[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sunshine Lake Pharma Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":276},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,64,85,104,129,147,167,191,211,233,255],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100449545","phase-1-a-phase-b-clinical-study-of-clifutinib-besylate-combined-with-chemotherapy-in-the-treatment-of-newly-diagnosed-aml-100449545",false,"NCT05133882","A Phase Ⅰb\u002FⅡ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML","A Phase Ib\u002FII, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1.Cohort 1: 18 years old ≤ age ≤65 years old;Cohort 2: The dose escalation trial only included AML subjects aged ≥60 years; the extended trial included subjects who were ≥60 years old or between 18 and 59 years old (including 18 and 59 years old) and could not tolerate strong chemotherapy.\n\n  2.It can be primary AML or AML secondary to MDS, and has not been treated; the extension phase requires the subject to be positive for the FLT3-ITD mutation.\n\n  3.The ECOG score according to the requirements of different groups is as follows: Cohort 1: 0\\~1 points; Cohort 2: Age ≥60 years old: 0\\~2 points; Age 18\\~59 years old (including 18 and 59 years old): 0\\~3 points.\n\n  4.Expected survival time ≥ 12 weeks. 5. Subjects must have adequate organ function. 6.subjects voluntarily participated in the study, and signed a written informed consent form by themselves or their guardians.\n\nExclusion Criteria:\n\n* 1.Diagnosed as APL and manifested as t(15;17)(q22;q12) chromosomal translocation, or BCR-ABL positive leukemia；Diagnosed as secondary to AML due to previous chemotherapy or radiotherapy of other tumors; previously received FLT3 inhibitor.\n\n  2.AML secondary to myeloproliferative tumor (MPN) or acute lymphoblastic leukemia (ALL).\n\n  3.Subjects who have infiltrated the central nervous system in the past or present.\n\n  4.Concomitant with other malignant tumors within 5 years before the first medication.\n\n  5.Thrombosis or embolism occurred within 12 months before the first medication. 6.Pulmonary function tests indicate that subjects have DLCO ≤50% or FEV1 ≤60%, or have difficulty breathing during rest or require continuous oxygen inhalation.\n\n  7.Subjects with uncontrollable, active infections。 8.Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects undergoing total gastrectomy。 9.Subjects with a history of psychotropic drug abuse and unable to quit or those with mental disorders。 10.Researchers believe that those who have other severe acute or chronic diseases who are not suitable for participating in clinical trials.","ALL","18 Years",{"count":19,"type":20},133,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML",[27],"Acute Myeloid Leukemia, Adult","RECRUITING","2026-05-11",{"date":31,"type":32},"2026-05-15","ACTUAL",{"date":34,"type":32},"2022-10-31",{"date":36,"type":20},"2028-06-30",{"name":38,"class":39},"Sunshine Lake Pharma Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100438071","phase-2-the-efficacy-and-safety-of-mitizodone-phosphate-tablets-in-the-treatment-of-patient-with-major-depressive-disorder-100438071","NCT04984512","The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder","A Phase II\u002FIII ,Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Adaptive Design Study Evaluating the Efficacy And Safety of Mitizodone Phosphate Tablets in the Treatment of Patient With Major Depressive Disorder","Inclusion Criteria:\n\n* 1.a Man or a woman with major depressive disorder(MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (classification code 296.22、296.23、296.32、296.33)\n* 2.Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.\n* 3.Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.\n\nExclusion Criteria:\n\n* 1.has major depressive disorder with psychotic features according to the DSM-5.\n* 2.Current or history of: bipolar disorder、schizophrenia、anixety disorder、insomnia、any substance abuse or dependence and other psychiatry disorder as defined in the DSM-5.\n* 3.Current or history of a clinically significant neurological disorder (including epilepsy、Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease).\n* 4\\. has Serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders.\n* 5\\. Current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri).\n* 6\\. Current or history of angle-closure glaucoma.\n* 7\\. has made a suicide behavior in the previous 1 year ，or has a score greater than or equal to 4 on item 10 (suicidal thoughts) of MADRS .\n* 8.has taken fluoxetine within 4 weeks prior to initial dosing.\n* 9\\. has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing.\n* 10.has psychotherap at Screening and\u002For Baseline Visits.\n* 11.has had physiotherapy within 3 months prior to initial dosing.\n* 12.Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.\n* 13.Has an alanine aminotransferase, aspartate aminotransferase level greater than 2 times the upper limits of normal；or total bilirubin， direct bilirubin，creatinine level greater than 1.5 times the upper limits of normal；or a thyroid stimulating hormone value outside the normal range.\n* 14.Has an abnormal electrocardiogram confirmed as clinically significant by the investigator.\n* 15.Has a history of severe allergies.","65 Years",{"count":50,"type":20},600,[24,52],"PHASE3","This is a phase 2 and 3 adaptive design study for Mitizodone Phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.Dose-finding will be done after 8 weeks of double-blinded treatment in phase 2 period and will be assessed by both efficacy and safety from 3 dose groups of Mitizodone Phosphate.The dose be found in phase 2 period will be evaluated on efficacy and safety when compared with placebo in phase 3 period with a duration of 8 weeks treatment.The target subjects are patients with MDD.",[55],"Depressive Disorder, Major","2026-04-29",{"date":58,"type":32},"2026-05-05",{"date":60,"type":32},"2021-12-14",{"date":62,"type":20},"2027-11",{"name":38,"class":39},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},"100484287","phase-3-hec73543-versus-salvage-chemotherapy-in-rr-flt3-itd-aml-100484287","NCT05586074","HEC73543 Versus Salvage Chemotherapy in R\u002FR FLT3-ITD AML","HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age at the time of obtaining informed consent.\n* Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification;\n* Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant )\n* Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab\n* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion\n\nExclusion Criteria:\n\n* Subject has received prior treatment with other FLT3 inhibitors\n* Subject has AML that has relapsed after or is refractory to more than 1 line of therapy\n* Subject has an active uncontrolled infection\n* Subject is known to have human immunodeficiency virus infection\n* Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation",{"count":72,"type":20},324,[52],"A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed\u002F refractory (R\u002FR) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR\u002FCRh rate in these subjects.",[76],"Leukemia, Acute Myeloid (AML)","2026-04-27",{"date":79,"type":32},"2026-04-28",{"date":81,"type":32},"2023-03-03",{"date":83,"type":20},"2028-05-30",{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":40},"100473954","phase-1-hec169096-in-participants-with-advanced-solid-tumors-100473954","NCT05451602","HEC169096 in Participants With Advanced Solid Tumors","Phase 1\u002F2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.\n* Phase 2： All participants must have an oncogenic RET-rearrangement\u002Ffusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.\n* Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n* Measurable or non-measurable disease as determined by RECIST 1.1;\n* Adequate hematologic, hepatic and renal function;\n* Life expectancy of at least 12 weeks;\n* Negative pregnancy test (urine or serum) for female patients of childbearing potential;\n* Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).