untreated central nervous system (CNS) metastases.\n16. Has uncontrollable or major cardiovascular disease.\n17. History of cerebrovascular accidents within 6 months before the first dose of study treatment.\n18. History of serious thromboembolism within 6 months before the first dose of study treatment.\n19. History of gastrointestinal perforation and\u002For fistula etc., within 6 months before the first dose of study treatment.\n20. Obvious gastrointestinal abnormalities during the screening period,which may affect the intake, transport or absorption of drugs.\n21. Known history of bleeding disorders or coagulopathy.\n22. Anticoagulants or thrombolytic agents are being used during the screening period.\n23. Uncontrolled pleural\u002Fabdominal\u002Fpericardial effusion that was drained within 14 days before the first dose of study treatment.\n24. Suspected interstitial lung disease (ILD) or pulmonary fibrosis or pulmonary inflammation requiring treatment.\n25. Severe or active infection requiring systemic therapy.\n26. Known active pulmonary tuberculosis.\n27. Active hepatitis B or hepatitis C.\n28. HIV positive or syphilis infection.\n29. History of malignant tumor.\n30. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n31. History of hypersensitivity to study drugs, or any of its excipients.\n32. History of alcohol or drug abuse.\n33. Unwilling or unable to comply with procedures required in this protocol.\n34. Pregnant or breast-feeding women. Male\u002FFemale is unwilling or unable to use a highly effective method of birth control.\n35. Any condition not suitable for participating in the trial in the opinion of the Investigator.",{"count":138,"type":20},430,[140],"PHASE3","A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS\u002FpMMR colorectal cancer patients.",[143],"Colorectal Cancer","2026-03-18",{"date":146,"type":35},"2026-03-19",{"date":148,"type":35},"2024-12-06",{"date":150,"type":20},"2028-09-30",{"name":41,"class":42},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":43},"100627181","phase-3-chiauranib-plus-pd-1-inhibitor-albumin-paclitaxel-and-gemcitabine-in-patients-with-metastatic-pancreatic-ductal-adenocarcinoma-100627181","NCT07445295","Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","A Phase III Study of Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the written informed consent form.\n2. Age 18-75 years on the day of signing the informed consent form, male or female.\n3. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.\n4. No prior systemic therapy for metastatic pancreatic ductal adenocarcinoma. Participants who have received prior induction chemotherapy, concurrent radiotherapy, or adjuvant\u002Fneoadjuvant chemotherapy with curative intent, the interval of recurrence or metastasis must be at least 6 months after the last treatment.\n5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Previously received local therapy lesion can be considered as measurable lesion unless imaging-confirmed progression.\n6. ECOG Performance Status 0 or 1.\n7. Life expectancy≥3 months.\n8. Major organ functions meet the following criteria(no blood transfusions, hematopoietic growth factors, albumin and other medications considered by the investigator to be corrective therapy within 14 days prior to examination, except for iron supplements): Hematology: hemoglobin≥90g\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets≥100×10\\^9\u002FL. Biochemistry: serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, AST\u002FALT≤2.5×ULN (≤5×ULN for patients with hepatic metastasis). Coagulation profile: INR \\\u003C 1.5×ULN(for participants undergoing prophylactic anticoagulation therapy, investigators should determine whether the INR is within a safe and effective therapeutic range).\n\nExclusion Criteria:\n\n1. Histological or cytological confirmed other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, pancreablastoma, etc.\n2. During screening, tumor invades major vessels (e.g., pulmonary artery, superior vena cava, or inferior vena cava) and significant risk of hemorrhage judged by the investigator; or known history of aneurysm.\n3. Presence of active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease during the screening period. However, enrolment is permitted for subjects who meet the following requirements and have measurable lesion outside the CNS: asymptomatic after treatment and stable on imaging for at least 28 days prior to the first dose (e.g., no new or enlarging brain metastases) and have been off systemic glucocorticosteroids and anticonvulsant medications for at least 14 days prior to the first dose.\n4. Presence of clinically symptomatic pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time\u002Fmonth) during the screening period.\n5. Previous received Aurora kinase inhibitors, or systemic treatment of VEGF\u002FVEGFR inhibitors such as bevacizumab, sorafenib, sunitinib, amlotinib, apatinib, and endostar, or immunotherapy drugs of PD-1, PD-L1, CTLA-4 inhibitors, etc.\n6. Previous radiation therapy, chemotherapy, immunotherapy, targeted therapy within 28 days prior to the first dose. Chinese patent medicine witn anti-malignancy effect approved by National Medical Products Administration within 14 days prior to the first dose.\n7. Adverse effects of prior antineoplastic therapy that have not returned to ≤grade 1 of CTCAE v5.0 criteria (except for alopecia without safety risk judged by the investigator and laboratory tests specified in Inclusion Criterion 8).\n8. Presence of peripheral neuropathy of CTCAE v5.0 criteria, Grade 2 or higher.\n9. Major surgery (craniotomy, thoracotomy, or laparotomy) or serious unhealed wounds, ulcers, or fractures within 28 days prior to the first dose. Needle biopsy or other minor surgery (except for intravenous infusion) within 7 days prior to the first dose.\n10. Significant arterial\u002Fvenous thrombotic events within 6 months prior to first dose, such as deep vein thrombosis and pulmonary embolism. Superficial vein thrombosis without safety risk judged by the investigator is permitted.\n11. Cardiac dysfunction or clinically meaningful cardiovascular disease, including: (1)New York Heart Association (NYHA) grade III\\~IV congestive cardiac failure, unstable angina pectoris, and\u002For myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) \\\u003C50% at screening. (2)Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy). (3)Clinically significant history of prolonged QTc interval, or QTcF interval \\>470ms for females or \\>450 ms for males during the screening period. (4)Coronary heart disease with symptoms requiring medication. (5)Documentation of hypertension treatment with≥3 antihypertensive medications simultaneously within 14 days before the first dose of medication or systolic blood pressure≥140 mmHg and\u002For diastolic blood pressure≥90 mmHg during the screening period (resting state, measured approximately every 5 minutes, averaged after three consecutive measurements, rounded to the nearest integer). (6)History of hypertensive crisis or hypertensive encephalopathy. (7)Other cardiovascular disease judged by the investigator to be unsuitable for enrolment.