[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":597},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,197,0,25,[9,41,69,105,130,149,176,201,223,251,275,300,323,344,363,385,405,430,450,473,493,515,533,551,576],{"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},"100645121","phase-2-trilaciclib-combined-with-immunochemotherapy-for-rm-hnscc-100645121",false,"NCT07679997","Trilaciclib Combined With Immunochemotherapy for R\u002FM HNSCC","A Prospective, Single-Arm, Phase II Trial of Trilaciclib Combined With Immunotherapy and Chemotherapy as First-Line Treatment for Recurrent and\u002For Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1.Age ≥18 and ≤75 years, male or female. 2.Histologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC).\n\n  3.Recurrent and\u002For metastatic HNSCC not suitable for locoregional therapy. Patients with recurrent-only disease (without metastasis) must have previously received radiotherapy (either as adjuvant therapy after surgery or as treatment for locally advanced SCCHN) as \"locoregional therapy,\" and radiotherapy must have been completed more than 6 months prior to screening imaging.\n\n  4.At least one measurable lesion per RECIST 1.1 criteria. 5.Laboratory tests meeting the following criteria:\n  1. Hemoglobin ≥ 100 g\u002FL (female) \u002F 110 g\u002FL (male)\n  2. Absolute neutrophil count ≥ 2.0 × 10⁹\u002FL\n  3. Platelet count ≥ 100 × 10⁹\u002FL\n  4. Serum creatinine ≤ 15 mg\u002FL or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n  5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or ≤ 5 × ULN in patients with liver metastases\n  7. Albumin ≥ 30 g\u002FL 6.ECOG Performance Status score of 0 or 1. 7.Expected survival time ≥ 3 months. 8.No plans for conception or breastfeeding from 2 weeks before the start of study treatment until 3 months after the end of the study.\n\n     9.Ability to understand and willingness to sign the informed consent form.\n\n     Exclusion Criteria:\n* 1.Diagnosis of a malignancy other than HNSCC within 5 years before the first dose (except for curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone radical resection).\n\n  2.Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA Class III or IV).\n\n  3.History of stroke or major cerebrovascular event within 6 months prior to enrollment.\n\n  4.QTcF interval \\>480 msec at screening, or \\>500 msec for patients with a ventricular pacemaker.\n\n  5.Prior hematopoietic stem cell or bone marrow transplantation. 6.Known hypersensitivity to the study drug or any of its components. 7.Any other condition for which the investigator deems the subject unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is a prospective, single-arm, phase II clinical trial involving patients with advanced HNSCC receiving immunotherapy plus platinum-based dual-drug chemotherapy. It aims to evaluate the myeloprotective efficacy of administering trilaciclib prior to immunotherapy and platinum-based chemotherapy. The objective is to reduce the incidence of chemotherapy-induced myelosuppression (CIM) through pre-chemotherapy myeloprotection, thereby enabling patients to receive chemotherapy on schedule and at full dose. This approach is intended to ensure the efficacy of the chemotherapy regimen and ultimately achieve survival benefits for the patients.",[28],"Head & Neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-28",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":22},"2026-06-01",{"date":37,"type":22},"2027-09-30",{"name":39,"class":40},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",{"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":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100602168","phase-1-clinical-trial-on-the-protective-role-of-vitamin-b3-in-enhancing-immunotherapy-for-bladder-cancer-patients-100602168","NCT07119996","Clinical Trial on the Protective Role of Vitamin B3 in Enhancing Immunotherapy for Bladder Cancer Patients","A Phase Ib Study Evaluating the Safety and Efficacy of Vitamin B3 Combined With Neoadjuvant Tislelizumab Plus Gemcitabine\u002FCisplatin in Antibiotic-Exposed Patients With cT2-T4aN0M0 Urothelial Carcinoma of the Bladder","Inclusion Criteria\n\n1. The patient voluntarily agrees to participate, is able to provide written informed consent, and is willing and able to comply with the protocol and schedule of assessments.