\n\nExclusion Criteria:\n\n* Participant's cancer has a known primary driver alteration other than RET.\n* Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment;\n* Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment;\n* Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment);\n* Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment;\n* Had received live vaccine within 4 weeks prior to study treatment;\n* Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials;\n* Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment .\n* Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.\n* Patients with other malignant tumors within 5 years before the first use of drugs\n* Patients have a history of severe cardiovascular disease;\n* Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU\u002F mL or ≥ 10\\^4 cps\u002F mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive.\n* Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment;\n* Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage);\n* Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption;\n* Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose.",{"count":93,"type":20},456,[23,24],"An Open, Multi-Center Phase I\u002FII Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.",[97],"Advanced Solid Tumor",{"date":79,"type":32},{"date":100,"type":32},"2022-10-21",{"date":102,"type":20},"2027-08-30",{"name":38,"class":39},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":40},"100619211","phase-1-a-single-center-randomized-open-label-parallel-design-clinical-study-to-evaluate-the-pharmacokinetic-effects-of-itraconazole-fluconazole-or-efavirenz-on-a-single-dose-of-clifutinib-in-healthy-participants-100619211","NCT07341672","A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants","The Drug-Drug Interaction Study of Clifutinib","Inclusion Criteria:\n\n1. Informed consents were signed voluntarily with full understanding of the trial content, process and possible adverse reactions. Be able to complete the trial according to the requirements of the trial protocol.\n2. Have no plans of fertility, sperm retrieval or egg donation during the trial, and are willing to take effective contraceptive measures within 6 months from the date of signing ICF to the end of drug administration.\n3. Male or female participants aged 18 to 50 years old (including 18 and 50 years old).\n4. Male participants weighed at least 50 kg and female participants weighed at least 45 kg. Body mass index (BMI) = weight (kg)\u002Fheight2 (m2), with BMI in the range of 18 to 28 kg\u002Fm2 (including cutoff).\n\nExclusion Criteria:\n\n1. During the screening period, physical examination, vital signs, laboratory tests(blood routine, blood biochemistry, coagulation function, urine routine), chest X-ray, abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), ophthalmic examination and other examinations were abnormal and had clinical significance.\n2. QTcF was calculated with Fridericia's correction formula QTcF = QT\u002FRR (RR\\^0.33=60\u002F heart rate (BPM)) in patients with abnormal 12-lead electrocardiogram (ECG) or corrected QT interval (QTcF) \\>450 ms.\n3. Any positive of hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or treponema pallidum antibody.\n4. The female participants were pregnant or lactating, and the blood pregnancy results at screening and admission exceeded the upper limit of the normal value.\n5. Taking any prescription medication, over-the-counter medication, any vitamin product, or herbal medicine within 14 days before screening.\n6. Taking any drugs that alter liver enzyme activity, such as barbiturates, rifampicin, within 30 days before screening.\n7. Taking an inhibitor or inducer of CYP3A4 within 30 days before screening.\n8. Were enrolled in a clinical trial of any drug within 3 months before screening and used a trial drug, or were planning to enroll in another clinical trial during the trial.\n9. Received a vaccination within 28 days before screening or planned to be vaccinated during the trial.\n10. Blood donation or blood loss \\>450 mL within 3 months before screening; Or planned to donate blood during the trial.\n11. Patients with dysphagia or a gastrointestinal, hepatic, or renal disease (whether cured or not) within 6 months before screening that can affect drug absorption or excretion.\n12. Suffering from any condition that increases the risk of bleeding, such as active hemorrhoids bleeding, acute gastritis or gastric and duodenal ulcers.\n13. Patients with past or present serious or chronic diseases of digestive system, urinary system, respiratory system, circulatory system, nervous system, blood system, endocrine system, immune system, mental system, etc.\n14. Acute illness or concomitant medication occurred from the date of signing the informed consent to the date of first administration of the investigational drug.\n15. Allergic constitution (multiple drugs and food allergy), allergic to Clifutinib or any drug component, allergic to itraconazole, fluconazole and efavirenz or any drug component.\n16. The average daily smoking was more than 5 cigarettes in the 3 months before the trial, or the habitual use of nicotine-containing products, and could not quit during the trial.\n17. If they had a history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or were unable to abstain from alcohol during the study period, or had an alcohol breath test result greater than 0 mg per 100 mL.\n18. Those with a positive urine drug screen or who had a history of drug abuse or drug use in the past 5 years.\n19. Ingested chocolate, any caffeinated or xanthine-rich food or drink within 24 hours before taking the test drug, or were unable to stop taking it during the trial.\n20. Had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 14 days before screening, or could not stop taking special diet or strenuous exercise during the trial; Or other factors affecting drug absorption, distribution, metabolism and excretion as judged by the researchers.\n21. Those who have special requirements for diet and cannot accept a uniform diet.\n22. Those who had a history of faintness in needles or blood, who had difficulty in blood collection or could not tolerate blood collection by venipuncture, or who had poor evaluation of venous blood collection.\n23. Participants were deemed by the investigator to be ineligible for the trial for any reason.",true,"50 Years",{"count":114,"type":20},80,[23],"Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib and the safety of the combination therapy in healthy participants.",[118],"Healthy Adult Subject",[120],"Clifutinib","NOT_YET_RECRUITING","2026-04-24",{"date":77,"type":32},{"date":125,"type":20},"2026-12-31",{"date":127,"type":20},"2027-05-08",{"name":38,"class":39},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":111,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":146,"locationsCount":40},"100600804","phase-1-a-study-to-evaluate-the-safety-tolerability-pkpd-of-hec-007-injection-in-healthy-and-overweightobese-subjects-100600804","NCT07102251","A Study to Evaluate the Safety, Tolerability, PK\u002FPD of HEC-007 Injection in Healthy and Overweight\u002FObese Subjects","A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HEC-007 Injection After Single-Dose Administration in Healthy Subjects and Multiple-Dose Administration in Overweight or Obese Subjects","Inclusion Criteria:\n\nSAD\n\n1. Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.\n2. Healthy adult subjects (including borderline values) aged 18 to 45 years, regardless of sex.\n3. Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. BMI =Body weight (kg)\u002Fheight2 (m2), with a body mass index ranging from 19.0 to 35.0 kg\u002Fm2 (including boundary values).\n4. Normal results or abnormalities deemed clinically insignificant by the investigator in vital signs, physical examination, laboratory tests, electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys), and thyroid ultrasound.