\n12. Active bleeding within 2 months prior to the first dose, or taking anticoagulants, such as warfarin, phenprocoumon (prophylactic low-dose aspirin and low-molecular heparin are permitted) during the screening period, or at high risk of bleeding judged by the investigator during screening period (e.g., esophageal varix associated with bleeding risk, locally active ulcer lesions, positive fecal occult blood that can not exclude gastrointestinal bleeding, intermittent haemoptysis) .\n13. Presence of significant gastrointestinal abnormalities during the screening period that may interfere with drug intake, transit or absorption (e.g. inability to swallow, chronic diarrhoea, post-small bowel resection or total gastrectomy), according to the investigator's judgment.\n14. History of gastrointestinal perforation and\u002For fistula, peptic ulcer disease, intestinal obstruction (including incomplete intestinal obstruction that requires parenteral nutrition), or biliary obstruction within 6 months prior to the first dose.\n15. History of other malignant tumors within 3 years prior to the first dose, except for those treated with expected curative outcomes, such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer, and papillary thyroid microcarcinoma.\n16. For urine protein≥2+ by urinalysis during the screening period, a 24-hour urine protein quantification test should be performed. The subject cannot be enrolled if the quantified urine protein is≥1g\u002F24h. If the quantified urine protein is \\\u003C1g\u002F24h, the subject can still be enrolled.\n17. Known severe hypersensitivity to any monoclonal antibody. Known hypersensitivity to Chiauranib capsules or any of its components. Known contraindications to albumin-paclitaxel and gemcitabine chemotherapy (refer to descriptions for albumin-paclitaxel and gemcitabine).\n18. Presence of active tuberculosis during the screening period. Suspected subjects should be excluded by a combination of chest imaging, sputum, and through clinical signs and symptoms.\n19. Presence of active hepatitis, positive HBsAg or positive HBcAb must undergo further HBV-DNA testing, enrollment is permitted only if the results meet either of the following criteria: within the normal range of the investigational site or \\\u003C200 IU\u002FmL. Positive HCV-Ab with positive viral replication. Positive of HIV. Active syphilis infection (syphilis-specific antibody and nonspecific antibody positive). (Note: Priority for qualitative detection and quantitative detection of viral replication when needed).\n20. Previous or screening chest imaging showing the presence of interstitial lung disease or pulmonary fibrosis or non-infectious pneumonitis requiring treatment.\n21. Active infection during the screening period, including systemic anti-infective therapy requiring oral or intravenous infusion within 2 weeks prior to the first dose, unexplained fever (≥38°C) during the screening period.\n22. Screening period or history of allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation.\n23. Unexplained weight loss of 5% or more between signing the ICF and the first dose.\n24. NRS pain score ≥4 after analgesic medication during the screening period.\n25. Severe central nervous system or psychiatric illness during the screening period.\n26. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion: vitiligo, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy, celiac disease controlled by diet alone, type I diabetes with good glycaemic control.\n27. Received corticosteroid medication within 14 days before the first dose(exceed 10 mg\u002Fday of prednisone or its equivalent) or other immunosuppressive drugs. The following are exceptions to this criterion: intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), corticosteroids as prophylaxis for allergic reactions (e.g. before imaging or chemotherapy), adrenal steroid replacement(not to exceed 10 mg\u002Fday of prednisone or its equivalent).\n28. Administration of a live attenuated vaccine within 28 days prior to the first dose. Live vaccines include but are not limited to: measles, epidemic parotitis, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin, typhoid fever vaccines. Injectable inactivated seasonal influenza vaccines are allowed, but intranasal live attenuated influenza, vaccines are not allowed.\n29. Pregnant or lactating females. Female participants of childbearing potential or male subjects whose partners of childbearing potential are unable or unwilling to use effective contraception (e.g., IUDs, subcutaneous implant, sterilisation, long-acting contraceptive injections, compound of short-acting oral contraceptives, etc.) from 7 days prior to the first dose until 6 months after the end of treatment. Female participants of childbearing potential must have a blood pregnancy test negative within 7days prior to the first dose. Note: Females with fertility include those who have experienced menarche and have not undergone successful artificial sterilization procedures (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not reached menopause.\n30. During the screening period, the investigator deems other conditions unsuitable for participation in this trial, such as clinically unacceptable worsening symptoms or signs of pancreatic cancer progression, comorbidities, concurrent treatments, or any laboratory abnormalities that may interfere with the assessment of efficacy and safety outcomes.",{"count":160,"type":20},558,[140],"This is a phase III, multi-center study to evaluate the efficacy and safety of chiauranib plus plus toripalimab, albumin-paclitaxel and gemcitabine as first-line therapy in patients with metastatic pancreatic ductal adenocarcinoma. The study includes two period: Run-in period and Randomized controlled period. The Run-in period is a single-arm, open-label study enrolling approximately 20 participants, who received the combination therapy of chiauranib plus toripalimab, albumin-paclitaxel and gemcitabine. The Randomized controlled period is a randomized, double-blind, parallel-controlled study enrolling approximately 538 participants, who are 1:1 randomly assigned to the experimental