\n2. Aged ≥18 years on the date of signing the informed-consent form (ICF).\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 1).\n4. Residual tumour after TURBT and histologically confirmed urothelial carcinoma of the bladder staged cT2-T4a N0 M0 by AJCC 8th edition imaging; for mixed-histology tumours, the urothelial component must be predominant (≥50 %).\n5. An infection occurring from 30 days to 1 day before the first dose of immuno-chemotherapy that, in the judgement of the attending physician, required oral or intravenous bactericidal antibiotics and met any of the following diagnostic criteria:\n\n   1. Clinical features (e.g. ≥38.3 °C or sustained ≥38 °C for ≥1 h with chills, local pain, dysuria, etc.) plus laboratory evidence (WBC \\> 10 × 10⁹\u002FL or \\\u003C 4 × 10⁹\u002FL, neutrophilia \u002F neutropenia, markedly elevated CRP) consistent with bacterial infection;\n   2. Abnormal urinalysis suggestive of urinary-tract infection (e.g. WBC \\> 10\u002FHPF, bacteria seen on high-power field, nitrite positive) with pathogen confirmed by urine culture;\n   3. Infection confirmed by imaging or other microbiological tests (e.g. blood culture, nasopharyngeal swab, sputum culture).\n\n   Permitted bactericidal antibiotics (oral or IV) include but are not limited to:\n   1. β-lactams (penicillins, cephalosporins, carbapenems);\n   2. Glycopeptides (vancomycin, teicoplanin);\n   3. Quinolones (levofloxacin, ciprofloxacin);\n   4. Aminoglycosides (gentamicin, streptomycin).\n6. Adequate organ function, documented within ≤14 days before enrolment:\n\n   a. No growth-factor support ≤14 days before sampling and: i. Absolute neutrophil count ≥1.5 × 10⁹\u002FL; ii. Platelets ≥90 × 10⁹\u002FL; iii. Haemoglobin ≥90 g\u002FL; b. INR or aPTT ≤1.5 × ULN; c. Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome or isolated indirect hyper-bilirubinaemia of extra-hepatic origin); d. AST, ALT and alkaline phosphatase ≤2.5 × ULN; e. Pulmonary function adequate to tolerate major abdominal surgery.\n7. Considered cisplatin-eligible by the investigator. Patients deemed cisplatin-ineligible must meet ≥1 of: ECOG \\> 1 or Karnofsky 60-70 %; creatinine clearance \\\u003C 60 mL\u002Fmin; NCI-CTCAE v5.0 grade ≥2 hearing loss; NCI-CTCAE v5.0 grade ≥2 peripheral neuropathy; New York Heart Association class III or IV heart failure.\n8. Women of child-bearing potential agree to use highly effective contraception during the study and for ≥120 days after the last dose of tislelizumab or chemotherapy (whichever is later) and have a negative urine or serum pregnancy test ≤7 days before enrolment. Non-sterilised men likewise agree to use highly effective contraception for the same period (Appendix 5).\n\nExclusion Criteria\n\nPatients meeting any of the following are ineligible:\n\n1. Previous therapy directed against PD-1, PD-L1, PD-L2, CTLA-4 or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.\n2. Systemic anticancer therapy or systemic immunomodulator (e.g. interferon, interleukin-2, TNF) within 28 days before enrolment.\n3. Prior radiotherapy to the bladder.\n4. Prior antitumour drug therapy, except:\n\n   1. ≥12 months since the last dose of systemic chemotherapy before study neoadjuvant therapy;\n   2. Intravesical chemotherapy or immunotherapy completed ≥1 week before study treatment.\n5. Major surgery or significant trauma within 28 days before enrolment (vascular-access placement and TURBT are not major surgery).\n6. Live vaccine within 28 days before enrolment (inactivated seasonal influenza vaccine is permitted; intranasal influenza vaccine is live and prohibited).\n7. Active autoimmune disease requiring systemic therapy that, in the investigator's opinion, would interfere with study treatment.\n8. Long-term high-dose corticosteroids or other immunosuppressants that, in the investigator's opinion, would interfere with study treatment.