[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shandong New Time Pharmaceutical 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,[8,39,63,85,107,133,153,173,193,213,234,253],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100641390","phase-1-phase-i-clinical-study-of-lnf2105-in-patients-with-advanced-solid-tumors-100641390",false,"NCT07661797","Phase I Clinical Study of LNF2105 in Patients With Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Efficacy of LNF2105 in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Male or female aged ≥18 years.\n2. Patients with advanced solid tumors (including but not limited to urothelial carcinoma, breast cancer, non-small cell lung cancer, ovarian cancer, endometrial cancer, and cervical cancer) that have been histologically or cytologically confirmed as having failed\u002Fcannot tolerate\u002Fhave no standard treatment\u002Fare currently unsuitable for standard treatment.\n3. Able to provide previous Nectin-4 expression testing results or preserved\u002Ffresh tumor tissue for Nectin-4 expression testing.\n4. At least one measurable lesion (CT or MRI long axis ≥ 10 mm, lymph node short axis ≥ 15 mm) according to RECIST v1.1 criteria. For lesions previously treated with radiotherapy, they will only be included as measurable lesions if there has been clear disease progression after radiotherapy.\n5. The function of vital organs must meet the following requirements (no blood components or cytokines may be used within 14 days prior to the first dose).\n\n7\\) ECOG score 0-1. 8) Expected survival ≥ 3 months. 9) Willing to participate and sign informed consent form, and willing to follow the trial treatment protocol and visitation plan.\n\nExclusion Criteria:\n\n1. Prior treatment with an antibody-drug conjugate (ADC) exhibiting one of the following characteristics: payload as a topoisomerase I inhibitor (TOP 1 inhibitor); antibody target as Nectin-4.\n2. Received any P-glycoprotein (P-gp) inducer\u002Finhibitor, strong CYP3A inhibitor, or breast cancer resistance protein (BCRP) inhibitor within 14 days prior to first administration (see Appendix 3 for the exclusion list).\n3. Patients who received chemotherapy within 3 weeks or radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks prior to first administration of the study drug, excluding the following.\n4. Patients who received systemic glucocorticoid therapy or any other form of immunosuppressive therapy (equivalent to a prednisone dose \\>10 mg\u002Fday) within 2 weeks prior to the first dose.\n5. Patients whose adverse reactions to previous antitumor therapy have not recovered to a CTCAE 5.0 grade ≤1 or the level specified in the inclusion\u002Fexclusion criteria (excluding toxicities deemed safe by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, and stable hypothyroidism after hormone replacement therapy).\n6. Patients with primary central nervous system (CNS) malignancies, CNS metastases that have failed local treatment, or carcinomatous meningitis; patients with asymptomatic brain metastases, or stable clinical symptoms such as neurological symptoms and who do not require corticosteroids or other treatments targeting brain metastases for ≥4 weeks may be enrolled.\n7. Patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n8. Patients with known interstitial lung disease (ILD) or non-infectious pneumonia, currently symptomatic or requiring prior systemic glucocorticoid therapy, whose toxicity assessment or management is deemed by the investigator to potentially affect the investigational treatment.\n9. Patients with a history of organ transplantation or allogeneic bone marrow transplantation, or who received autologous stem cell transplantation within 3 months prior to the first dose.\n10. Patients who underwent major surgery within 4 weeks prior to the first dose or have not yet recovered from surgery.\n11. Patients with any of the following laboratory findings.\n12. Patients with uncontrolled or severe cardiovascular disease, including those who developed NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, or other cardiovascular diseases within 6 months prior to the first dose; or those with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg after treatment).\n13. Patients with active infections requiring intravenous anti-infective therapy or a history of the following conditions, including but not limited to active autoimmune diseases, severe mental illness, severe endocrine disorders such as severe thyroid dysfunction.\n14. Patients with the following ocular diseases: a) active infection or corneal ulcer; b) history of corneal transplantation; c) expected contact lens wear during the study period; d) poorly controlled glaucoma; e) poorly controlled or progressive retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disease; f) or other currently existing ocular diseases that would affect the assessment of ocular toxicity after the trial intervention.\n15. Glycated hemoglobin (HbA1c) ≥ 8.0%.\n16. Suffering from severe and\u002For uncontrolled comorbidities, such as decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, active inflammatory bowel disease, gastrointestinal perforation, intestinal obstruction, or gastrointestinal bleeding.\n17. Having a bleeding tendency (e.g., abnormal coagulation function tests, clinically significant as determined by the investigator, or clinically significant bleeding symptoms as assessed by the investigator).\n18. Having received any other clinical trial drug\u002Fdevice treatment within 4 weeks prior to the first dose.\n19. Having a history of drug abuse or alcoholism within 6 months prior to the first dose.\n20. Having a history of severe allergies, or a known history of allergy to macromolecular protein preparations\u002Fmonoclonal antibodies, or to any component of the investigational drug.\n21. Having received a live or attenuated live vaccine within 4 weeks prior to the first dose.\n22. Pregnant or breastfeeding women, female participants of childbearing age, or male participants whose partners are women of childbearing age who do not agree to use medically approved effective contraception (such as an intrauterine device or condom) during the study period and for 6 months after the last study drug treatment.\n23. Individuals deemed unsuitable for enrollment by the investigator.","ALL","18 Years",{"count":19,"type":20},294,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor efficacy of LNF2105 in patients with advanced solid tumors.",[26],"Patients With Advanced Solid Tumors","NOT_YET_RECRUITING","2026-06-16",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2028-08",{"name":37,"class":38},"Shandong New Time Pharmaceutical Co., LTD","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100638687","phase-3-a-multicenter-randomized-open-label-parallel-group-controlled-superiority-phase-iii-clinical-study-comparing-the-efficacy-and-safety-of-f182112-versus-standard-of-care-in-patients-with-relapsed-or-refractory-multiple-myeloma-100638687","NCT07579234","A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma","Phase III Clinical Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n2. Provide informed consent and voluntarily sign the informed consent form; Be male or female, aged ≥18 years;\n3. Have relapsed or refractory multiple myeloma (RRMM) who have previously failed therapy with regimens containing at least one agent from each of the following three drug classes: proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies; i. Relapsed: Disease progression requiring salvage therapy after achieving a minimal response (MR) or better following prior anti-myeloma therapy; ii. Refractory: Lack of response (failure to achieve MR or better) during the last anti-myeloma therapy, or disease progression within 60 days after the last anti-myeloma therapy;\n4. Before randomization, the investigator must pre-select a standard of care (SOC) treatment regimen based on the patient's disease status;\n5. Have an ECOG performance status of 0-2;\n6. Have at least one measurable disease parameter:\n\n   * Serum M-protein ≥5 g\u002FL;\n   * Urine M-protein ≥200 mg\u002F24 h;\n   * Serum free light chain (FLC) assay: involved FLC level ≥100 mg\u002FL with an abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65);\n7. Have organ function meeting the following requirements (no blood components or hematopoietic growth factors permitted within 7 days prior to first dose):\n\n   * Hematology: Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL, hemoglobin ≥70 g\u002FL, platelets ≥50×10⁹\u002FL;\n   * Liver function: Total bilirubin ≤1.5×ULN, ALT ≤2.5×ULN, AST ≤2.5×ULN;\n   * Renal function: Creatinine clearance ≥30 mL\u002Fmin;\n8. All prior treatment-related toxicities (as defined by NCI CTCAE v6.0) must be ≤Grade 1 at screening, except for alopecia, non-clinically significant and asymptomatic Grade 2 laboratory abnormalities, and those parameters specifically permitted in the inclusion criteria;\n9. Have an expected survival of ≥3 months.