arm(chiauranib plus Toripalimab, albumin-paclitaxel and gemcitabine) or the control arm (Chiauranib placebo plus toripalimab placebo, albumin-paclitaxel and gemcitabine).",[164],"Metastatic Pancreatic Ductal Adenocarcinoma","2026-02-28",{"date":167,"type":35},"2026-03-03",{"date":169,"type":20},"2026-03-31",{"date":171,"type":20},"2028-11-30",{"name":41,"class":42},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":73,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100624621","pilot-bioequivalence-study-of-chiglitazarmetformin-extended-release-tablets-100624621","NCT07412015","Pilot Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Tablets","Pilot Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions","Inclusion Criteria:\n\n* Healthy male or female participants；\n* Age from 18 to 45 years, inclusive；\n* Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；\n* From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；\n* Voluntarily agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine\u002Fmetabolic disorders;\n* Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;\n* Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;\n* Surgery within 3 months prior to screening or planned surgery during the study period;\n* Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;\n* History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;\n* Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;\n* Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;\n* History of drug or substance abuse, or a positive alcohol or urine drug screening test;\n* Intolerance to venipuncture, or a history of fainting in response to needles or blood;\n* Fasting blood glucose \\> 6.1 mmol\u002FL or \\\u003C 3.9 mmol\u002FL at screening, and\u002For a history of hypoglycemia\u002Fsyncope;\n* Participation in any interventional clinical trial within 3 months prior to screening;\n* Blood donation or significant blood loss (\\> 200 mL) within 3 months prior to screening;\n* Pregnant or lactating women;\n* Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;\n* Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;\n* Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;\n* Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;\n* Glomerular Filtration Rate (GFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m²;\n* Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \\\u003C 60 mmHg or ≥ 90 mmHg at screening;\n* A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody;\n* Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;\n* Plans to or is required to engage in strenuous physical activity or exercise during the study period;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.",{"count":181,"type":20},24,[78],"This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.",[57],"2026-02-09",{"date":187,"type":35},"2026-02-17",{"date":189,"type":20},"2026-05-27",{"date":191,"type":20},"2026-06-29",{"name":41,"class":42},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":43},"100588942","phase-3-tucidinostat-in-combination-with-chop-in-newly-diagnosed-peripheral-t-cell-lymphoma-with-follicular-helper-of-t-cell-phenotype-100588942","NCT06947967","Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype","A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype (SWIFT 02)","Inclusion Criteria:\n\n1. Provide written informed consent for the study.\n2. Male or female, age ≥ 18 years and ≤80 years.\n3. ECOG PS 0,1 or 2.\n4. Participants with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH), including: a. angioimmunoblastic T-cell lymphoma, b. follicular helper T-cell lymphoma, follicular type, c. follicular helper T-cell lymphoma, NOS.\n5. At least one measurable disease according to the Lugano 2014 Classification.\n6. Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):\n\n(1)Hematology values:Hemoglobin (Hb)≥90g\u002FL,Absolute neutrophil count (ANC) ≥1.5×10 9\u002FL, platelets ≥90×10 9\u002FL (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN),Total bilirubin ≤1.5 × ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT, AST≦5×ULN if liver involved).\n\n7.Expected survival≥6 months.\n\nExclusion Criteria:\n\n1. Presence of CNS involvement.\n2. Received prior therapies targeting lymphoma.\n3. Participants planned for autologous or allogeneic transplant as consolidation after CR.\n4. Participants with any other malignancy in past 5 years, except for local tumors that have been cured.\n5. Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis).\n6. Any investigational therapy within 3 months.\n7. Contraindication to any of the individual components of CHOP.\n8. Corticosteroid use \\> 30 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control, and the following conditions for inclusion must be met, a. participants receiving corticosteroid treatment with ≤ 30 mg\u002Fday of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization, b. If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 7 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment.\n9. Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.\n10. Have uncontrolled or significant cardiovascular disease, including a. Grade Ⅱ or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% during screening stage b.Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al) c.History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male), QTc≥470ms（female）at screening d.Symptomatic coronary heart disease requiring treatment e.Any other cardiovascular disease which is inappropriate for the study according to investigators' judgment.\n11. History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.\n12. Participants with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.\n13. History of deep vein thrombosis or pulmonary embolism.\n14. History of active bleeding within 2 months prior to the start of Cycle 1;or participants receiving anticoagulation therapy; or participants with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). participants with bleeding led by lymphoma according to investigators' judgment are eligible.\n15. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures were performed within 4 weeks. Tissue biopsy or other minor surgical procedure (other than venipuncture for intravenous fluids) within 7 days.\n16. Active infection requiring systemic treatment (oral, intravenous infusion) was present within 2 weeks prior to the first dose. Participants receiving prophylactic antibiotic therapy (e.g., interstitial pneumonia) may be enrolled.\n17. HBsAg or HBcAb positive with virus replication (except for virus replication positive that non-active hepatitis B assessed by investigators), HCV-Ab positive with virus replication positive, active syphilis infection (positive for syphilitic-specific and non-specific antibodies).