\n9. Clinically significant abnormalities that could affect treatment, including electrolyte disturbance (K, Na, Ca), hypoalbuminaemia, interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g. diabetes, hypertension, cardiovascular disease such as severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, or clinically significant ventricular arrhythmia within 6 months).\n10. Untreated chronic HBV infection with HBV-DNA ≥500 IU\u002FmL (2,500 copies\u002FmL) or HBsAg carrier status. Patients with inactive HBsAg carriage or stable active HBV on antiviral therapy with HBV-DNA \\\u003C 500 IU\u002FmL may enrol. HBV-DNA testing is required only for anti-HBc-positive patients.\n11. Active HCV infection. Patients who are anti-HCV-negative, or anti-HCV-positive but HCV-RNA-negative, may enrol. Anti-HCV-positive patients must have HCV-RNA testing.\n12. History of immunodeficiency (including HIV positivity or other acquired\u002Fcongenital immunodeficiencies), or prior allogeneic stem-cell or solid-organ transplantation (Appendix 3).\n13. Known hypersensitivity to other monoclonal antibodies.\n14. Known hypersensitivity to any study drug or excipient.\n15. Unresolved toxicities from prior therapy that have not returned to baseline or stabilised, unless considered by the investigator not to pose a safety risk (e.g. alopecia, neuropathy, certain laboratory abnormalities).\n16. Any condition (medical or substance abuse) that could impede study-drug administration, confound interpretation of results, or place the patient at high risk of complications.",{"count":49,"type":22},12,[51],"PHASE1","When bladder cancer patients are treated to mobilize their own immune system to fight the tumor, drugs that kill the bacteria can impair the effectiveness of the treatment. The purpose of this study is to find out if the common dietary supplement Vitamin B3 could allow drugs that kill bacteria to not negatively affect treatments that mobilize the immune system to fight tumors.",[54],"Bladder (Urothelial, Transitional Cell) Cancer",[56,57,58,59],"Antibiotics","Nicotinamide nucleotides","Immunotherapy","Bladder Cancer","RECRUITING",{"date":62,"type":33},"2026-06-30",{"date":64,"type":33},"2025-08-01",{"date":66,"type":22},"2027-02-01",{"name":39,"class":40},1,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":77,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100643918","phase-2-hexaminolevulinate-photodynamic-therapy-hal-pdt-versus-surgery-for-high-grade-squamous-intraepithelial-lesions-hsil-100643918","NCT07669363","Hexaminolevulinate Photodynamic Therapy (HAL-PDT) Versus Surgery for High-grade Squamous Intraepithelial Lesions (HSIL)","A Prospective, Open-label, Randomized, Controlled, Non-inferiority Phase II Study Comparing Hexaminolevulinate Photodynamic Therapy (HAL-PDT) Treatment Versus Surgical Treatment in Subjects With High-grade Squamous Intraepithelial Lesions (HSIL)","Aurora","Inclusion Criteria:\n\n* Voluntarily participate in this clinical study, fully understand the study content, procedures, and potential adverse reactions, and be able to sign the written informed consent form.\n* Able to complete the study in accordance with the study protocol.\n* Subject age ≥18 years.\n* Presence of High-Grade Squamous Intraepithelial Lesion (HSIL) (CIN2 P16 positive\u002FCIN3), specifically: HSIL with histopathological diagnosis of grade II\u002FIII (CIN2 P16 positive\u002FCIN3) within 3 months prior to the first treatment.\n* Adequate colposcopy, including: (a) Complete visibility of the cervical transformation zone, including the squamocolumnar junction; (b) Complete visibility of lesion margins.\n* The investigator determines that non-surgical treatment is acceptable for the participant.\n* The investigator determines that the cervical size is suitable for placement of the HAL-PDT device.\n* Meets the following conditions: Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result prior to the start of treatment. No plan for pregnancy during the study period; no sexual activity or use of effective and reliable contraception from the end of the last menstrual period to the start of the study, and agreement to use condoms for barrier contraception during the study period. WOCBP is defined as a female who has experienced menarche, has not undergone hysterectomy or bilateral oophorectomy, and has not reached natural menopause (i.e., no menstruation at all for the past 24 consecutive months).