\n\nExclusion Criteria:\n\n1. Central nervous system involvement or clinical symptoms of meningeal involvement by multiple myeloma;\n2. Concomitant light chain amyloidosis, plasma cell leukemia, Waldenström macroglobulinemia, or POEMS syndrome;\n3. History of any other malignancy within 3 years prior to first dose, except for malignancies with very low recurrence risk after curative treatment (e.g., squamous cell carcinoma or basal cell carcinoma of the skin, in situ cervical or breast cancer), or those who have undergone curative surgical resection (or other treatment) with no current evidence of disease and unlikely to impact survival during the study period;\n4. Dysphagia or active gastrointestinal dysfunction that may impair drug absorption;\n5. Evidence of cardiovascular risk, including any of the following:\n\n   * QTc interval: ≥450 ms in males, ≥470 ms in females (QT interval must be corrected for heart rate using Friderici's formula);\n   * Left ventricular ejection fraction (LVEF) \\\u003C50%;\n   * Electrocardiographic abnormalities deemed by the investigator to pose unacceptable risk, including clinically significant untreated or uncontrolled arrhythmias, second-degree (Mobitz II) or third-degree atrioventricular (AV) block;\n   * History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stent placement, or bypass surgery within 6 months prior to screening;\n   * Heart failure classified as NYHA Class III or IV;\n   * Uncontrolled severe hypertension (systolic blood pressure ≥170 mmHg or diastolic blood pressure ≥110 mmHg);\n6. Active infection requiring antimicrobial, antiviral, or antifungal therapy (prophylactic therapy excluded):\n\n   * Oral antimicrobial therapy within 2 weeks prior to first dose;\n   * Intravenous antimicrobial therapy within 4 weeks prior to first dose;\n   * History of viral respiratory infection (e.g., COVID-19, influenza A or B) within 2 weeks prior to first dose;\n7. Serological findings:\n\n   * HBsAg positive and\u002For HbcAb positive with HBV-DNA positive or above upper limit of normal (ULN); HCV antibody positive with HCV-RNA positive or above ULN;\n   * Active autoimmune disease, including HIV infection. Patients with well-controlled type 1 diabetes, euthyroid autoimmune thyroiditis, or skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis) are permitted;\n   * Active syphilis infection;\n   * Active tuberculosis (evidenced by chest imaging or other relevant testing within 3 months prior to screening or during screening; tuberculosis screening will be conducted per center protocol);\n8. Received live or attenuated vaccine within 4 weeks prior to first dose;\n9. Underwent major surgery within 4 weeks prior to first dose, or anticipated to undergo major surgery during the study period;\n10. Received the following anti-myeloma therapies prior to first dose:\n\n    * Plasmapheresis within 28 days prior to first dose;\n    * Monoclonal antibody therapy within 21 days prior to first dose;\n    * Small molecule targeted therapy, cytotoxic chemotherapy, and\u002For proteasome inhibitor and\u002For other anti-tumor traditional Chinese medicine within 14 days or 5 half-lives (whichever is shorter) prior to first dose;\n    * Systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent dose) within 7 days prior to first dose;\n    * Autologous stem cell transplantation within 3 months prior to first dose;\n    * CAR-T or CAR-NK cell therapy within 3 months prior to first dose;\n11. Previously received allogeneic stem cell transplantation;\n12. Previously received BCMA-targeted therapy;\n13. Plan to receive other anticancer therapy or investigational drugs during the study period;\n14. Any severe and\u002For unstable pre-existing medical condition, psychiatric disorder, or other disease (including laboratory abnormalities) that may affect participant safety, informed consent acquisition, or adherence to study procedures;\n15. Pregnant or lactating women; male participants (or their partners) or female participants who plan to become pregnant during the study or within 6 months after the last dose, and who are unwilling to use a medically accepted effective contraceptive method (e.g., intrauterine device or condom) during the study period;\n16. Any patient deemed unsuitable for participation by the investigator..\n\n    SAT-specific exclusion criteria:\n17. Inability to receive bortezomib as determined by the investigator;\n18. Contraindication to bortezomib or history of life-threatening allergic reaction or intolerance (defined as drug-related AE leading to discontinuation of treatment);\n19. Grade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy;\n20. Received a strong CYP3A4 inducer within 5 half-lives prior to first dose;\n21. Previously received pomalidomide or have a contraindication to pomalidomide (e.g., history of arterial or deep vein thrombosis within the past 3 months \\[except intermuscular vein thrombosis\\], contraindication to or unwillingness to receive prophylactic antithrombotic therapy as required by protocol), or life-threatening allergic reaction or intolerance to pomalidomide;\n22. Previously received selinexor or have a contraindication to selinexor or life-threatening allergic reaction or intolerance to selinexor.",{"count":47,"type":20},261,[49],"PHASE3","A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing F182112 with Standard of Care in Patients with Relapsed or Refractory Multiple Myeloma",[52],"Relapsed or Refractory Multiple Myeloma (RRMM)","RECRUITING","2026-05-06",{"date":56,"type":31},"2026-05-12",{"date":58,"type":31},"2026-01-25",{"date":60,"type":20},"2029-01-25",{"name":37,"class":38},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":62},"100616943","phase-2-a-study-of-f182112-in-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-100616943","NCT07312188","A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma","A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.\n* The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.\n* Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.\n* Have an ECOG performance status score of 0 - 2.\n* Meet at least one of the following measurable disease indicators:\n\n  1. Serum M - protein ≥ 5 g\u002FL.\n  2. Urine M - protein ≥ 200 mg\u002F24 h.\n  3. Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg\u002FL and abnormal serum free light chain ratio (\\\u003C 0.26 or \\> 1.65).\n\nExclusion Criteria:\n\n* Patients with primary light - chain amyloidosis or plasma cell leukemia .\n* Patients with symptoms of central nervous system involvement of multiple myeloma.\n* Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose.\n* Patients with active mucosal or visceral bleeding.\n* Patients who have previously received BCMA - targeted therapy.",{"count":71,"type":20},90,[73],"PHASE2","This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.",[76],"Relapsed or Refractory Multiple Myeloma","2025-12-16",{"date":79,"type":31},"2025-12-31",{"date":81,"type":31},"2025-07-02",{"date":83,"type":20},"2028-05-20",{"name":37,"class":38},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100596500","phase-3-phase-iii-clinical-study-on-the-efficacy-and-safety-of-semaglutide-and-ozempic-in-patients-with-type-2-diabetes-100596500","NCT07046273","Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes","A Multicenter, Randomized, Open, Parallel-controlled, Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* 1\\) Voluntary signing of informed consent; 2) Aged 18-75 years (inclusive) at the time of signing the informed consent, male or female; 3) Diagnosed with type 2 diabetes according to the WHO diabetes diagnostic criteria; 4) Laboratory tests at the research center at screening: 7.5%≤HbA1c≤10.5%; 5) Before randomization, study participants received stable doses of metformin (≥1500mg\u002Fday or maximum tolerated dose: \\\u003C1500mg\u002Fday, but ≥1000mg\u002Fday) for at least 8 weeks (maximum tolerated dose must be supported by previous medical records); 6) Body mass index (BMI) ≥18.5kg\u002Fm2 and ≤35.0kg\u002Fm2 at screening; 7) Willing and able to undergo treatment and follow-up as required by the protocol.