[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Biostar Pharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,71,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100580774","phase-2-utidelone-capsule-combined-with-fluoropyrimidine--and-platinum-containing-therapy-in-first-line-treatment-of-patients-with-gastric-or-gastroesophageal-junction-adenocarcinoma-100580774",false,"NCT06841679","Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma","A Multi-national, Open-label, Randomized Phase II\u002FIII Clinical Study of Utidelone Capsule (UTD2) Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participants must meet the following criteria to be eligible for the study:\n\n  1. Sign the informed consent form (ICF) to participate with accordance with GCP, ICH and local regulations and are willing to adhere to the study protocol.\n  2. Male and female aged ≥ 18 years as of the date of baseline visit.\n  3. Participant must have unresectable locally advanced or metastatic GC or GEJ and have histologically\u002Fpathologic confirmed predominant adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging.\n  4. Phase II Study: No restriction on PD-L1 expression. Phase III study: Participant must have tumor with PD-L1 Combined Positive Score (CPS) \\\u003C 1 by immunohistochemical (IHC). IHC results from site are acceptable.\n  5. Participant must have at least one measurable lesion per RECIST 1.1 criteria.\n  6. Participant must not receive previously systemic treatment in the advanced setting. Previously neoadjuvant\u002Fadjuvant therapy for GC or GEJ with no progression after 6 months from completion is allowed. Palliative radiotherapy is allowed.\n  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n  8. Participant with adequate hematological function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site) and who have not received recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products\u002Ferythropoietin (EPO) within 14 days before enrollment.\n\n     * White blood cell count (WBC) ≥ 3.0 × 109\u002FL;\n     * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n     * Platelet count (PLT) ≥ 100 × 109\u002FL;\n     * Hemoglobin (Hb) ≥ 9.0 g\u002FdL.\n  9. Participant with adequate liver and renal function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site).\n\n     * Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);\n     * Alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);\n     * Aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);\n     * Creatinine clearance (Ccr) ≥ 50 mL\u002Fmin.\n  10. Female Participants of childbearing potential must agree to use highly effective contraceptive methods during the study and within 6 months after the last dose of the investigational product. Female patients of childbearing potential shall have a negative serum or urine pregnancy test at screening and be willing to have additional pregnancy tests as required throughout the study. Women of non-childbearing potential (WONCBP) must not donate ova from signing informed consent until at least 6 months after the last administration of the investigational product. Please refer to Appendix 1. Males must be surgically sterile (\\> 6 months since vasectomy with confirmation of no viable sperm), or if engaged in sexual relations (intercourse) with a WOCBP, either his partner must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Screening until 6 months after last IMP administration; or Males with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle; or Males must not donate sperm from the first dose of IMP until at least 90 days after the last dose of IMP.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study for any of the following reasons:\n\n  1. Known HER2-positive tumor (HER2-positive is defined as having an IHC score of 3 +, or IHC2 + and positive HER2 expression by in situ hybridization (ISH) (refer to ASCO\u002FCAP guidelines 2020).\n  2. Participants with other malignancies over the past 5 years, except for cured skin basal cell carcinoma, in-situ carcinoma of the cervix, or papillary thyroid cancer.\n  3. Participants who have received radiotherapy or other investigational drug or investigational therapy within 4 weeks prior to the first dose of investigational product.\n  4. Participants who have undergone major surgery (except biopsy) had significant trauma within 4 weeks prior to the first dose of investigational product or required elective surgery during the study.\n  5. Participants with pre-existing \\> Grade 1 peripheral sensory neuropathy (NCI CTCAE 5.0).\n  6. Participants with known hypersensitivity to any components of the investigational product.\n  7. Participants who are pregnant (positive pregnancy test) or lactating.\n  8. Adverse events due to previous anti-tumor therapy have not recovered to CTCAE v5.0 Grade ≤ 1 (except for alopecia and other toxicities judged by the investigator to have no safety risk).\n  9. Participants with esophageal obstruction, pyloric obstruction, intestinal obstruction, or inability to eat on their own after gastrointestinal resection, or other factors that cause difficulty swallowing and inability to take oral drugs.