[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Yizhong Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100573940","phase-3-polymeric-micellar-paclitaxel-for-metastatic-pancreatic-cancer-100573940",false,"NCT06752811","Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer","A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Clinical Trial for Evaluating the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Plus Gemcitabine and Paclitaxel for Injection (Albumin-bound) Plus Gemcitabine for Injection in the First-line Treatment of Metastatic Pancreatic Cancer","pompom","Inclusion Criteria:\n\n* 1\\) Men or women aged 18 to 75 years old (including the critical value).\n* 2）Metastatic pancreatic cancer confirmed by histology or cytology.\n* 3）Patients who have not previously received any systemic therapy (including chemotherapy, targeted, and immunotherapy), radiotherapy, surgery, or investigational drugs for the treatment of metastatic pancreatic cancer; Patients who have previously received neoadjuvant or adjuvant chemotherapy could be enrolled if the interval between last treatment and recurrence and metastasis is more than 6 months.\n* 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* 5）Survival is expected to be at least 3 months.\n* 6）At least one metastatic lesion (non-lymph node lesions with a major diameter of ≥ 10 mm on CT or MRI and lymph node lesions with a minor diameter of ≥ 15 mm) that is measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and is amenable to accurate repeated measurement. Suspected metastatic lesions (non-regional lymph nodes) that do not meet the above measurable standards and the primary lesions are measurable, the metastatic lesions are confirmed pathologically, can also be included.\n* 7）The major organs function well: a) white blood cell count ≥ 3.0 × 10\\^9\u002FL. b) Hemoglobin ≥ 90.0 g\u002FL. c) Absolute neutrophil count ≥1.5 × 10\\^9\u002FL. d) Platelet count ≥100 × 10\\^9\u002FL. e) Total bilirubin ≤1.5 × upper limit of normal range (ULN). f) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; For patients with liver metastasis, ALT, AST and ALP ≤ 5 × ULN; ALP ≤ 10 × ULN in patients with bone metastases.\n\n  g) Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance estimated by Cockcroft Gault formula ≥50 ml\u002Fmin.\n\n  h) International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n* 8）Women of childbearing age are required to have a negative pregnancy test at the screening period and to use a highly effective contraceptive method for 6 months from the screening period to the last dose. Male participants whose partners are women of childbearing age are required to use a highly effective contraceptive method for 6 months after the first dose of a trial product until the last dose.\n* 9）Patients are able to understand the steps of this trial, are willing to follow the clinical trial protocol to complete the trial, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* 1）Patients who are allergic to the investigational drugs and their analogues, or excipients.\n* 2）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.\n* 3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.\n* 4）Patients with tumor liver metastasis exceeding 1\u002F2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA\\>500 IU\u002Fml or research center detection limit \\[only when the research center limit is above 500 IU\u002Fml\\]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA \\> research center detection limit).\n* 5） Human Immunodeficiency Virus test is positive.\n* 6）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.\n* 7） Patients who have a history of drug or alcohol abuse prior to screening.\n* 8）Patients with severe organic lesions or major organ failure, such as decompensated heart and lung failure, leading to intolerance to chemotherapy.\n* 9） Patients with bleeding tendency (e.g., presence of active ulcer lesions in stomach, melena and\u002For hematemesis within 3 months, hemoptysis).\n* 10） History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. NYHA (New York Heart Association) class III or IV heart disease;\n  2. Uncontrollable hypertension (i.e. systolic blood pressure ≥ 160 mmHg, and\u002For diastolic blood pressure ≥ 100 mmHg)；\n  3. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;\n  4. QT interval prolongation corrected for heart rate (corrected for QTc interval using Fridericia formula, males\\>450ms, females\\>470ms);\n  5. Individuals with significant abnormalities in electrocardiogram with clinical significance;\n  6. Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events occurring within 6 months prior to the first administration;\n* 11） Clinically uncontrollable third space effusion, such as pleural effusion, pericardial effusion, peritoneal effusion, etc. If there were no clinical symptoms, small amounts of pleural effusion or ascites that did not require clinical intervention could be enrolled only after strict control.\n* 12） serious psychiatric disorders in the past or current.\n* 13）Organ transplant recipients.\n* 14）Use of the prohibited medications specified in the protocol is planned during the screening and treatment periods.\n* 15） Patients with a history of psychotropic drug abuse and unable to quit.