\n\nExclusion Criteria:\n\n1. Type 1 diabetes, special type of diabetes;\n2. Received hypoglycemic drugs other than metformin (including Chinese medicine) within 8 weeks before randomization;\n3. Used non-diabetes treatment drugs that may have a significant impact on glucose metabolism for 1 week or more within 3 months before randomization, such as glucocorticoids (systemic glucocorticoids used for \\\u003C7 days, excluding inhalation, ocular medication or topical application), sympathetic nerve stimulants (such as isoproterenol, dopamine, atropine, etc.), growth hormone, high-dose salicylates (300 mg\u002Fday and above), danazol, octreotide and anabolic androgenic steroids (such as oxymetholone, oxandrolone, etc.);\n4. Has a history of ≥2 episodes of grade 3 hypoglycemia within 1 year before randomization;\n5. Diabetic ketoacidosis or hyperglycemic hyperosmolar state within 3 months before randomization;\n6. Severe complications of diabetes at screening: such as proliferative diabetic retinopathy, macular edema; history of renal transplantation; severe peripheral vascular disease (such as amputation, chronic foot ulcers, intermittent claudication);\n7. Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg) at screening\u002Frandomization;\n8. Cardiovascular diseases such as acute coronary syndrome (including but not limited to acute myocardial infarction, or unstable angina), arrhythmia requiring treatment, severe heart failure (refer to New York Heart Association heart function grade III or IV), coronary artery bypass grafting or coronary stent implantation within 6 months before screening;\n9. New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack, etc.) within 6 months before screening;\n10. Severe trauma or severe infection or surgery that may affect blood sugar control within 1 month before screening;\n11. History of acute or chronic pancreatitis;\n12. History of cholecystitis due to cholelithiasis or other reasons within 6 months before screening;\n13. Cushing's syndrome, hyperthyroidism, and uncontrolled hypothyroidism at screening;\n14. Significant gastric emptying abnormalities (such as gastric outlet obstruction) and severe gastrointestinal diseases at screening;\n15. Any disease that may cause hemolysis or red blood cell instability and affect HbA1c detection, such as blood system tumors, hemolytic anemia, sickle cell disease;\n16. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);\n17. History of malignant tumors in the past 5 years (regardless of organ system, whether treated or not, and whether there is evidence of recurrence or metastasis) or currently being evaluated for potential malignant tumors, but excluding clinically cured cervical carcinoma in situ and skin basal cell carcinoma;\n18. Meet any of the following criteria at screening:\n\n    Liver function impairment: ALT or AST ≥ 5 times the upper limit of normal, or total bilirubin ≥ 2 times the upper limit of normal; Renal function impairment: glomerular filtration rate (eGFR, CKD-EPI formula) \\\u003C 45mL\u002Fmin\u002F1.73m2; Fasting triglyceride (TG) ≥ 5.7mmol\u002FL after stable medication; Calcitonin ≥ 50ng\u002FL; Hemoglobin ≤ 100g\u002FL; Thyrotropin (TSH) \\> 6mIU\u002FL after stable medication; Blood amylase or lipase ≥ 3 times the upper limit of normal; Hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis serological test results are positive, hepatitis B virus surface antigen is positive and HBV-DNA is positive.\n19. Known allergy to any component of semaglutide injection or allergy to other GLP-1 RA drugs;\n20. Donated blood or lost ≥400mL of blood within 3 months before screening, or received blood transfusion therapy, or planned to donate blood during the trial;\n21. Received other clinical research drugs or device treatments within 3 months before screening, or participated in other drug clinical trials and are still within 5 half-lives of the trial drug, whichever is older; or planned to participate in other clinical studies during the trial;\n22. Have a history of drug abuse (including drug abuse) and\u002For alcohol dependence within 6 months before screening;\n23. Mental disorder or language barrier, unable to fully understand and cooperate;\n24. Pregnant or lactating women;\n25. Male and female research participants who have fertility plans during the trial and within 2 months after the last dose of the trial drug, or are unwilling to take reliable contraceptive measures for contraception;\n26. Other situations that the researcher considers unsuitable for participation in this study. -","75 Years",{"count":94,"type":20},496,[49],"This study is a multicenter, randomized, open, parallel-controlled, Phase III clinical study aimed to evaluate the efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes.",[98],"Type 2 Diabetes (T2DM)","2025-06-23",{"date":101,"type":31},"2025-07-01",{"date":103,"type":20},"2025-08-01",{"date":105,"type":20},"2029-02-01",{"name":37,"class":38},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":62},"100579090","phase-3-phase-iii-clinical-study-of-cetirizine-hydrochloride-injection-in-treatment-of-acute-urticaria-100579090","NCT06819774","Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute Urticaria","Efficacy and Safety of Cetirizine Hydrochloride Injection in the Treatment of Acute Urticaria: a Randomized, Double-blind, Positive Controlled, Multicenter Phase III Clinical Study","Phase III","Inclusion Criteria:\n\n1. Age range: 18 - 65 years old (inclusive of the threshold value), gender not limited;\n2. Diagnosed with acute urticaria (the definition of acute urticaria: spontaneous wheals and\u002For angioedema attacks ≤ 6 weeks);\n3. At screening，the severity score of pruritus of the patient was ≥ 1 point ;\n4. At screening，the degree score of wheals\u002Ferythema of the patient assessed by the investigator was ≥ 1 point ;\n5. Be willing and able to give informed consent.\n\nExclusion Criteria:\n\n1. Patients in whom an antihistamine are contraindicated (such as those with angle-closure glaucoma, symptomatic benign prostatic hyperplasia, etc.);\n2. Patients who used H1 antagonists (such as diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine, etc.) within 2 hours before randomization;\n3. Patients who used H2 antagonists (such as cimetidine, ranitidine, famotidine, roxatidine, etc.) within 2 hours before randomization;\n4. Patients who used doxepin within 2 hours before randomization;\n5. Patients who received steroid hormone treatment for acute allergic reactions within 4 hours before randomization;\n6. Patients who used epinephrine within 20 minutes before randomization;\n7. Patients who are known to be allergic to hydroxyzine, cetirizine, levocetirizine, diphenhydramine;\n8. Pregnant or lactating women; or those who have a pregnancy plan or plan to donate sperm\u002Feggs from the screening day to the end of medication within 1 month; or those who are unwilling to take one or more contraceptive measures from the screening day to the end of medication within 1 month;\n9. Patients with urticarial drug eruption;\n10. Patients with acute urticaria who have concurrent symptoms such as laryngeal edema, allergic asthma, anaphylactic shock during screening;\n11. Patients with urticarial vasculitis, hereditary angioedema, antihistamine-resistant urticaria or skin diseases that interfere with the evaluation of treatment efficacy during screening;\n12. Patients with a history of immunodeficiency;\n13. Patients with other major medical conditions (such as blood diseases, cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases, etc.) or mental disorders and judged by the investigator to be unsuitable to participate in this study;\n14. Patients who are concurrently using P-glycoprotein inhibitors (such as cyclosporine, itraconazole, dronedarone, amiodarone, quinidine, verapamil, etc.) during screening;\n15. Patients who participated in other clinical trials within 3 months before screening (excluding those who only participated in the screening of the clinical trial but did not use the trial drugs or devices);\n16. Patients with acute urticaria accompanied by fever during screening;\n17. Patients engaged in dangerous jobs such as driving, high-altitude work, mechanical operation, etc., and cannot stop within 48 hours after medication;\n18. Other various situations.","65 Years",{"count":117,"type":20},284,[49],"The objective of this study was to evaluate the efficacy and safety of cetirizine hydrochloride injection in the treatment of acute urticaria.The participants were randomized to receive cetirizine hydrochloride or diphenhydramine hydrochloride.",[121],"Acute Urticaria",[123,124],"Cetirizine hydrochloride injection","acute urticatia","2025-02-06",{"date":127,"type":31},"2025-02-11",{"date":129,"type":31},"2024-04-22",{"date":131,"type":20},"2025-08",{"name":37,"class":38},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":138,"conditions":143,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100576281","phase-2-phase-ii-clinical-study-of-vonorasan-fumarate-injection-in-the-treatment-of-peptic-ulcer-bleeding-100576281","NCT06783257","Phase II Clinical Study of Vonorasan Fumarate Injection in the Treatment of Peptic Ulcer Bleeding","A Multicenter, Randomized, Double-Blind, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Vonoprazan Fumarate Injection for the Treatment of Peptic Ulcer Bleeding","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Individuals aged between 18 and 75 years, regardless of gender.