[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":548},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,41,65,89,112,134,156,177,198,220,241,262,283,303,323,343,363,383,404,425,445,466,486,507,528],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100638047","phase-3-a-phase-iii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-octreotide-long-acting-injection-in-patients-with-acromegaly-100638047",false,"NCT07623824","A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly","A Randomized, Parallel, Open-label, Multicenter, Positive-controlled, Superiority Phase III Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly","Inclusion Criteria:\n\n* Male or female participants aged 18 to 80 years (including boundary values)\n* Diagnosed with acromegaly, currently in the active stage of the disease (for patients who have not undergone pituitary tumor surgery before, MRI shows a pituitary mass, fasting GH ≥ 2.5 ng\u002FmL and IGF-1 index ≥ 1.3; for patients who have undergone pituitary tumor surgery, fasting GH ≥ 2.5 ng\u002FmL and IGF-1 index ≥ 1.3)；\n\nExclusion Criteria:\n\n* Have received pituitary radiotherapy within the 5 years prior to screening\n* Have undergone major surgery (including pituitary surgery) within 6 months prior to screening or are expected to require surgery (including pituitary surgery) or radiotherapy during the study period\n* Within three months before the screening, participants received drugs such as long-acting lanretide, long-acting octreotide, pervesomone, and cabergoline, or traditional Chinese medicines for treating acromegaly. Receive bromocriptine within one month before screening; Received short-acting octreotide or lanretide short-acting preparations for treatment within 7 days before screening; Or have received any other investigational drug within 30 days before screening or within 5 half-lives (whichever is longer)\n* Previous failure to respond to octreotide or lantreotide monotherapy (defined as: after at least 3 months of treatment with octreotide microspheres ≥30 mg or lantreotide ≥120 mg, or after at least 3 months of treatment with parietide microspheres ≥40 mg, random GH ≥2.5 ng\u002FmL and\u002For IGF-1 index ≥1.3) or history of intolerance.\n* Participants with obvious visual field defects caused by optic chiasm compression and requiring surgical intervention\n* HbA1c\\>8.5%","ALL","18 Years","80 Years",{"count":21,"type":22},154,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.",[28],"Diagnosed With Acromegaly, Currently in the Active Stage of the Disease","NOT_YET_RECRUITING","2026-05-29",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":22},"2026-05-31",{"date":37,"type":22},"2029-12-30",{"name":39,"class":40},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100605697","phase-2-sirolimus-for-injection-albumin-bound-combined-with-octreotide-long-acting-injection-in-patients-with-metastatic-gastroenteropancreatic-neuroendocrine-tumors-100605697","NCT07165886","Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors","Phase II\u002FIII Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)","Inclusion Criteria:\n\n* 1\\. Unresectable locally advanced or metastatic G1\u002FG2 GEP-NETs diagnosed by histology, according to the 2019 WHO histological grading criteria.\n* 2\\. Having poor prognostic factors.\n* 3\\. Non-functional GEP-NETs are required.\n* 4\\. At least one evaluable lesion meets the RECIST V1.1 standard (Applicable only to the phase II safety run-in stage)\n* 6\\. ECOG 0\\~2.\n* 7\\. Organ function reserve is good.\n* 8\\. Be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received SSTR-targeted therapies (including somatostatin analogs \\[SSAs\\] and peptide receptor radionuclide therapy) and\u002For mTOR inhibitors (Patients who received SSAs in the adjuvant setting and experienced recurrence ≥6 months after treatment completion may be enrolled)\\[ Applicable to Phase II dose expansion and Phase III stages\\].\n* 2\\. Has uncontrolled\u002Fsevere diarrhea or an axillary temperature \\> 38.0°C at enrollment.\n* 3\\. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug.\n* 4\\. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.\n* 5\\. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug.\n* 6\\. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug.\n* 7\\. Those who have used strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 2 weeks prior to the first use of the investigational drug or still need to continue using such drugs.\n* 8\\. Has a serious history of cardiovascular and cerebrovascular diseases.\n* 9\\. Having active brain metastasis and\u002For malignant meningitis.\n* 10\\. With a history of severe lung diseases.\n* 11\\. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed.\n* 12\\. Abnormal thyroid function during screening.\n* 13\\. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients.\n* 14\\. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.\n* 15\\. History of autoimmune diseases (excluding tuberous sclerosis), history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.",{"count":49,"type":22},298,[51,25],"PHASE2","There is limited evidence regarding the benefit of adding somatostatin analogs to molecular targeted agents for well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with poor prognostic factors. This trial is conducted to evaluate sirolimus for injection (albumin bound) combined with octreotide long-acting injection in patients with unresectable or recurrent GEP-NETs.",[54],"Gastroenteropancreatic Neuroendocrine Tumors","RECRUITING","2026-04-21",{"date":58,"type":33},"2026-04-24",{"date":60,"type":33},"2025-08-29",{"date":62,"type":22},"2028-08-29",{"name":39,"class":40},1,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100633897","phase-1-a-single-ascending-dose-study-of-syh2082-injection-in-healthy-participants-100633897","NCT07532655","A Single Ascending Dose Study of SYH2082 Injection in Healthy Participants","A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of SYH2082 Injection in Healthy Participants","Inclusion Criteria:\n\n* Fully understands the content, procedures, and possible adverse reactions of the study, and voluntarily signs the ICF before the study;\n* At screening, age 18-65 years (inclusive, at the time of signing the ICF), male or female;\n* At screening, body weight ≥50 kg for males and ≥45 kg for females; body mass index (BMI) between 22.0 and 40.0 kg\u002Fm2 (inclusive);\n* Body weight change ≤5% within 3 months prior to screening (including the screening period);\n* From the time of signing the ICF until 6 months after the last dose, the participant (including their partner) has no plans for childbirth and agrees to use highly effective contraceptive measures.\n\nExclusion Criteria:\n\n* Known or suspected allergy to glucagon-like peptide-1 (GLP-1) or Glucose dependent insulinotropic polypeptide (GIP) receptor agonists or any component of the investigational product; or has an allergic constitution (allergic to multiple drugs and foods);\n* Abnormal results in vital signs, physical examination, laboratory tests, and ECG that are judged by the investigator to be clinically significant within the screening period. Specifically, the following conditions are not excluded:\n\n  1. Systolic blood pressure (SBP) \\\u003C 160 mmHg, diastolic blood pressure (DBP) \\\u003C 100 mmHg;\n  2. Fasting TG ≤ 5.6 mmol\u002FL, fasting TC ≤ 7.5 mmol\u002FL, fasting LDL-C ≤ 5 mmol\u002FL, and abnormal fasting HDL-C;\n  3. Alanine aminotransferase (ALT) \\\u003C 2 × ULN, aspartate aminotransferase (AST) \\\u003C 2 × ULN, gamma-glutamyl transferase (GGT) \\\u003C 2.5 × ULN, and total bilirubin (TBIL) \\\u003C 1.5 × ULN. Participants with values outside the normal range may be included if the abnormality is deemed benign by the investigator (e.g., Gilbert's syndrome);\n* History or laboratory evidence of diabetes mellitus (type 2, type 1, or other forms of diabetes), including fasting glucose of ≥126 mg\u002FdL (7.0 mmol\u002FL) and\u002For HbA1c ≥ 6.5% within the screening period;\n* With any previous episode of hypoglycemia or with screening fasting glucose \\\u003C 3.9mmol\u002FL (even on a single sample);\n* With obesity due to identifiable endocrinologic, genetic or syndromic causes;\n* Meets any of the following criteria within the screening period:\n\n  1. Calcitonin ≥25 ng\u002FL;\n  2. Estimated glomerular filtration rate (eGFR) \\\u003C80 mL\u002Fmin\u002F1.73m2\n  3. Thyroid-stimulating hormone (TSH) outside the normal reference range;\n  4. Fasting serum amylase and\u002For lipase \\>1.5× ULN.\n* At screening, has a prolonged QT\u002FQTc interval (QTcF \\>450 ms for males and QTcF\\>470 ms for females), or a history of risk factors for Torsades de Pointes (e.g., cardiac failure\u002Fcardiomyopathy or a family history of long QT syndrome), or is currently taking concomitant medications that prolong the QT\u002FQTc interval;\n* Positive for any of the following: Hepatitis B surface antigen, Hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis serology;\n* Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune or psychiatric disorder as determined by the Investigator or medical designees;\n* History of severe trauma or major surgery within 3 months prior to screening, or plans to undergo surgery or any procedures requiring general anesthesia or sedation during the study period;\n* History of thyroid nodules diagnosed as C-TIRADS category 3 or higher;\n* Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2, or a personal history of pancreatitis or gallbladder\u002Fgallstone disease;\n* History of malignancy, except for non-melanoma skin cancer excised more than 1 year prior to Screening and cervical intraepithelial neoplasia that has been successfully cured more than 2 years prior to Screening;\n* History of major depressive disorder, including any medication or psychological therapy, in the last 2 years, or any clinically significant mental health condition;\n* Lifetime history of any suicide attempts or suicide behavior according to the C-SSRS, or any suicidal ideation in the last two years according to the C-SSRS;\n* Non-suicidal self-injury more than 5 years ago is permissible, if it is clear there was no suicidal intent. Participants should be excluded if any doubt;\n* History of gastric emptying abnormalities (e.g., gastric outlet obstruction) or severe chronic gastrointestinal diseases (e.g., inflammatory bowel disease, active ulcer);\n* History of gastrointestinal surgery that could lead to malabsorption, or long-term use of drugs that directly affect gastrointestinal motility. For example: has undergone bariatric surgery or procedures (e.g., gastric banding) within 3 months prior to screening;\n* History of use GLP-1 or GIP receptor agonists or any drug or product that may cause weight changes and affect weight assessment considered by the investigator within 3 months prior to screening;\n* Has dermatitis or other skin abnormalities (including tattoos) at or around the injection site;\n* Use of any prescription drugs, within 2 weeks prior to dosing or no more than 5 half-life (whichever is longer) after the last use of the above drugs. Non-prescription drugs, herbal preparations and supplements excluded 7 days prior to dosing, and allow short term use of paracetamol and anti-inflammatory drug use within the 7 days prior to dosing, within investigator discretion;\n* Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective β-blockers, monoamine oxidase inhibitors) within 1 month prior to screening, or no more than 5 half-life (whichever is longer) after the last use of the above drugs;\n* Average weekly alcohol consumption exceeding 21 units (males) \u002F 14 units (females) within 3 months prior to screening (1 unit ≈ 375 mL of mid-strength beer (3.5% alcohol\u002Fvolume), 100 mL of wine (13.5% alcohol\u002Fvolume), or 30 mL of spirits (40% alcohol\u002Fvolume)), or has a positive alcohol breath test, or is unable to abstain from alcohol during the hospital stay;\n* Smokes more than 10 cigarettes per day on average within 3 months prior to screening, or is unable to stop using any nicotine products during the hospital stay;\n* Consumes excessive amounts of tea, coffee, and\u002For caffeinated beverages (average of more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to screening, or is unable to stop consumption during the hospital stay;\n* Engaged in strenuous exercise within 48 hours prior to clinic visits, such as weightlifting, sprinting, long-distance running, cycling, swimming, or playing football;\n* History of drug abuse within 6 months prior to screening, or a positive drug abuse screening test at screening and D-2;\n* Has donated blood or plasma within 30 days prior to screening or had a loss of whole blood of more than 500ml within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening;\n* History of needle or blood phobia, difficulty with blood collection, or unable to tolerate intravenous blood draws;\n* Has special dietary requirements and cannot adhere to the standardized diet and schedule;\n* Female participants who are pregnant, lactating, or have a positive pregnancy test result at screening and D-2;\n* Has received an investigational agent\u002Fdevice in another clinical study within 3 months or 5 half-lives prior to Screening (whichever is longer), or is currently participating in or plans to participate in another drug or medical device clinical study during the study period;\n* Participants whom the investigator considers to have other factors making them unsuitable for participation in this trial.",true,"65 Years",{"count":75,"type":22},44,[77],"PHASE1","To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants.",[80],"Overweight or Obesity","2026-04-09",{"date":83,"type":33},"2026-04-16",{"date":85,"type":22},"2026-04-14",{"date":87,"type":22},"2027-02-09",{"name":39,"class":40},{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":64},"100625138","phase-2-a-phase-ii-study-of-cm326-in-subjects-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-100625138","NCT07418736","A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease","A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM326 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease（COPD）","Inclusion Criteria:\n\n1. Understand the study and voluntarily sign the informed consent form.\n2. Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.\n3. weight ≥40 kg.\n4. Diagnosed with COPD for at least 12 months.\n5. Post-bronchodilator FEV1\u002FFVC ratio \\\u003C0.70 and post-bronchodilator FEV1 % predicted ≥20% and \\\u003C80%.\n6. Background therapy for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening.\n7. Exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening.\n8. COPD assessment test (CAT) Total Score ≥10.\n9. Blood eosinophils ≥0.15×10\\^9 \u002FL at screening.\n10. Current smoking or a history of smoking ≥ 10 pack-years, or exposure to biomass smoke (including but not limited to biomass fuel, secondhand smoke, and the like) for ≥ 10 years.\n11. Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）\n2. Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator. Or other conditions that could lead to elevated eosinophils.\n3. The presence of any severe and\u002For uncontrolled medical condition that in the judgment of the investigator would affect the evaluation of the drug, including but not limited to: severe neurological disease (eg, epilepsy, dementia, etc), history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation（male \\>450 msec, female \\>470 msec）, or persistent arrhythmia.\n4. History of malignancy.\n5. Previous history of known or suspected immunosuppression; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment.\n6. Prior autoimmune disease or inflammatory treatment with biologic agents\u002Fsystemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever is longer) prior to informed consent.\n7. Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the investigator or with evidence of right cardiac failure.\n8. Myocardial infarction, unstable angina, or stroke occurring within 6 months prior to signing the informed consent form (ICF).\n9. Parasitic infection diagnosed within 24 weeks prior to signing the informed consent form (ICF), which has not received standard treatment or is refractory to standard treatment.\n10. Acute moderate or severe exacerbation of COPD from 4 weeks before signing consent to the time of randomization.\n11. Acute infection requiring systemic anti-infective therapy from 4 weeks before signing consent to the time of randomization.\n12. Major surgery within 8 weeks prior to consent or planned surgery requiring general anesthesia or hospitalization for \\> 1 day during the study period.\n13. History of or planned pneumonectomy or lung volume reduction surgery for COPD 12 months prior to screening.