\n5. Female subjects of childbearing potential or male subjects must agree to use effective contraception from signing the informed consent until 6 months after the last administration of the investigational product to avoid pregnancy or impregnating a partner, with no plans for sperm or egg donation or pregnancy.\n6. Glycated hemoglobin (HbA1c) \\\u003C5.7% during the screening period. MAD\n\n1\\. Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.\n\n2\\. Age between 18 to 65 years (inclusive), both male and female. 3. Obesity: BMI ≥28.0 kg\u002Fm2; or overweight: 24.0 \\\u003CBMI \\\u003C28.0 kg\u002Fm2, and with at least one of the following manifestations: prediabetes (as detailed in 14.4), hypertension, dyslipidemia, fatty liver, weight-bearing joint pain, obesity-related dyspnea, or obstructive sleep apnea syndrome.\n\n4\\. At screening, weight change of \\\u003C 5% over at least 12 weeks of diet and exercise control alone.\n\n5\\. Female subjects of childbearing potential or male subjects must agree to use effective contraceptionfrom signing the informed consent until 6 months after the last administration of the investigational product to avoid pregnancy or impregnating a partner, with no plans for sperm or egg donation or pregnancy.\n\n6\\. Glycated hemoglobin (HbA1c) \\\u003C6.5% during the screening period.\n\nExclusion Criteria:\n\nSAD\n\n1. Those diagnosed with type 1, type 2, or other types of diabetes before screening;\n2. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;\n3. Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;\n4. Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);\n5. Presence of clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders) during screening;\n6. Diseases or conditions affecting gastric emptying or gastrointestinal nutrient absorption during screening;\n7. Major surgery within 3 months before screening or planned surgery during the study;\n8. History of hypersensitivity to the investigational product or any of its components, or allergic constitution (allergy to two or more drugs or foods).\n9. Use of medications (including prescription drugs, over-the-counter drugs, herbal medicines, health supplements, etc.) within 3 months prior to screening that, in the investigator's judgment, significantly affect weight or glucose metabolism;\n10. Individuals who have undergone bariatric surgery prior to screening;\n11. Those with a history of recurrent skin disorders (e.g., urticaria) or skin lesions at the administration site;\n12. Those who received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled formulations) within 3 months prior to screening, or systemic glucocorticoid therapy within 1 month prior to screening;\n13. Female subjects with HbA1c \\\u003C110 g\u002FL or male subjects with HbA1c \\\u003C120 g\u002FL at screening, or any other known condition that interferes with HbA1c measurement;\n14. Those with suicidal behaviors or ideation within 6 months prior to screening;\n15. Use of GLP-1R, GLP-1R\u002FGIPR, GLP-1R\u002FGCGR, or GLP-1R\u002FGIPR\u002FGCGR agonists within 6 months prior to screening;\n16. Those with regular alcohol consumption within 3 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine); or those with a positive alcohol breath test during screening; or those unable to comply with the protocol's alcohol restrictions;\n17. Those with a history of drug abuse or illicit drug use within 2 years prior to screening, or those with a positive urine drug screen before administration;\n18. Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to abstain from smoking during intensive PK blood sampling;\n19. Those with a history of needle or blood phobia, intolerance to venipuncture, or difficulty in blood collection;\n20. Those with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum-specific antibody;\n21. Alanine aminotransferase \\>1.5 × upper limit of normal (ULN), aspartate aminotransferase \\>1.5 × ULN, alkaline phosphatase \\>1.5 × ULN, or total bilirubin \\>1.5 × ULN at screening;\n22. Those with blood amylase or lipase \\> ULN at screening;\n23. Those with serum calcitonin ≥20 ng\u002FL at screening;\n24. Those with fasting blood glucose ≥6.1 mmol\u002FL or \\\u003C3.9 mmol\u002FL at screening;\n25. Those with glomerular filtration rate (GFR) \\\u003C90 mL\u002Fmin\u002F1.73m2 at screening;\n26. Fridericia-corrected QT interval (QTcF=QT\u002FRR0.33) \\>450 ms (for male) or \\>470 ms (for female) on 12-lead ECG at screening;\n27. Use of strong inhibitors or inducers of hepatic metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4, and 3A5) within 4 weeks prior to the first dose, including strong inhibitors such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin, etc., or strong inducers such as rifampin, carbamazepine, phenytoin sodium, St. John's wort, etc.;\n28. Use of any prescription drugs, over-the-counter medications, vitamin products, or Chinese herbal medicines within 2 weeks prior to the first dose;\n29. Consumption of any foods or beverages affecting CYP3A4, CYP2E1, or CYP2D6 metabolic enzymes, such as grapefruit or grapefruit-containing beverages, within 48 hours prior to the first dose;\n30. Ingestion of chocolate, any caffeine-containing or xanthine-rich food or beverage within 48 hours prior to the first dose;\n31. Blood donation ≥200 mL, any component blood donation, or total blood loss ≥200 mL due to any reason within 3 months prior to screening, or a history of blood transfusion or blood product use;\n32. Participation in other clinical trials within 3 months prior to screening (subjects who withdrew from the study before treatment, i.e., were not randomized or did not receive treatment, may be enrolled in this study);\n33. Occurrence of acute illness or concomitant medication use from the signing of the informed consent form until the first dose;\n34. Female subjects who are currently breastfeeding or have a positive pregnancy test result at screening;\n35. Subjects deemed by the investigator to have other factors unsuitable for participation in this trial.\n\nMAD\n\n1. Those diagnosed with type 1, type 2, or other types of diabetes before screening;\n2. Those diagnosed with overweight or obesity caused by other diseases or medications, such as Cushing's syndrome;\n3. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;\n4. Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;\n5. Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);\n6. Presence of clinically significant diseases at screening, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders (excluding weight-related comorbidities);\n7. Any of the following diseases or medical histories within 6 months prior to screening or before randomization: cardiac insufficiency (New York Heart Association \\[NYHA\\] Class III or IV), myocardial infarction, unstable angina, uncontrolled arrhythmias requiring treatment (including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second- to third-degree atrioventricular block, sick sinus syndrome, etc.), coronary artery bypass grafting, percutaneous coronary intervention (diagnostic angiography allowed), cerebrovascular accident (ischemic stroke, hemorrhagic stroke, transient ischemic attack), cirrhosis, etc.;\n8. Diseases or conditions affecting gastric emptying or gastrointestinal nutrient absorption during screening;\n9. Major surgery within 3 months before screening or planned surgery during the study;\n10. History of hypersensitivity to the investigational product or any of its components, or to acetaminophen and its excipients, or allergic constitution (allergy to two or more drugs or foods);\n11. Use of medications (including prescription drugs, over-the-counter medications, Chinese herbal medicines, health supplements, etc.) within 3 months prior to screening that, in the investigator's judgment, significantly affect body weight;\n12. Subjects taking lipid-lowering or antihypertensive medications with unstable doses within 30 days