\n3. Clinical manifestations of upper gastrointestinal bleeding, such as hematemesis, melena, or positive fecal occult blood, within 48 hours prior to screening.\n4. Patients diagnosed with upper gastrointestinal bleeding caused by gastric and\u002For duodenal ulcers through endoscopic examination within 24 hours prior to random group selection, with ulcer maximum diameter ranging from 3 to 20 mm.\n5. The classification of peptic ulcers according to Forrest is as follows: Ia, Ib, IIa, IIb. For multiple ulcers, the higher Forrest grade is used for determination. After confirming the ability to achieve hemostasis through endoscopic treatment, the following requirements for endoscopic treatment are as follows:\n\n   * For Forrest Ia, Ib, IIa: Thermal hemostasis or mechanical hemostasis is the primary method, and it is also permissible to combine local epinephrine injection based on the aforementioned primary methods;\n   * For Forrest IIb: To confirm the specific grade, endoscopic irrigation to remove attached blood clots should be attempted first. If the blood clots are cleared, the Forrest grade should be reassessed. If it is classified as Forrest Ia, Ib, or IIa, endoscopic hemostatic treatment should be performed as per the above requirements. If the blood clots are not cleared and it is ultimately confirmed as Forrest IIb, direct grouping is permitted.\n\nExclusion Criteria:\n\n1. Individuals with a clinically significant history of drug allergies or known allergies to the components and excipients of the study drug;\n2. Subjects with other severe central nervous system, cardiovascular, respiratory, organ, renal, gastrointestinal, urinary, endocrine, or hematological diseases, which the investigator believes may confound the study results or affect the safety of the subjects;\n3. Hematological disorders: ① Platelet count \\\u003C80×10\\^9\u002FL; ② PT exceeds the upper limit of normal by 3 seconds; ③ APTT exceeds the upper limit of normal by 10 seconds; (If any of these criteria are met, the patient is not eligible for selection)\n4. Renal function abnormalities: ① ALT or AST ≥1.5×ULN; ② Total bilirubin \\>1.5×ULN; ③ Serum creatinine (Cr) \\> ULN; (If any of these criteria are met, the patient is not eligible for selection)\n5. A history of drug abuse within the last 5 years;\n6. Receipt of live vaccines or attenuated live vaccines within 30 days prior to the first administration, or plans to receive vaccinations during the study period;\n7. Hemorrhagic shock (occurring during the screening period with systolic blood pressure \\\u003C90 mmHg and heart rate \\>120 beats\u002Fmin, accompanied by symptoms such as pallor, cold and clammy extremities, restlessness, or altered mental status) or requiring arterial catheter embolization or surgical intervention due to unsuccessful endoscopic treatment;\n8. Concurrent upper gastrointestinal bleeding from other causes or suspected gastric malignancy under endoscopy; There is a clear history of surgery to reduce gastric acid or a history of gastric surgery (including but not limited to partial gastrectomy, gastric plasty, vagotomy, excluding simple perforation suturing);\n\n10\\. A history of malignant tumors within 5 years prior to screening (if the subject has been cured of skin basal cell carcinoma or cervical carcinoma in situ, he\u002Fshe may participate in this study); 11. Use of proton pump inhibitors (PPIs) or H2 receptor antagonists or P-CAB preparations exceeding a single dose of the standard dose within 24 hours prior to screening, or having undergone endoscopic treatment\u002Fintervention before signing the informed consent form, and having used PPIs, P-CAB preparations, H2 receptor antagonists, somatostatin, or hemostatic agents after endoscopic treatment\u002Fintervention until the selection for this study; 12. Patients currently using drugs with a clear risk of interaction with the investigational drug, such as azanavir sulfate, nelfinavir, saquinavir, or liponavir; 13. Use of hemostatic powder Endoclot AHP® or other local hemostatic agents during endoscopy that, in the investigator's judgment, affect the efficacy of the investigational drug; 14. Pregnant or breastfeeding women, as well as those with plans for pregnancy or sperm\u002Fegg donation within 3 months after the end of the study, who are unwilling to adopt a medically recognized contraceptive method (such as an intrauterine device or condom) during the study; 15. Participation in other drug\u002Fdevice clinical studies and use of investigational drugs\u002Fdevices within 3 months prior to randomization; 16. Other subjects deemed unsuitable for selection by the investigator.",{"count":141,"type":20},150,[73],[144],"Peptic Ulcer Bleeding","2025-01-17",{"date":147,"type":31},"2025-01-20",{"date":149,"type":20},"2025-02",{"date":151,"type":20},"2027-02",{"name":37,"class":38},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"100576230","phase-2-a-phase--study-of-mosapride-citrate-injection-in-the-treatment-of-postoperative-gastrointestinal-dysfunction-100576230","NCT06782594","A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction","A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction","Inclusion Criteria:\n\n1）Voluntary participation and signing of informed consent;\n\n2\\) Aged ≥18 years and ≤75 years and BMI≤28kg\u002Fm2, regardless of gender;\n\n3\\) Patients undergoing elective laparoscopic-assisted intestinal resection and the surgical site is part of the intestinal segment from the ileocecal region to the sigmoid colon;\n\n4\\) Vital organ functions meet the following requirements:iver function:\n\nALT and AST≤3×ULN, total bilirubin level≤2×ULN;\n\nRenal function: serum creatinine (Cr)≤1.5×ULN or creatinine clearance≥50mL\u002Fmin (when Cr\\>1.5×ULN);\n\nBlood routine examination: hemoglobin (HGB)≥80g\u002FL;\n\nBlood biochemistry: albumin (ALB)≥30g\u002FL;\n\n5\\) Those classified as physical condition 1 to 3 by the American Society of Anesthesiologists (ASA).\n\nExclusion Criteria:\n\n1\\) Patients with a history of clinically significant drug allergy or known allergy to the study drug ingredients and excipients;\n\n2）Those who have a history of severe heart, lung, liver, kidney, blood, endocrine, immune, skin, neurological or mental diseases in the past two years or currently have diseases of the above systems;\n\n3\\) Those with a history of drug abuse in the past 6 months;\n\n4\\) Those with a history of constipation in the past 6 months (less than 3 bowel movements per week);\n\n5\\) Severe mechanical intestinal obstruction that is not expected to be relieved after surgery, short bowel syndrome, significant gastrointestinal motility disorders (such as gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), poorly controlled Those with diabetes (HbA1c\\>8.5%) or gastrointestinal pacemakers installed in their bodies;\n\n6\\) Patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) and intestinal adhesions;\n\n7\\) Those who have undergone major abdominal surgery (such as gastrectomy, gastric bypass, sleeve gastrectomy, gastric band surgery, Whipple surgery, pancreatectomy, colectomy, hemicolectomy);\n\n8\\) QTcF interval: ≥450 milliseconds for men and ≥470 milliseconds for women (the QT interval must be corrected for heart rate using the Fridericia formula \\[QTcF\\]);\n\n9\\) Patients who received chemotherapy within 4 weeks before surgery;\n\n10\\) Those who are scheduled for emergency surgery or undergo any of the following surgeries: appendectomy, low anterior resection, colostomy, ileostomy, or stoma reversal, or diagnosed with needing proctocolectomy\u002Flow anterior resection Subjects whose disease may cause impaired rectal function or postoperative incontinence (except for lesions that do not involve the sigmoid