\n  10. Participants with symptomatic\u002Funcontrollable central nervous system metastases or meningeal metastases, including but not limited to those with confirmed metastatic disease progression by examination within 2 months after radiotherapy or other local treatment, or who are ineligible for enrollment as judged by the investigator.\n  11. Participants with uncontrollable bone metastases, i.e., existing or recent fracture risk, recent need for surgery or local radiotherapy, or other crisis conditions as judged by the investigator.\n  12. Participants with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once monthly or more frequently).\n  13. Participants with an active infection and who currently require systematic anti-infective therapy.\n  14. Participants with known history of human immunodeficiency virus (HIV) infection with an exception that if they have not had an opportunistic infection within the past 12 months, they are eligible.\n  15. Participants who are HBV DNA positive or HCV RNA positive (who are HBsAg negative, or HCV antibody negative could be eligible without testing for HBV DNA or HCV RNA).\n  16. Participants with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n      * Patients with severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention or second\u002Fthird-degree atrioventricular block; patients with a mean corrected QT interval (QTcF) \\> 470 msec obtained from three 12-lead electrocardiograms (ECGs) at rest.\n      * Patients who have had an acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardio-cerebrovascular events within 3 months before the first dose.\n      * Patients with clinically uncontrollable hypertension.\n      * Symptomatic Cerebral Infarction\n      * Patients with other cardiac disorders that put the patients at a high risk as judged by the investigator.\n  17. Participants with uncontrolled diabetes mellitus.\n  18. Participants with a mental disorder or poor compliance.\n  19. Participants also participate in another interventional clinical study or receive other study treatments (patients who have discontinued other investigational treatments and are only in the follow-up period are allowed to be enrolled in this study).\n  20. Participants requiring concomitant use of strong CYP3A4 inhibitors or inducers or medications that prolong the QT interval within 14 days prior to the first dose of study treatment and during the study.\n  21. Participants with a history of other systemic severe diseases or abnormal laboratory findings that would, in the Investigator's judgment, be inappropriate for this study.","ALL","18 Years",{"count":19,"type":20},778,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This is a multi-national, open-label, randomized, seamless phase II\u002FIII clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.",[27],"Gastric or Gastroesophageal Junction Adenocarcinoma",[29,30,31],"UTD2","GC","GEJ","RECRUITING","2025-11-20",{"date":35,"type":36},"2025-11-25","ACTUAL",{"date":38,"type":36},"2025-08-28",{"date":40,"type":20},"2030-09-01",{"name":42,"class":43},"Beijing Biostar Pharmaceuticals Co., Ltd.","INDUSTRY",10,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100596353","phase-2-phase-ii-clinical-study-of-utidelone-capsule-utd2-in-patients-with-advanced-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100596353","NCT07044349","Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. Participants who voluntarily sign the informed consent form, are willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other study procedures.\n2. Female participants aged ≥ 18 years when signing the informed consent form.\n3. Pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n4. Participants with at least one measurable lesion as defined per RECIST v1.1.\n5. Participants must meet the criteria for platinum-resistant recurrence, which is defined as disease progression during platinum-based therapy or disease progression or recurrence within 6 months after the last platinum-based therapy. Note: Participants must have radiographically confirmed disease progression during or after the most recent line of systemic therapy. Biochemical progression is not considered disease progression in this study.\n6. Participants must meet the requirements of failure or intolerance to the existing standard of treatment or no standard of treatment. Prior use of at least 1 but ≤ 3 lines of systemic antitumor treatment (neoadjuvant and adjuvant treatment are not considered prior systemic treatment, unless disease progression occurred during treatment or within 6 months after the last dose of treatment). Maintenance therapy (e.g., bevacizumab, poly-ADP ribose polymerase \\[PARP\\] inhibitors, hormonal therapy) is considered part of the prior line of treatment. Treatment changes due to toxicity without progression will be considered part of the prior line of treatment (i.e., not counted separately).