\n18. History of HIV infection, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or stem cell transplantation.\n19. Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements\u002F treatment.\n20. Drug or alcohol abuse.\n21. Women patients of childbearing potential who are unwilling or unable to use an effective method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of tucidinostat\u002Fplacebo or CHOP, whichever is the latest, or the spouses of male participants.\n22. Any other condition which is inappropriate for the study according to investigators' judgment.","80 Years",{"count":202,"type":20},224,[140],"A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype",[206],"Lymphoma, T-Cell, Peripheral","2025-09-09",{"date":209,"type":35},"2025-09-15",{"date":211,"type":35},"2025-08-12",{"date":213,"type":20},"2032-12",{"name":41,"class":42},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":226,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},"100602889","phase-1-a-study-to-evaluate-the-efficacy-and-safety-of-cs32582-in-participants-with-moderate-to-severe-plaque-psoriasis-100602889","NCT07129382","A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib\u002FII Study to Evaluate the Efficacy and Safety of CS32582 Capsule in Adult Patients With Moderate to Severe Plaque Psoriasis","MECAP","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form (ICF) after fully understanding the trial.\n* Age 18-70 years (inclusive) at consent, any gender\n* Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening.\n* Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed).\n* Moderate-to-severe disease at screening\u002Frandomization: PASI≥12, sPGA≥3, and BSA≥10%;\n* Candidate for phototherapy or systemic therapy per investigator's judgment.\n* Women of childbearing potential and males: Agreement to use highly effective contraception from consent until 30 days post-last dose.\n\nExclusion Criteria:\n\n* Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis) .\n* Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment.\n* Immune-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs.\n* History of severe drug allergies.\n* Major surgery within 2 months before randomization or planned during the study.\n* Drug\u002Falcohol abuse within 6 months before screening.\n* Uncontrolled hypertension at screening (SBP \\>160 mmHg or DBP \\>100 mmHg).\n* Myocardial infarction, unstable angina, TIA, stroke, PCI, or CABG within 6 months before screening.\n* NYHA Class III\u002FIV heart failure at screening.\n* History of malignancy or lymphoproliferative disorders within 5 years (exceptions: basal cell carcinoma, localized squamous cell carcinoma, or cervical carcinoma in situ cured ≥1 year).\n* Prosthetic joint infection (unless prosthesis removed\u002Freplaced ≥2 months before randomization).\n* History of opportunistic infections (e.g., PJP, histoplasmosis, coccidioidomycosis).\n* Active\u002Flatent TB infection (positive IGRA without clinical manifestations).\n* Herpes infection:a) Active herpes zoster\u002Fsimplex (HSV-1\u002F2) at screening;b) History of severe herpes (disseminated disease, multidermatomal HSV, encephalitis, ophthalmic herpes, or recurrent zoster \\[≥2 episodes in 2 years\\]).\n* History of severe bacterial, fungal, or viral infection requiring hospitalization for IV antibiotic or antiviral administration within 2 months before randomization.\n* History of live vaccine administration within 2 months before randomization or plans to receive a live vaccine during the study period.\n* Evidence of active infection and\u002For febrile illness requiring systemic anti-infective therapy within 2 weeks before randomization.\n* Abnormal virology at screening:\n\n  * HBsAg(+) or HBcAb(+) with detectable HBV-DNA\n  * HCV Ab(+) with detectable HCV-RNA\n  * History of HIV infection or HIV Ab(+)\n  * Treponema pallidum Ab(+) with positive RPR\u002FTRUST\n* Prior use of TYK2 inhibitors (e.g., deucravacitinib).\n* Use of any of the following therapeutic agents within 6 months before randomization:\n\n  * IL-12\u002F23, IL-17, or IL-23 inhibitors (ustekinumab, secukinumab, tildrakizumab, ixekizumab, guselkumab)\n  * Rituximab or other B-cell depleting agents\n  * Leflunomide\n* Use of any of the following therapeutic agents within 3 months before randomization: Integrin pathway modulators (natalizumab) or B\u002FT-cell modulators (alemtuzumab, abatacept, vedolizumab).\n* Use of TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab) within 2 months before randomization.\n* Any biologic psoriasis therapy within 3 months or 5 half-lives (whichever longer) before randomization.\n* Use of systemic non-biologic psoriasis agents and\u002For any systemic immunosuppressants within 4 weeks before randomization, including but not limited to: apremilast, methotrexate, azathioprine, cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate, hydroxyurea, tacrolimus, oral\u002Finjectable corticosteroids, retinoids, calcitriol\u002Fanalogs, psoralen, sulfasalazine, fumarates).\n* Use of Lithium, antimalarials, or intramuscular gold preparations within 4 weeks before randomization.\n* Use of any botanical agents for the treatment of psoriasis or other immune disorders within 4 weeks before randomization, including herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals.\n* Received phototherapy within 4 weeks before randomization.\n* Use of medicated shampoos and\u002For body washes within 2 weeks before randomization, including but not limited to products containing: corticosteroids, coal tar, \\>3% salicylic acid, vitamin D3 analogs.\n* Use of any topical agents that may affect psoriasis symptoms within 2 weeks before randomization.\n* Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) before randomization, OR current participation in other trial.\n* Laboratory values meeting any of the following criteria during screening or before randomization:\n\n  * Liver: ALT\u002FAST ≥3×ULN; total bilirubin \\>2×ULN\n  * Hematology: WBC \\\u003C3.0×10⁹\u002FL (3000\u002Fmm³); ANC \\\u003C1.0×10⁹\u002FL (1000\u002Fmm³); lymphocyte count \\\u003C0.5×10⁹\u002FL (500\u002Fmm³); platelets \\\u003C100×10⁹\u002FL (100,000\u002Fmm³); hemoglobin \\\u003C9.0 g\u002FdL (90 g\u002FL)\n  * Renal: eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI equation)\n* Pregnant or lactating women.\n* Any condition deemed unsuitable by the investigator.","70 Years",{"count":225,"type":20},220,[23,227],"PHASE2","\" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks.\n\nPart 2 (Efficacy and Safety Assessment): A randomized, double-blind, placebo-controlled evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment.\n\nThe resulting data will provide preliminary evidence on the safety and efficacy profile of CS32582, informing its subsequent development strategy.",[230],"Plaque Psoriasis","2025-09-08",{"date":233,"type":35},"2025-09-10",{"date":231,"type":35},{"date":236,"type":20},"2027-09-18",{"name":41,"class":42},11,{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100585437","phase-1-safety-pharmacokinetics-and-preliminary-efficacy-of-cs231295-in-advanced-solid-tumors-100585437","NCT06902350","Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CS231295 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Understand and sign the informed consent form voluntarily.\n2. ≥18 years old when signing the informed consent, regardless of sex.\n3. Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors (including but not limited to small cell lung cancer, glioblastoma, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer, and liver cancer) for which standard therapy has failed or was intolerable, and currently no standard treatment is available.\n\n   * Radiological or histopathological evidence indicating disease progression should be documented.\n   * Intolerance is defined as discontinuation of treatment due to adverse events during therapy.\n   * Recurrence is based on radiological or histopathological results.\n4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. Note: Target lesions can be located in previously irradiated areas, but must be confirmed by imaging to show disease progression after radiation.\n5. For glioblastoma: KPS score ≥60. For other solid tumors: ECOG performance status of 0 or 1.\n6. Meet the following laboratory criteria (without receiving any blood products, hematopoietic growth factors, albumin, or other treatments within 14 days prior to testing, except iron supplements):\n\n   * Hematology: Hemoglobin (Hb) ≥100 g\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet (PLT) count ≥100×10\\^9\u002FL.\n   * Biochemistry: 1) Dose escalation phase: Serum creatinine (Cr) ≤ upper limit of normal (ULN); total bilirubin (TBIL) ≤1.25×ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤3×ULN). 2) Cohort expansion phase: Cr ≤1.5×ULN; TBIL ≤1.5×ULN; ALT, AST ≤2.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤5×ULN).\n   * Coagulation: International normalized ratio (INR) ≤1.5×ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN (for participants receiving prophylactic anticoagulation, the INR and APTT should be within a safe and effective therapeutic range as judged by the investigator).\n   * Urinalysis: Urine protein \\\u003C2+; if ≥2+, a 24-hour urine protein quantification should be performed. \\\u003C1 g\u002F24 h can be enrolled but ≥1 g\u002F24 h is prohibited. without quantification when urine protein ≥2+ is not allowed.\n7. Expected survival ≥12 weeks.\n8. Cohort Expansion Phase: 1) Cohort 1: Histologically or cytologically confirmed small cell lung cancer (SCLC) that has progressed or recurred after at least two lines of systemic chemotherapy (including a platinum-based regimen). Note: A new line of treatment is defined as a change in treatment due to disease progression, not due to toxicity or other reasons. Re-initiation of the same treatment regimen after initial progression is considered a new line of treatment. 2) Cohort 2: Recurrent or progressive glioblastoma confirmed by histopathology or imaging, which has progressed or recurred after at least one prior treatment with temozolomide.\n\nExclusion Criteria:\n\n1. Received any form of intracranial radiotherapy within 3 months prior to the first dose.\n2. Received any anti-tumor treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, cellular therapy, radiation therapy \\[see exclusion criterion #1 for head\\], endocrine anti-tumor therapy, tumor embolization) or unapproved investigational drugs or devices within 28 days prior to the first dose. Also, received Traditional Chinese Medicine (TCM) approved by the National Medical Products Administration (NMPA) for treating malignant tumors within 14 days prior to the first dose.\n3. Previously received Aurora kinase inhibitors.\n4. Used strong inducers or inhibitors of cytochrome P450 3A (CYP3A) enzymes within 14 days prior to the first dose or are still within 7 half-lives of such drugs (whichever is longer).\n5. For glioblastoma only: \\>5 mg\u002Fday dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioblastoma within 1 week prior to the first dose.\n6. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures as judged by the investigator at screening.\n7. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1, except for alopecia or laboratory abnormalities deemed no clinical significant by the investigator.\n8. History of other primary malignancies within 5 years prior to the first dose, except for adequately treated in situ carcinoma, non-melanoma skin cancer, or malignant melanosis.\n9. For solid tumors other than glioblastoma: Unstable brain metastases. Stable brain metastases are allowed if:\n\n   * No immediate or planned local treatment for brain metastases during the study.\n   * No neurological symptoms or signs (e.g., increased intracranial pressure, seizures, cognitive impairment) at screening.\n   * Brain lesions stable for ≥2 weeks prior to the first dose without corticosteroid or anticonvulsant treatment.\n10. Leptomeningeal metastasis (except glioblastoma).\n11. Severe brain herniation or risk thereof.\n12. For glioblastoma only: who had wafer(s) implantation during surgery.\n13. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms (e.g., chest tightness, shortness of breath, dyspnea).\n14. Uncontrolled or significant cardiovascular disease, including:\n\n    * NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose, or arrhythmias requiring treatment, left ventricular ejection fraction (LVEF) \\\u003C50% at screening.\n    * Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).\n    * Symptomatic coronary artery disease requiring medication at screening.\n    * Clinically significant QTcF prolongation history or QTcF \\>470 ms (females) and \\>450 ms (males) at screening.\n    * Significant cerebrovascular accident (including cerebral hemorrhage, transient ischemic attack) within 6 months prior to the first dose.\n    * Use of ≥3 antihypertensive drug components within 14 days prior to the first dose or inadequately controlled blood pressure (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) at screening.\n    * Other cardiovascular conditions deemed unsuitable by the investigator.