colon and above);\n\n11\\) Within 3 days before the first dose, patients had received stimulants such as alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride or azithromycin. Gastrointestinal motility drugs;\n\n12\\) Pregnant or lactating women, as well as those who plan to become pregnant or donate sperm or eggs during the study period and within 3 months after the end of the study, and are unwilling to use a medically recognized contraceptive measure (such as intrauterine contraceptive device or contraceptive) during the study period. sets);\n\n13\\) Participated in other clinical trials within 3 months before enrollment;\n\n14\\) Other subjects deemed unsuitable for inclusion by the researcher.",{"count":141,"type":20},[73],"This study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study.",[164],"Postoperative Gastrointestinal Dysfunction","2025-01-16",{"date":147,"type":31},{"date":168,"type":31},"2024-10-18",{"date":170,"type":20},"2025-10",{"name":37,"class":38},2,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100573912","phase-1-a-phase-i-study-oflnf2007-monotherapy-in-patients-with-advanced-solid-tumors-100573912","NCT06752447","A Phase I Study OfLNF2007 Monotherapy in Patients with Advanced Solid Tumors","A Phase I Clinical Study of Safety, Tolerability, Pharmacokinetic\u002Fpharmacodynamic Characteristics and Initial Efficacy of LNF2007 Monotherapy in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n* Study participants must meet all of the following inclusion criteria to be enrolled in the study:\n\n  1. Age ≥18 years old, gender unlimited;\n  2. United States Eastern Oncology Consortium (ECOG) physical strength score 0-1;\n  3. Expected survival ≥12 weeks;\n  4. Patients with advanced solid tumors confirmed histologically or cytologically (gastric cancer, pancreatic cancer, and cholangiocarcinoma are preferred) who have failed after adequate standard treatment, or who lack standard treatment options (standard treatment is defined as the standard treatment guidelines that have been agreed in the country (if applicable) or the standard treatment status in the country); Standard treatment failure is defined as disease progression or tumor recurrence or metastasis during or after treatment, or intolerance);\n  5. Agree to provide archived tumor tissue specimens or fresh tissue specimens within 2 years of the primary or metastatic lesion (to explore the characteristics of biomarkers in tumor tissue); If the subject is unable to provide a tumor tissue sample, the participant can be enrolled after evaluation by the investigator, provided that other inclusion criteria are met.\n  6. There is at least one evaluable tumor lesion according to RECIST V1.1;\n  7. Tumor tissue samples were confirmed to be Claudin18.2 positive by immunohistochemical (IHC) detection, and positive was defined as ≥1+ by IHC detection (only applicable to patients in the dose escalation phase of 60μg\u002Fkg or above and in the dose expansion phase);\n  8. Adequate organ function before the first administration of the test drug (no blood components, cell growth factors, whitening drugs, platelet enhancing drugs, etc., have been used within 14 days before the first administration) 1.Absolute neutrophil count ≥1.5×109\u002FL; 2.Platelet ≥100×109\u002FL; 3.Hemoglobin ≥90g\u002FL; 4.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for liver cancer or liver metastasis, ≤5×ULN); Total bilirubin (TBIL) ≤1.5×ULN (liver cancer or liver metastasis, ≤3×ULN); 5. Serum creatinine (Cr) ≤1.5×ULN, creatinine clearance (CLcr) ≥50mL\u002Fmin when Cr \\> 1.5×ULN (CLcr was calculated using Cockcroft-Gault equation); 6.Activated partial thromboplastin time (APTT) ≤1.5×ULN, International Normalized ratio (INR) ≤1.5×ULN.\n  9. Understand and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Study participants with any of the following were not eligible for the study:\n\n  1. Received any antitumor therapy within 4 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is shorter);\n  2. Had undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the trial drug, or required elective surgery during the trial;\n  3. Received systemic corticosteroid (systemic corticosteroid equivalent to prednisone \\>10mg daily) or other immunosuppressive therapy within 2 weeks prior to the first use of the experimental drug;\n  4. Prior to first administration of the investigational drug, all reversible adverse effects of previous antitumor therapy did not return to CTCAE v5.0 rating ≤1, excluding alopecia (any grade) and ≤2 peripheral sensory neuropathy or other toxicities deemed by the investigators to be of no safety risk;\n  5. Received dual antibody or CAR-T drug therapy targeting Claudin18.2 within 3 months before the first use of the experimental drug;\n  6. have an active autoimmune disease and have had systemic systemic treatment within 3 months prior to the first use of the trial drug;\n  7. Patients with clinical symptoms of central nervous system metastasis and other evidence of uncontrolled central nervous system metastasis were judged by the investigators to be unsuitable for inclusion; Any meningeal metastases;\n  8. Subjects with a known history of severe hypersensitivity to other monoclonal antibodies or intravenous gamma globulin, and a known history of hypersensitivity or hypersensitivity to LNF2007 components;\n  9. have a severe systemic active infection that currently requires systemic anti-infection therapy;\n  10. Patients with active gastrointestinal bleeding or other gastrointestinal diseases deemed unsuitable for inclusion by researchers as having high risk factors for gastrointestinal bleeding, such as active gastrointestinal perforation requiring clinical intervention, pyloric obstruction, complete or incomplete intestinal obstruction, etc.;\n  11. There are clinical symptoms of pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time\u002Fmonth);\n  12. Impaired heart function or suffering from major cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  \u003C!-- -->\n\n  1. myocardial infarction, unstable angina pectoris, cerebrovascular accident, acute or persistent myocardial ischemia, symptomatic heart failure (grade 2 or higher according to the New York Heart Association Functional Scale), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolism event in the six months prior to initial administration;\n  2. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose;\n  3. aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis and other major vascular diseases that may be life-threatening or require surgery within 6 months;\n  4. Previous history of myocarditis and cardiomyopathy;\n  5. Left ventricular ejection fraction (LVEF) \\\u003C 50%; 13) Patients currently suffering from interstitial lung disease or pulmonary fibrosis, pneumoconiosis, radiation pneumonia, severe impairment of lung function, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity; 14) Hepatitis B patients (if HBsAg and\u002For HBcAb positive and HBV-DNA≥200IU\u002Fml (or 1000cps\u002Fml)); Hepatitis C patients (HCV antibody positive and HCV-RNA testing indicates viral replication); Syphilis screening positive (specific antibody test positive, non-specific antibody test negative and combined with clinical judgment confirmed as inactive infection), known HIV positive history or HIV screening positive; 15) The patient is known to have a history of psychotropic substance abuse, alcohol abuse or drug use; 16) Pregnant or lactating women, female subjects of childbearing age, or male subjects with partners of women of childbearing age who did not consent to contraception during the study period and within 6 months after the last study drug treatment; 17) Two or more malignancies in the 5 years prior to the first dose. With the exception of early stage malignancies that have been cured (carcinoma in situ or stage I tumours), such as carcinoma in situ of the cervix, basal cell or squamous cell skin cancer that has been adequately treated; 18)Patients who were not suitable for enrollment according to the judgment of the investigator.",{"count":181,"type":20},94,[23],"A non-randomized, open-ended, phase I dose-escalation and dose-expansion study was designed to evaluate the safety, tolerability, antitumor efficacy, PK and immunogenic characteristics of LNF2007 in patients with advanced solid tumors",[185],"Advanced Solid Tumors (Phase 1)","2024-12-22",{"date":188,"type":31},"2024-12-30",{"date":147,"type":20},{"date":191,"type":20},"2026-12",{"name":37,"class":38},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":4},"100571645","phase-2-phase-ii-clinical-study-of-ac591-in-preventing-oxaliplatin-induced-peripheral-neuropathy-100571645","NCT06722950","Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy","A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n1. Understand the experimental procedures and contents, and voluntarily sign a written informed consent;\n2. Male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent;\n3. Patients with histologically confirmed colorectal adenocarcinoma. Prepare to receive CAPEOX postoperative adjuvant chemotherapy within 3 weeks to 2 months after surgery, and have never used oxaliplatin;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before the first medication in the study;\n5. Organ function level before the first medication in the study meets the following requirements:\n\n   Peripheral blood cell count: white blood cell count ≥3×109\u002FL and neutrophil ≥1.5×109\u002FL, platelet count ≥75×109\u002FL, hemoglobin ≥90g\u002FL; Liver function: total bilirubin ≤1.5 times the upper limit of normal reference value; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal reference value; Renal function: serum creatinine ≤1.5 times the upper limit of normal reference value.