\n14. As judged by the investigator, long-term daily oxygen therapy for more than 15 hours per day due to medical necessity, or concurrent hypercapnia requiring the use of bilevel positive airway pressure (BiPAP) non-invasive ventilation.\n15. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who start rehabilitation \\\u003C4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program could be included).\n16. Patients who are treated with systemic corticosteroids (topical, ophthalmic, or intranasal corticosteroids are excluded) from 4 weeks before signing the informed consent to the date of randomization. Except for short-term (≤7 days) use of systemic glucocorticoids to prevent or treat non-autoimmune allergic diseases.\n17. Use of macrolide antibiotics (eg, azithromycin) unless stable \\>3 months prior to screening visit and maintain the treatment during the planned study period.\n18. Treatment with a PDE-4 inhibitor (roflumilast) (unless on stable treatment for ≥ 3 months with a plan to maintain stable treatment throughout the study period).。\n19. Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days before consent or any other biologic therapy (including other anti-IL4R mAb, anti-IL5 mAb, anti-IL5R mAb, anti TSLP mAb, anti-IL33 mAb, anti-ST2 mAb) within 3 months or 5 half-lives before signing consent, whichever is longer.\n20. Have been enrolled in a clinical trial of any drug or medical device within 3 months before signing informed consent, or are within the follow-up period of a clinical study or the five half-lives of the trial drug (whichever is longer) before signing informed consent.\n21. Received immune globulin or blood products within 30 days before informed consent.\n22. Receipt of traditional Chinese medicines (TCMs), ethnic medicines, or natural medicines approved by the National Medical Products Administration (NMPA) for the indication of COPD treatment within 4 weeks prior to randomization.\n23. Receipt of live or attenuated vaccine within 3 months before consent signing or during the planned study period.\n24. Non-negative HIV serological test result at screening, or Treponema pallidum infection requiring treatment.\n25. Subjects infected with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) must meet the following laboratory criteria during the screening period: a. HBsAg positive b. HBsAg negative , HBcAb positive, HBV DNA exceed the lower limit of quantitation (LLOQ) or 1000 copies\u002FmL c. HCV antibody positive, HCV RNA exceed the LLOQ.\n26. At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 × upper limit of normal (ULN), or serum creatinine (Cr) \\> 1.5 × ULN or serum creatinine \\> 1.5 × ULN.\n27. Females with a positive pregnancy test, pregnant females, or lactating females.\n28. Allergy or intolerance to components of CM326 injection or placebo or history of severe drug allergy or anaphylactic shock.\n29. History of drug abuse within 5 years before signing informed consent.\n30. \\\u003C70% compliance with usual COPD controller therapy in subjects during the screening phase.\n31. The investigator considers that there are any conditions that may prevent the subject from completing the study .","40 Years","85 Years",{"count":99,"type":22},318,[51],"This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease.\n\nThe study consists of a screening period of up to 4 weeks, a randomized treatment period of 24 to 52 weeks, and a 12-week safety follow-up period.",[103],"Chronic Obstructive Pulmonary Disease","2026-02-11",{"date":106,"type":33},"2026-02-18",{"date":108,"type":33},"2025-12-18",{"date":110,"type":22},"2027-10-10",{"name":39,"class":40},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":72,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":64},"100624647","phase-1-a-single-ascending-dose-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-syh2085-100624647","NCT07412353","A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085","A Phase І, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYH2085 in Chinese Healthy Participants","Inclusion Criteria:\n\n1. Age of 18 - 45 years (inclusive), male or female; BMI: 19.0-28.0 kg\u002Fm\\^2 (inclusive), with a minimum weight of 50.0 kg (inclusive) for male and 45.0 kg (inclusive) for female;\n2. Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray);\n3. Participants and their partners agree to use effective and reliable contraceptive methods to avoid pregnancy, and male subjects had no plans to donate sperm, and female subjects had no plans to donate eggs, from the time they signed the informed consent to 3 months after the end of the study;\n4. Participants must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.\n\nExclusion Criteria:\n\n1. History of hypersensitivity or allergy to drug or food, or any component of the study drug；\n2. Participants with a history of serious diseases, including pancreas, cardiovascular, liver, kidney, blood and lymphatic, central nervous system, and gastrointestinal systems, or other important diseases that may affect the absorption, metabolism, or excretion of the study drug;\n3. History of gastrointestinal surgery or resection that may alter the absorption and\u002For elimination of orally administered drugs (except for appendectomy);\n4. Participants who have undergone any surgical procedure within 6 months prior to the trial;\n5. Participants with a history of respiratory or systemic acute infection within 2 weeks prior to screening;\n6. Participants who have experienced blood loss exceeding 400 mL (e.g., due to blood donation or other reasons) within 3 months prior to the trial;\n7. Participants who have participated in another investigational drug study within 3 months prior to the planned administration of the study drug, where the last dose was received less than 3 months before screening for this trial; or subjects who plan to participate in another drug trial during the course of this study;\n8. Participants who have been vaccinated within 28 days prior to screening or plan to receive vaccination during the trial period;\n9. Participants who have taken any prescription drugs, over-the-counter (OTC) medications, Chinese patent medicines, herbal medicines, health supplements, or oral supplements (e.g., calcium, iron, magnesium, selenium, zinc, etc.) within 28 days prior to screening or during the trial period;\n10. Participants who have used oral long-acting contraceptives or implanted long-acting contraceptives within 28 days prior to screening;\n11. Participants who have used any known inducers or inhibitors of hepatic enzymes (e.g., grapefruit, orange juice, etc.) within 28 days prior to screening or during the trial period;\n12. Participants with any electrocardiogram (ECG) abnormality considered clinically significant by the investigator, including but not limited to: QTcF interval ≥450 ms, or a history of QTcF interval prolongation; PR interval ≥210 ms; QRS duration ≥120 ms; or a history of arrhythmia, syncope related to arrhythmia, use of a cardiac pacemaker, or other cardiac-related conditions. Note: Conditions include but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, premature atrial contractions, premature ventricular contractions, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of Long QT Syndrome (LQTS); or family history of sudden death;\n13. Participants with one or more abnormal vital signs at screening: aural temperature \\>37.5°C, pulse rate \\>100 beats per minute, systolic blood pressure ≥140 mmHg or \\\u003C90 mmHg, diastolic blood pressure ≥90 mmHg or \\\u003C50 mmHg;\n14. Participants who smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or who are unable to discontinue the use of any tobacco products during the trial period；\n15. Participants who habitually consumed excessive amounts of xanthine- or caffeine-containing foods, beverages, or other items that may affect drug absorption, distribution, metabolism, or excretion within 1 month prior to screening and are unwilling to abstain during the trial. Examples include: coffee (\\>1100 mL daily), tea (\\>2200 mL daily), cola (\\>2200 mL daily), energy drinks (\\>1100 mL daily), chocolate (\\>510 g daily);\n16. Participants with alcohol abuse: alcohol consumption exceeding 14 units per week within 1 month prior to signing the informed consent form (1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine)；\n17. Participants with a positive alcohol breath test (\\>0 mg\u002F100 mL) or those unable to abstain from alcohol during the trial period;\n18. Participants with a positive result for any of the following: Hepatitis B virus surface antigen (HBsAg), anti-Hepatitis C virus antibody (Anti-HCV), Treponema pallidum specific antibody, or anti-Human Immunodeficiency Virus antibody (Anti-HIV);\n19. Participants with a history of drug abuse and\u002For use of illicit drugs within 3 months prior to screening;\n20. Participants with a positive urine drug screen;\n21. Participants with a history of needle phobia, blood phobia, or intolerance to venipuncture for blood sampling;\n22. Participants who are pregnant, breastfeeding, or have a positive β-HCG pregnancy test;\n23. Participants with specific dietary requirements who cannot comply with the standardized diet and schedule;\n24. Participants deemed unsuitable for participation in this study by the investigator for any other reason.","45 Years",{"count":121,"type":22},74,[77],"Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2085 tablet. Part 2 is to assess the food effect on SYH2085 at a selected dose in a cross-over design.",[125],"Healthy Participants","2026-02-09",{"date":128,"type":33},"2026-02-17",{"date":130,"type":33},"2026-01-12",{"date":132,"type":22},"2026-12-31",{"name":39,"class":40},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100614662","phase-1-safety-and-efficacy-of-paclitaxel-liposome-arterial-infusion-combined-with-systemic-therapy-for-second-line-treatment-of-advanced-liver-cancer-100614662","NCT07282509","Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety and Efficacy of Transcatheter Arterial Infusion of Paclitaxel Cationic Liposome Combined With Systemic Therapy in Participants With Advanced Hepatocellular Carcinoma for Second-line Treatment","Inclusion Criteria:\n\n* 1.Aged 18 to 75 years (inclusive), regardless of gender;\n* 2.Diagnosed with hepatocellular carcinoma (HCC) by histopathology, cytology, or imaging;\n* 3.HCC classified as B\u002FC stage per BCLC (Barcelona Clinic Liver Cancer) staging system, or IIb\u002FIIIa\u002FIIIb stage as defined in Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition) (organized by the Guidelines Committee of the Chinese Society of Clinical Oncology, 2024);\n* 4.Child-Pugh liver function class ≤ 7 points within 7 days prior to the first dose administration;\n* 5.Progressive disease after prior first-line systemic antineoplastic therapy containing PD-1\u002FPD-L1 monoclonal antibody;\n* 6.At least one measurable lesion at the hepatic arterial infusion site per RECIST (Response Evaluation Criteria in Solid Tumors) Version 1.1 (lesion longest diameter ≥ 1 cm; lesions that have not received prior local therapy, or lesions that progressed again after local therapy);\n* 7.ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) score: 0-1.\n* 8.Controlled hypertension, with blood pressure ≤ 150\u002F90 mmHg and no changes to the antihypertensive regimen within one week prior to screening;\n* 9.Estimated survival time of more than 3 months;\n* 10.Before randomization, major organ\u002Fsystem functions are basically normal, meeting the criteria as assessed by laboratory tests.\n* 11.Eligible individuals of childbearing potential (both males and females) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for at least 6 months after the last dose; female individuals of childbearing age must have a negative serum pregnancy test within 7 days before enrollment;\n* 12.Participants must be informed about the study prior to the trial and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1.Pathologically confirmed fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocellular carcinoma, or combined hepatocellular-cholangiocarcinoma;\n* 2.History of liver surgery and\u002For local treatment for HCC within 4 weeks prior to the first dose;\n* 3.Previous antineoplastic treatment with lenvatinib;\n* 4.Use of traditional Chinese medicine (TCM) preparations with indicated efficacy for anti-HCC within 14 days prior to the first dose; having received immune checkpoint inhibitors within 28 days prior to the first dose.\n* 5.Active brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression;\n* 6.Adverse reactions from previous antineoplastic treatment that have not resolved to ≤ Grade 1 per NCI-CTCAE Version 5.0 (except for toxicities such as alopecia that are deemed to pose no safety risks by the investigator);\n* 7.Contraindications to transcatheter arterial infusion interventional surgery; known contraindications or severe allergic reactions to any component of lenvatinib, PD-1\u002FPD-L1 monoclonal antibody, paclitaxel, or cationic liposomes;\n* 8.Malabsorption syndrome or inability to take oral medications due to other reasons;\n* 9.Need for administration of strong inducers or strong inhibitors of CYP2C8 and CYP3A4 within 2 weeks prior to the first study treatment or during the treatment period;\n* 10.Active infection within 2 weeks prior to the first dose; presence of peripheral neuropathy of Grade II or higher (per NCI-CTCAE Version 5.0);\n* 11.History of autoimmune disease, immunodeficiency, other acquired or congenital immunodeficiency diseases, or current use of immunosuppressants;\n* 12.Untreated active hepatitis B.\n* 13.Participants positive for anti-hepatitis C virus antibody (HCV-Ab) with HCV-RNA level above the lower limit of the central laboratory's detection range;\n* 14.Participants with active syphilis;\n* 15.A history of past or current hepatic encephalopathy;\n* 16.Presence of ascites detectable on physical examination, ascites causing clinical symptoms, or ascites requiring special management during screening. Uncontrolled pleural effusion or pericardial effusion during screening;\n* 17.Active gastrointestinal bleeding or a documented history of gastrointestinal bleeding within 6 months before the first dose; history of gastrointestinal perforation and\u002For fistula, or history of gastrointestinal obstruction within 6 months before the first dose;\n* 18.History of major surgery within 4 weeks before the first dose (procedures such as central venous catheterization, needle biopsy, and feeding tube placement are not considered major surgery);\n* 19.History of solid organ or hematopoietic stem cell transplantation;\n* 20.Past or current non-infectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid treatment;\n* 21.Cardiac dysfunction, including:\n\n  1. Diagnosis of long QT syndrome, or QTcF (corrected QT interval using Fridericia's formula) ≥ 450 ms in males and ≥ 470 ms in females during screening (only one ECG recheck is permitted during screening, with the result of the last ECG in the screening period taken as final);\n  2. High-grade atrioventricular block;\n  3. Malignant arrhythmia poorly controlled by medication;\n  4. History of chronic heart failure with NYHA (New York Heart Association) functional class ≥ 3;\n  5. Severe valvular heart regurgitation or stenosis requiring treatment;\n  6. Acute coronary syndrome or severe myocardial disease (including primary cardiomyopathy and other severe myocardial diseases assessed by the investigator) within 6 months prior to screening; severe pericardial disease (including acute pericarditis, constrictive pericarditis and other severe pericardial diseases assessed by the investigator) within 6 months prior to screening;\n  7. Left ventricular ejection fraction (LVEF) \\\u003C 50% as indicated by echocardiography;\n* 22.History of severe neurological or psychiatric disorders (including epilepsy or dementia) that affect trial compliance;\n* 23.Limb vascular thrombosis with potential severe consequences detected by ultrasound during screening; or history of thromboembolic events within 12 months prior to enrollment;\n* 24.Participants with severe bleeding tendency, or history of major bleeding events within the past 6 months (e.g., previous intracranial hemorrhage, gastrointestinal bleeding, or purpura);\n* 25.Urinary protein ≥ 1 g\u002F24 h. Participants with proteinuria \\> 1+ on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria;\n* 26.Other conditions deemed by the investigator to potentially increase participant risk or interfere with trial results.","75 Years",{"count":143,"type":22},116,[77,51],"This trial is an open-label, dose-escalation, and randomized controlled Phase Ib\u002FII clinical study for second-line treatment in participants with advanced hepatocellular carcinoma (HCC). Its primary objective is to evaluate the safety, tolerability, pharmacokinetic profiles, and efficacy of transcatheter arterial infusion of HA131 combined with systemic therapy in the second-line treatment of participants with advanced HCC.",[147],"Advanced Hepatocellular Carcinoma (HCC)","2025-12-01",{"date":150,"type":33},"2025-12-15",{"date":152,"type":22},"2025-12-23",{"date":154,"type":22},"2029-02-03",{"name":39,"class":40},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":64},"100611542","phase-1-a-study-of-sirolimus-albumin-bound-in-combination-with-different-adcs-treatment-of-advanced-solid-tumors-100611542","NCT07241936","A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors","A Phase Ib\u002FII Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Subjects aged 18 to 75 years (inclusive).