prior to screening;\n13. Individuals who have undergone bariatric surgery prior to screening;\n14. Those with a history of recurrent skin disorders (e.g., urticaria) or skin lesions at the administration site;\n15. Those who received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled formulations) within 3 months prior to screening, or systemic glucocorticoid therapy within 1 month prior to screening;\n16. Female subjects with HbA1c \\\u003C110 g\u002FL or male subjects with HbA1c \\\u003C120 g\u002FL at screening, or any other known condition that interferes with HbA1c measurement;\n17. Those with suicidal behaviors or ideation within 6 months prior to screening;\n18. History of depression or other psychiatric disorders within 6 months prior to screening;\n19. Use of GLP-1R, GLP-1R\u002FGIPR, GLP-1R\u002FGCGR, or GLP-1R\u002FGIPR\u002FGCGR agonists within 6 months prior to screening;\n20. Those with regular alcohol consumption within 3 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine); or those with a positive alcohol breath test during screening; or those unable to comply with the protocol's alcohol restrictions;\n21. Those with a history of drug abuse or illicit drug use within 2 years prior to screening, or those with a positive urine drug screen before the first dose;\n22. Smoking more than 5 cigarettes per day within 3 months prior to screening or inability to abstain from smoking during intensive PK blood sampling;\n23. Those with a history of needle or blood phobia, intolerance to venipuncture, or difficulty in blood collection;\n24. Resting seated blood pressure at screening: systolic blood pressure \\>160 mmHg or \\\u003C90 mmHg, diastolic blood pressure \\>100 mmHg or \\\u003C55 mmHg;\n25. Heart rate at screening \\>100 beats per minute or \\\u003C50 beats per minute;\n26. Those with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum-specific antibody;\n27. Alanine aminotransferase \\>2 × ULN, aspartate aminotransferase \\>2 × ULN, alkaline phosphatase \\>1.5 × ULN, or total bilirubin \\>1.5 × ULN at screening;\n28. Blood amylase or lipase \\> ULN at screening;\n29. Those with serum calcitonin ≥20 ng\u002FL at screening;\n30. Fasting triglyceride levels ≥5.6 mmol\u002FL at screening;\n31. Fasting blood glucose ≥7.0 mmol\u002FL or \\\u003C3.9 mmol\u002FL at screening; or OGTT 2-hour ≥11.1 mmol\u002FL;\n32. Those with glomerular filtration rate (GFR) \\\u003C90 mL\u002Fmin\u002F1.73m2 at screening;\n33. Fridericia-corrected QT interval (QTcF=QT\u002FRR0.33) \\>450 ms (for male) or \\>470 ms (for female) on 12-lead ECG at screening; or severe arrhythmia (second-degree or higher atrioventricular block, ventricular tachycardia, etc.);\n34. Use of strong inhibitors or inducers of hepatic metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4, and 3A5) within 4 weeks prior to the first dose, including strong inhibitors such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin, etc., or strong inducers such as rifampin, carbamazepine, phenytoin sodium, St. John's wort, etc.;\n35. Consumption of any foods or beverages affecting CYP3A4, CYP2E1, or CYP2D6 metabolic enzymes, such as grapefruit or grapefruit-containing beverages, within 48 hours prior to the first dose;\n36. Ingestion of chocolate, any caffeine-containing or xanthine-rich food or beverage within 48 hours prior to the first dose;\n37. Blood donation ≥200 mL, any component blood donation, or total blood loss ≥200 mL due to any reason within 3 months prior to screening, or a history of blood transfusion or blood product use;\n38. Participation in other clinical trials within 3 months prior to screening (subjects who withdrew from the study before treatment, i.e., were not randomized or did not receive treatment, may be enrolled in this study);\n39. Occurrence of acute illness or concomitant medication use from the signing of the informed consent form until the first dose;\n40. Female subjects who are currently breastfeeding or have a positive pregnancy test result at screening;\n41. Subjects deemed by the investigator to have other factors unsuitable for participation in this trial.",{"count":137,"type":20},126,[23],"This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese subjects.\n\nThe trial consists of two parts: Part A is a single ascending dose (SAD) study, planning to enroll 54 Chinese healthy subjects; Part B is a multiple ascending dose (MAD) study, planning to enroll 72 Chinese overweight or obese subjects.",[141],"Healthy Subjects",{"date":77,"type":32},{"date":144,"type":32},"2025-09-21",{"date":125,"type":20},{"name":38,"class":39},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":111,"sex":16,"minAge":17,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":40},"100600563","phase-1-a-safety-tolerability-pharmacokineticspharmacodynamics-study-of-hec169584-capsules-in-healthy-subjects-100600563","NCT07099118","A Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics Study of HEC169584 Capsules in Healthy Subjects","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics of Single and Multiple Doses of HEC169584 Capsules and the Effect of Food on Its Pharmacokinetics in Healthy Subjects","Inclusion Criteria:\n\n1. Subjects should understand and abide by the research procedures, volunteer to participate, and sign the informed consent form.\n2. When signing the informed consent form, subjects should be between 18 and 45 years old (including the boundary values), and both genders are eligible.\n3. Male subjects should weigh ≥ 50.0 kg, and female subjects should weigh ≥ 45.0 kg. For the single - dose trial, the body mass index \\[BMI = weight (kg) \u002F height² (m²)\\] should be within the range of 18.0 - 28.0 kg\u002Fm² (including the boundary values). For the multiple - dose trial, the BMI should be within the range of 18.0 - 30.0 kg\u002Fm² (including the boundary values).\n4. Subjects enrolled in the MAD (Multiple - Ascending - Dose) trial should also meet the requirement that 2.6 mmol\u002FL (100 mg\u002FdL) ≤ LDL - C \\\u003C 4.1 mmol\u002FL (160 mg\u002FdL).\n5. The results of vital signs, physical examinations, clinical laboratory tests, electrocardiograms, chest X - rays (posteroanterior view), abdominal color Doppler ultrasounds, etc. should be normal, or if judged as abnormal by the investigator, they should be of no clinical significance.\n6. Subjects (including their partners) should voluntarily adopt effective contraceptive measures from the screening stage until 3 months after the last drug administration, and should have no plans for sperm or egg donation.\n\nExclusion Criteria:\n\n1. Subjects had clinically significant diseases as follows (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, mental, or cardiovascular and cerebrovascular diseases) before screening.\n2. Subjects with allergic constitution (allergic to multiple drugs or foods).\n3. Subjects who smoked more than 5 cigarettes per day on average within 3 months before screening, or smoked within 48 hours before taking the investigational product, or could not stop using any tobacco products during the trial.\n4. Subjects had a history of dysphagia before screening, or had a history of gastrointestinal, hepatic, or renal diseases or surgeries that potentially affect the absorption, distribution, metabolism, and excretion of the investigational product (except uncomplicated appendectomy and hernia repair).\n5. Subjects had a history of alcoholism within 1 year before screening (consuming 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or had a positive alcohol breath test during the screening period.\n6. Subjects had a history of drug abuse or used drugs within 2 years before screening, or had a positive urine drug screening during the screening period.\n7. Subjects donated blood or lost blood ≥ 400 mL within 3 months before screening, or planned to donate blood within 1 month after the end of the trial.\n8. Subjects had a history of thyroid diseases, or the thyroid - stimulating hormone (TSH) index in the thyroid function test during the screening period was beyond the normal range.