\n6. Male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration.\n\nExclusion Criteria:\n\n1. known neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease, Huntington's disease) or neuromuscular disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis, poliomyelitis, hereditary neuromuscular disease);\n2. Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;\n3. Patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography;\n4. Patients with known allergic reactions to any component of the study drug;\n5. Patients with intestinal obstruction that requires treatment;\n6. Active severe clinical infection (\\> grade 2, National Cancer Institute-Common Adverse Event Evaluation Criteria \\[NCI-CTCAE V5.0\\]), including active tuberculosis;\n7. Uncontrolled diabetes, severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease, but excluding recovered radiation pneumonia), liver failure;\n8. Clinically significant cardiovascular disease, New York Heart Association \\[NYHA\\] grade III-IV congestive heart failure, unstable angina, myocardial infarction, etc. within 6 months before the first dose. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg after adequate treatment);\n9. Patients who need to take coumarin derivative anticoagulants (such as warfarin, phenprocoumon) regularly within 3 weeks before screening or during the study;\n10. Patients who have used drugs that interfere with the evaluation of neuropathic pain (such as antidepressants, antiepileptic drugs) within 2 weeks before the first dose;\n11. Renal replacement therapy;\n12. Previous history of organ transplantation, autologous\u002Fallogeneic stem cell transplantation;\n13. History of other malignant tumors except colorectal cancer in the past 5 years. However, cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or early papillary thyroid carcinoma are excluded;\n14. HIV infection, hepatitis B surface antigen positive (and peripheral blood hepatitis B virus deoxynucleotide HBV DNA ≥ 1×104 copies\u002FmL or ≥ 2000IU\u002FmL), hepatitis C virus antibody positive (and peripheral blood hepatitis C virus nucleotide HCV RNA ≥ 1×103 copies\u002Fml or ≥ 200IU\u002FmL) or active syphilis patients;\n15. Pregnancy (confirmed by menstrual pregnancy test) or lactation;\n16. Current alcohol or drug dependence;\n17. Suffering from known mental illness disorders that may affect trial compliance;\n18. Adverse events of previous anti-tumor treatment have not recovered to grade 1 (NCI-CTCAE V5.0) or abnormalities have no clinical significance;\n19. Subjects who have participated in other interventional clinical trials within 4 weeks before the first study drug;\n20. The investigator believes that the patient has other factors that affect the efficacy or safety evaluation of this study",{"count":201,"type":20},120,[73],"A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy",[205],"Colorectal Adenoma","2024-12-03",{"date":208,"type":31},"2024-12-09",{"date":210,"type":20},"2024-12",{"date":191,"type":20},{"name":37,"class":38},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100533480","phase-1-phase-i-study-of-lnf1901-in-advanced-malignant-tumors-100533480","NCT06226363","Phase I Study of LNF1901 in Advanced Malignant Tumors","Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of LNF1901 in Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Male or female ≥18 years of age;\n2. Patients with advanced malignant tumors who have been confirmed histologically or cytologically and have failed to receive standard therapy, or cannot tolerate standard therapy, or cannot receive standard therapy for other reasons;\n3. Participants enrolled in the dose expansion phase had at least one measurable lesion; (4) Those who adopted the United States Eastern Oncology Consortium (ECOG) physical status score of 0\\~1;\n\n5\\) The researchers judged that the expected life of the subjects was ≥3 months; 6) The function of vital organs meets the following requirements (drugs with blood components and cytokines are not allowed to be used within 14 days before the first administration) : Blood routine: Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet count ≥80×109\u002FL; Hemoglobin (Hb) ≥90g\u002FL; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, serum total bilirubin (TBIL) ≤1.5×ULN; If liver metastasis exists, AST and ALT≤5×ULN, TBIL≤1.5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50mL\u002Fmin (Cr \\> 1.5×ULN); Coagulation function: International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN; Thyroid function: Thyroid stimulating hormone (TSH) within the normal range or free triiodothyronine (FT3), free thyroxine (FT4) normal or abnormal without clinical significance; 7) Subjects voluntarily participate in the study and sign the informed consent after receiving full informed consent.\n\nExclusion Criteria:\n\n1. Those who have previously received antibody treatment with any tumor necrosis factor receptor (TNFR) superfamily agonists, such as CD40, OX40, CD137, CD27, CD357, etc.;\n2. Those who have received anti-tumor therapy 4 weeks before the first administration or within 5 half-lives of the drug (whichever is shorter);\n3. Chronic systemic glucocorticoid therapy within 2 weeks prior to initial administration (daily dose equivalent to prednisone \\> 10mg of systemic corticosteroids) or any other form of immunosuppressive therapy;\n4. The toxicity of previous anti-tumor therapy has not returned to CTCAE5.0 version of the definition ≤ Class 1 (except hair loss);\n5. A history of cancer within the past 5 years, except for locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix);\n6. Patients with primary central nervous system (CNS) malignancies, CNS metastases after local treatment failure, and cancerous meningitis; Patients with asymptomatic brain metastases or stable neurological symptoms without steroid hormones or other BMS for ≥4 weeks could be enrolled.\n7. Patients with a history of organ transplantation or allogeneic bone marrow transplantation or who have received autologous stem cell transplantation within 3 months before the first administration of the drug;\n8. Those who have undergone major surgery or have not recovered from surgery within 4 weeks prior to the first dosing (except for diagnostic surgery);\n9. Physical examination or laboratory examination, any of the following conditions:\n\n   Hepatitis B: HBsAg positive and\u002For HBcAb positive with HBV-DNA titers positive or higher than the upper limit of normal (excluded if only the lower limit of detection is present); Hepatitis C: HCV antibody positive and HCV-RNA positive or greater than the upper limit of normal; Human immunodeficiency virus (Anti-HIV) positive; active treponema pallidum infection;\n10. Uncontrolled or severe cardiovascular disease, such as New York Heart Association (NYHA) Class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular disease, poorly controlled arrhythmias, within 6 months before the first administration of the drug. Difficult to control hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg after adequate treatment);\n11. Patients with a history of the following, including but not limited to active autoimmune diseases, active infections (such as active tuberculosis), severe mental illness, and severe endocrine disorders;\n12. Patients who have been treated with any other investigational drug\u002Fdevice within 4 