\n* 2\\. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.\n* 3\\. At least one measurable lesion, as defined by RECIST 1.1 criteria.\n* 4\\. ECOG performance status of 0 or 1.\n* 5\\. Expected survival ≥ 3 months.\n* 6\\. Adequate function of major organs and bone marrow.\n* 7\\. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy.\n* 8\\. Women or man of childbearing potential must use highly effective contraception.\n* 9\\. Able to understand and voluntarily sign the written informed consent form (ICF).\n\nExclusion Criteria:\n\n* 1\\. Previous use of antibody-conjugated drugs with similar loading agents for treatment.\n* 2\\. Previous anti-tumor treatment drugs were not adequately removed.\n* 3\\. Active leptomeningeal disease or uncontrolled CNS metastasis.\n* 4\\. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.\n* 5\\. Previous interstitial lung disease requiring glucocorticoid treatment, Or currently suffering from interstitial lung disease\u002Fnon-infectious pneumonia, or the imaging examination during the screening period cannot rule out interstitial pneumonia\u002Flung disease.\n* 6\\. Patients who developed severe and moderately severe lung diseases that significantly affected lung function within 6 months of the first medication administration; patients requiring supplementary oxygen therapy.\n* 7\\. Individuals who currently have eye diseases such as corneal disorders, retinal disorders, or active ocular infections that require intervention, or who have a history of serious corneal-related eye diseases in the past; or who are unwilling to stop wearing corneal contact lenses during the study; or who have other existing eye diseases that affect the assessment of ocular toxicity after the administration of the investigational drug.\n* 8\\. Currently suffering from skin diseases that require oral or intravenous medication treatment.\n* 9\\. Had a history of ulcerative colitis or Crohn's disease.\n* 10\\. Within 14 days prior to the first administration of the medication, there is a need for systemic antibacterial, antifungal or antiviral treatment for severe chronic or active infections, and there is no cure for active tuberculosis.\n* 11\\. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product.\n* 12\\. Participants with poor compliance.",{"count":164,"type":22},444,[77,51],"This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c\u002FSYS6043\u002FSYS6002\u002FSYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).",[168],"Advanced Solid Tumors","2025-11-21",{"date":171,"type":33},"2025-11-28",{"date":173,"type":33},"2025-11-13",{"date":175,"type":22},"2028-10-30",{"name":39,"class":40},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":64},"100588890","phase-2-safety-and-efficacy-of-glumetinib-combined-with-docetaxel-for-injection-albumin-bound-in-patients-with-advanced-gastric-cancergastroesophageal-junction-adenocarcinoma-and-other-solid-tumors-100588890","NCT06947291","Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer\u002FGastroesophageal Junction Adenocarcinoma and Other Solid Tumors","A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer\u002FGastroesophageal Junction Adenocarcinoma and Other Solid Tumors With MET Overexpression and\u002For Amplification","Inclusion Criteria:\n\n* 1\\. Patients who are able to understand and voluntarily sign the written ICF;\n* 2\\. Male or female patients aged ≥ 18 years (inclusive);\n* 3\\. Patients with advanced solid tumors diagnosed by pathology or cytology;\n* 4\\. Patients with a past medical history showing either negative or positive Her-2 expression can be enrolled. For those with unknown Her-2 expression, the Her-2 status needs to be determined before enrollment. For patients with positive Her-2 expression, their previous treatments should include anti-Her-2 drug therapy.\n* 5\\. Overexpression and\u002For amplification of MET in tumor tissue specimens\u002Fblood samples confirmed by the central laboratory.\n* 6\\. There are measurable lesions or non-measurable but evaluable lesions according to RECIST v1.1.\n* 7\\. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1.\n* 8\\. The expected survival time is ≥ 3 months.\n* 9\\. The functions of major organs and bone marrow meet the criteria.\n\nExclusion Criteria:\n\n* 1\\. Patients with prior treatment with targeted MET drugs;\n* 2\\. Previous treatments included docetaxel;\n* 3\\. Patients with meningeal metastases, spinal cord compression, symptomatic or progressive brain metastases are not eligible for enrollment.\n* 4\\. Known hypersensitivity or intolerable conditions to any component of the drugs in the study protocol or their excipients.\n* 5\\. According to NCI-CTCAE 5.0, adverse events caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 (excluding toxicities such as Grade 2 alopecia which are judged by the investigator to pose no safety risk).\n* 6\\. Any severe and\u002For uncontrolled co-existing diseases that may prevent the patient from participating in the study.\n* 7\\. Female patients who are lactating or pregnant; Women of childbearing potential with a positive blood pregnancy test result within 7 days before trial enrollment. Lactating women can participate in this study if they stop breastfeeding, but they must not resume breastfeeding during and after the completion of the study treatment.\n* 8\\. Any male or female patient of childbearing potential who refuses to use a highly effective contraceptive method throughout the trial period and within 6 months after the last administration.\n* 9\\. Those who are unwilling or unable to comply with the study procedures and requirements, or those who, in the judgment of the investigator, are not suitable for participating in this study.",{"count":185,"type":22},350,[51],"The trial consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (proof-of-concept study). Among them, Stage 2 adopts a randomized, controlled, open-label, and multicenter design.",[189],"Advanced Gastric Cancer\u002FGastroesophageal Junction Adenocarcinoma and Other Solid Tumors","2025-09-02",{"date":192,"type":33},"2025-09-08",{"date":194,"type":33},"2025-06-04",{"date":196,"type":22},"2027-10-30",{"name":39,"class":40},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":205,"maxAge":18,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":4},"100605503","phase-3-a-study-to-evaluate-the-effects-and-safety-of-hydroxocobalamin-in-participants-with-combined-methylmalonic-academia-cblc-type-100605503","NCT07163364","A Study to Evaluate the Effects and Safety of Hydroxocobalamin in Participants With Combined Methylmalonic Academia (cblC Type)","A Single-arm Phase III Clinical Study to Evaluate the Efficacy and Safety of Hydroxocobalamin Chloride Injection in Participants With Methylmalonic Acidemia (MMA) With Elevated Homocysteine (Cobalamin C Deficiency)","Inclusion Criteria:\n\n1. Age 6 months (inclusive) to \\\u003C 18 years at the time of first investigational product administration; both sexes eligible.\n2. Confirmed diagnosis of cobalamin C (cbl C)-type methylmalonic acidemia (MMA) fulfilling ALL of the following:\n\n   1. Documented vitamin B12 responsiveness: ≥ 50 % reduction from pre-treatment baseline in plasma C3\u002FC2 ratio and urinary methylmalonic acid following vitamin B12 therapy.\n   2. Presence of pathogenic MMACHC gene variants in a participant with MMA associated with hyperhomocysteinemia.\n3. Investigator-assessed clinical stability, defined as:\n\n   * No emergency room visits or hospitalizations within 6 months prior to screening for metabolic crises (e.g., electrolyte disturbances, metabolic acidosis, dysglycaemia, multi-organ failure); AND\n   * Plasma methylmalonic acid within the normal reference range at screening.\n4. Continuous treatment with injectable hydroxocobalamin for ≥ 3 months immediately preceding first dose of study drug.\n5. Written informed consent obtained from participant and\u002For legally authorised representative; willingness and ability to comply with all study visits and procedures.\n6. Female participants of childbearing potential (post-menarche) must have a negative serum β-hCG test at screening. All participants of reproductive potential (post-menarche females or males with documented spermarche) must use a highly effective contraceptive method throughout the study and for an appropriate post-study period as defined by local regulations.\n\nExclusion Criteria:\n\n1. Use of any vitamin B12 preparation other than injectable hydroxocobalamin within 3 months prior to screening.\n2. Participation in another clinical trial within 28 days or 5 half-lives of the investigational agent (whichever is longer) before screening initiation, except for screening-only participants who did not receive study drug.\n3. Prior liver or kidney transplantation, or any prior cell-based therapy.\n4. Any of the following laboratory abnormalities:\n\n   * Hemoglobin \\\u003C 90 g\u002FL; or\n   * Platelet count \\\u003C 100 × 10⁹\u002FL; or\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m²; or\n   * Requirement for dialysis due to renal disease.\n5. Evidence of clinically significant hepatic dysfunction defined as:\n\n   1. Alanine aminotransferase (ALT) \\> 2.0 × upper limit of normal (ULN);\n   2. Aspartate aminotransferase (AST) \\> 2.0 × ULN or total bilirubin \\> 1.5 × ULN;\n   3. Prothrombin time \\> 1.5 × ULN.\n6. Hyperammonemia characterised by blood ammonia ≥ 3 × ULN, or any acute metabolic decompensation (e.g., lethargy, restlessness, somnolence, feeding refusal, or vomiting).\n7. Evidence on prior imaging of a space-occupying lesion suspicious for malignancy, or any known history of malignancy.\n8. New York Heart Association (NYHA) Class III or IV heart failure, or moderate-to-severe pulmonary hypertension.\n9. Clinically significant urolithiasis identified on imaging performed during screening.\n10. Presence of any of the following underlying conditions: immunodeficiency, severe malnutrition, congenital heart disease, congenital malformations of the respiratory system, or any clinically significant cardiac, hepatic, pulmonary, or renal disorder; diabetes mellitus; severe hematological disease; uncontrolled epilepsy or other significant central nervous system disorders.\n11. History of severe hypersensitivity or known hypersensitivity\u002Fintolerance to hydroxocobalamin, structurally related compounds, or any excipients in the investigational product.\n12. Any other condition or circumstance that, in the judgment of the investigator, would compromise participant safety, compliance, or data integrity.","6 Months",{"count":207,"type":22},20,[25],"This study is a Single-Center, Single-Arm, open-label, Phase III clinical study to evaluate the efficacy, safety characteristics of Hydroxocobalamin Chloride Injection (20 mg\u002FmL) for Maintenance Therapy in participants with Methylmalonic Acidemia (MMA) with Elevated Homocysteine (Cobalamin C Deficiency).",[211],"Methylmalonic Acidemia (MMA)","2025-09-01",{"date":214,"type":33},"2025-09-09",{"date":216,"type":22},"2025-08-31",{"date":218,"type":22},"2027-04-28",{"name":39,"class":40},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100601924","phase-2-hb1801-combined-treatment-of-her2-positive-breast-cancer-100601924","NCT07116824","HB1801 Combined Treatment of HER2-positive Breast Cancer","A Phase II Trial to Evaluate the Safety and Efficacy of HB1801 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Voluntarily participate in this study and sign the Informed Consent Form (ICF);\n* Age ≥ 18 years;\n* Histologically and\u002For cytologically confirmed unresectable locally recurrent or metastatic breast cancer;\n* HER2-positive (IHC 3+, or IHC 2+ with ISH-positive);\n* No prior systemic chemotherapy and\u002For HER2-targeted therapy for unresectable locally recurrent or metastatic breast cancer (participants who have received ≤1 line of endocrine therapy are eligible); Participants who relapsed \\>12 months after completing (neo)adjuvant chemotherapy or HER2-targeted therapy may be considered for enrollment;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n* At least one measurable lesion per RECIST 1.1. The measurable lesion should not have received local treatment such as radiotherapy (lesions in previously irradiated areas may be selected as target lesions if progression is confirmed). Target lesions cannot be bone-only metastases;\n* Adequate organ and bone marrow function (without transfusion or hematopoietic growth factor support within 14 days prior to testing):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n  2. Platelet count ≥ 100 × 10\\^9\u002FL;\n  3. Hemoglobin ≥ 90 g\u002FL;\n  4. Liver function: Total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (ALT\u002FAST≤ 5 × ULN for participants with liver metastases; AST\u002FALT ≤ 1.5 × ULN for participants with alkaline phosphatase (ALP) \\> 2.5 × ULN);\n  5. Renal function: Creatinine clearance ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n  6. Coagulation: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for participants receiving anticoagulation therapy, the investigator should confirm that INR and APTT are within safe and effective therapeutic ranges);\n  7. Left ventricular ejection fraction (LVEF) \\> 50%;\n* Expected survival ≥ 3 months;\n* For women of childbearing potential: Negative serum pregnancy test within 7 days before randomization and agreement to use reliable contraception during the study and for 3 months after last dose of docetaxel\u002FHB1801 or 7 months after last dose of trastuzumab\u002Fpertuzumab (whichever is longer). For male participants with partners of childbearing potential: Agreement to use reliable contraception during the study and for 3 months after last dose of docetaxel\u002FHB1801 or 7 months after last dose of trastuzumab\u002Fpertuzumab (whichever is longer).\n\nExclusion Criteria:\n\n* Contraindications to trastuzumab, pertuzumab, or docetaxel, or deemed by the investigator as unsuitable for treatment with HB1801, docetaxel, pertuzumab, or trastuzumab;\n* Participants with ≥ Grade 3 peripheral neuropathy at randomization;\n* Toxicities from prior anticancer therapy have not resolved to ≤ Grade 1 per CTCAE v5.0 (except for alopecia, peripheral neuropathy, or laboratory abnormalities deemed non-risky by the investigator, which must be ≤ Grade 2);\n* History of LVEF decline to \\\u003C 50%, symptomatic congestive heart failure (CHF), or toxicity leading to permanent discontinuation during prior HER2-targeted therapy;\n* Known hypersensitivity or contraindications to corticosteroids (including but not limited to active peptic ulcer, severe hypertension, severe hypokalemia, glaucoma, etc.);\n* Prior anthracycline therapy exceeding cumulative doses of: Doxorubicin or liposomal doxorubicin \\> 360 mg\u002Fm², Epirubicin \\> 720 mg\u002Fm², Mitoxantrone \\> 120 mg\u002Fm², Other anthracyclines \\> doxorubicin-equivalent 360 mg\u002Fm²(If multiple anthracyclines were used, the total dose must not exceed 360 mg\u002Fm² doxorubicin-equivalent);\n* Use of strong CYP3A4 inhibitors within 14 days before randomization;\n* History of hypersensitivity to any study drug component or excipients;\n* Untreated or unstable brain\u002Fspinal metastases, leptomeningeal disease, or cord compression (participants with treated, asymptomatic CNS lesions stable for ≥4 weeks on imaging, without edema, and off corticosteroids may be eligible);\n* Active malignancies within 3 years prior to randomization, except: studied breast cancer, locally cured tumors (e.g., resected basal\u002Fsquamous skin cancer, superficial bladder cancer, cervical\u002Fbreast carcinoma in situ, early-stage thyroid cancer);\n* Uncontrolled or significant cardiovascular disease, including:\n\n  1. NYHA Class II+ CHF, unstable angina, myocardial infarction, or hemodynamically unstable arrhythmia within 6 months;\n  2. Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive);\n  3. Clinically significant QTc prolongation (Fridericia-corrected QTcF \\> 450 ms at screening);\n  4. Arterial\u002Fvenous thromboembolism within 6 months (e.g., stroke, TIA, DVT, PE);\n  5. Uncontrolled hypertension (SBP \\> 160 mmHg and\u002For DBP \\> 100 mmHg);\n* Active\u002Fchronic infection requiring systemic antimicrobial\u002Fantiviral therapy within 14 days (including tuberculosis);\n* Active hepatitis: HBV (HBsAg+ with HBV-DNA ≥ 2×10³ IU\u002FmL), HCV (anti-HCV+ with detectable HCV-RNA) \\*Note: HBsAg+ carriers with HBV-DNA \\\u003C 2×10³ IU\u002FmL may enroll if willing to receive entecavir\u002Fantiviral therapy;\\*\n* Known HIV infection;\n* Concurrent participation in other interventional clinical trials (except observational studies or follow-up phases) or \\\u003C4 weeks since last dose in prior interventional trials;\n* Anticancer therapy within 28 days (radiotherapy, targeted\u002Fimmunotherapy, investigational drugs) or 14 days (traditional Chinese medicine with antitumor indications);\n* Uncontrolled effusions requiring frequent drainage\u002Fmedical intervention within 7 days (e.g., pleural, ascites, pericardial) or needing re-intervention within 2 weeks (excluding cytology);\n* Major surgery within 28 days (excluding biopsies);\n* Pregnant or lactating women;\n* Other conditions compromising study participation\u002Fbenefit (e.g., psychiatric disorders, substance abuse, or clinically significant comorbidities).",{"count":228,"type":22},80,[51],"This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.",[232],"HER2-positive Breast Cancer","2025-08-07",{"date":235,"type":33},"2025-08-12",{"date":237,"type":22},"2025-09-15",{"date":239,"type":22},"2027-11-07",{"name":39,"class":40},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":64},"100601971","phase-1-paclitaxel-cationic-liposome-hepatic-arterial-infusion-in-combination-with-systemic-therapy-as-first-line-treatment-in-colorectal-liver-metastases-100601971","NCT07117435","Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases","A Phase Ib\u002FIII Study to Evaluate the Safety and Efficacy of Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases","Inclusion Criteria:\n\n* 1\\. Age range: 18 - 75 years old (inclusive), gender not limited.\n* 2\\. For patients with colorectal liver metastases have been histologically or cytologically confirmed and who are assessed by multidisciplinary team (MDT) to be inoperable for radical surgical resection:\n\n  1. Have not received systemic treatment for the metastatic or recurrent disease;\n  2. For patients who have received neoadjuvant\u002Fadjuvant therapy before, the time interval between the last administration and disease progression must be ≥ 6 months;\n  3. Allow patients who have received local treatment and progressed.\n* 3\\. According to RECIST v1.1, at least one measurable lesion in the hepatic arterial infusion area (long diameter ≥ 1 cm and no previous local treatment).\n* 4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* 5\\. Life expectancy of at least 3 months.\n* 6\\. Adequate organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factors within 14 days)\n* 7\\. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the study and for at least 6 months after the last dose of study intervention. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n* 8\\. Fully understand the clinical study and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients known to have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR), and have been evaluated by the investigators to be eligible for immune checkpoint inhibitor therapy.\n* 2\\. Patients known to have wild-type RAS and BRAF, and have been evaluated by the investigators to be eligible for anti-epidermal growth factor receptor (EGFR) drug therapy.\n* 3\\. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigators).\n* 4\\. Central nervous system metastasis with clinical symptoms, or meningeal metastasis, or there are other evidences indicating that the patient's central nervous system metastasis or meningeal metastatic lesions have not been controlled, and the investigators judges that the patient is not suitable for enrollment.\n* 5\\. Patients with contraindications for transcatheter arterial infusion.\n* 6\\. Patients with active infections within 2 weeks prior to administration (NCI CTC AE v5.0 ≥ grade 2) (Defined as requiring intravenous administration of antibacterial, antifungal or antiviral drugs for treatment).\n* 7\\. Patients with grade 2 or above peripheral neuropathy (NCI CTC AE v5.0).\n* 8\\. Patients with a history of autoimmune diseases, immunodeficiency disorders, including HIV positive test results, or suffering from other acquired or congenital immune deficiencies, or those currently using immunosuppressive agents.\n* 9\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with HBV DNA ≥ 2×103 IU\u002FmL (can use continuous antiviral treatment); or anti-hepatitis C virus antibody (HCV-Ab) positive with HCV RNA above the measurable limit; or active syphilis.\n* 10\\. Patients with known contraindications to capecitabine or oxaliplatin, paclitaxel or cationic liposome, or have severe allergic reactions; note: If the subject has contraindications to bevacizumab or has severe allergic reactions to any component of bevacizumab, it will not affect the enrollment but should not use bevacizumab in the study, and the specific reasons need to be recorded.\n* 11\\. Patients need to receive strong inducers and strong inhibitors of CYP2C8 and CYP3A4 within 2 weeks before the first study treatment or during the treatment.\n* 12\\. Patients had or have non-infectious pneumonia\u002Finterstitial lung disease that requires systemic glucocorticoid treatment.\n* 13\\. Severe cardiovascular disease history, including but not limited to:\n\n  * Long QT syndrome;\n  * High-degree atrioventricular block;\n  * Severe arrhythmia that is not well controlled by medication;\n  * Chronic heart failure history and NYHA cardiac function classification ≥ 3;\n  * Severe valvular regurgitation or stenosis that requires treatment;\n  * Acute coronary syndrome or severe myocardial disease within 6 months before screening;\n  * Uncontrolled hypertension;\n  * Echocardiography suggests LVEF \\\u003C 50%;\n* 14\\. Patients with a previous history of severe neurological or mental disorders (including epilepsy or dementia) lead to compliance issues.\n* 15\\. Patients with ultrasound-detected limb vascular thrombosis with potentially serious consequences during screening, or who with thromboembolic events within 3 months prior to enrollment.\n* 16\\. Patients with a history of severe bleeding, or who experienced major bleeding events such as intracranial hemorrhage, gastrointestinal bleeding, or purpura within the last 3 months.\n* 17\\. Any other reasons deemed by the investigators.",{"count":249,"type":22},7,[77],"This is a phase Ib\u002FIII, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.",[253,254],"Colorectal Liver Metastases","First-line Treatment","2025-08-05",{"date":235,"type":33},{"date":258,"type":33},"2025-05-13",{"date":260,"type":22},"2026-06-01",{"name":39,"class":40},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":64},"100568991","phase-1-a-study-to-evaluate-the-safety-and-preliminary-efficacy-of-sys6020-car-t-cells-in-patients-with-refractory-generalized-myasthenia-gravis-100568991","NCT06688435","A Study to Evaluate the Safety and Preliminary Efficacy of SYS6020 CAR T-cells in Patients With Refractory Generalized Myasthenia Gravis","A Phase I Study to Evaluate BCMA-targeted Chimeric Antigen Receptor T Cell (SYS6020 Injection) in Patients With Refractory Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* 1\\) The ages ≥18 and ≤ 65 years old;\n* 2)Diagnosed as generalized myasthenia gravis (GMG), the clinical classification of MGFA II-IV；\n* 3\\) Diagnosed as refractory myasthenia gravis (refractory MG) ；\n* 4\\) QMG score \\>11 in the screening period and before apheresis;\n* 5\\) Positive acetylcholine receptor antibody (AChR-Ab) and\u002For muscle-specific receptor tyrosine kinase (MuSK) antibody in the screening period;\n* 6\\) The daily dose of concomitant glucocorticoid therapy must not exceed 40mg prednisone or equivalent dose and the dose have to be stable for ≥4 weeks prior to baseline.\n* 7\\) Participants have a thorough understanding of this clinical trial and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Have been known to have allergic reactions, hypersensitivity, intolerance or contraindications to SYS6020（including its active ingredient and excipient dextran 40） or the drugs potentially used in the study, or who have had a previous history of severe allergic reactions;\n* 2\\) Participants with major chronic diseases that are not well-controlled and considered to increase the participant's risk potentially by the investigator;\n* 3\\) Participants with other autoimmune diseases that require systemic treatment. Participants with stable autoimmune thyroid diseases who have a normal thyroid function and are at a stable therapeutic dose are allowed to be enrolled.\n* 4\\) Participants with a severe recurrent infection during the screening period, or any active infection that the investigator considers may affect the patient's participation;\n* 5)Participants with a history of positive HIV; participants with positive HBsAg; participants with positive HBcAb and with HBV-DNA above the measurable limit;\n* 6\\) Participants with a history of malignant tumors within the past 5 years or with current active malignant tumors. Participants with successfully treated localized tumors, as well as those with thymomas classified as A, AB and B1 subtypes according to the WHO pathological classifications, are allowed to be enrolled;\n* 7\\) Any serious respiratory system disease.\n* 8\\) Participants with a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities.\n* 9\\) Abnormal laboratory findings with clinical significance, including ALT, AST\\>3\\*ULN； Scr\\>1.5\\*ULN； INR\\>1.5\\*ULN, and so on. .\n* 10\\) Individuals with potential disease conditions (including laboratory abnormalities) which are considered of clinical significance by the investigator; individuals with alcohol dependence or drug abuse .\n* 11\\) Individuals with a current psychotic disorder that interferes with adherence.\n* 12\\) Participants with a history of primary immunodeficiency disease, organ or hematopoietic stem cell\u002Fbone marrow transplantations before screening; or those planning to undergo a transplantation during the trial;\n* 13\\) Participants with a history of ≥ Grade 2 (CTCAE 5.0 standard) bleeding within 30 days before screening, or those requiring long-term continuous treatments with anticoagulant drugs.\n* 14\\) Participants who have received any CAR-T therapy or gene therapy before.\n* 15\\) Participants who have received intravenous injection of human immunoglobulin (IVIG) or plasmapheresis (PE), plasma separation, or hemodialysis within 1 month before apheresis.\n* 16\\) Participants who have used calcineurin inhibitors, or cyclophosphamide or neonatal Fc receptor antagonists within 3 weeks before apheresis and 8 weeks before the first dosing. Participants who have used targeted B-cell biological agents such as rituximab within 3 months before apheresis. Participants who started receiving eculizumab treatment within 8 weeks before the first dosing；\n* 17\\) Any situations that the investigator believes that the participant is not suitable for this clinical trial for any other reasons.",{"count":270,"type":22},50,[77],"This study is a single-arm, open, 2-stage (dose-escalation phase and dose-expansion phase), multi-center, phase I clinical trial to evaluate the safety and tolerance of SYS6020 injection in the participants with refractory systemic myasthenia gravis, and determine the recommended dose (RD) for subsequent studies of the product, and to preliminarily evaluate the clinical efficacy of the product, as well as to explore the pharmacokinetics and immunogenicity of the product in vivo.\n\nThe dose-escalation phase and dose-expansion phase include 7 periods, and they are respectively in sequence as follows: the screening period, apheresis period, pre-dosing assessment, SYS6020 injection infusion, DLT observation period, the primary follow-up period (6 months), and the long-term follow-up period (5 years). The DLT observation period is 28 days after receiving SYS6020 injection. The participants will not undergo lymphodepleting chemotherapy.\n\nThe efficacy and safety profile of the participants will be continuously assessed during the trial. Efficacy measurement includes the MG-ADL, QMG, MGC, MG-QoL 15R scale, MGFA clinical classification, and MGFA post-intervention state (MGFA PIS) grading scales, as well as self-antibodies, etc. Safety measurement includes vital signs, physical examination, laboratory tests, cytokines, and ECG, etc. The adverse events and concomitant therapy will be continuously collected during the trial. In addition, during the study period, blood samples will be collected from participants who have received SYS6020 treatment for PK\u002FPD test, and immunogenicity test.\n\nFor the dose-escalation phase, 3 to 5 dose levels are proposed to be explored. The Safety Monitoring Committee (SMC) will discuss the safety data and make a decision if the next SYS6020 injection could be initiated or dose-escalation could be initiated. After the completion of the dose-escalation phase, the recommended doses would be determined for dose-expansion phase. For the dose-expansion phase, further safety and efficacy data will be collected among the participants who will receive the recommended dose of SYS6020 injection.",[274],"Myasthenia Gravis","2025-08-01",{"date":277,"type":33},"2025-08-06",{"date":279,"type":33},"2025-01-08",{"date":281,"type":22},"2033-05-01",{"name":39,"class":40},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":4},"100599362","phase-2-a-study-comparing-the-efficacy-and-safety-of-hb1801-with-taxotere-in-advanced-breast-cancer-100599362","NCT07083505","A Study Comparing the Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer","A Multicenter, Randomized, Open-Label Phase II Clinical Trial Comparing Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old (based on the date of signing the informed consent form).\n* 2\\. Voluntarily participate in this clinical trial, sign the informed consent form, and be willing and able to adhere to the treatment, visits, and related procedures specified in the protocol.\n* 3\\. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer, meeting the following criteria: a) The investigator determines that the patient is suitable for single-agent docetaxel treatment, in accordance with the 2025 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Treatment Guidelines. b) At least one measurable lesion according to RECIST 1.1 criteria. For lesions previously treated with radiotherapy, the lesion can only be included as a measurable lesion if clear disease progression occurs after radiotherapy.\n* 4\\. Within 7 days before randomization, major organ\u002Fsystem functions are basically normal, meeting the criteria as assessed by laboratory tests.\n* 5\\. ECOG performance status of 0-1 within 7 days before randomization.\n* 6\\. Expected survival time ≥ 3 months.\n* 7\\. For women of childbearing potential (WOCBP): Negative serum pregnancy test within 7 days before randomization. The subject and spouse must agree to use effective contraception from the date of signing the informed consent until 6 months after the last study drug administration. During this period: Female subjects must not be lactating; Male subjects must avoid sperm donation.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with docetaxel monotherapy or combination therapy for unresectable locally advanced or metastatic breast cancer.\n* 2\\. Subjects with partially or completely intestinal obstruction that cannot be relieved by active treatment; history of inflammatory bowel disease, chronic diarrhea, or gastrointestinal bleeding.\n* 3\\. Known severe allergic history or hypersensitivity (NCI-CTCAE v5.0, ≥ grade 3) to human albumin or docetaxel, and\u002For contraindications; known severe allergic history and\u002For contraindications to glucocorticoids (including but not limited to active peptic ulcer, severe hypertension, severe hypokalemia, glaucoma, etc.).\n* 4\\. Untreated active brain metastases (including symptomatic brain metastases or leptomeningeal metastases); subjects with treated brain metastases are eligible if the metastatic lesions are stable (brain imaging demonstrates stability for at least 4 weeks before randomization, no new neurological symptoms or neurological symptoms have returned to baseline, and no hormonal therapy is required for at least 14 days before randomization for investigational treatment), and there is no evidence of new or enlarged pre-existing brain metastases.\n* 5\\. History of other malignant tumors within 5 years before randomization, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, or in-situ carcinoma (e.g., cervical in-situ carcinoma).