\n9. Subjects had a corrected QT interval (QTcF = QT\u002FRR0.33 calculated by the Fridericia formula) of the 12 - lead electrocardiogram \\> 450 ms during screening.\n10. Subjects had a glomerular filtration rate \\\u003C 90 mL\u002Fmin (the glomerular filtration rate is calculated using the simplified MDRD formula: for men, eGFR = 186 × creatinine (mg\u002FdL)-1.154 × age - 0.203; for women, eGFR = 186 × creatinine (mg\u002FdL)-1.154 × age - 0.203 × 0.742). Note: The unit of creatinine in the formula is mg\u002FdL. When calculating, the creatinine result in μmol\u002FL needs to be converted to mg\u002FdL, and 1 μmol\u002FL = 0.01131 mg\u002FdL.\n11. Subjects received vaccination within 1 month before screening, or planned to receive vaccination during the trial.\n12. Subjects took inhibitors and\u002For inducers of CYP3A4, CYP2C8, P - gp, or BCRP within 4 weeks before screening.\n13. Subjects took any prescription drugs, over - the - counter drugs, any vitamin products, or Chinese herbal medicines within 14 days before screening.\n14. Subjects consumed foods or beverages containing chocolate, caffeine, xanthine, alcohol, or grapefruit within 48 hours before the first drug administration.\n15. Subjects developed an acute illness or had concomitant medications from the screening stage to before the first drug administration.\n16. Subjects had a history of fainting at the sight of needles or blood, could not tolerate intravenous puncture for blood collection, or had difficulty in blood collection.\n17. Lactating or pregnant women, or women of child - bearing potential with a positive pregnancy test.\n18. Subjects participated in other clinical trials within 3 months before screening (if the subject withdrew from the study before treatment, that is, was not randomized or did not receive treatment, they can be enrolled in this study).\n19. Subjects tested positive for any one of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or treponema pallidum antibody.\n20. Subjects had special dietary requirements and could not accept the unified diet.\n21. Subjects with other factors that, in the investigator's opinion, make them inappropriate to participate in this trial.","45 Years",{"count":156,"type":20},96,[23],"The safety, tolerability, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) characteristics study of HEC169584 capsules in healthy subjects .",[160],"Non - Alcoholic Steatohepatitis",{"date":77,"type":32},{"date":163,"type":32},"2025-09-03",{"date":165,"type":20},"2027-03-06",{"name":38,"class":39},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":111,"sex":174,"minAge":17,"maxAge":154,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100621867","phase-1-single-ascending-dose-study-of-hec-151-injection-100621867","NCT07376200","Single-ascending Dose Study of HEC-151 Injection","An I-phase Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics of a Single Dose of HEC-151 Injection in Healthy Chinese Participants in a Single-center, Randomized, Placebo (Single-blind) and Positive Control (Open-label) Study","Inclusion Criteria:\n\n1. Voluntarily participate in the trial and sign the informed consent form, understanding and abiding by the research procedures;\n2. When signing the informed consent form, men aged 18-45 years old (including the boundary value) are eligible;\n3. During the screening process, male subjects with a body weight of ≥ 50 kg and a body mass index (BMI) of ≥ 19.0 and ≤ 24.0 kg\u002Fm2 are included;\n4. Normal glucose tolerance \\[3.9 mmol\u002FL \\\u003C fasting blood glucose (FPG) \\\u003C 6.1 mmol\u002FL, and 2-hour post-glucose tolerance test (OGTT) blood glucose after sugar intake \\\u003C 7.8 mmol\u002FL\\];\n5. Normal results of insulin release test (IRT), or abnormal results but judged by the researcher to have no clinical significance;\n6. Glycated hemoglobin (HbA1c) \\\u003C 5.7%;\n7. During the study period, there are no plans for reproduction, sperm collection, or sperm donation, and are willing to take effective contraceptive measures throughout the study period until 3 months after the administration of the investigational drug.\n\nExclusion Criteria:\n\n1. Participants with abnormal medical histories or surgical histories judged clinically significant by the researchers, or currently suffering from any diseases in the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, etc. that are judged clinically significant by the researchers, or any other diseases or physiological conditions that can significantly affect the absorption, distribution, metabolism or excretion of the drugs;\n2. Participants who have a known severe allergic history or are allergic to the test drugs and any of their components;\n3. Participants who had severe trauma or undergone surgery within 90 days before the screening, or plan to undergo major surgery during the study;\n4. Participants who have a history of hypoglycemia or hyperglycemia within 90 days before the screening, or have a family history of diabetes (first-degree direct relatives);\n5. Participants who have donated blood or suffered significant blood loss (≥ 400 mL) within 90 days before the screening, or plan to donate blood during the study;\n6. Participants who have acute diseases or concurrent medication use from the signing of the informed consent form to the first administration of the drug;\n7. Participants whose vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray examination, etc. results are abnormal and judged by the researchers to have clinical significance;\n8. Participants whose test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), combined human immunodeficiency virus antigen antibody (HIV), or syphilis spirochete antibody (TP) are positive;\n9. Participants who have a history of drug abuse or drug use, or whose urine drug screening is positive before the screening;\n10. Participants who have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, health supplements (except for regular supplementary vitamins and calcium) within 30 days before the screening;\n11. Participants who have participated in any clinical research of drugs or devices (defined as receiving the test drugs or devices) within 90 days before the screening;\n12. Participants who have received any vaccine within 30 days before the screening, or plan to receive any type of vaccine during the study;\n13. Participants who smoke more than 5 cigarettes per day within 90 days before the screening, or cannot comply with the smoking prohibition rule during the study;\n14. Participants who frequently drink alcohol, that is, consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or have a positive alcohol breath test; or who cannot comply with the alcohol prohibition rule during the study;\n15. Participants who consume excessive tea, coffee and\u002For caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 mL) or food (such as chocolate) every day within 90 days before the screening, or during the study;\n16. Participants who have used special diets (including dragon fruit, mango, pomelo, etc.) and\u002For xanthine diet (salmon, sardines, liver, kidney, etc.) or have other factors affecting drug absorption, distribution, metabolism, and excretion before the signing of the informed consent form to the use of the test drugs, or who cannot comply with the prohibition of eating during the study;\n17. Participants who have had significant changes in diet or exercise habits within 90 days before the screening, or have engaged in intense exercise before the signing of the informed consent form to the use of the test drugs, or cannot stop during the study;\n18. Participants who have difficulty in venous blood collection, or cannot tolerate venipuncture, or have a history of fainting or hematemesis;\n19. Participants who, in the researcher's opinion, have other factors that are not suitable for participating in this study.","MALE",{"count":176,"type":20},81,[23],"Evaluate the safety, tolerability, PK\u002FPD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants",[180],"Healthy Adult Male",[182],"HEC-151 Injection","2026-04-23",{"date":56,"type":32},{"date":186,"type":32},"2026-02-24",{"date":188,"type":20},"2026-09-27",{"name":38,"class":39},2,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":40},"100449994","phase-2-a-study-to-explore-the-therapeutic-effect-of-hec585-on-delaying-forced-vital-capacity-fvc-decline-and-tolerance-in-progressive-fibrosing-interstitial-lung-disease-pf-ild-patients-100449994","NCT05139719","A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients","A Phase IIb, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With Progressive Fibrosing Interstitial Lung Disease","Inclusion Criteria:\n\n1. Volunteer to participate and sign the ICF.