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Hematology test within 7 days prior to enrollment (based on the laboratory normal range at each site), and no use of recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products \u002Ferythropoietin (EPO) within 14 days prior to the laboratory test during the screening period.\n\n   Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 100 × 109\u002FL; Hemoglobin ≥ 9.0 g\u002FdL.\n9. Blood chemistry test within 7 days prior to enrollment (based on the laboratory normal range at each site); Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastases); AST ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastasis); Creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n10. Life expectancy ≥ 12 weeks.\n11. Female participants of childbearing potential must agree to use highly effective contraceptive methods and not to donate eggs during the study and for 8 weeks after the last dose of study treatment. Female patients of childbearing potential must have a negative blood or urine pregnancy test result at screening and be willing to undergo additional pregnancy tests as needed throughout the study. See Appendix 1 for details.\n\nExclusion Criteria:\n\n1. The best overall response during the first-line platinum-based treatment is disease progression, or disease recurrence or progression within 3 months after the end of the platinum-based treatment.\n2. History of other malignancies within 5 years prior to enrollment, excluding cured skin basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma.\n3. Anti-tumor therapy, including chemotherapy, radiotherapy, target therapy, immunotherapy, etc. within 4 weeks prior to the first dose of the investigational drug, except for the following items;\n\n   1. Received nitrosourea or mitomycin C within 6 weeks prior to the first dose of the investigational drug;\n   2. Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks or within 5 half-lives of the drug prior to the first dose of the investigational drug, whichever is shorter;\n   3. Use of traditional Chinese medicine with anti-tumor indications or endocrine therapy within 2 weeks prior to the first dose of the investigational drug.\n4. Participants who have undergone major surgery (craniotomy, thoracotomy, or laparotomy, or as defined by the investigator) or have experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or those who require elective surgery during the study.\n5. Participants with adverse reactions due to previous antitumor therapy that have not recovered to Grade ≤1 (based on CTCAE 5.0), except toxicities without safety risks as judged by the investigator, such as alopecia.\n6. Participants with gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess, or patients with gastrointestinal hemorrhage, gastrointestinal obstruction (including paralytic ileus), or imaging\u002Fclinical symptoms suggestive of bowel obstruction within 3 months prior to the first use of the investigational product;\n7. Participants who are unable to take oral medications, or with other factors that interfere with the oral administration and absorption of the drug, or those who require total parenteral nutrition.\n8. Participants who need concomitant use of strong CYP3A4 inhibitors or inducers, or medications that prolong the QT interval, within 14 days prior to the first use of the investigational product or during the study.\n9. Participants with symptomatic or uncontrolled central nervous system (CNS) metastases or meningeal metastases, i.e., patients with brain metastasis disease progression confirmed by examination within 2 months after radiotherapy or other local treatments, or patients who are judged by the investigator to be unsuitable for enrollment.\n10. Uncontrolled bone metastases, i.e., patients who have experienced fracture or have the risk of fracture in recent days, patients who need surgery or localized radiotherapy in recent days, or those with other critical conditions as determined by the investigator.\n11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequently).\n12. History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    Patients with acute myocardial infarction, severe\u002Funcontrolled angina, or coronary artery bypass surgery within 6 months prior to the first dose of the investigational product; congestive heart failure with a New York Heart Association (NYHA) classification ≥ 2; left ventricular ejection fraction (LVEF) \\\u003C 50%; Fridericia corrected QT interval \\> 470 ms (average of three measurements); or a history of myocarditis (including patients with a past history of myocarditis that recovered after treatment) or other Grade ≥ 3 cardiovascular events.\n\n    Stroke and\u002For transient ischemic attack within 6 months prior to the first dose of the investigational product; Uncontrolled hypertension despite standard treatment; Other heart diseases at high risk, as judged by the investigator.\n13. Participants with uncontrolled diabetes mellitus.