\n* 6\\. Uncontrolled serous effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring frequent drainage or medical intervention within 14 days before randomization, or requiring additional intervention within 2 weeks after intervention (excluding exfoliative cytology of exudates).\n* 7\\. Severe neurological diseases (e.g., epilepsy, dementia) and ≥ grade 3 peripheral neuropathy.\n* 8\\. Severe respiratory diseases, such as asthma requiring glucocorticoid use, chronic obstructive pulmonary disease (acute exacerbation phase), etc.\n* 9\\. History of severe cardiovascular diseases within 6 months before randomization, including but not limited to: 1)Uncontrolled hypertension (defined as sustained systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication); 2)Severe arrhythmias and conduction abnormalities requiring anti-arrhythmic drugs other than β-blockers or digoxin (except atrial fibrillation and paroxysmal supraventricular tachycardia); 3)History of myocardial infarction, unstable angina, angioplasty, coronary artery bypass surgery; 4)New York Heart Association (NYHA) class II or higher heart failure; 5)QTcF \\> 480 ms \\[QTcF = QT\u002F(RR 0.33), where RR is normalized heart rate (60\u002Fheart rate)\\], calculated by Fridericia formula (if abnormal, average three consecutive measurements taken 2 minutes apart); 6)Other clinically significant cardiac diseases as determined by the investigator.\n* 10\\. Severe chronic or active infection requiring intravenous antibacterial, antifungal, or antiviral therapy within 2 weeks before randomization.\n* 11\\. Major organ surgery (except biopsy or infusion device implantation) within 4 weeks before randomization, or scheduled for major organ surgery during the trial.\n* 12\\. Chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or other investigational drugs within 4 weeks or 5 half-lives (whichever is shorter, but at least 2 weeks) before randomization; radiotherapy within 2 weeks before randomization; traditional Chinese medicine with anti-tumor indications within 2 weeks before randomization.\n* 13\\. Unresolved toxicities from prior anticancer therapy to grade 1 or lower (per CTCAE v5.0), except for grade 2 neuropathy, alopecia, hypothyroidism (with hormone replacement), and toxicities determined by the investigator to pose no safety risk.\n* 14\\. Use of strong CYP3A4 inhibitors or inducers within 2 weeks before randomization.\n* 15\\. Vaccination (including live and attenuated live vaccines) within 4 weeks before randomization or planned during the trial.\n* 16\\. Active hepatitis B infection (HBsAg-positive and HBV-DNA \\> ULN); hepatitis C infection (antibody-positive and HCV-RNA PCR-positive); human immunodeficiency virus (HIV) carrier; active tuberculosis or syphilis infection.\n* 17\\. Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) study or follow-up of an interventional study.\n* 18\\. Other conditions deemed by the investigator as unsuitable for trial participation, including but not limited to severe or uncontrolled medical conditions interfering with trial result interpretation or trial compliance.",{"count":291,"type":22},60,[51],"This is a randomized, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of HB1801 compared with Taxotere® in patients with advanced breast cancer. A total of 60 subjects with advanced breast cancer are planned to be enrolled.The trial consists of three phases: screening period, open-label treatment period, and follow-up period. HB1801 is Docetaxel for injection (Albumin-bound).",[295],"Advanced Breast Cancer","2025-07-22",{"date":298,"type":33},"2025-07-24",{"date":300,"type":22},"2025-08-15",{"date":132,"type":22},{"name":39,"class":40},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100588418","phase-1-a-study-of-sirolimus-albumin-bound-in-combination-with-palbociclib-and-fulvestrant-for-the-treatment-of-advanced-breast-cancer-100588418","NCT06941142","A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer","An Ib\u002FIII Study to Evaluate the Safety and Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer","Inclusion Criteria:\n\n* 1\\. Subjects should be over 18 years old, regardless of gender.\n* 2\\. Histologically or cytologically confirmed HR - positive, HER2 - negative advanced breast cancer.\n* 3\\. For patients in the dose escalation stage, there are no limitation on previous treatments. The investigator must assess whether the patients are currently suitable for enrollment and eligible to receive the study drug treatment. For patients in the dose expansion stage need to meet the following criteria: The patient has received (neo)adjuvant endocrine therapy and has evidence of radiographic recurrence or progression during the treatment or within 12 months after the end of the treatment. The patient is allowed to receive no more than one line of systemic chemotherapy at the recurrence and metastasis setting. The patient has not received CDK4\u002F6 inhibitor treatment at the recurrence and metastasis setting.\n* 4\\. At least one measurable lesion meeting RECIST V1.1 criteria (patients with bone-only metastases may be enrolled in the dose escalation stage).\n* 5\\. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 - 1.\n* 6\\. The predicted survival time is more than 6 months.\n* 7\\. The major organ functions must meet the protocol criteria within 7 days prior to treatment.\n* 8\\. Voluntarily participate in this clinical study, understand the research procedures, and be able to sign the written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Previously diagnosed with HER2 - positive breast cancer through pathological examination.\n* 2\\. Patients deemed by the investigator as unsuitable for endocrine therapy (e.g., those with visceral crisis posing immediate life-threatening risks in the short term, including: uncontrolled massive effusions \\[pleural, pericardial, or peritoneal\\], pulmonary lymphangitic carcinomatosis, or hepatic involvement \\>50%).\n* 3\\. Patients who have previously received treatment with fulvestrant or inhibitors such as PI3K\u002FAKT\u002FmTOR.\n* 4\\. Patients with uncontrolled third-space fluid accumulation (e.g., pericardial effusion, pleural effusion, or ascites) requiring repeated drainage or other therapeutic interventions, and deemed ineligible for enrollment by investigators.\n* 5\\. Patients with a history of severe lung diseases, such as interstitial lung disease and\u002For pneumonia, or pulmonary hypertension, or radiation pneumonia requiring glucocorticoid treatment.\n* 6\\. Patients with chronic gastrointestinal dysfunction mainly manifested as diarrhea, such as Crohn's disease, ulcerative colitis, malabsorption, or diarrhea of grade ≥ 1; intestinal obstruction, or other gastrointestinal diseases deemed clinically significant by investigators.\n* 7\\. Patients with known coagulation disorders such as bleeding tendency; or those who need to use anticoagulants, which may affect the intramuscular injection of fulvestrant or the use of LHRH agonists.\n* 8\\. Patients with known hypersensitivity or intolerance to any component of the investigational drug(s), their excipients, or LHRH agonists (if applicable).\n* 9\\. Patients with a history of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases (including positive HIV test), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.",{"count":311,"type":22},382,[77],"This study adopts multicenter\u002Frandomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy. Dose-escalation and dose-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with palbociclib and fulvestrant in this patient population.",[295],"2025-04-16",{"date":317,"type":33},"2025-04-23",{"date":319,"type":22},"2025-04-30",{"date":321,"type":22},"2028-06",{"name":39,"class":40},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":64},"100587510","phase-3-sirolimus-for-injection-albumin-bound-combined-with-fulvestrant-for-hrher2--advancedmetastatic-breast-cancer-patients-previously-treated-with-cdk46-inhibitors-100587510","NCT06929325","Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer Patients Previously Treated With CDK4\u002F6 Inhibitors","A Randomized, Double-blind, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant Versus Placebo Combined With Fulvestrant in HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Patients After Prior CDK4\u002F6 Inhibitor Treatment.","Inclusion Criteria:\n\n* 1\\. Aged 18 or above, regardless of gender; female patients must be postmenopausal, or premenopausal\u002Fperimenopausal.\n* 2\\. Pathologically confirmed HR+, HER2- breast cancer.\n* 3\\. Locally advanced or metastatic breast cancer, not suitable for curative surgery or radiotherapy, and no current clinical indication for chemotherapy.\n* 4\\. Previously received at least one, up to two lines of systemic therapy (including at least one line of endocrine therapy combined with CDK4\u002F6 inhibitor therapy).\n* 5\\. At least one measurable lesion according to RECIST 1.1 criteria.\n* 6\\. Willing to provide tumor and\u002For blood samples for biomarker testing; if unable to provide, subject to investigator and sponsor evaluation for eligibility.\n* 7\\. ECOG performance status score of 0-1.\n* 8\\. Investigator-assessed life expectancy ≥6 months.\n* 9\\. Adequate organ and bone marrow function.\n* 10\\. Premenopausal female patients using LHRH agonists to suppress ovarian function must agree to use two acceptable forms of highly effective contraception during the study and for 2 years after stopping study treatment; female patients of childbearing potential must have a negative pregnancy blood test before starting study treatment and must not be breastfeeding.\n* 11\\. Male patients must agree to use barrier contraception (i.e., condoms) during the study and for 2 years after stopping study treatment; for men with future fertility plans, sperm freezing is recommended before starting study treatment.\n* 12\\. Participants must provide informed consent before the trial and voluntarily sign the written ICF.\n\nExclusion Criteria:\n\n* 1\\. Previous pathological diagnosis of HER2-positive breast cancer.\n* 2\\. Patients judged by the investigator to be unsuitable for endocrine therapy.\n* 3\\. Patients who have previously received PI3K\u002FAKT\u002FmTOR inhibitors, fulvestrant, or other ER-targeted therapies (including oral SERDs, ER protein degraders PROTAC, etc.).\n* 4\\. Received chemotherapy, radiotherapy, biological therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before randomization.\n* 5\\. Received other unapproved investigational drugs within 4 weeks before randomization.\n* 6\\. Underwent major surgery within 4 weeks before randomization or has not fully recovered from any previous invasive procedures.\n* 7\\. Received systemic glucocorticoids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive treatments within 2 weeks before randomization.\n* 8\\. Had an infection within 2 weeks before randomization requiring systemic (oral or IV) anti-infective treatment (uncomplicated urinary tract infections or upper respiratory tract infections excluded).\n* 9\\. Received inactivated or live attenuated vaccines or COVID-19 vaccines within 4 weeks before randomization.\n* 10\\. Used strong inhibitors or inducers of CYP3A4 hepatic metabolic enzymes within 2 weeks before randomization or still need to continue using such drugs.\n* 11\\. Diagnosed with other malignancies within 5 years before randomization.\n* 12\\. Suffering from severe cardiovascular or cerebrovascular diseases.\n* 13\\. Adverse reactions from previous anti-tumor treatments have not recovered to CTCAE 5.0 grade ≤1.\n* 14\\. Active leptomeningeal disease or poorly controlled central nervous system metastases.\n* 15\\. Presence of pleural\u002Fabdominal effusion or pericardial effusion with clinical symptoms or requiring symptomatic treatment.\n* 16\\. Known bleeding tendency (constitution) or coagulation disorders.\n* 17\\. History of severe lung diseases such as interstitial lung disease and\u002For pneumonia, pulmonary hypertension, or radiation pneumonitis requiring glucocorticoid treatment.\n* 18\\. Known hypersensitivity or intolerance to any component of the study drug or its excipients, or LHRH agonists (if applicable).\n* 19\\. History of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or organ transplant history.\n* 20\\. Active HBV, HCV, syphilis, or tuberculosis infection.\n* 21\\. Other conditions judged by the investigator to be unsuitable for participation in this study.",{"count":331,"type":22},312,[25],"A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.",[335],"HR+\u002FHER2- Advanced\u002FMetastatic Breast Cancer","2025-04-14",{"date":315,"type":33},{"date":339,"type":22},"2025-04",{"date":341,"type":22},"2027-12",{"name":39,"class":40},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":4},"100579679","phase-3-the-research-of-ammoxetine-hydrochloride-enteric-coated-tablets-in-subjects-with-depression-100579679","NCT06827431","The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression","Efficacy and Safety of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression: A Multicenter, Randomized, Double-blind, Double-Dummy, Placebo-controlled and Sertraline Active-controlled, Parallel-group, Phase III Study","Inclusion Criteria:\n\n* 1\\. Subjects aged 18 and 65 years (inclusive), no gender limitation;\n* 2\\. Subject has recurrent Major Depressive Disorder (MDD) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5, 5th Edition), single episode or recurrent episodes (classification code 296.2\u002F296.3).The duration of the current depressive episode should be ≥3 months for first-episode patients and ≥1 month for relapsing patients;\n* 3\\. Subjects with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 at screening and baseline. Subjects with Clinical Global Impression Scale Disease Severity CGI-S severity score ≥ 4 at screening and baseline. Score of first item (depressed mood) of the HAMD-17 scale ≥2 at the screening and baseline.\n* Be able to read and understand the study procedures and trial requirements, agree to abide by the restrictions of the trial and return to the site on time for evaluation, and sign the informed consent form prior to the trial.\n\nExclusion Criteria:\n\n* 1\\. Subjects with ≥ 25% reduction in MADRS score in the baseline period compared to the screening period;\n* 2\\. There is a clinically significant risk of suicide or risk of self-injury and harm to others. Those who meet any of the following:\n\n  1. A score of ≥4 on item 10 (Suicidal Ideation) of the MADRS scale;\n  2. Subjects who in the judgment of the investigator, are at significant risk for suicide (e.g., participant answered \"yes\" to question 4 (active suicidal ideation with intent to act but no specific plan) or question 5 (active suicidal ideation with a specific plan and intent) on the Screening C-SSRS and the most recent suicidal intent or suicidal plan occurred within the last six months);\n  3. Attempted suicide during the current depressive episode;\n* 3\\. Subjects meet DSM-5 diagnostic criteria for other mental disorders (Schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders, substance-related and addiction disorders, etc.)\n* 4\\. Subjects who meet any of the following diagnoses of depressive disorders:\n\n  1. Those who have been determined by the investigator to have TRD (current or prior use of 2 or more antidepressants with different mechanisms that have not been effective with a full course (at least 8 weeks) of treatment at the full dosage (the maximum recommended amount of the instructions);\n  2. Subjects with depressive disorders due to other types of mental disorders or somatic diseases (e.g., depressive disorders due to hypothyroidism);\n  3. Subjects with depressive disorders due to substances\u002Fdrugs;\n* 5\\. Subjects who stopped using the following drugs for less than 5 half-lives prior to randomization:\n\n  1. CYP2C19 and CYP3A4 strong inducers and strong inhibitors (e.g., fluoxetine, rifampicin, carbamazepine, etc.);\n  2. Combined use of drugs that cause QTc interval prolongation (e.g., levofloxacin, fluconazole, ondansetron, amiodarone, metronidazole, erythromycin, and haloperidol, etc.) or drugs that can cause QTc interval prolongation and may induce torsade de pointes ventricular tachycardia;\n  3. Antipsychotics, antidepressants, or mood stabilizers;\n* 6\\. Subjects who have failed previous treatment with a full course (at least 8 weeks) of sertraline at the maximum recommended dose or who have a known allergy to sertraline;\n* 7\\. Subjects who stopped using MAOI (e.g., phenelzine, isocarbazide, antiphencyclidine, linezolid, methylene blue, etc.) for less than 2 weeks before randomization;\n* 8\\. Subjects on long half-life antipsychotics;\n* 9\\. Subjects who have received any of the following non-pharmacologic treatments within 3 months prior to screening:\n\n  1. Electroconvulsive therapy (ECT)\n  2. Systemic psychotherapy (e.g., interpersonal therapy, motivational therapy, cognitive behavioral therapy, etc.)