\n2. Male or female patients' age ≥ 18 years when signing the ICF.\n3. Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.):\n\n   i) Worsening respiratory symptoms like cough, shortness of breath. ii) Physiological evidence of disease progression (either of the following):\n   1. absolute FVC (% of predicted) decline ≥ 5%.\n   2. absolute DLco\\[Hb corrected\\] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following):\n\n   \u003C!-- -->\n\n   1. Increased extent or severity of traction bronchiectasis and bronchiolectasis.\n   2. New ground-glass opacity with traction bronchiectasis.\n   3. New fine reticulation.\n   4. Increased extent or increased coarseness of reticular abnormality.\n   5. New or increased honeycombing.\n   6. Increased lobar volume loss.\n4. Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of \\>10% as confirmed by central readers.\n5. For patients with underlying connective tissue disease (CTD) should be in the stable status which is defined by no initiation of new therapy, treatment dose adjustment or withdrawal of therapy within 12 weeks prior to randomization.\n6. FEV1\u002FFVC ≥ 0.7 before using bronchodilators.\n7. %FVC ≥ 45% predicted.\n8. Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) ≥ 30% and ≤ 80% predicted of normal.\n9. Fertile female or male subjects agreed and promised to take effective contraception measures from signing the ICF till 30 days after last administration.\n10. Subjects are willing and able to comply with the protocol requirements and attend visits assessed by the investigator.\n\nExclusion Criteria:\n\n1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).\n2. Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study.\n3. Significant Pulmonary Arterial Hypertension (PAH), such as meeting the following: Previous clinical or echocardiographic evidence of significant right heart failure, History of right heart catheterization showing a cardiac index ≤ 2 L\u002Fmin\u002Fm², or PAH requiring parenteral therapy with epoprostenol\u002Ftreprostinil.\n4. Major extrapulmonary physiological or pathological restriction (e.g. chest wall abnormality, large pleural effusion).\n5. Expected to receive lung transplantation during the study.\n6. Expected survival time is less than 6 months.\n7. History of malignant tumors within 5 years (except for localized cancers such as basal cell carcinoma and carcinoma in situ of cervix).\n8. Thyroid dysfunction that the investigator assessed to be clinically significant and needed to be treated.\n9. History of unstable or worsening heart disease during the 6 months prior to screening, including but not limited to the following:\n\n   1. Unstable cardiac angina,\n   2. Acute Myocardial infarction,\n   3. Congestive heart failure (need to be treated in hospital or NYHA III\u002FIV),\n   4. Uncontrolled Severe Arrhythmias.\n10. TBIL \\>1.2 × ULN, AST or ALT \\> 1.5 × ULN.\n11. CLcr \\\u003C 50 mL\u002Fmin.\n12. Human immunodeficiency virus (HIV) or treponema pallidum antibody is positive.\n13. Uncontrolled hepatitis B virus infection or hepatitis C virus infection.\n14. Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD) or influence the effect or safety of investigational drug:\n\n    1. Strong inducers or strong inhibitors of CYP3A4 within 4 weeks before randomization.\n    2. Azathioprine (AZA), cyclosporine, MMF ( \\> 1.5 g\u002Fd or equivalent dose), tripterygium glycosides , hydroxychloroquine, tacrolimus, prednisone \\> 15mg\u002Fday or equivalent systemic glucocorticoid therapy, and the combination of OCS+AZA+NAC within 4 weeks before randomization.\n    3. Cyclophosphamide within 8 weeks before randomization.\n    4. Combination of ≤ 15mg\u002Fday or equivalent systemic glucocorticoid therapy with ≤ 1.5 g\u002Fd or equivalent dose MMF within 12 weeks before randomization.\n    5. Pirfenidone or nintedanib within 1 months before screening.\n    6. Rituximab, Adalimumab, Secukinumab, Infliximab, Tocilizumab, Certolizumab, Golimumab, Tofacitinib, Baricitinib, Etanercept, Abatacept within 6 months before randomization.\n15. Subjects cannot complete the PFT、6MWT,or questionnaires.\n16. Allergic to any component of HEC585 Tablets.\n17. Participated in other clinical study and received the last dose within 3 months before screening.\n18. Pregnant or breastfeeding.\n19. History of smoking (≥ 10 cigarettes\u002Fday) within 3 months before screening or are unwilling to quit smoking during the study.\n20. History of alcohol or drug abuse within 6 months before the screening.\n21. Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study.",{"count":199,"type":20},110,[24],"The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.",[203],"Progressive Fibrosing Interstitial Lung Disease (PF-ILD) \u002F Progressive Pulmonary Fibrosis (PPF)","2026-04-21",{"date":122,"type":32},{"date":207,"type":32},"2023-02-15",{"date":209,"type":20},"2026-12",{"name":38,"class":39},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":218,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":40},"100599311","phase-3-confirmatory-clinical-study-of-hec585-tablets-in-patients-with-ipf-100599311","NCT07082842","Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF","A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study and sign the informed consent form before the study begins;\n2. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted;\n3. Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading;\n4. The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;\n5. The percentage of FVC as a percentage of the normal predicted value at the screening period is ≥ 45%;\n6. The percentage of DLco (hemoglobin \\[Hb\\] corrected) as a percentage of the normal predicted value at the screening period is ≥ 30%;\n7. Female or male subjects with potential fertility agree and commit to taking effective contraceptive measures from the time of signing the informed consent form until 30 days after the last administration of the investigational drug; at the same time, avoid sperm\u002Fegg collection, sperm\u002Fegg donation;\n8. According to the assessment by the investigator, the subjects are willing and able to comply with the requirements of the protocol and attend the visits.\n\nExclusion Criteria:\n\n1. The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.\n2. Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.\n3. Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.\n4. Within one month before randomization, any active infection requiring systemic treatment (such as oral or intravenous administration) in the form of activity (including bacterial, viral, parasitic or fungal infections).\n5. Expected to undergo lung transplantation during the course of the study.\n6. Expected survival period less than 6 months.\n7. History of malignant tumors within the previous 5 years (excluding localized cancers such as basal cell carcinoma).\n8. Moderate to severe liver dysfunction (Child-Pugh classification of grade B or C).\n9. Within six months before screening, history of unstable or deteriorating heart disease, including but not limited to the following conditions:\n\n   1. Unstable angina pectoris;\n   2. Myocardial infarction;\n   3. Congestive heart failure requiring hospitalization or NYHA III\u002FIV grade;\n   4. Uncontrolled severe arrhythmia.