\n* 16）Before screening, participants have participated in another clinical trial with an investigational nonbiologic agent (administered within the past 30 days or five half-lives, whichever was longer) or an investigational biologic agent (monoclonal or polyclonal antibody) (within the past 4 months or five half-lives, whichever is longer).\n* 17）Pregnant or lactating female patients.\n* 18）Participants who are judged by the investigator to be unable to follow trial procedures or who are judged by the investigator to be unfit to participate in the trial for other reasons.","ALL","18 Years","75 Years",{"count":21,"type":22},416,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.",[28],"Pancreatic Cancer Metastatic",[30],"paclitaxel polymeric micelles for injection","RECRUITING","2026-02-09",{"date":34,"type":35},"2026-02-10","ACTUAL",{"date":37,"type":35},"2025-02-05",{"date":39,"type":22},"2027-12-31",{"name":41,"class":42},"Shanghai Yizhong Pharmaceutical Co., Ltd.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100527114","phase-3-efficacy-and-safety-of-paclitaxel-polymeric-micelles-for-injection-in-the-treatment-of-metastatic-breast-cancer-100527114","NCT06143553","Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer","A Randomized, Controlled Phase Ⅲ Study of Paclitaxel Polymeric Micelles for Injection Versus Physician's Choice(TPC) in Human Epidermal Growth Factor Receptor 2-negative (HER2-) Metastatic Breast Cancer (MBC) Subjects Who Have Failed at Least Two Previous Chemotherapy Regimens.","Inclusion Criteria:\n\n* Eligible subjects must meet all the following criteria:\n\n  1. Male or female 18 years and older;\n  2. Understand the purpose, benefits and risks of this clinical trial, voluntarily participate in and sign the written informed consent;\n  3. The Eastern Cooperative Oncology Group (ECOG)performance status is 0 or 1;\n  4. Histologically or cytologically confirmed (local laboratory) HER2-metastatic breast cancer from recently acquired or newly acquired tumor biopsies from locally-relapsed or metastatic sites (HER2- is defined as a standard immunohistochemical (IHC) test result of 0 or 1+; Or the IHC test result is 2+ and the ISH test result is negative including FISH\u002FCISH\u002FSISH)；\n  5. Archival slides or newly obtained biopsy slides from metastatic or recurrent sites are available (Note: Bone lesion biopsy is not accepted);\n  6. Subjects who are refractory or relapsed after ≥2 and ≤4 prior systemic chemotherapy regimens or antibody-drug conjugates (ADC) for MBC are eligible(Subjects were eligible for inclusion if their previous chemotherapy regimen included taxanes or not; Subjects using taxanes for adjuvant or neoadjuvant chemotherapy more than 6 months after the treatment, and Subjects using taxanes for advanced-stage treatment more than 3 months after the treatment, with recurrence or metastasis are eligible.) Adjuvant or neoadjuvant chemotherapy for early-stage disease can be considered as one of the required prior chemotherapy regimens if unresectable, locally advanced, or metastatic disease develops within 12 months after completion of the regimen.( Note: Therapies for bone metastases (e.g., bisphosphonates, denosumab, etc.) are not considered prior systemic chemotherapy for advanced disease.)；\n  7. Subjects are eligible to receive one the chemotherapy regimens in the TPC group；\n  8. According to RECIST 1.1, subjects with measurable lesions on contrast-enhanced CT or MRI (≥10mm in the major dimension on CT or MRI scan, and ≥15mm in the minor dimension of lymph nodes); Subjects with unmeasurable skeletal lesions only are not accepted；\n  9. Functions of major organs such as heart, lung, liver and kidney are basically normal；\n  10. Blood routine examination meets the following criteria (No blood transfusions, blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors were used within 7 days before the blood routine test)：\n\n      1. : White blood cell count ≥3.0x109\u002FL; Neutrophil count ≥1.5x109\u002FL；\n      2. : Platelet count ≥100×109\u002FL;\n      3. ：Hemoglobin≥90g\u002FL;\n      4. : If subjects receive blood component transfusion (red blood cells, platelets, etc.) during the screening period, blood routine test should be performed again at an interval of 1 week to meet the above criteria before continuing screening.\n  11. Blood biochemical examination must meet the following criteria:\n\n      1. : Total bilirubin ≤1.5 times the upper limit of normal (ULN);\n      2. : Aspartate Transaminase（AST）, Alanine Aminotransferase（ALT）, or Alkaline phosphatase（ALP）≤2.5 times ULN (ALT, AST, or ALP≤ 5×ULN for subjects with liver metastases, and ALP≤10×ULN for subjects with bone metastases);\n      3. : Creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 ml\u002Fmin.