\n15. Poorly controlled diabetes (fasting glucose \\>10 mmol\u002FL).\n16. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, bowel obstruction, small bowel resection, or total gastrectomy).\n17. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose (e.g., gastrointestinal bleeding); currently on anticoagulants (e.g., warfarin, phenprocoumon, but low-dose aspirin and heparin for prophylaxis allowed); high-risk bleeding tendency at screening (e.g., esophageal varices, active ulcerative lesions, positive occult blood in stool, imaging evidence of tumor invasion into large vessels).\n18. Serious thromboembolic events within 6 months prior to the first dose (e.g., arterial thrombosis, pulmonary embolism, deep vein thrombosis). Implanted venous port or catheter-related thrombi, superficial vein thrombi, or those deemed stable and not requiring emergency medical intervention are not considered \"serious.\"\n19. Active infection requiring intravenous treatment at screening. Severe infections (e.g., hospitalization due to infection, bacteremia, severe pneumonia complications) within 28 days prior to the first dose. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or COPD exacerbations) can be enrolled.\n20. Known active tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.\n21. Active hepatitis B (HBsAg or HBcAb positive with viral replication) or hepatitis C (HCV antibody positive with viral replication) at screening.\n22. Human immunodeficiency virus (HIV) infection or syphilis infection (positive specific antibody test followed by positive non-specific antibody test) at screening.\n23. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.\n24. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n25. History of alcohol abuse or drug abuse.\n26. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.\n27. Unwilling or unable to use effective contraception methods during the entire treatment period and up to 3 months after the last dose for women of childbearing potential (defined as having experienced menarche and not undergone successful artificial sterilization \\[hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\\] or not postmenopausal) or male patients whose partners are women of childbearing potential; pregnant or breastfeeding women.\n28. Other conditions deemed unsuitable for participation in this trial by the investigator.",{"count":247,"type":20},102,[23],"This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period.\n\nThe primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).",[251,252,253],"Neoplasms","Glioblastoma, Adult","Small Cell Lung Carcinoma (SCLC)","2025-05-22",{"date":256,"type":35},"2025-05-25",{"date":258,"type":35},"2025-05-21",{"date":260,"type":20},"2029-04",{"name":41,"class":42},2,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":271,"minAge":17,"maxAge":223,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":43},"100433238","phase-3-chiauranib-plus-weekly-paclitaxel-in-patients-with-platinum-refractory-or-platinum-resistant-recurrent-ovarian-cancer-100433238","NCT04921527","Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","CHIPRO","Inclusion Criteria:\n\n* Willingness to sign a written informed consent document .\n* Female, age ≥18 yrs and ≤70 yrs.\n* Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.\n* Patients with platinum refractory or platinum resistant ovarian cancer:\n\n  * Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;\n  * Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);\n  * Radiological progression during the last treatment administered;\n  * no more than 1 prior treatment regimens for recurrent disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least 1 lesion can be accurately measured, as defined by RECIST1.1.\n* Laboratory criteria are as follows:\n\n  * Complete blood count: hemoglobin (Hb) ≥90g\u002FL ; absolute neutrophil count (ANC) ≥1.5×109\u002FL ; platelets ≥90×109\u002FL;\n  * Biochemistry test: serum creatinine(cr) \\\u003C1.5×ULN; total bilirubin\\\u003C1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;\n  * Coagulation test: International Normalized Ratio (INR) \\\u003C 1.5, activeated partial thromboplasting time (APTT) \\\u003C1.5×ULN\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Patients received vascular endothelial growth factor(VEGF)\u002Fvascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.\n* Patients received weekly paclitaxel therapy.\n* Has known allegies to Chiauranib, paclitaxel or any of the excipients.\n* Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.\n* prior major surgery or trauma within 14 days prior to first dose of study drug and\u002For presence of any non-healing wound, fracture, or ulcer.\n* Treatment with an investigational agent\u002Finstrument within 28 days prior to first dose of study drug.\n* Any ongoing toxicity from prior anti-cancer therapy that is \\>Grade 1.\n* Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.\n* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.\n* clinically significant central\u002Fperipheral nervous system disease.\n* Have uncontrolled or significant cardiovascular disease, including:\n\n  * Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% requiring treatment with agents during screening stage.\n  * primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)\n  * History of significant QT interval prolongation, or Corrected QT Interval (QTc) \\> 470 ms prior to study entry\n  * Symptomatic coronary heart disease requiring treatment with agents\n  * History of hypertension treated by≥2 agents, or the Blood pressure (Bp) ≥140\u002F90 mmHg prior to study entry.\n  * Other condition investigator considered inappropriate\n* Significant intravenous or arterial thrombosis, such as cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.\n* History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy.\n* CT or MRI of the chest during the screening period shows interstitial lung disease or pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before the first dose, history of pneumonia requiring oral or intravenous steroid treatment, history of immune-associated pneumonia after treatment of PD1\u002FPDL1 inhibitor.\n* Have clinical significant gastrointestinal abnormality that would impair the ingestion, transportation or absorption of oral agents, history of gastrointestinal perforation or abdominal fistula, peptic ulcer disease within 6 months prior to first dose of study drug or GI obstruction within the past 3 months.\n* Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period, or history of drainage for therapy within 1 months prior to first dose of study drug.