\n\nExclusion Criteria:\n\n* Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions.\n* CIN2 with P16 negative.\n* Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva.\n* Prior physical or surgical treatment to the cervix resulting in incomplete cervical structure (e.g., cold knife conization), or receipt of physical or surgical therapy for CIN2 or CIN3 after the current histopathological diagnosis.\n* The first study treatment day falls within 7 half-lives of the last antiviral medication.\n* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infectious diseases found on colposcopic or clinical examination.\n* Investigator judges that vaginal bleeding during treatment may affect treatment outcomes.\n* Receipt of any inactivated vaccine within 2 weeks prior to the first treatment, or any live vaccine within 4 weeks prior to the first treatment.\n* Previous severe cardiovascular, cerebrovascular, neurological, psychiatric, endocrine, or hematopoietic disease that has not been cured; known severely compromised immune function, or need for long-term use of corticosteroids or immunosuppressants; history of malignancy within 5 years.\n* History of clinically significant immunosuppression or confirmed autoimmune disease; or primary immunodeficiency.\n* Known or newly identified active sexually transmitted diseases (STDs), including but not limited to HIV, syphilis, genital herpes, unless adequately treated and tested negative before study treatment.\n* Presence of a cardiac pacemaker.\n* Suspected or known porphyria, or known allergy to the study drug, its chemically similar compounds, or photosensitizers.\n* Allergy to silicone.\n* Pregnant or breastfeeding women.\n* Delivery or miscarriage within 6 weeks prior to enrollment.\n* Participation in any other clinical trial within 30 days prior to study treatment.\n* Poor compliance or judged by the investigator to be unsuitable for participation in this clinical study.","FEMALE","18 Days",{"count":80,"type":22},230,[25],"High-grade squamous intraepithelial lesions (HSIL), encompassing cervical intraepithelial neoplasia grade 2 (CIN2) with p16 positivity and grade 3 (CIN3), are precancerous conditions that require effective intervention. This Phase II study aims to comprehensively evaluate the efficacy, safety, and impact on quality of life of hexaminolevulinate photodynamic therapy (HAL-PDT) compared to immediate surgical treatment in subjects with HSIL.\n\nThis is a prospective, open-label, randomized, controlled, non-inferiority trial. A total of 230 subjects are planned to be enrolled, with 115 subjects allocated to each treatment group (HAL-PDT and surgery).\n\nThe primary endpoint is the pathological regression rate at 12 months, defined as histological findings of normal tissue or low-grade squamous intraepithelial lesions (LSIL) via colposcopy-directed biopsy. Key secondary endpoints include Human Papillomavirus (HPV) clearance rates at 6 and 12 months, pathological regression rate at 6 months, quality of life assessed by the EORTC QLQ-CX24 questionnaire, safety profiles (incidence, severity, and duration of AEs and SAEs, as well as their relationship to the study treatments), and the proportion of subjects developing cervical cancer within 12 months.",[84,85],"Cervical Intraepithelial Neoplasia","Papillomavirus Infections",[87,88,89,90,84,91,92,93,94,95,96,97,98],"HSIL","High-Grade Squamous Intraepithelial Lesions","CIN2","CIN3","HAL-PDT","Hexaminolevulinate Photodynamic Therapy","Photodynamic Therapy","LEEP","Cold Knife Conization","Cervical Cancer Prevention","Non-inferiority Trial","HPV Clearance","2026-06-25",{"date":62,"type":33},{"date":32,"type":22},{"date":103,"type":22},"2029-06-16",{"name":39,"class":40},{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":19,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100641646","molecular-subtype-guided-postoperative-radiotherapy-for-phyllodes-tumor-of-the-breast-a-randomized-controlled-trial-100641646","NCT07657169","Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Randomized Controlled Trial","Efficacy and Safety of Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Prospective, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤75 years.