\n  12. Subjects have no symptoms of cardiac dysfunction (NYHA class ≤II) at baseline and no significant or clinically insignificant ECG abnormalities;\n  13. Subjects have good compliance and voluntarily comply with the clinical trial protocol during the study, followed up by the investigators;\n  14. All women of childbearing age, men of childbearing potential, or their spouses who have no plans to have children or donate sperm during the entire trial period and up to 6 months after the last dose of medication, or who voluntarily used effective contraception; Women of childbearing age who have a negative blood\u002Furine pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n* Subjects meet the following criteria are not eligible for inclusion:\n\n  1. Known allergy or intolerance to either study treatment or any excipients；\n  2. Previous use of antibody-drug conjugate (ADC) with anti-microtubule inhibitor as payload drug are not eligible;\n  3. Primary brain tumors or central nervous system metastases (including leptomeningeal metastases), except for single brain metastases strictly controlled asymptomatic subjects; Subjects with intracranial hypertension or neuropsychiatric symptoms after treatment of central nervous system tumors;\n  4. Subjects with acute or chronic infections that have not been eliminated, or subjects with other serious diseases at the same time;\n  5. Subjects have other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n  6. Subjects with a known history of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory disease within 6 months before enrollment;\n  7. Subjects with active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), clinically significant gastrointestinal (GI) bleeding, intestinal obstruction, or GI perforation within 6 months before enrollment;\n  8. Subjects with active hepatitis, or liver metastasis is more than 3\u002F4 of the whole liver;\n  9. Subjects with third-space effusions (e.g., moderate-to-massive pleural effusion, moderate-to-massive pericardial effusion, ascites) that cannot be controlled by drainage or other means; Subjects with a small amount of pleural effusion without clinical symptoms and no need for clinical intervention should be strictly controlled before enrollment;\n  10. Subjects with mental illness or disorder, poor compliance, or inability to cooperate, or describe treatment responses;\n  11. Subjects who cannot tolerate chemotherapy due to severe organic disease or major organ failure, such as decompensated heart and lung failure;\n  12. Subjects with bleeding disorders;\n  13. Subjects with organ transplant;\n  14. Subjects with bad drug addicts, long-term alcoholics, infectious diseases such as AIDS;\n  15. Subjects on long-term use of adrenocortical hormones or immunosuppressants;\n  16. Subjects who received vaccines (including live and live attenuated vaccines) such as measles, mumps, rubella, varicella, yellow fever, rabies, Bacille Calmette-Guérin vaccine（BCG ）and typhoid (oral) vaccines within 4 weeks before enrollment, or are scheduled to receive vaccines during the study period; Subjects who received all types of COVID-19 vaccines within two weeks before enrollment;\n  17. Subjects who received antineoplastic drugs (including but not limited to chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy, surgery (except diagnostic biopsy), etc.) within 2 weeks before enrollment or who still have grade ≥2 toxicity from previous antineoplastic therapy (except alopecia and grade ≤2 neurotoxicity caused by platinum) at enrollment;\n  18. Subjects with active hepatitis B or C (previous history of hepatitis B infection, with or without drug control, HBV DNA≥1×104 copies or ≥2000 IU\u002FmL; Hepatitis C infection, HCV RNA≥15IU\u002FmL); Or HIV antibody positive (testing is not necessary if there is no clinical evidence to suggest possible HIV infection);\n  19. Subjects are considered not able to complete the trial or otherwise unfit to participate in the study by the investigators.",{"count":51,"type":22},168,[25],"This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens.\n\nTreatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physician's Choice (TPC) group by the proportion of 1:1. Randomization is stratified according to three factors: number of lines of previous treatment for metastatic disease (2 or 3\u002F4 lines), receptor status (triple-negative, non-triple-negative), and visceral metastasis (yes\u002Fno).\n\nProgression-free survival (PFS) is the main efficacy indicator in this study. Treatment Group: Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.\n\nControl Group: Physician's Choice Group, subjects are given Eribulin Mesilate injection; or capecitabine tablets; or gemcitabine hydrochloride for injection; or vinorelbine tartrate injection; or paclitaxel (albumin-bound). Three or four weeks constitutes one cycle of treatment.\n\nIf subject does not develop disease progression after 6 cycles of dosing, the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.\n\nSuperiority design is used in this study, progression-free survival (PFS) is the main efficacy indicator. Assuming α = 0.0249(unilateral, adjusted test level), power=80%, the median PFS of the treatment group is 6.0 months, the median PFS of the control group is 3.7 months, the enrollment period is 12 months, and the study period is 24 months. Using PASS (version 11.0) for calculation, a total of 152 subjects (76 in each group) are required to meet the statistical significance between the treatment group and the control group. In consideration of case expulsion, enlarged by 10%, a total of 168 subjects (84 in each group) are required.",[55],"Metastatic Breast Cancer (MBC)",[57,55,58],"Paclitaxel Polymeric Micelles for Injection","human epidermal growth factor receptor 2-negative (HER2-)","2024-11-26",{"date":61,"type":35},"2024-11-29",{"date":63,"type":35},"2023-09-25",{"date":65,"type":22},"2025-12",{"name":41,"class":42},3,""]