\n10. Unable to perform the 6MWT or pulmonary function test, such as if the patient is mentally unstable and unable to cooperate, etc.;\n11. Allergic to any component of Ifinonate Hydrochloride Tablets (except the active ingredient, the excipients include microcrystalline cellulose, pre-gelatinized starch, cross-linked povidone, povidone, dibutyl hydroxytoluene, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide) or pirfenidone tablets;\n12. The last administration of the study drug for other clinical trials occurred within 4 weeks before randomization or 5 half-lives (whichever is longer);\n13. Pregnant or breastfeeding;\n14. Within 3 months before screening, had a smoking history or was unwilling to maintain a smoking-free status during the study;\n15. Within 6 months before screening, frequently drank alcohol \\[average weekly alcohol consumption exceeding 21 units (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of 40% alcohol spirits)\\];\n16. Had a history of drug abuse within 6 months before screening;\n17. Has a family or personal history of long QT interval syndrome;\n18. The investigator believes that the subject has conditions that may compromise their safety or compliance, significantly affect the pharmacokinetics of the drug, or prevent them from completing the study.\n19. During the screening period, liver function test values exceeded any of the following standards: total bilirubin \\> 1.5 times the upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \\> 2 times ULN;\n20. During the screening period, glomerular filtration rate \\\u003C 45 mL\u002Fmin\u002F1.73 m2, calculated using the CKD-EPI (based on serum creatinine) formula ;\n21. At the time of screening, human immunodeficiency virus antibody or syphilis spirochete antibody test results were positive;\n22. At the time of screening, there was an uncontrolled hepatitis B virus infection (positive hepatitis B surface antigen, and hepatitis B DNA ≥ 2x102 IU\u002FmL) or hepatitis C virus infection (positive anti-hepatitis C antibody and hepatitis C RNA);\n23. During the screening period, QTcF \\> 480 ms (using the Fridericia formula, QTcF = QT\u002FRR\\^0.33).\n24. Those who have previously taken isoniazidine hydrochloride;\n25. Within the first 4 weeks before randomization, used any of the following treatments:\n\n    1. Any cytotoxic drugs or immunosuppressants, including but not limited to azathioprine, cyclophosphamide, methotrexate, cyclosporine, etc.;\n    2. Pirfenidone or nintedanib;\n    3. \\> 15 mg\u002Fd prednisone or equivalent dose of other glucocorticoids;\n    4. Strong inducers or inhibitors of CYP3A4, CYP2C8 or CYP2C19 (including but not limited to ritonavir, clarithromycin, aletris, carbamazepine, gemfibrozil, fluoxetine, fluvoxamine, etc.);\n    5. Moderate, strong inhibitors or inducers of CYP1A2 (including but not limited to fluvoxamine, ciprofloxacin, enoxacin, etc.).","40 Years","80 Years",{"count":221,"type":20},472,[52],"A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)",[225],"Idiopathic Pulmonary Fibrosis (IPF)","2026-04-16",{"date":204,"type":32},{"date":229,"type":32},"2025-10-27",{"date":231,"type":20},"2032-02-15",{"name":38,"class":39},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":111,"sex":16,"minAge":17,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":40},"100442975","phase-1-pharmacokinetics-study-of-larotinib-in-subjects-with-impaired-hepatic-function-100442975","NCT05048368","Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function","A Pharmacokinetic Study of Larotinib in Subjects With Mild\u002FModerate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function","Inclusion Criteria:\n\n* healthy subjects with normal hepatic function (cohorts A and C) :\n* 1\\. Sign the informed consent form before the trial；\n* 2\\. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight \\>50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg\u002Fm\\^2, (including critical value) \\[BMI= weight (kg)\u002Fheight\\^2 (m\\^2)\\] (BMI matching ±15% with liver dysfunction cohort);\n* 3.Must be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening；\n* 4.Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.\n* Subjects with mild\u002F Moderate hepatic Impairment (cohorts B and D) :\n* 1\\. Sign the informed consent form before the trial.\n* 2\\. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight \\>50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg\u002Fm\\^2；\n* 3\\. Must satisfy the criteria for hepatic Impairment as evidenced by a Child-Pugh class of A or B at Screening:Class A; Mild; Child-Pugh score 5-6；Class B; Moderate; Child-Pugh score 7-9\n* 4\\. The liver function status of the subjects was determined to be stable between 1 month before taking the experimental drug and the end of the study, with no significant change.\n* 5\\. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.\n\nExclusion Criteria:\n\n* ALL subjects\n* 1\\. The subject has been diagnosed with acquired immune deficiency syndrome (AIDS), or tests positive for human immunodeficiency virus (HIV).\n* 2\\. Currently suffering from any bleeding disease, such as gastric and duodenal ulcer\n* 3\\. Those who had undergone major surgery within 6 months before the screening period or the surgical incision did not completely heal;\n* 4\\. History of hand foot syndrome;\n* 5\\. Those who have a history of liver cancer or other malignant tumors before signing the informed consent\n* 6\\. Those who have a history of gastrointestinal and renal diseases or surgery that may affect drug absorption, distribution, metabolism and excretion within 6 months before screening, or have diseases that can reduce compliance\n* 7\\. Take any food or beverage products containing alcohol, caffeine, xanthine and grapefruit within 48 hours prior to the first dose.\n* 8\\. The subject has received blood within 1 month, or donated loss of blood over 400 mL within 3 months prior to the screening\n* 9\\. Have a history of alcoholism or positive alcohol breath test during the screening period;\n* 10\\. Those who smoke more than 5 cigarettes a day or habitually use nicotine containing products 3 months before screening\n* 11\\. Those who had a history of drug abuse or used drugs within 2 years before screening or those who were positive for urinary drug screening during the screening period Allergic constitution\n* 12\\. Allergic constitution\n* 13\\. Within 28 days before screening, inhibitors or inducers of CYP3A4, cyp2c8, CYP2C19 and P-gp were used\n* 14\\. Participated in any other intervention clinical trial within 3 months before screening\n* 15\\. Female subjects with positive pregnancy test results or breastfeeding during screening;\n* 16\\. Any other circumstances that the investigator considers unsuitable for participation in this study\n* The following exclusion criteria apply only to healthy subjects with normal hepatic function (cohorts A and C) :\n* 17\\. he subject has evidence of clinically significant cardiovascular, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities.\n* 18\\. The subject tests positive for HBsAg or Hepatitis C antibody\n* 19\\. The subject has used any prescription or nonprescription drugs within 2 weeks prior to the screening.\n* The following exclusion criteria apply only to subjects with mild\u002F Moderate hepatic Impairment (cohorts B and D) :\n* 17\\. The following exclusion criteria apply only to subjects with liver function impairment (cohorts B and D) :\n* a) ALT\\>10×ULN；\n* b) AST\\> 10×ULN；\n* c) Absolute count of neutrophils \\\u003C0.75×10\\^9\u002FL;\n* d) PLT\\\u003C50×10\\^9\u002FL\n* e) HGB\\\u003C60 g\u002FL\n* f) AFP \\>100 ng\u002FmL; If 20 ng\u002FmL≤AFP≤100 ng\u002FmL, liver MRI are required to exclude subjects with suspected HCC.\n* g) eGFR\\\u003C60 mL\u002Fmin\u002F1.73m\\^2.\n* h) Male：QTcF\\> 450 msec，Female：QTcF\\>470 msec。