\n14. Participants with active hepatitis B and\u002For hepatitis C, i.e., HBsAg positive and HBV DNA positive; anti-HCV positive and HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; positive for treponema pallidum specific antibody.\n15. Participants who had active infection prior to screening and initial use of the investigational drug and required systemic anti-infective therapy.\n16. Pregnant or breastfeeding women, or women who plan to become pregnant during the study.\n17. Participants with mental disorder or poor compliance.\n18. Participants with prior use of utidelone.\n19. Participants with known hypersensitivity to the investigational product or any of the excipients.\n20. Participants who simultaneously participate in another interventional clinical trial or use other investigational therapies.\n21. Participants who, in the opinion of the investigator, are not suitable to participate in this study due to history of severe systemic diseases or other reasons.","FEMALE",{"count":53,"type":20},72,[23],"This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.",[57,58,59],"Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer",[29,61],"Utidelone Capsule","NOT_YET_RECRUITING","2025-06-23",{"date":65,"type":36},"2025-06-30",{"date":67,"type":20},"2025-09",{"date":69,"type":20},"2027-03",{"name":42,"class":43},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100572231","phase-2-utidelone-capsule-monotherapy-for-patients-with-advanced-solid-tumors-100572231","NCT06730581","Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors","Phase II Clinical Trial of Utidelone Capsule in the Treatment of Advanced Solid Tumor Patients","Inclusion Criteria:\n\n\\-\n\n1、 For participants with advanced gastric cancer:Histologically and\u002For cytologically confirmed unresectable HER2-negative locally advanced or recurrent\u002Fmetastatic gastric or gastroesophageal junction adenocarcinoma (according to the 2019 WHO Classification of Digestive System Oncology).\n\n2、 For participants with advanced cholangiocarcinoma:Histologically and\u002For cytologically, patients were diagnosed with surgically unresectable advanced or metastatic cholangiocarcinoma.\n\n3、 For participants with advanced ovarian cancer:A histologically or pathologically confirmed diagnosis of high-grade serous ovarian cancer was consistent with platinum-resistant recurrent ovarian cancer (progression within 6 months after the last platinum-based chemotherapy) according to the 2020 WHO histopathological classification of ovarian tumors.\n\n4、 For participants with other tumors:\n\n1. Esophageal cancer: locally advanced recurrent or metastatic squamous esophageal cancer confirmed by histology or cytology.\n2. Hepatocellular carcinoma: clinically diagnosed or histologically\u002Fcytologically confirmed diagnosis of inoperable resectable or metastatic hepatocellular carcinoma (HCC) (according to the Guidelines for the Management of Primary Hepatocellular Carcinoma (2024 edition)); Child-Pugh score ≤ 7.\n3. Colorectal cancer: unresectable advanced\u002Fmetastatic colorectal cancer (mCRC) confirmed by histology or cytology.\n4. Recurrent or metastatic cervical cancer confirmed by histopathology, not amenable to radical surgical resection and\u002For radical radiotherapy, and pathologic type of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n\n5、For all participants:\n\n1. Subjects must give informed consent to the study prior to the study, and voluntarily sign a written informed consent form (ICF), understanding and agreeing to comply with the study requirements and test procedures;\n2. ≥18 years old and ≤70 years old;\n3. According to RECIST v1.1, patients had at least one target lesion (non-radiotherapy field) that could be measured by computed tomography (CT) or magnetic resonance imaging (MRI) (longest diameter ≥10mm, lymph node diameter ≥15mm, scan layer thickness ≤ 5mm).\n4. Have received at least one standard systemic therapy, and the number of previous systemic anti-tumor therapy lines is ≤4 (neoadjuvant and adjuvant chemotherapy regiments are not considered prior systemic therapy unless disease progression occurs during their chemotherapy or within 6 months after the last chemotherapy);\n5. The blood routine examination within 1 week before enrollment was basically normal (the normal value of the laboratory of each research center was the standard); No rhG-CSF, blood transfusion \u002FEPO and other drugs were used within 14 days before enrollment.\n\n   a. White blood cell count (WBC) ≥3.5 × 109\u002FL b.Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; c.Platelet count (PLT) ≥ 100 × 109\u002FL; d.Hemoglobin ≥ 9.0 g\u002FdL.\n6. Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory):\n\n   a.Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) b.SGPT\u002FALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); c.SGOT\u002FAST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); d.The creatinine clearance rate (Ccr) is ≥ 60 ml\u002Fmin (Cockcroft Gault formula).\n7. adequate coagulation function, defined as INR or PT ≤1.5 times ULN; If the subject was receiving anticoagulant therapy, as long as the PT was within the prescribed range of anticoagulant drugs.