weeks prior to initial administration;\n13. Have a history of drug abuse or alcoholism within 6 months before the first dose;\n14. Have a history of severe allergy, and known subjects are previously allergic to macromolecular protein preparations\u002Fmonoclonal antibodies and to any investigational drug components;\n15. Those who received live or attenuated vaccine within 4 weeks before the first dose or planned to receive live or attenuated vaccine during the study period;\n16. Pregnant or lactating women, female subjects of childbearing age, or male subjects whose partners are women of childbearing age who do not consent to the use of medically approved effective contraceptive methods (such as Iuds or condoms) during the study period and within 6 months after the last study drug treatment;\n17. Those who were judged not suitable for inclusion by the researchers.",{"count":221,"type":20},82,[23],"This is a multicenter, open, phase I dose-escalation and dose-expansion study to evaluate the safety, tolerability, initial antitumor efficacy, PK and immunogenic characteristics of LNF1901 in patients with advanced malignancies.",[225],"Advanced Malignant Tumors","2024-01-17",{"date":228,"type":31},"2024-01-26",{"date":230,"type":20},"2024-02-01",{"date":232,"type":20},"2027-02-01",{"name":37,"class":38},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":252,"locationsCount":4},"100531985","phase-1-phase-i-study-of-xz120-in-malignant-tumors-100531985","NCT06206915","Phase I Study of XZ120 in Malignant Tumors","To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of XZ120 in Patients With Malignant Tumors in a Phase Ⅰ Clinical Trial","Inclusion Criteria:\n\n1. male or female aged ≥18 years old;\n2. The enrolled population was divided into the first part of monotherapy and the second part of combination therapy:\n\n   The first part of the monotherapy study was as follows:\n\n   A: single drug dose escalation is confirmed by histology and cytology and received a standard after treatment failure or intolerance to standard treatment or for other reasons can not accept standard or the lack of effective treatment of patients with late malignant tumor; B:Single-agent dose expansion: patients with histologically or cytologically confirmed advanced breast cancer who are eligible for standard anthracycline monotherapy;\n\n   The second part of the combination therapy dose expansion phase consists of the following cohorts:\n\n   Cohort 1: the pathology diagnosed patients with DLBCL treated first; Cohort 2: Histologically or cytologically confirmed advanced breast cancer patients eligible for anthracycline-based standard therapy;\n\n   Note: The patients with advanced breast cancer met any of the following criteria: ① Initially diagnosed as inoperable locally advanced or metastatic breast cancer; (2) did not receive chemotherapy after the eradicative resection of recurrent or metastatic breast cancer; ③ Recurrent or metastatic breast cancer after receiving anthracyclines for more than 12 months;\n3. subjects with at least one measurable and evaluable target lesion were enrolled in the dose-expansion phase;\n4. patients with ECOG performance status score of 0-1;\n5. dose extension stage lymphoma patients international prognostic index (IPI) score of 0 \\~ 2 points;\n6. the researchers determine subjects were expected to survive a period of 3 months or more;\n7. heart echocardiography measured LVEF 50% or higher;\n8. important organ function meet the following requirement (first dose not allowed within 2 weeks before blood transfusion treatment, and use the growth factors of drug) : Blood routine: absolute neutrophil count (ANC) ≥1.5×109\u002FL; The platelet count 75 x 109 \u002F L or higher; Hemoglobin (Hb) ≥90g\u002FL; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, total bilirubin (TBIL) ≤1.5×ULN; If there is liver metastasis, AST and ALT≤5×ULN, TBIL≤3×ULN; Renal function: serum creatinine (Cr) \\\u003C1.5×ULN or creatinine clearance ≥50mL\u002Fmin (Cr≥1.5×ULN); coagulation function: international standardization ratio (INR) 1.5 x ULN or less and part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;\n9. understand the procedure and content of the trial and sign the informed consent form voluntarily.\n\nExclusion Criteria:\n\n1. always use too much Doxorubicin (or pirarubicin) \\> total cumulative dose of 360 mg\u002Fm2, or epirubicin total cumulative quantity \\> 600 mg\u002Fm2;\n2. patients received antineoplastic therapy 4 weeks before the first dose or within 5 half-lives of the drug, whichever was less; Patients who received a modern traditional Chinese medicine preparation with anti-tumor effect approved by NMPA within 2 weeks before the first medication;\n3. Prednisone acetate tablets at a maximum dose of \\>100mg or equivalent cortisol for more than 5 days for the purpose of controlling lymphoma symptoms in patients with lymphoma; For other purposes, use of prednisone acetate tablets at a dose of \\>30mg per day or a cortisol equivalent for more than 10 days (for patients receiving ≤30mg per day of prednisone acetate tablets or a cortisol equivalent, there was a written record of stable use of the dose for at least 4 weeks before randomization);\n4. patients with high-grade B-cell lymphoma;\n5. the toxicity of previous antineoplastic therapy has not recovered to ≤ grade 1 according to CTCAE version 5.0 definition (except alopecia);\n6. patients with other malignant tumors within 5 years before enrollment, except for the following: (1) radical cervical carcinoma in situ or non-melanoma skin cancer; (2) second primary cancer after radical resection without recurrence within 5 years; (3) The investigators thought that both patients with double primary cancers might benefit from this study; (4) if the metastatic lesion was clearly excluded from the primary tumor;\n7. primary central nervous system (CNS) malignant tumor, CNS metastasis failed by local treatment, and carcinomatous meningitis; Patients with asymptomatic brain metastases or clinically stable neurological symptoms and no need for steroids and other treatments for brain metastases for more than 4 weeks were eligible for enrollment.\n8. patients with a history of organ or allogeneic bone marrow transplantation or autologous stem cell transplantation within 3 months before the first dose;\n9. patients who underwent major surgery within 4 weeks before the first dose or minor surgery within 2 weeks before the first dose or who have not recovered from surgery (excluding diagnostic surgery);\n10. hepatitis b: HBsAg positive and\u002For HBcAb positive, and HBV DNA drop degree is higher than 2000 iu\u002FmL or 104 copies\u002FmL (hepatitis b virus infection should receive antiviral treatment according to local standard treatment guidelines and willing to accept the antiviral treatment) during the whole research; C: HCV antibody positive, and HCV RNA upper limit of normal value is higher than research center;\n11. human immunodeficiency virus antibody (Anti-HIV) positive and active syphilis infection;\n12. patients with uncontrolled or severe cardiovascular disease, congestive heart failure (NYHA class Ⅱ or above), unstable angina pectoris, myocardial infarction and other cardiovascular diseases within 6 months before the first drug administration; Patients with uncontrolled hypertension (systolic blood pressure ≥180mmHg and\u002For diastolic blood pressure ≥100mmHg);\n13. has the following patients medical history, including but not limited to active autoimmune diseases, active infection (such as active tuberculosis), severe mental illness, serious endocrine diseases such as serious abnormal thyroid function;\n14. for the first time to give medicine have received within 4 weeks before any other clinical trial drug\u002Finstruments treatment;\n15. with a history of drug abuse or alcohol abuse within 6 months before the first drug administration;\n16. patients with a history of severe allergy or known previous allergy to anthracyclines or anthradiones, or to any component of the investigational drug;\n17. planning to receive live or live attenuated vaccine within 4 weeks before the first dose or during the study;\n18. pregnancy or lactation women, women of childbearing age subjects or partner for women of child-bearing age male subjects to study period, and at the end of the study medication use medical certification within six months after effective contraceptive measures (such as intrauterine device or a condom);\n19. the researchers determine doesn't fit into the group.",{"count":242,"type":20},123,[23],"This research includes two parts: the first part of the patients with late malignant tumor monotherapy study, at the beginning of the second part in treat DLBCL and research on combination therapy in patients with advanced breast cancer.