\n  3. Transcranial magnetic stimulation therapy (TMS)\n  4. Vagus Nerve Stimulation (VNS)\n  5. Light therapy, etc.\n  6. Or those who, in the judgment of the investigator, currently require the above treatments\n* 10\\. Participation in any clinical trial within 3 months prior to screening;\n* 11\\. Those with degree II or III AV block, long QT syndrome, or QTcF \\>450 ms (males)\u002F460 ms (females) on 12-lead ECG at the time of screening, or those deemed unsuitable for enrollment by the investigator (e.g., tachyarrhythmias requiring clinical management, etc.)\n* 12\\. Screening subjects with ALT or AST greater than 2 times the upper limit of laboratory normal; Severe subclinical hypothyroidism (thyroid function indices only with abnormally elevated TSH and TSH ≥ 10.0 mIU\u002FL); Abnormalities in 2 or more of the 5 thyroid function parameters (TSH, FT3, FT4, TT3, or TT4 values less than 0.9 times the lower limit of normal or more than 1.1 times the upper limit of normal);\n* 13\\. Allergic constitution (e.g. allergic to two or more drugs or to SNRIs);\n* 14\\. Prior history of seizures; or any other condition that increases the risk of seizures (e.g., stroke, severe head trauma, significant metabolic disorders, etc.);\n* 15\\. By the judgment of the investigator, presence of any clinically significant hematologic, endocrine\u002Fmetabolic, cardiovascular, respiratory, renal, hepatic, gastrointestinal, infectious, or neurological disease or the presence of an unstable or progressive chronic disease that unsuitable for entry into the study;\n* 16\\. History of malignancy, including solid tumors, hematologic malignancies, and carcinoma in situ (except completely resected and cured basal cell carcinoma of the skin, squamous cell carcinoma, and carcinoma in situ of the cervix), within 5 years prior to screening;\n* 17\\. Previous history of increased intraocular pressure or narrow-angle glaucoma;\n* 18\\. Subjects with conditions that interfere with the absorption of oral medications, such as active enteropathy, partial or complete intestinal obstruction, and chronic diarrhea, etc;\n* 19\\. Female subjects who are breastfeeding or have a positive pregnancy test during the screening period or during the study;\n* 20\\. Alcohol or drug dependence within 3 months before screening;\n* 21\\. Male or female with fertility do not agree to use an effective method of contraception during the study and for 1 month after the end of the trial to ensure that contraception is effective for the sexual partner or for themselves;\n* 22\\. Subjects who in the opinion of the investigator, have any other condition that makes them unsuitable for participation in this trial.",{"count":351,"type":22},770,[25],"The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.",[355],"Major Depressive Disorder (MDD)","2025-02-10",{"date":358,"type":33},"2025-02-14",{"date":358,"type":22},{"date":361,"type":22},"2026-09-30",{"name":39,"class":40},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":4},"100575358","phase-3-a-phase-iii-clinical-trial-evaluating-the-efficacy-and-safety-of-valsartanlevamlodipine-syh9056-tablets-in-hypertensive-patients-100575358","NCT06771245","A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan\u002FLevamlodipine (SYH9056) Tablets In Hypertensive Patients","A Multicenter, Randomized, Double-Blind Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan\u002FLevamlodipine (SYH9056) Tablets in Patients With Mild to Moderate Essential Hypertension Not Controlled After 4 Weeks of Monotherapy With Amlodipine Or Levamlodipine Alone","Inclusion Criteria:\n\n1. 18-75 (inclusive) years old;\n2. 18.0 kg\u002Fm\\^2 ≤ BMI ≤ 35.0 kg\u002Fm\\^2 and ≥ 50 kg for men and ≥ 45 kg for women at screening;\n3. Diagnosis of mild or moderate essential hypertension;\n4. Office blood pressure measurements meet any of the following at the time of screening:\n\n   ① Patients who have not used any antihypertensive medication for at least 4 weeks prior to screening, with an average office sitting blood pressure (average of 3 measurements) of 150 mmHg ≤ SBP \\\u003C 180 mmHg and DBP \\\u003C 110 mmHg;\n\n   ② Patients who have been using a stable dose of one or two component of antihypertensive medications (including single agents, two-drug combination or two-component combinations) for at least 4 weeks prior to screening, and who, in the judgment of the clinician, can be switched to levlevamlodipine maleate tablets (2.5 mg\u002Fday) or valacyclovir capsules (80 mg\u002Fday), and whose mean office sitting blood pressure meets 140 mmHg ≤ SBP \\\u003C 180 mmHg and DBP \\\u003C 110 mmHg;\n5. Prior to randomization, mean office sitting blood pressure meets 140 mmHg ≤ SBP \\\u003C 180 mmHg and DBP \\\u003C 110 mmHg;\n6. Medication adherence between 80% and 120% (including borderline values) during the introductory period.\n\nExclusion Criteria:\n\n1. Rrefractory hypertension, hypertensive emergencies, hypertensive sub-emergencies and secondary hypertension;\n2. Allergy (≥ 3 drug or food allergies) or known hypersensitivity to levamlodipine, levlevamlodipine, valsartan and related drugs (dihydropyridine calcium channel blockers, angiotensin II receptor blockers);\n3. History of malignancy within the last 5 years (with the exception of cured basal cell carcinoma of the skin, limited squamous cell carcinoma of the skin, or cervical cancer in situ), or an underlying malignancy currently under evaluation;\n4. Known or suspected symptomatic upright\u002Fpostural hypotension ;\n5. Uncontrolled diabetes mellitus;\n6. Abnormal thyroid function;\n7. Severe cardiovascular or cerebrovascular disease within 6 months prior to screening or randomization.",{"count":371,"type":22},606,[25],"SYH9056 tablets are a combination of valsartan and levamlodipine maleate. This is a multicenter, randomized, double-blind, parallel-controlled phase III study, designed to validate the efficacy and safety of SYH9056 tablets in patients with mild-to-moderate essential hypertension not controlled after 4 weeks of treatment with either levamlodipine maleate tablets or valsartan capsules, using either levamlodipine maleate tablets or valsartan capsules as a control. The study consisted of 4 phases: a screening period (2 weeks), an introduction period (4 weeks), a core treatment period (12 weeks), an extended treatment period (12 weeks), and a safety follow-up period (1 week), totaling approximately 31 weeks.",[375],"Mild-to-moderate Essential Hypertension",{"date":377,"type":33},"2025-01-13",{"date":379,"type":22},"2025-01-24",{"date":381,"type":22},"2026-10-30",{"name":39,"class":40},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100569442","phase-1-a-study-of-sys6020-injection-in-refractory-active-systemic-lupus-erythematosus-100569442","NCT06694298","A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus","A Phase I Clinical Study of BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection in Refractory Active Systemic Lupus Erythematosus Patients","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old, ≤70 years old;\n* 2\\. SLE is diagnosed according to SLICC 2012 or EULAR\u002FACR 2019 revised criteria.\n* 3\\. Patients are required to have received glucocorticoid combined with immunosuppressive agents and\u002For biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.\n* 4\\. Antinuclear antibody, anti-ds-DNA antibody and\u002For anti-Smith antibody are positive.\n* 5\\. SLEDAI-2K score≥7.\n* 6\\. BILAG2004 meets one of the following two criteria:a）BILAG grade A is defined as ≥1 organ system；b）BILAG grade B is defined as ≥2 organ systems\n* 7\\. PGA \\> 1.0;\n\nExclusion Criteria:\n\n* 1\\. Severe lupus nephritis within 8 weeks before screening;\n* 2\\. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;\n* 3\\. uncontrolled lupus crisis within 8 weeks before screening;\n* 4\\. clinically significant central nervous system diseases or pathological changes other than lupus before screening;\n* 5\\. vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;\n* 6\\. complicated with other autoimmune diseases;\n* 7\\. A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，\n* 8\\. received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;\n* 9\\. participants who will undergo major surgery or invasive intervention within 4 weeks prior to apheresis or plan for systemic or local tumor resection during the study period;\n* 10\\. participants with a known allergy, hypersensitivity, intolerance, or contraindications to SYS6020 or any component of the drugs that may be used in the study,\n* 11\\. active bacterial, fungal, or viral infection within 2 weeks before apheresis;","70 Years",{"count":270,"type":22},[77],"This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of SYS6020 injection in those participants.",[395],"Refractory Active Systemic Lupus Erythematosus","2024-11-17",{"date":398,"type":33},"2024-11-19",{"date":400,"type":22},"2024-12-26",{"date":402,"type":22},"2029-01-29",{"name":39,"class":40},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":64},"100538889","phase-3-a-clinical-study-of-docetaxel-for-injection-albumin-bound-in-patients-with-gastric-cancer-100538889","NCT06296706","A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer","A Multicenter, Randomized, Controlled Phase III Clinical Study of Docetaxel for Injection (Albumin-bound) Versus Taxotere in Gastric Cancer","Inclusion Criteria:\n\n* 1\\. Age: 18-75 years (inclusive) (Whichever is on the day of signing the informed consent form).\n* 2\\. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.\n* 3\\. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction that has progressed after receiving first-line systematic treatment (defined as platinum\u002Ffluorouracil containing dual drug chemotherapy, with or without immunotherapy).\n* 4\\. Evidence of disease progression on imaging during or after the last systemic treatment as confirmed by investigator.\n* 5\\. At least one assessable lesion according to RECIST V1.1; the area should not have received previous radiotherapy, or there should be evidence of definite progress of the lesion after completion of radiotherapy.\n* 6\\. Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.\n* 7\\. Adequate main organ function.\n* 8\\. Eastern Cooperative Oncology Group (ECOG) score 0-1.\n* 9\\. Expected lifetime≥ 3 months.\n* 10\\. Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation.\n* 11\\. Fully understand this clinical trial and willing to sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Medical history of other malignant tumors or other active malignant tumors within 5 years prior to randomization (cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included).\n* 2\\. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 14 days before randomization (Additional intervention is required within 2 weeks after intervention, such as pleural effusion, abdominal effusion, pericardial effusion, etc., excluding exfoliative cytology testing of exudate).\n* 3\\. Patients with central nervous system metastasis.\n* 4\\. Patients who have used paclitaxel\u002Fdocetaxel in the past (except patients with disease progression more than one year after neoadjuvant\u002Fadjuvant treatment with paclitaxel\u002Fdocetaxel).\n* 5\\. Patients whose previous medical history shows dMMR\u002FMSI-H (deficient Mismatch Repair or High Microsatellite Instability) and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR\u002FMSI status is unknown need to clarify the status before enrollment.\n* 6\\. History of serious cardiovascular or cerebrovascular disease, including but not limited to:\n\n  1. Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc;\n  2. Acute coronary syndrome, congestive heart failure, stroke, or other level 3 or higher cardiovascular events occurring within 6 months before randomization;\n  3. The New York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ or left ventricular ejection fraction (LVEF) of\\<50%;\n  4. Long QTc syndrome or QTc interval\\>480 milliseconds, as well as the use of any known concomitant medication that can prolong the QT interval;\n  5. Poor control of hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg during the screening period).\n* 7\\. History of gastrointestinal perforation and\u002For fistula within 6 months before randomization.\n* 8\\. Patients with active hepatitis B(Hepatitis B surface antigen (HBsAg) or HBcAb -positive, and in the active phase of hepatitis B (HBV-DNA ≥ 10\\^4 cps\u002FmL or ≥ 2000 IU\u002FmL)), hepatitis C(Hepatitis C antibody (Anti HCV) positive and tested positive for HCV RNA by PCR) or HIV.\n* 9\\. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy within 14 days before randomization. Note: Patients with viral hepatitis are allowed to receive antiviral treatment.\n* 10\\. Tuberculosis treatment history within 2 years before randomization.\n* 11\\. Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization.\n* 12\\. Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0) (excluding anemia, alopecia, fatigue, poor appetite, or other toxicities that the investigator deems to have no safety risk to patients).\n* 13\\. Received major organ surgery or invasive intervention treatment within 28 days before randomization. Or planned to undergo systematic or local tumor resection surgery during the study period.\n* 14\\. Received intravenous chemotherapy or biopolymer therapy within 28 days before randomization. Or received oral chemotherapy, immunotherapy (such as interleukin, interferon, thymosin, etc.), hormone therapy, small molecule targeted therapy, or any experimental intervention within 14 days or 5 half-lives (whichever is shorter) before randomization. Received traditional Chinese medicine or traditional Chinese patent medicines with anti-tumor indications within 14 days before randomization.\n* 15\\. Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization.\n* 16\\. Allergic to and\u002For contraindication to albumin or docetaxel.\n* 17\\. Known allergy and\u002For contraindication to glucocorticoids (including but not limited to active gastrointestinal ulcers, severe hypertension, severe hypokalemia, glaucoma, etc).\n* 18\\. Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence\u002Falcohol dependence.\n* 19\\. Patients participated in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or is in the follow-up period of an intervention study.\n* 20\\. Other situations that the investigator thinks are not suitable for patients in this study.",{"count":412,"type":22},630,[25],"This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure.",[416],"Gastric Cancer","2024-11-12",{"date":419,"type":33},"2024-11-14",{"date":421,"type":33},"2024-02-27",{"date":423,"type":22},"2027-06-01",{"name":39,"class":40},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":64},"100564699","phase-1-a-clinical-study-of-paclitaxel-cationic-liposomes-for-the-treatment-of-patients-with-advanced-solid-tumors-100564699","NCT06632574","A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of Paclitaxel Cationic Liposome for Injection in the Treatment of Patients With Advanced Solid Tumors Via Transcatheter Arterial Infusion Therapy.","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years.\n* 2\\. Histologically or cytologically diagnosed advanced solid tumors suitable for arterial infusion chemotherapy, including but not limited to the following types:\n\n  * Gastrointestinal tumors (e.g., gastric cancer, liver cancer, cholangiocarcinoma, pancreatic cancer, colorectal cancer, etc.);\n  * Gynecological tumors (e.g., ovarian cancer, endometrial cancer, etc.);\n  * Non-small cell lung cancer (NSCLC);\n  * Liver metastases.\n* 3\\. According to RECIST 1.1, at least one measurable lesion in the arterial infusion area.\n* 4\\. If life-threatening primary lesions are within the arterial infusion area, limited lesions outside the arterial infusion area at baseline are acceptable.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* 6\\. Life expectancy of at least 3 months.\n* 7\\. Adequate organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factors within 14 days):\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^2\u002FL.\n  * Platelets (PLT) ≥ 100 × 10\\^9\u002FL.\n  * Hemoglobin (Hb) ≥ 90 g\u002FL.\n  * Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for individuals with liver metastasis or liver cancer, TBIL ≤ 2 × ULN.\n  * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 × ULN; for liver metastasis or liver cancer, ALT, AST ≤ 5 × ULN.\n  * Creatinine clearance (Ccr) \\> 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n  * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; international normalized ratio (INR) ≤ 1.5 × ULN.