\n8. ECOG 0-1 with an expected survival of more than 12 weeks;\n9. Patients of childbearing potential had to consent to use a reliable contraceptive method (hormonal or barrier methods or abstinence) with their partner simultaneously during the trial and for at least 3 months after the last dose; Female patients of reproductive age had to have a negative blood or urine pregnancy test before enrollment.\n\nExclusion Criteria:\n\n\\-\n\n1、 For participants with advanced gastric cancer:Patients with HER2-positive disease.\n\n2、 For participants with advanced ovarian cancer: 1) Having a clear cell, mucinous or sarcomatous histology, containing mixed tumours of any histological type, or low grade\u002Fborderline ovarian cancer; 2) Platinum-refractory ovarian cancer: tumor progression assessed within 1 month after the last dose of platinum therapy.\n\n3、 For all participants:\n\n1. Other malignancies within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid;\n2. Received nitrosourea or mitomycin C within 6 weeks prior to the first use of the study drug; Anti-tumor therapy, including chemotherapy, radiotherapy, biotargeted therapy, immunotherapy, etc. within 4 weeks or 5 half-lives (whichever is shorter) prior to the first use of the investigational drug; Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug, whichever is shorter; Use of traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks prior to the first use of the investigational drug.\n3. had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or required elective surgery during the trial period.\n4. Patients with peripheral neuropathy CTCAE 5.0 grade ≥2.\n5. The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risk judged by investigators, such as alopecia).\n6. Patients who had previously used Utidelone injection.\n7. Patients with gastrointestinal bleeding, active gastrointestinal ulcers or gastrointestinal obstruction (including paralytic ileus), gastrointestinal perforation or fistula, and intraperitoneal abscesses within 6 months prior to the first use of the investigational drug;\n8. Patients with dysphagia, or other factors that affect the oral administration and absorption of drugs, or who require parenteral nutrition;\n9. Clinically active brain metastases, spinal cord compression, or spread of pia meningioma, defined as symptomatic or requiring steroid hormone or anticonvulsant therapy to control related symptoms; Patients with confirmed progression of brain metastases within 2 months after radiotherapy or other local treatment;\n10. Clinically severe lung injury caused by concurrent lung disease, including but not limited to any underlying lung disease (i.e., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc., with clinical symptoms requiring intervention within 3 months prior to the first use of the investigational drug);\n11. Patients with clinical symptoms of cancerous ascites, pleural effusion and pericardial effusion requiring puncture and drainage; Or had undergone drainage of ascites, pleural effusion, or pericardial effusion within 30 days prior to the first use of the study drug.\n12. Imaging shows that the tumor has invaded the vicinity of important blood vessels or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding;\n13. Have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:\n\n    1. Have severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree Ⅱ-Ⅲ atrioventricular block, etc.; At rest, QTcF\\> 450 ms in men or 470ms in women was examined by 12-lead electrocardiogram (Fredericia's formula, see Appendix IV);\n    2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular event within 6 months prior to first use of the study drug;\n    3. Clinically uncontrollable hypertension;\n    4. Other researchers have identified a high risk of heart disease.\n14. Patients with uncontrolled diabetes within 3 months prior to first use of the study drug.\n15. Patients with active hepatitis B and\u002For hepatitis C, i.e. HBsAg positive and\u002For HBcAb positive with HBV DNA positive and\u002For anti-HCV positive and HCV RNA positive; Positive for human immunodeficiency virus (HIV) antibodies; The specific antibody of treponema pallidum was positive.\n16. Those who have an active infection and currently require systemic anti-infective therapy.\n17. Had an active autoimmune disease that required systemic treatment (i.e., disease modulators, corticosteroids, or immunosuppressive drugs) within 2 years prior to enrollment. Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a systemic treatment.\n18. Women who are pregnant or nursing or plan to become pregnant during the study period.\n19. Patients with mental disorders or poor compliance.\n20. Known allergy to the investigational drug or any of its excipients.\n21. Concurrent participation in another interventional clinical trial or use of another investigational treatment.