\n\nResearch purpose: to evaluate XZ120 safety, tolerability, for the treatment of malignant tumor patients pharmacokinetic characteristics and preliminary effectiveness.",[246],"Advanced Malignancies","2024-01-04",{"date":249,"type":31},"2024-01-16",{"date":230,"type":20},{"date":232,"type":20},{"name":37,"class":38},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100470619","phase-2-the-efficacy-and-safety-of-rulonilimab-in-combination-with-lenvatinib-in-hepatocellular-carcinoma-100470619","NCT05408221","the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma","Phase Ⅱ\u002FIII Studies to Investigate the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Hepatocellular Carcinoma","HCC","Inclusion Criteria:\n\n1. Age of 18-75 full years (inclusive), male or female.\n2. Subjects are with unresectable advanced HCC by histologically or cytologically confirmed diagnosis, Stage B or C based on Barcelona Clinic Liver Cancer \\[BCLC\\] ,that is not eligible for surgery and\u002For locoregional therapy or disease progression after surgery and\u002For locoregional therapy , surgery and\u002For locoregional therapy must be finished more than 4 weeks before baseline imaging scan .\n3. Subjects have not received any systemic therapy for HCC previously (mainly including systemic chemotherapy, anti-angiogenic drugs or other molecular targeted therapy, antibodies\u002Fdrugs targeting T cell co-regulatory proteins (such as anti-CTLA-4, anti-PD-1 \u002FPD-L1, anti-OX-40, anti-CD137, anti-TIM-3, anti-LAG-3 antibodies, etc.).\n4. Subjects with at least one measurable lesion by RECIST1.1, baseline imaging scan should be performed within 21 days prior to first administration，target lesions located in the field of previous radiotherapy or in the area of local treatment (interventional or ablative) are considered measurable if radiographic progression is confirmed.\n5. Child-Pugh score A or B (≤7 ），There was no history of hepatic encephalopathy .\n6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.\n7. Life expectancy ≥ 12 weeks.\n8. The functions of vital organs meet the following requirements: No blood transfusion, no hematopoietic stimulating factors (including G-CSF, GM-CSF, EPO, TPO, etc.) and human albumin preparation are required within 14 days before the first administration:\n\n   Blood test: neutrophil count (ANC) ≥1.5×109\u002FL, hemoglobin (HGB) ≥90g\u002FL, platelet count (PLT) ≥75×109\u002FL; liver function: Total bilirubin level (TBIL) ≤2×ULN, ALT and AST≤5×ULN; kidney function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50mL\u002Fmin (Cr\\>1.5 x ULN); coagulation function: International standardized ratio (INR) ≤1.5×ULN; serum albumin ≥29g\u002FL; urine protein \\\u003C2+ (if urine protein ≥2+, 24h urine protein quantification should be performed, 24h urine protein quantification\\\u003C 1.0g can be included).\n9. Subjects with hepatitis B virus infection,and HBV DNA \\\u003C2000 IU\u002FmL during the screening period , willing to receive anti-HBV therapy throughout the study period.\n10. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.\n\nExclusion criteria:\n\n1. Fibrolamellar-HCC, sarcomatoid, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.\n2. History of other malignancy(ies) in the past 5 years, except for locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix, etc.).\n3. Palliative radiotherapy was performed for bone metastases within 2 weeks prior to firstl administration; Received drugs with anti-liver cancer effect (including Traditional Chinese medicine preparations) within 2 weeks before the first administration.Toxicity induced by previous therapy (except alopecia) not recovered to ≤ grade 1 (NCI-CTCAE v5.0).\n4. Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate peritoneal effusion at screening.\n5. Serious, uncured wound, active ulcer or untreated bone fracture.\n6. History of gastrointestinal hemorrhage within 6 months prior to initial administration or clear tendency of gastrointestinal hemorrhage (including severe esophageal-gastric varices with hemorrhagic risk, locally active peptic ulcer, persistent fecal occult blood (+)).\n7. Inability to swallow tablets, malabsorption syndrome or any other condition that affects gastrointestinal absorption.\n8. Having ≥ grade 3 (NCI-CTCAE v5.0) gastrointestinal or non-gastrointestinal fistula at present.\n9. According to CT\u002FMRI examination, the main portal vein carcinoma thrombus involved the contralateral portal vein branch or the superior mesenteric vein at the same time;inferior vena cava carcinoma thrombus ;\n10. Serious cardiovascular and cerebrovascular diseases:\n\n    Appears New York Heart Association (NYHA) grade II or above congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident or poorly controlled arrhythmia within 12 months before the first administration (QTc interval ≥480ms, QTc interval calculated by Fridericia formula).\n\n    LVEF (left ventricular ejection fraction) \\\u003C 50%; uncontrolled hypertension (systolic blood pressure ≥150mmHg and\u002For diastolic blood pressure ≥100mmHg) (the average of ≥3 BP readings based on ≥2 measurements); has a hypertensive crisis or hypertensive encephalopathy.\n11. Other obvious hemorrhagic tendency or evidence on important coagulation disorder:\n\n    clinically significant hemoptysis or tumour hemorrhage of any cause within 4 weeks before first administration; a thrombosis or embolism event occurs within 6 months before first administration (e.g., aortic aneurysm or peripheral artery thrombosis requiring surgical repair; Uncontrolled deep vein thrombosis); use of anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) within 2 weeks before first administration; requires antiplatelet therapy.\n12. Medium or major surgery within 4 weeks prior to initial administration, but diagnostic biopsy was not included.\n13. Central nervous system metastasis; If suspected, an MRI scan of the brain and\u002For spinal cord should be performed to rule it out.\n14. For those who received live (attenuated) vaccines within 28 days prior to first administration or who planned to receive vaccines during the study period, the seasonal influenza vaccine for injection or COVID-19 vaccine is usually an inactivated virus vaccine and is allowed to be administered during the study period.\n15. Presence of immunodeficiency or receiving long-term systemic steroid therapy within 7 days prior to randomization (daily dose \\>10mg Prednisone or other equivalent glucocorticoid), or other immunosuppressive therapy.\n16. Active autoimmune diseases requiring systemic treatment (i.e., immunomodulatory drug, corticosteroid or immunosuppressant) in the past two years; Except for:\n\n    alternative therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy due to adrenal or pituitary insufficiency); a patient with well-controlled eczema, psoriasis, chronic simple moss or vitiligo with skin manifestations only, meeting the requirements of a rash ≤10% of body surface area and requiring no systemic drug therapy (including but not limited to hormones, immunosuppressants, etc.).\n17. History of clear interstitial lung disease or non-infectious pneumonia, unless induced by local radiotherapy.\n18. Active tuberculosis or received antituberculosis therapy within 1 year prior to randomization.\n19. Any serious acute and chronic infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, not including viral hepatitis.\n20. A known history of human immunodeficiency virus (HIV) infection; Treponema pallidum antibody positive; HCV antibody positive and HCV-RNA positive or higher than the upper limit of normal value.\n21. Previously receiving solid organ transplantation.\n22. Known contraindication or history of hypersensitivity to any investigational drug or any known excipient.\n23. Women who are pregnant or lactating, Female subjects at childbearing age or male subjects whose partners are of childbearing potential do not agree with contraception during the study period and for 6 months after the last administration.\n24. Other participants who are unsuitable for inclusion as judged by the investigator.",{"count":262,"type":20},576,[73,49],"There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .",[266],"Hepatocellular Carcinoma","2023-03-08",{"date":269,"type":31},"2023-03-10",{"date":271,"type":31},"2022-11-11",{"date":273,"type":20},"2026-08-01",{"name":37,"class":38},5,""]