\n* 8\\. Fertile individuals (male and female) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for at least 6 months after the last dose of study medication. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n* 9\\. Fully understand the clinical trial and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or participated in another clinical trial within 4 weeks prior to the first administration of the study drug, or within 4 weeks or 5 half-lives of the treatment drug (whichever is shorter).\n* 2\\. Known symptomatic central nervous system or meningeal metastases, or other evidence of uncontrolled central nervous system or meningeal metastases, deemed unsuitable for enrollment by the investigator.\n* 3\\. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigator).\n* 4\\. Concurrent participation in another clinical trial, unless it is observational (non-interventional) or in the follow-up period of an interventional trial.\n* 5\\. Major surgery or invasive intervention within 28 days prior to the first dose.\n* 6\\. Use of any anti-cancer herbal or traditional Chinese medicine approved by the National Medical Products Administration (NMPA) within 14 days prior to the first dose.\n* 7\\. Known severe allergic reactions to the study drug or its components\u002Fexcipients.\n* 8\\. Active bacterial, fungal, or viral infections requiring intravenous antibiotic, antifungal, or antiviral treatment prior to the first dose. Participants receiving prophylactic infection treatment with no signs of active infection may be considered for enrollment.\n* 9\\. History of immunodeficiency diseases, including positive HIV antibodies.\n* 10\\. Hepatitis B surface antigen (HBsAg) positive with HBV DNA above the measurable limit or 1000 copies\u002FmL (500 IU\u002FmL) (whichever is lower), or HCV antibody positive with HCV RNA above the measurable limit or 1000 copies\u002FmL (whichever is lower). Individuals whose levels are reduced to below the standard following antiviral treatment may be screened.\n* 11\\. Underlying medical conditions (including laboratory abnormalities), alcohol or drug abuse, or dependence that may impair the administration of study drugs or interpretation of drug toxicity and adverse events (AEs), or lead to insufficient or reduced trial compliance.\n* 12\\. Severe cardiovascular disease history, including but not limited to:\n\n  * Severe cardiac rhythm or conduction abnormalities requiring clinical intervention, such as ventricular arrhythmias or grade II-III atrioventricular block;\n  * Average QTcF \\> 450 ms from three resting 12-lead ECGs;\n  * Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months prior to the first dose;\n  * New York Heart Association (NYHA) class II or higher, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  * Any factors increasing the risk of QTc prolongation or arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relative under 40 years old, or concurrent use of QT-prolonging drugs.\n  * Uncontrolled hypertension (screening systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg).\n* 13.History of other malignancies within the past 3 years or concurrent active malignancies (localized, curable malignancies such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ prostate cancer, cervical carcinoma in situ, and in situ breast cancer may be included).\n* 14\\. Patients with ultrasound-detected limb vascular thrombosis with potentially serious consequences during screening, or participants with thromboembolic events within 3 months prior to enrollment.\n* 15\\. Individuals with coagulopathy or a history of severe bleeding, or who experienced major bleeding events such as intracranial hemorrhage, gastrointestinal bleeding, or purpura within the last 3 months.\n* 16\\. Pregnant or breastfeeding women.\n* 17\\. Any other reasons deemed by the investigator to make the individual unsuitable for participation in the clinical trial.",{"count":291,"type":22},[77],"This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors.",[436],"Advanced Solid Tumor","2024-10-07",{"date":439,"type":33},"2024-10-09",{"date":441,"type":33},"2014-03-19",{"date":443,"type":22},"2027-03-31",{"name":39,"class":40},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":64},"100554923","phase-2-a-trial-to-assess-efficacy-safety-pharmacokinetics-of-octreotide-subcutaneous-injection-in-patients-with-gastroentero-pancreatic-neuroendocrine-tumor-gep-net-100554923","NCT06505395","A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)","A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET","Inclusion Criteria:\n\n1. Male or female patient ≥18 years old;\n2. Histologically confirmed, advanced GEP-NET;\n3. At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;\n4. Previous treatment with ≤2 systemic antitumor drugs;\n5. Patients who do not have liver metastasis, with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) levels ≤ 2.5 times the upper limit of normal (ULN) ; and who do have liver metastasis, with ALT and AST ≤ 5 times ULN; Serum total bilirubin \\\u003C1.5 times the ULN; absolute neutrophil count (ANC) of ≥1.5×10\\^9\u002FL, platelet count of ≥90×10\\^9\u002FL, and hemoglobin ≥9 g\u002FdL; or International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN;\n6. ECOG performance status of 0 to 1\n7. Have expected survival of more than 3 months;\n8. Adequately understand the study and voluntarily sign the Informed Consent Form;\n9. Females patients with reproductive potential must agree to use an effective contraceptive method, for example, intrauterine devices, birth control medicine or condoms, during the study and within 3 months after study treatment discontinuation; or serum pregnancy tests negative and must be non-lactating participants; or males should agree contraception during the study and for within 3 months after study treatment discontinuation.\n\nExclusion Criteria:\n\n1. Uncontrolled or severe diarrhea with significant dehydration;\n2. Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;\n3. Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, for example mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase inhibitors (TKI); or short-acting octreotide acetate was received subcutaneously or intravenously within 1 weeks prior to the initiation of the investigational treatment;\n4. Interferon was received within 4 weeks prior to the initiation of the investigational treatment; or chemotherapy was received within 4 weeks prior to the initiation of the investigational treatment; or transarterial chemoembolization was received within 12 months prior to screening; or previously received peptide receptor radionuclide therapy (PRRT) at any time; or received radiation therapy, anti-tumor traditional Chinese medicine treatment, hepatic artery intervention embolization, liver metastasis cryoablation or radiofrequency ablation, and other systemic anti-tumor drug treatments within 4 weeks prior to the initiation of the investigational treatment; or had participated in other clinical trials within 30 days prior to screening\n5. Surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;\n6. Glycated hemoglobin (HbA1c) \\> 8.5%;\n7. Patients have symptomatic cholelithiasis or a history of symptomatic cholelithiasis at screening, but with no performed surgery treatment;\n8. Patients with active brain metastases or cancerous meningitis meet any of the following criteria: a) Patients with prior brain metastases, imaging within 4 weeks prior to the first use of investigational drug show progression of the original lesion, or new brain metastases; b) Clinical symptoms associated with central nervous system metastasis did not recovery to baseline; c) Use cortisols, radiotherapy and other drugs to control the symptoms of central nervous system metastasis within 4 weeks before the first use of the investigational drug;\n9. The adverse reactions of previous antitumor therapy have not returned to ≤ grade 1 according to CTCAE V5.0 (except that the investigators evaluate no safety risk, such as hair loss, grade 2 peripheral neuropathy or dysfunction);\n10. Any clinically significant uncontrolled neurological, gastrointestinal, renal (serum creatinine \\> 1.5 ULN), pulmonary, or other significant disease requiring exclusion assessed in the opinion of the Investigator;\n11. Patients had hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10\\^4\u002Fml or ≥2000 IU\u002Fml); known Hepatitis C antibodies positive and HCV RNA higher than the lower detection limit ; or human immunodeficiency virus (HIV) positive, treponema pallidum antibody positive;.\n12. A history of allergy to any excipient of the investigational drug or any similar chemical structure to the investigational drug;\n13. Patients had any severe or uncontrolled disease, including: 1) poor blood pressure control (systolic ≥160 mmHg or diastolic ≥100 mmHg);2) grade I or higher myocardial ischemia or myocardial infarction, symptomatic or poorly controlled arrhythmia, or congenital long QT syndrome (including QTcF ≥450ms for males, QTcF ≥470ms for females), or ≥ Grade 2 congestive heart failure \\[NYHA classification\\]; 3) serious infections that are not under control (oral or intravenous systemic anti-infection therapy is required for 2 weeks before the first use of the investigational drug, except for uncomplicated urinary tract infections and upper respiratory tract infections);4) previous or current severe bleeding (\\>30ml of bleeding within 3 months), hemoptysis (\\>5ml of fresh blood within 4 weeks), or thromboembolic events (including transient ischemic attacks) within 12 months;\n14. Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions are inappropriate for the use of the investigational product or affect interpretation of study results.",{"count":453,"type":22},90,[51],"The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.",[457],"Gastrointestinal Neuroendocrine Pancreatic Tumor","2024-08-22",{"date":460,"type":33},"2024-08-26",{"date":462,"type":33},"2024-07-30",{"date":464,"type":22},"2028-08-01",{"name":39,"class":40},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":96,"maxAge":97,"enrollmentInfo":473,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":4},"100558147","phase-2-a-study-of-cm310-in-subjects-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-100558147","NCT06547333","A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease","A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease（COPD）","Inclusion Criteria:\n\n1. Have the ability to understand the nature of the study and voluntarily sign the informed consent form.\n2. Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.\n3. The patient has been diagnosed with COPD for at least 1 year, and meet the following criteria at screening.\n\n   1. Moderate to severe COPD (post-bronchodilator FEV1\u002FFVC ratio \\\u003C0.70 and post-bronchodilator FEV1 % predicted \\>30% and ≤70%) at screening.\n   2. Modified Medical Research Council (mMRC) Dyspnea Scale grade ≥2.\n   3. Signs and symptoms (chronic productive cough) of chronic bronchitis for at least 3 months in the year up to screening and in the absence of other known causes of chronic cough.\n   4. Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)\u002Flong acting beta agonist (LABA)\u002Flong acting muscarinic antagonist (LAMA) (or LABA\u002FLAMA if ICS is contraindicated). Moderate acute exacerbation of COPD (AECOPD) aredefined as exacerbations that require either systemic corticosteroids (intramuscular, intravenous, or oral) and\u002For antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe AECOPD are defined as exacerbations requiring hospitalization or observation \\>24 hours in emergency department\u002Furgent care facility.\n   5. Background triple therapy (ICS + LABA + LAMA) for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.\n   6. Evidence of Type 2 inflammation: Patients with blood eosinophils ≥0.3×10\\^9 \u002FL at Visit 1.\n4. Body mass index (BMI) ≥16 kg\u002Fm\\^2\n5. Participants (including partners) have no plans to have children and voluntarily used highly effective contraception within 3 months after the last dose of study drug from the date of signing the informed consent.\n\nExclusion Criteria:\n\n1. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）.\n2. Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator.\n3. Subjects with other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), eosinophilic esophagitis or other disease(e.g., active parasitic infection (helminthes) which has not been treated with, or has failed to respond to standard of care therapy.)\n4. Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the Investigator or with evidence of right cardiac failure.\n5. Treatment with oxygen of more than 15 hours per day or hypercapnia requiring BiPAP, in the opinion of the investigator,\n6. Acute moderate or severe exacerbation of COPD (AECOPD, as defined above in Inclusion Criteria) from 4 weeks before signing consent to the time of randomization.\n7. Acute infection requiring systemic anti-infective therapy from 4 weeks before signing consent to the time of randomization.\n8. History of or planned pneumonectomy or lung volume reduction surgery for COPD. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who start rehabilitation \\\u003C4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program could be included).\n9. Diagnosis of α-1 anti-trypsin deficiency.\n10. Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days before consent or any other biologic therapy (including other anti-IL4R mAb, anti-IL5 mAb, anti-IL5R mAb, anti TSLP mAb, anti-IL33 mAb, anti-ST2 mAb) within 3 months or 5 half-lives before signing consent, whichever is longer.\n11. Prior autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc) or inflammatory treatment with biologic agents\u002Fsystemic immunosuppressive agents (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) within 8 weeks or 5 half-life periods (whichever is longer) prior to consent.\n12. Receipt of immune globulin or blood products within 30 days before consent.\n13. Patients who are treated with systemic corticosteroids (topical, ophthalmic, or intranasal corticosteroids are excluded) from 4 weeks before signing the informed consent to the date of randomization. Except for short-term (≤7 days) use of systemic glucocorticoids to prevent or treat non-autoimmune allergic diseases.\n14. Use of macrolide antibiotics (eg, azithromycin) unless stable \\>3 months prior to screening visit and maintain the treatment during the planned study period.\n15. Receipt of live or attenuated vaccine within 3 months before consent signing or during the planned study period\n16. Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment.\n17. History of malignancy: subjects with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are eligible to enter the study if they have completed curative treatment for at least 12 months before signing the informed consent. Subjects with other malignancies are allowed to enter the study if they have completed curative treatment for at least 5 years before signing the informed consent.\n18. The presence of any severe and\u002For uncontrolled medical condition that in the judgment of the investigator would affect the evaluation of the drug, including but not limited to: severe neurological disease (eg, epilepsy, dementia, etc), history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation（male \\>450 msec, female \\>470 msec）, or persistent arrhythmia.\n19. Positive screening serologic test for HIV or treponema pallidum during screening.\n20. Chronic hepatitis B virus or hepatitis C virus infection meets the criteria:\n\n    * HBsAg positive;\n    * If HBsAg is negative and HBcAb is positive, HBV DNA should be tested (test result ≥1000 IU\u002FmL).\n    * If the test is positive for HCV antibody, HCV RNA is added (with a result above the upper limit of the normal range at the participating center).\n21. Subjects with abnormal liver and kidney function, such as aspartate aminotransferase or alanine aminotransferase \\>3 times the upper limit of normal, or serum creatinine\\>1.5 times the upper limit of normal.\n22. Acute myocardial infarction \\\u003C6 months from screening visit.\n23. Stroke \\\u003C 6 months from screening visit.\n24. Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (ie, selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) and stable appropriate level of anticoagulation for at least 6 months may be considered for inclusion.\n25. Unstable ischemic heart disease or other relevant cardiovascular disorder such as pulmonary embolism, deep vein thrombosis within ≤6 months from screening visit that in investigator's judgment may put the patient at risk or negatively affect the study outcome.\n26. Major surgery within 8 weeks prior to consent or planned surgery requiring general anesthesia or hospitalization for \\> 1 day during the study period.