\n22. The researchers believe that the subjects have a history of serious systemic disease, or other reasons should not be enrolled in this study.","70 Years",{"count":80,"type":20},100,[23],"This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.",[84,57,85],"Gastric Cancer Adenocarcinoma Metastatic","Bile Duct Cancer",[87,57,88],"Gastric Cancer","bile duct cancer","2024-12-08",{"date":91,"type":36},"2024-12-12",{"date":93,"type":20},"2024-12-01",{"date":95,"type":20},"2026-12-31",{"name":42,"class":43},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100568628","phase-2-utidelone-injection-combined-with-bevacizumab-injection-for-non-small-cell-lung-cancer-patients-with-brain-metastases-100568628","NCT06683703","Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases","Phase II Clinical Trial on the Efficacy and Safety of Utidelone Combined with Bevacizumab in Patients with Non-small Cell Lung Cancer with Brain Metastases.","Inclusion Criteria:\n\n1. Informed consent for the study was obtained from the participants and a written informed consent form (ICF) was provided.\n2. age ≥18 years old and ≤70 years old, regardless of gender;\n3. non-squamous non-small cell lung cancer (adenocarcinoma or adenocarcinoma component dominant) with brain parenchymal metastasis confirmed by histology or cytology, but unsuitable or refused local treatment\u002Fsurgery;\n4. at least one measurable intracranial lesion according to RECIST v1.1 criteria (a lesion previously treated with radiotherapy could not be considered a target lesion unless it had definite progression after radiotherapy);\n5. stable brain metastases requiring no immediate or planned local treatment for brain metastases during the study;\n6. driver gene negative patients, unable to tolerate standard treatment or disease progression during or after first-line treatment with platinum-based chemotherapy and immunotherapy concurrent or sequential treatment, and with brain metastasis (regardless of whether the brain metastasis had been systematically treated); Note: (new) no progression within 6 months after the last dose of adjuvant therapy does not count as line count.\n7. ECOG 0-1, life expectancy \\> 12 weeks;\n8. Patients should have adequate bone marrow reserve and no liver, kidney, or coagulation disorders. The following laboratory values should be met during screening and at baseline of enrollment:\n\n1\\) Bone marrow reserve function: absolute neutrophil count ≥1.5×109\u002FL and white blood cell count ≥3×109\u002FL; Platelet count ≥100×109\u002FL; Hemoglobin\n\n* 90g\u002FL; No blood transfusion or treatment with growth factors such as erythropoietin, thrombopoietin, or granulocyte colony-stimulating factor within 14 days; 2) Renal function: serum creatinine ≤1.5× upper limit of normal value (ULN) and creatinine clearance ≥50 mL\u002Fmin (calculated according to Cockcroft and Gault formula); Urine protein \\\u003C2+ (24-hour urine protein quantification within 7 days if baseline urine protein ≥2+, eligible if urine protein ≤1g) 3) Liver function: if there is no confirmed liver metastasis, AST and ALT should be ≤3×ULN; AST, ALT≤5×ULN if liver metastasis was confirmed; If there is no confirmed liver metastasis, the total bilirubin should be ≤1.5×ULN; Patients with confirmed liver metastasis or Gilbert's syndrome (indirect hyperbilirubinemia, total bilirubin ≤3×ULN); 4) Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial prothrombin time (APTT) ≤1.5×ULN. (9) Eligible patients (men and women) of childbearing potential had to agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence) with their partner during the trial and for at least 3 months after the last dose; Female patients of reproductive age had to have a negative blood or urine pregnancy test before enrollment.\n\nExclusion Criteria:\n\n1. primary malignant brain tumors and symptomatic or investigator-judged unstable brain metastases; Patients with leptomeningeal metastasis;\n2. mixed adenosquamous carcinoma with squamous cells as the main component confirmed by histology or cytology (squamous cell carcinoma cells accounted for ≥10%);\n3. The presence of EGFR, ALK, ROS1, NTRK and MET driver genes in patients with previous pathology can be determined according to the results of gene detection during the first-line treatment.\n4. Patients without disease progression after whole brain radiotherapy or stereotactic conformal radiotherapy for all intracranial lesions were not eligible for measurable lesions;\n5. third-space effusion (such as massive pericardial, pleural or peritoneal effusion) that could not be controlled by drainage or other methods within 4 weeks before enrollment;\n6. patients received palliative radiotherapy for non-target lesions for symptom relief (e.g., pain relief by radiotherapy for bone lesions) within 2 weeks before enrollment; Patients with previous whole brain radiotherapy (WBRT) were eligible if they had received previous stereotactic radiotherapy (SRT) or other local CNS treatments (such as intrathecal chemotherapy) more than 2 weeks after the first study dose.