\n* 18\\. The subject has any of the following conditions: Diseases affecting bile excretion such as biliary obstruction; Drug induced liver injury; History of liver transplantation; Liver failure, or liver cirrhosis patients with complications such as hepatic encephalopathy, rupture and bleeding of esophageal and gastric varices, etc; Patients with severe or advanced peritoneal effusion or pleural effusion need puncture drainage and albumin supplementation. Patients with hepatorenal syndrome.\n* 19\\. Previous severe esophagogastric varices or previous portosystemic shunt, including transjugular intrahepatic portosystemic shunt (TIPS)\n* 20\\. Cardiovascular events occurred within 6 months before screening\n* 21\\. Those who use prescription drugs, over-the-counter drugs, Chinese herbal medicine or food supplements other than drugs for the treatment of liver function impairment and other accompanying diseases within 14 days before screening;\n* 22\\. Medical conditions which are not adequately and stably controlled on stable doses of medications or which, in the clinical opinion of the Principal Investigator, may interfere with study procedures or participant safety.","70 Years",{"count":242,"type":20},32,[23],"To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration",[246,97],"Esophageal Cancer","2025-05-16",{"date":249,"type":32},"2025-05-18",{"date":251,"type":20},"2026-10-30",{"date":253,"type":20},"2026-12-30",{"name":38,"class":39},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":219,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":275,"locationsCount":40},"100394422","phase-3-study-of-larotinib-in-unresectable-advanced-or-recurrent-esophageal-cancer-100394422","NCT04415853","Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer","Lerotinib Versus Investigator's Choice Single-agent Chemotherapy in Patients With Locally Advanced\u002FMetastatic Esophageal Squamous Cell Carcinoma and EGFR Overexpression That Progressed After Second-line Therapy:Phase 3 Study","Inclusion Criteria:\n\n1. Age:18-75 years, male or female.\n2. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus or advanced\u002Fmetastatic disease.\n3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy of greater than 3 months.\n5. Documented objective radiographic or clinical disease progression on two previous lines of standard therapy.\n6. Can provide archival tumor tissue sample for biomarker analysis (such as EGFR overexpression\u002Fexpansion status), biopsies are required if tissue samples cannot be provided\n7. Confirmed by the central laboratory as EGFR high expression.\n8. Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.\n9. Ability to swallow drugs.\n10. Adequate organ function.\n11. Voluntarily join the study and sign informed consent ad has good compliance.\n\nExclusion Criteria:\n\n1. Prior therapies with EGFR targeted drugs including EGFR antibodies.\n2. Previously treated with Irinotecan and Tegafur.\n3. Anthracycline, nitrosourea, and mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks;immune anti-tumor therapy. within 8 weeks;other anti-tumor therapies within 4 weeks before randomization.\n4. Not recovered from adverse events due to a previously administered agent.\n5. Have undergone major surgery within 4 weeks prior to randomization (not including diagnostic surgery) or expect major surgery during the study period.\n6. Previously or currently participating in other clinical trials within 4 weeks before randomization (subjects who have entered the follow-up period are calculated based on the last use of experimental drugs or devices).\n7. Received a live vaccine within 28 days before randomization or plan to receive live vaccine after enrollment.\n8. Received a strong inducer or inhibitor of CYP3A4 enzyme within 1 week or received Solivudine or its structurally similar drugs within 56 days prior to randomization.\n9. Simultaneously receiving any other anti-tumor treatment.\n10. Has a known additional malignancy previously within the last 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or any other tumor that has been cured。\n11. Central nervous system metastasis or uncontrolled central nervous system metastasis currently in need of treatment; or confirmed central nervous system metastasis, but not stable for more than 4 weeks after anti-tumor therapy; spinal cord compression, cancerous meningitis, or meningitis.\n12. Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs.\n13. Having active gastrointestinal ulcer, active gastrointestinal bleeding, and perforation;\n14. Risk of major bleeding or esophageal fistula;\n15. Previous or present with interstitial lung disease or immunotherapy-associated pneumonia; currently suffering from drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or clinically symptomatic active pneumonia, or other moderate to severe lungs that seriously affect lung function disease\n16. Active infection during the screening period (including but not limited to infection requiring intravenous drip therapy), or unexplained fever (\\> 38.5°C)within 2 weeks prior to randomization.\n17. Has congenital or acquired immune deficiency (such as HIV infection).\n18. Known active Hepatitis B or C.\n19. Has any of the following diseases within the first 12 months of randomization: myocardial infarction, coronary artery bypass grafting or peripheral artery bypass graft surgery, heart failure (NYHA III to IV), etc and unstable angina with 6 months.\n20. Has thrombosis or embolism occurred within the first 12 months of randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism with heparin or other similar drugs.\n21. QTc interval (QTcF) corrected by Fridericia method\\> 470 ms; history of congenital long QT interval syndrome; any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation) Or torsion-type ventricular tachycardia); left ventricular ejection fraction (LVEF) \\\u003C50%.\n22. Allergies or contraindications to Z650 excipients (mannitol, sodium carboxymethyl starch, micronized silica gel, magnesium stearate, silicified microcrystalline cellulose), or to Irinotecan or Tegafur or its formulation ingredients.\n23. Has uncontrolled pleural effusion, pericardial effusion, pelvic effusion, or ascites requiring repeated drainage.\n24. Has a history of organ transplantation or a history of allogeneic bone marrow transplantation.\n25. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of study medication.\n26. Has other serious acute or chronic diseases and are not suitable for participating in clinical trials judged by investigators.",{"count":263,"type":20},416,[52],"This is a randomized, controlled, multi-center, open trial, unresectable locally advanced or metastatic esophageal squamous cell carcinoma patients that failed at least second-line treatment and overexpressed EGFR were enrolled and randomly assigned to the experimental group and control group at a 1: 1 ratio.,who received Larotinib and the chemotherapy regimen chosen by the investigator (Irinotecan Hydrochloride Injection or Tegafur Gimeracil Oteracil Potassium Capsule),respecitively.\n\nSubjects are administered until disease progression assessed by the RECIST V1.1 standard (unless the investigator evaluates that the subject continues to have clinical benefit from continuing treatment, the subject may be allowed to continue treatment), and begins to receive new anti-tumor treatment, unacceptable toxicity, withdrawal of informed consent, or other conditions that meet the criteria for terminating trial treatment \u002F withdrawal from the trial.\n\nThe research phase of this study is divided into pre-screening period (\\~ D-28), screening period (D-28 \\~ D-1), treatment period, treatment end visit (± 7 days after the last dose), safety follow-up ( Until 28 ± 7 days after the last dose) and survival follow-up.",[246],[268,269,270],"ESCC;","EGFR overexpression;","Phase 3",{"date":249,"type":32},{"date":273,"type":32},"2021-01-21",{"date":253,"type":20},{"name":38,"class":39},""]