\n27. Fertile women with positive pregnancy test results during screening; Pregnant or lactating women.\n28. Allergy or intolerance to components of CM310 injection or placebo or history of severe drug allergy or anaphylactic shock.\n29. Exposure to another investigative drug (small molecules as well as monoclonal antibodies) within a time period prior to consent signing that is less than 6 months. The minimum interval since exposure to any other (non-antibody) investigative study medication is 30 days prior to signing consent.\n30. History of drug abuse within 5 years before signing informed consent.\n31. Background medication treatment compliance \\\u003C 70%\n32. Investigators and associated site personnel or others directly involved in the implementation of the protocol.\n33. The investigator considers that there are any conditions that may prevent the subject from completing the study or present a significant risk to the subject or other factors that may reduce the likelihood of enrolment.",{"count":474,"type":22},884,[51,25],"This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ\u002FⅢ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe Chronic Obstructive Pulmonary Disease（COPD）.\n\nThe study has two parts. Each part consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 8-week safety follow-up period.",[103],"2024-08-11",{"date":480,"type":33},"2024-08-14",{"date":482,"type":22},"2024-09-13",{"date":484,"type":22},"2032-10-31",{"name":39,"class":40},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100556457","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-the-combination-of-glumetinib-and-docetaxelalbumin-boundverse-docetaxel-for-the-treatment-of-met-overexpressed-non-small-cell-lung-cancer-100556457","NCT06525350","A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer","A Randomized, Controlled, Open-label Phase Ⅱ Study to Evaluate the Safety, Tolerability, and Efficacy of the Combination of Glumetinib Tablets and Docetaxel for Injection（Albumin Bound）Verse Docetaxel in the Treatment of Locally Advanced\u002FRecurrent or Distant Metastasized Non-small Cell Lung Cancer Patients With MET Overexpression","Inclusion Criteria:\n\n* 1\\. Able to understand and voluntarily sign a written informed consent form;\n* 2\\. Age ≥ 18 years old, gender unlimited;\n* 3\\. Unresectable locally advanced or metastatic non-small cell lung cancer (IIIB, IIIC, or IV according to the 8th edition TNM staging standards of IASLC) confirmed by histology or cytology;\n* 4\\. Participants must provide tumor tissue samples that meet the testing requirements of the central laboratory, or agree to accept the tumor tissue biopsy, used for central laboratory testing of MET expression and amplification, and the development of MET associated diagnostic reagents;\n* 5\\. Confirmation of MET overexpression in tumor tissue specimens through the central laboratory designated by the sponsor;\n* 6\\. Driver genes alterations must be negative (including EGFR mutations, ALK fusion, ROS1 rearrangement fusion, BRAF V600 mutation, NTRK fusion, MET 14 exon skipping mutation, RET rearrangement, HER2 Mutations, KRAS activation mutations, etc.);\n* 7\\. Previously received immunotherapy with PD-1\u002FPD-L1 monoclonal antibody and platinum-containing chemotherapy (combination therapy or sequential therapy);\n* 8\\. At least one measurable lesion exists at the baseline that meets the definition of RECIST 1.1;\n* 9\\. ECOG performance score of 0 or 1;\n* 10.Expected survival time ≥ 3 months;\n* 11.Adequate organs and bone marrow function within 7 days prior to initial administration.\n\nExclusion Criteria:\n\n* 1\\. Previously received MET-targeted drug therapy;\n* 2\\. Previous treatments included docetaxel;\n* 3\\. Existence of meningeal metastasis, spinal cord compression, or active and untreated brain metastasis;\n* 4\\. Imaging evidence of clear tumor cavity, capsule or large vessel invasion, and tumor adjacent to important vascular structures , Which has been determined by researchers that there is a risk of fatal bleeding;\n* 5\\. Suffering from central squamous cell lung cancer with cavities or hemoptysis (\\>50 mL\u002Fd);\n* 6\\. Within 14 days before the first administration, there is an uncontrollable accumulation of serous cavity effusion that requires frequent drainage or medical intervention;\n* 7\\. Adverse reactions from previous anti-tumor treatments (including radiotherapy) have not yet recovered to ≤ level 1(according to CTCAE 5.0) or baseline level (excluding toxicity assessed by researchers as having no safety risk such as hair loss, fatigue, pigmentation, etc);\n* 8\\. Suffering from other malignant tumors within 5 years prior to the first administration. (Except already treated local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ);\n* 9\\. Received any systemic anti-tumor therapy within 28 days or 5 half-lives prior to initial administration (whichever is shorter) treatment, including chemotherapy, targeted therapy, biological therapy, immunotherapy, immunomodulatory drugs (including thymosin, interleukin-2, interferon, tumor necrosis factor, etc.), or other research drugs;\n* 10\\. Received radiation therapy involving the chest cavity within 28 days prior to the first administration, o received radiation therapy not involving the chest cavity within 14 days prior to the first administration;\n* 11\\. Received Chinese herbal medicine or traditional Chinese patent medicines for tumor control within 14 days before the first administration;\n* 12\\. Received potent cytochrome P450 3A4 (CYP3A4) inhibitor or induction within 14 days prior to initial administration or Patients who cannot suspend the use of CYP3A4 potent inhibitors during the study;\n* 13\\. Having undergone major surgery (excluding biopsy) or severe traumatic damage within 28 days before the first administration, or expected to undergo major surgery during the study;\n* 14\\. A history of gastrointestinal perforation and\u002For fistula, severe gastrointestinal ulcers or surgery, gastrointestinal dysfunction, or other diseases that may affect the absorption of experimental drugs within 6 months prior to the first administration;\n* 15\\. Existence of ≥ grade 2 edema and lymphedema that cannot be relieved through clinical intervention;\n* 16\\. Received live vaccine or attenuated live vaccine within 28 days prior to initial administration or planned to receive live vaccine or attenuated live vaccine during the study period;\n* 17\\. Within 14 days prior to the first administration, there is a need of systemic antibiotics, antifungal or antiviral for the treatment of severe chronic or active infections (including tuberculosis infections, etc.);\n* 18\\. Severe or uncontrollable cardiovascular diseases that require treatment 6 months before screening;\n* 19\\. Interstitial lung disease (ILD) or drug-induced interstitial pneumonia, non-infectious pneumonia, including radiation pneumonia, pulmonary fibrosis, or acute lung disease that require steroid treatment;\n* 20\\. History of immunodeficiency, including human immunodeficiency virus (HIV) infection or known acquired immunodeficiency history of AIDS, or other acquired or congenital immunodeficiency diseases, or organ transplantation history;\n* 21\\. Active hepatitis B, active hepatitis C, active syphilis or active Tuberculosis;\n* 22\\. History of autoimmune diseases;\n* 23\\. Previous serious illnesses;\n* 24.Known to have allergies or hypersensitivity reactions to any investigational drug or any investigational drug excipients, or other serious allergy history;\n* 25\\. Breastfeeding or pregnant women; The blood pregnancy test conducted by women with fertility within 7 days prior to enrollment in the trial is positive;\n* 26\\. Any male and female patients with fertility who refuse to use highly effective contraceptive methods during the entire trial period and 6 months after the last administration.",{"count":494,"type":22},256,[51],"This study consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (randomized controlled study). The main purpose of Stage 1 is to preliminarily evaluate the safety and tolerability of the combination of glumetinib Tablets and Docetaxel for Injection（Albumin Bound）(HB1801) in the treatment of MET-overexpressed non-small cell lung cancer (NSCLC); The main purpose of Stage 2 is to evaluate the efficacy of the combination of glumetinib tablets and HB1801 compared to glumetinib tablets monotherapy or docetaxel in the treatment of MET-expressed NSCLC.",[498],"Locally Advanced\u002FRecurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression","2024-07-26",{"date":501,"type":33},"2024-07-29",{"date":503,"type":22},"2024-07",{"date":505,"type":22},"2028-06-25",{"name":39,"class":40},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":4},"100553965","phase-3-a-study-of-docetaxel-for-injection-albumin-bound-in-patients-with-advanced-pancreatic-cancer-100553965","NCT06492941","A Study of Docetaxel for Injection (Albumin Bound) in Patients With Advanced Pancreatic Cancer","A Randomized, Double-blind, Multicenter Phase Ⅲ Clinical Study of Docetaxel for Injection (Albumin Bound) Combined With Best Supportive Care Versus Placebo Plus Best Supportive Care in Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* 1\\. Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.\n* 2\\. Histologically or cytologically confirmed diagnosis of pancreatic cancer (including adenosquamous carcinoma).\n* 3\\. Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy).\n* 4\\. At least one evaluable lesion according to RECIST 1.1 .\n* 5\\. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* 6\\. Patients with fine organ function (no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections):\n\n  1. ANC≥1.5×10\\^9\u002FL；\n  2. Hb≥90 g\u002FL；\n  3. PLT≥100×10\\^9\u002FL；\n  4. ALB≥30 g\u002FL；\n  5. CR≤1.5× ULN and creatinine clearance≥40 mL\u002Fmin（Cockcroft-Gault）；\n  6. Total bilirubin≤1.5 × ULN(≤ 2 × ULN for patients with obstructive jaundice, ≤3 × ULN for patients with Gilbert's syndrome)；\n  7. ALT and AST ≤ 3× ULN (≤5× ULN for patients with liver metastasis)；\n  8. ALP≤2.5× ULN；\n  9. PT、INR≤1.5×ULN。\n* 7\\. The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose, women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug.\n\nExclusion Criteria:\n\n* 1\\. Patients who have a history of severe allergy to any excipients of the investigational drug or taxanes，or known allergy and\u002For contraindications to glucocorticoids (including but not limited to active digestive tract ulcers, severe hypertension, severe hypokalemia, glaucoma, etc.).\n* 2\\. Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment.\n* 3\\. Previous history of inflammatory bowel disease, chronic diarrhea, and gastrointestinal bleeding.\n* 4\\. Patients who had a history of other active malignant tumors within 2 years before the first dose of the investigational drug, except for the study disease pancreatic cancer and curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised).\n* 5\\. Patients with active hepatitis B (HBsAg and\u002For HBcAb positive but HBV DNA \\\u003C 2000 IU\u002FmL can be included), active hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive.\n* 6\\. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for alopecia, hyperpigmentation, or other toxicity without safety risk judged by the investigator).\n* 7\\. Patients with a history of severe cardiovascular disease, including but not limited to:：\n\n  1. Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug；\n  2. History of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug;；\n  3. Heart failure with New York Heart Association (NYHA) Classification of Class Ш and above；\n  4. Long QTc syndrome or QTc \\> 480 msec；\n  5. Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg at screening period).\n* 8\\. Patients with uncontrolled serous cavity effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, abdominal effusion, pericardial effusion, etc., additional intervention was needed within 2 weeks after intervention, excluding exfoliative cytology testing of the exudate) within 2 weeks before the first dose of the investigational drug.\n* 9\\. Patients with severe or active infections (including tuberculous infections) that require systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of the investigational drug, antiviral therapy for patients with viral hepatitis is permitted.\n* 10\\. Received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) and any clinical trial intervention within 4 weeks prior to the first use of the investigational drug or within 5 half-lives of the most recently used anti-tumor drug (whichever is shorter), and used traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications within 14 days before the first use of the investigational drug.\n* 11\\. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.\n* 12\\. Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug and had not recovered sufficiently, or who need to undergo major surgery during the study.\n* 13\\. Pregnant or nursing women.\n* 14\\. Patients who is participating in another clinical study simultaneously unless it is an observational (non-interventional) clinical study or within the follow-up period of an interventional study.\n* 15\\. Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which will increase the safety risk, interfere with the interpretation of study results or affect the study compliance.",{"count":515,"type":22},142,[25],"This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin Bound) in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received gemcitabine-containing and fluorouracil-containing regimens.",[519],"Advanced Pancreatic Cancer","2024-07-02",{"date":522,"type":33},"2024-07-09",{"date":524,"type":22},"2024-08-12",{"date":526,"type":22},"2026-11-21",{"name":39,"class":40},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":64},"100540149","phase-3-dp303c-versus-trastuzumab-emtansine-in-in-patients-with-her2-positive-advanced-breast-cancer-100540149","NCT06313086","DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer","A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer","Inclusion Criteria:\n\n* 1．Voluntarily agree to participate in the study and sign the informed consent;\n* 2．Age≥18 years old;\n* 3．Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology;\n* 4．Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);\n* 5．Previously received regimens containing trastuzumab and taxanes at the advanced stage of disease.\n* 6．The Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;\n* 7．Patients with adequate organ functions;\n* 8．Life expectancy ≥ 3 months;\n* 9．Female and male patients of childbearing age must agree to take adequate contraceptive measures during the entire study period.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received tubulin inhibitor-loaded HER2 ADC therapy\n* 2\\. History of any other malignant tumors within three years\n* 3\\. With uncontrollable serous effusion within 14 days before randomization, which required frequent drainage or medical intervention.\n* 4\\. Known contraindication to the study drugs;\n* 5\\. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 or baseline (refer to NCI CTCAE 5.0);\n* 6\\. NCI-CTCAE 5.0 ≥Grade 2 peripheral nephropathy occurred during previous systemic anti-tumor treatment;\n* 7\\. Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received endocrine therapy, cytotoxic drug chemotherapy and small molecular targeted drug therapy within 2 weeks before randomization, or received traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before randomization .\n* 8\\. Major organ surgery (excluding needle biopsy) within 28 days before randomization;\n* 9\\. Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.\n* 10.The cumulative amount of previous exposure to anthracyclines has reached the dosage;\n* 11.History of LVEF \\\u003C 40%, symptomatic congestive heart failure (CHF),\n* 12.Serious or uncontrolled cardiovascular disease;\n* 13.History of (non-infectious) interstitial lung disease\u002Fpneumonitis requiring steroid hormone therapy;\n* 14.Patients who currently have ocular diseases that require medication or surgical intervention; or unwilling to stop wearing contact lenses during the study.\n* 15.Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization;\n* 16.There are other circumstances that may interfere with the subject's participation in the study procedures or do not meet the subject's maximum benefit from participating in the study or affect the study results.",{"count":536,"type":22},442,[25],"A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer",[232],"2024-05-08",{"date":542,"type":33},"2024-05-10",{"date":544,"type":33},"2024-03-13",{"date":546,"type":22},"2028-02",{"name":39,"class":40},""]