\n7. Systemic therapy: all patients had received previous anti-angiogenic drugs (bevacizumab, recombinant human endostatin, anlotinib), including previous anti-angiogenic drugs; Patients received systemic anti-tumor therapy such as chemotherapy and immunotherapy within 4 weeks before the first study medication. Traditional Chinese medicine (including patent Chinese medicine) which had received small molecule targeted therapy or tumor indication within 2 weeks before the first study medication.\n8. known contraindications to gadolinium-based MRI, such as cardiac pacemaker, shraphings, or eye foreign bodies;\n9. two or more seizures within 4 weeks before enrollment;\n10. known to be allergic to eutideron injection, bevacizumab or any of its excipients;\n11. patients with grade ≥2 peripheral neuropathy or skin abnormalities requiring treatment, or any toxicity caused by previous antineoplastic therapy that has not recovered to CTCAE grade 5.0 ≤1 (excluding grade 2 alopecia) before the first dose of the study drug;\n12. There are contraindications to bevacizumab use, including but not limited to the following: - Uncontrolled severe hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥100 mmHg) - cerebral hemorrhage, These included brain metastases related to cancer - history of severe proteinuria (e.g., urine dipsticule ≥ 2+ or 24-hour urinary protein ≥ 2 g) - previous history of hypertensive crisis or hypertensive encephalopathy - history of central nervous system disease unrelated to cancer (e.g., convulsions) - vascular disease (e.g., aneurysm requiring treatment) within 6 months before the first dose of treatment. - history of hemoptysis (2 tablespoons of bright red blood per dose) within 3 months before the first dose - history of bleeding disorder or coagulation disorder in the absence of therapeutic anticoagulants - tumor involving large vessels - history of gastrointestinal perforation or fistula within 6 months before the first dose;\n13. Patients with malignant tumors other than the primary tumor within 5 years before screening (cured cervical carcinoma in situ, skin basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, breast ductal carcinoma in situ, and thyroid papillary carcinoma were excluded).\n14. had undergone major surgery within 4 weeks before the first dose of study medication or had not fully recovered from any previous invasive procedure;\n15. use of aspirin (\\>325mg\u002F day), clopidogrel, ticlopidine, cilostazol, or other drugs known to inhibit platelet function and\u002For a full-dose anticoagulant within 10 days before the first dose of study medication;\n16. patients with active hepatitis B and\u002For hepatitis C, that is, HBsAg positive and\u002For HBcAb positive simultaneously detected HBV DNA positive and\u002For anti-HCV positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody was positive; Treponema pallidum specific antibody was positive.\n17. Major cardiovascular and cerebrovascular diseases occurred within 6 months before the first study medication, such as congestive heart failure (New York Heart Association functional class ≥2), acute myocardial infarction, unstable angina, QTcF \\> 450 ms in men or QTcF \\> 470 ms in women (formula: See Appendix VII), stroke, transient ischemic attack, unstable deep-vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention (except infusion-related thrombosis);\n18. Active infection requiring systemic therapy within 2 weeks before enrollment, such as severe pneumonia, bacteremia, sepsis, etc.; .\n19. Systemic glucocorticoid therapy (more than 4 mg of dexamethasone or equivalent per day for \\> 3 consecutive days) within 14 days before the first study dose or planned during the study period; Patients with chronic diseases such as severe radiation pneumonitis or severe interstitial pneumonitis were treated with immunosuppressive therapy.\n20. pregnant or lactating women;\n21. patients who participated in other anti-tumor clinical trials and received corresponding treatment within 4 weeks before the first study medication.\n22. Other reasons for not participating in the study as judged by the investigator.",{"count":105,"type":20},118,[23],"This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases.\n\nThe main objective of the first stage was to determine the combined dose of the first stage and the second stage, and to compare the intracranial efficacy of the two treatment groups. Secondary objectives were to compare other intracranial efficacy, systemic efficacy, safety and tolerability between the two treatment groups.In the second stage, the main purpose was to evaluate the intracranial efficacy of Utidelone combined with Bevacizumab in patients, and the secondary purpose was to evaluate the other intracranial efficacy, systemic efficacy, safety and tolerability of Utidelone combined with Bevacizumab in patients, and to explore the improvement of patients' quality of life.",[109],"Non-small Cell Lung Cancer Patients with Brain Metastases",[111],"efficacy and safety","2024-11-08",{"date":114,"type":36},"2024-11-12",{"date":93,"type":20},{"date":117,"type":20},"2027-12-01",{"name":42,"class":43},""]