\n* Screening for HIV antibody positive.\n* Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication.\n* Active infection requiring oral or intravenous systemic antimicrobial therapy during the screening period.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* History of organ transplantation or allo-HSCT.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* Candidates with drug and alcohol abuse.\n* Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study.Pregnant or breastfeeding women.\n* Any other condition which is inappropriate for the study in the opinion of the investigators.","FEMALE",{"count":273,"type":20},454,[140],"This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.",[277,278,279,280],"Ovarian Cancer","Relapsed or Refractory","Chiauranib","Paclitaxel","2024-10-17",{"date":283,"type":35},"2024-10-18",{"date":285,"type":35},"2021-12-20",{"date":287,"type":20},"2025-07-31",{"name":41,"class":42},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":296,"targetDuration":4,"studyType":21,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":43},"100514488","phase-1-a-study-of-nwy001-in-subjects-with-advanced-solid-tumors-100514488","NCT05979155","A Study of NWY001 in Subjects With Advanced Solid Tumors","A Multicenter, Non-randomized, Open-label, Multiple-Dose Phase I Study of NWY001, in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Willingness to sign a written informed consent document\n2. Participant with advanced solid malignant tumor that has relapsed from or is refractory to standard therapy or for which no standard therapy exists\n3. 18\\~75 years of age at the time of screening\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n5. Life expectancy ≥3 months\n6. Laboratory tests meet the following criteria (no corrective treatment, such as G-CSF, erythropoietin, and blood transfusion, within 14 days before first dose):\n\n1\\) absolute neutrophil count (ANC) ≥1.5×109\u002FL 2) platelet ≥100×109\u002FL 3) hemoglobin ≥90 g\u002FL 4) creatinine clearance \\>50 mL\u002Fmin (according to Cockcroft-Gault equation) 5) both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×upper limit of normal (ULN) (≤5×ULN for patients with hepatic metastasis) 6) total bilirubin ≤1.5×ULN (≤3×ULN for patients with gilbert syndrome) 7) international normalized ratio (INR) \\\u003C2.0, activated partial thromboplastin time (aPTT) ≤1.5×ULN\n\n7\\. Prior anti-cancer therapy meets the following criteria:\n\n1. major surgery ≥4 weeks\n2. radiotherapy ≥4 weeks\n3. endocrine therapy ≥2 weeks\n4. chemotherapy (including antibody) ≥3 weeks\n5. immunotherapy ≥4 weeks\n\n8\\. At least one measurable target lesion as defined by RECIST1.1\n\n9\\. For part 2a: Participant has a diagnosis of histologically confirmed advanced (unresectable) or metastatic gastric or gastroesophageal junction adenocarcinoma\n\n1. participant with HER2 overexpression (IHC 3+ or IHC 2+\u002FISH+) is refractory or intolerant to standard therapy or for which no standard therapy exists. Prior treatment with trastuzumab or HER2-targeted drugs\n2. participant with no HER2 expression is refractory or intolerant to standard therapy or for which no standard therapy exists\n\n10\\. For part 2b: Participant has a diagnosis of histologically confirmed advanced esophageal squamous carcinoma\n\n11\\. For part 2c: Participant has a diagnosis of histologically confirmed advanced pancreatic ductal adenocarcinoma\n\n12\\. For part 2d: Participant has a diagnosis of histologically confirmed advanced hepatocellular carcinoma\n\n13\\. For part 2e: Participant has a diagnosis of histologically confirmed advanced intrahepatic cholangiocarcinoma\n\n14\\. For part 2f: Participant has a diagnosis of histologically confirmed advanced MSI-H\u002FdMMR colorectal cancer\n\nExclusion Criteria:\n\n1\\. Current or previous history of other active aggressive malignancies in the last 5 years, except :\n\n1. previous history of non-aggressive malignancies, such as cervical carcinoma in situ, melanoma in situ, or ductal carcinoma in situ of the breast that remains in complete remission for years after curative treatment\n2. malignancies with negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and focal prostate cancer)\n\n2\\. Current or previous history of hematological malignancies\n\n3\\. Primary central nervous system (CNS) malignancies or CNS metastases\n\n4\\. History of allergy or hypersensitivity to monoclonal antibodies or excipients, or a known history of allergy to antibodies produced by Chinese hamster ovary cell\n\n5\\. Uncontrolled infection that requires intravenous antibiotics, antivirals, or antifungal medications\n\n6\\. History of clinically significant lung diseases (such as interstitial pneumonia, pneumonia, pulmonary fibrosis, and severe radiation pneumonia), or patients suspected of having these diseases on radiographic examination during the screening period\n\n7\\. Uncontrolled complications, including, but not limited to, persistent active infections, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled chest and abdominal fluid accumulation, psychiatric disorders that do not meet study requirements, and other serious conditions requiring systemic treatment\n\n8\\. Known history of HIV, active infections of hepatitis B or hepatitis C\n\n9\\. Active pulmonary tuberculosis. Participants vaccinated with BCG vaccine may be false positive for PPD, and they could be enrolled if negative for IGRA\n\n10\\. Women who are pregnant or breastfeeding or intended to become pregnant during the study period\n\n11\\. Participants of childbearing potential who refuse to take highly effective contraceptive measures during the entire study treatment period and for 120 days after the last dose of study drug",{"count":297,"type":20},196,[23],"This is a Phase 1, single-arm, open-label, dose-escalation study in patients with advanced solid tumors including 2 parts:\n\nPart 1: Dose-Escalation Part Part 2: Dose-Expansion Part",[301],"Advanced Solid Tumor","2024-07-15",{"date":304,"type":35},"2024-07-16",{"date":306,"type":35},"2024-01-05",{"date":308,"type":20},"2028-05",{"name":41,"class":42},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":238},"100460105","phase-1-chiauranib-for-advanced-solid-malignant-tumors-and-relapsedrefractory-sclc-100460105","NCT05271292","Chiauranib for Advanced Solid Malignant Tumors and Relapsed\u002FRefractory SCLC.","A Phase 1b\u002F2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Tumors and Relapsed\u002FRefractory SCLC","SCLC","Phase 1b\n\nInclusion Criteria:\n\n1. Patient is at least 18 years of age, regardless of gender. Patient has a diagnosis of histologically or cytologically confirmed advanced solid malignant tumor (including SCLC, NSCLC, colorectal carcinoma, pancreatic carcinoma, hepatocellular carcinoma, ovarian cancer, neuroendocrine tumors, non-Hodgkin's lymphoma, and others) that has relapsed from or is refractory to standard therapy or for which no standard therapy exists.\n2. Patient has at least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at enrollment.\n4. Major organ functions meet the following criteria (no corrective treatment, such as G CSF, erythropoietin, and blood transfusion, within 2 weeks before enrollment):\n\n   1. Hematology: absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet ≥100×109\u002FL, hemoglobin ≥100 g\u002FL.\n   2. Biochemistry: total bilirubin ≤1.25×upper limit of normal (ULN), both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN (≤5×ULN for patients with hepatic metastasis), creatinine clearance \\>60 mL\u002Fmin (according to Cockcroft-Gault equation), fasting triglyceride ≤3.0 mmol\u002FL, fasting total cholesterol ≤7.75 mmol\u002FL.\n   3. Coagulation panel: international normalized ratio (INR) \\\u003C1.5.\n5. Patient has a life expectancy ≥3 months.\n6. Patient is able to provide voluntary informed consent.\n7. Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of study drug (see Appendix 11.7). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.\n8. Male patients must be willing and able to use male condoms and their female partners who are WOCBP during the entire study treatment and for the 12 weeks after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Patient has received any systemic anticancer therapy (including chemotherapy, targeted therapy, biological immunotherapy, any investigational drug, or anti-cancer herbal medicine) within 21 days before enrollment, or any blood support therapy (including blood transfusion, blood products, or hematopoiesis stimulating agents such as granulocyte-colony stimulating factor \\[G-CSF\\]) within 2 weeks before enrollment.\n\n   a. Patients who are receiving corticosteroids at a dose of \\> 10 mg prednisone or equivalent of other systemic steroids will be excluded.\n2. Patient with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of investigational regimen.\n3. Patient has uncontrolled or significant cardiovascular diseases, including:\n\n   1. New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and\u002For myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) \\\u003C 50% at screening.\n   2. Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).\n   3. Clinically significant history of prolonged QTc interval, or QTcF interval \\>470ms for females or \\>450 ms for males during screening.\n   4. Coronary heart disease with symptoms requiring medication.\n4. Patient has hypertension at screening (defined as systolic blood pressure \\[SBP\\] ≥140 mmHg, diastolic blood pressure \\[DBP\\] ≥90 mmHg). (Patients with a known history of hypertension if blood pressure is considered well controlled on a single anti-hypertensive medication (systolic blood pressure \\\u003C140 mmHg and diastolic blood pressure \\\u003C90 mmHg at screening) and in whom there has been no change in blood pressure medication for 3 months prior to screening due to poor control.)\n5. Patient has active hemoptysis, has had active bleeding within 6 months prior to enrollment, or has definite predisposition to gastrointestinal bleeding as determined by the investigator (e.g., esophageal varix associated with bleeding risk, local active ulcer lesions).\n6. Patient has uncontrolled pleural effusion, hydropericardium, or ascites.\n7. Patient has active or symptomatic central nervous system (CNS) metastases that require treatment.\n8. Patient has a history of deep vein thrombosis, pulmonary embolism, or other serious thrombotic event within 6 months prior to enrollment.\n9. Patient has an interstitial lung disease (ILD) that requires treatment, such as idiopathic interstitial pneumonia, pulmonary fibrosis, or evidence of ILD in baseline chest computed tomography (CT) or magnetic resonance imaging (MRI).\n10. Patient has any current toxicity (except alopecia) of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, Grade 2 or higher caused by previous therapy.\n11. Patient has clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the study drug (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or has had total gastrectomy, according to the investigator's judgment.\n12. Patients has undergone a major surgical operation within 6 weeks prior to screening or a minor surgical operation within 2 weeks prior to screening. A major surgical operation refers to an operation involving general anesthesia but excludes procedures such as endoscopies for diagnostic purpose or an implantation of vascular access devices.\n13. Patient has urine protein ≥2+ by urine routine examination and urine protein ≥1 g\u002F24 h by 24-hour urine protein quantification.\n14. Patient has serious active infection or known infectious disease including hepatitis B, hepatitis C infection in active stage, or HIV\u002FAIDS.\n15. Patient has any mental or cognitive impairment that may limit their understanding and implementation of written informed consent and compliance in this study.\n16. Patient has previously experienced toxicity leading to discontinuation of treatment with Aurora kinase inhibitors or VEGF\u002FVEGFR inhibitors, such as sorafenib, sunitinib, pazopanib, bevacizumab, regorafenib, axitinib, vandetanib, or dasatinib.\n17. Patient has current drug or alcohol abuse disorders that may affect study participation, according to the investigator's judgment.\n18. Women who are pregnant, planning to become pregnant, lactating, or who have positive pregnancy test results at screening or before the first dose.\n19. Patients who are currently taking and have to continue taking strong CYP3A4 inhibitor drugs, such as ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, or tipranavir, as well as strong CYP3A4 inducers, such as rifampin, dexamethasone, carbamazepine, during Phase 1b (dose escalation stage) of the study.\n20. Any other conditions that make the patient inappropriate for participation in this study, at the investigator's discretion.",{"count":319,"type":20},36,[23,227],"This is a Phase 1b\u002F2, single-arm, open-label, dose-escalation study including 2 stages:\n\nPhase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods)\n\nPhase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.",[323,324],"Small Cell Lung Cancer","Advanced Solid Malignant Tumor",{"date":304,"type":35},{"date":327,"type":35},"2022-08-26",{"date":329,"type":20},"2025-05",{"name":41,"class":42},""]