\n2. Histologically confirmed breast phyllodes tumor (PT) by the central laboratory, with molecular classification as MN1 or MN2 subtype via transcriptome sequencing or IHC;\n3. Primary or ipsilateral local recurrence following R0 resection (negative margins) before enrollment;\n4. Pathologically confirmed borderline or malignant PT;\n5. No evidence of distant metastasis (M0);\n6. ECOG performance status 0-1;\n7. Signed informed consent before treatment;\n8. Expected randomization and study entry within 8-12 weeks (no later than 16 weeks) after surgery.\n\nExclusion Criteria:\n\n1. Previous radiation to the same-side breast or chest;\n2. women, or those of childbearing potential refusing effective contraception; Pregnancy, lactation, or refusal of contraception by fertile subjects;\n3. Grade III-IV bone marrow suppression: WBC≤1.9\\*109\u002FL，ANC≤0.9\\*109\u002FL，PLT≤49\\*109\u002FL，AST, ALT≥2\\*ULN;\n4. Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF \\\u003C 50%;\n5. Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF \\\u003C 50%;\n6. Prior or planned systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, or investigational agents) during the study;\n7. Participation in other clinical trials that precludes study inclusion;\n8. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for the trial.",{"count":113,"type":22},160,[115],"NA","Phyllodes tumor (PT) of the breast is a rare fibroepithelial neoplasm, and the role of postoperative radiotherapy (PORT) remains controversial. Our team has previously established a molecular subtyping system for PT, classifying patients into four subtypes. Among them, the malignant novel 1\u002F2 (MN1\u002FMN2) subtypes exhibit extremely high risk of local recurrence, and retrospective data suggest that PORT may significantly improve local control in these subtypes. This study aims to evaluate the efficacy and safety of molecular subtype-guided postoperative radiotherapy (PORT) in patients with MN-subtype phyllodes tumor of the breast. This prospective, multicenter, open-label, randomized controlled trial plans to enroll 160 patients with molecularly confirmed MN1 or MN2 subtype who have undergone R0 resection. Patients will be randomized in a 1:1 ratio to either the PORT group or the observation-only group, with stratification by negative margin width (\\\u003C1 cm vs. ≥1 cm) and molecular subtype (MN1 vs. MN2). The primary endpoint is 2-year local recurrence-free survival (LRFS). Secondary endpoints include distant metastasis-free survival (DMFS), disease-free survival (DFS), overall survival (OS), and the incidence of acute and late radiotherapy-related toxicities. By using an innovative molecular subtyping system to precisely select the target population, this study seeks to assess the benefit and safety of PORT in MN-subtype phyllodes tumors. The results are expected to provide the highest level of evidence for this specific subgroup, advance treatment strategies toward \"molecular subtype-guided precision radiotherapy,\" improve patient outcomes, and inform future clinical guidelines.",[118,119,120,121],"Radiotherapy, Adjuvant","Phyllodes Breast Tumor","Prognosis","Molecular Typing","2026-06-15",{"date":124,"type":33},"2026-06-18",{"date":35,"type":22},{"date":127,"type":22},"2030-12-31",{"name":39,"class":40},4,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":148,"locationsCount":68},"100642013","tace-andor-haic-combined-with-molecular-targeted-therapy-and-immunotherapy-for-hcc-100642013","NCT07658833","TACE and\u002For HAIC Combined With Molecular-targeted Therapy and Immunotherapy for HCC","Study of the Safety, Clinical Efficacy and Prognostic Factors of TACE and\u002For HAIC Combined With Molecular-targeted Therapy and Immunotherapy for Hepatocellular Carcinoma","Inclusion Criteria:\n\n* aged 18-80 years\n* Eastern Cooperative Oncology Group (ECOG) performance status score \\\u003C 2\n* maximum tumor diameter ≥ 7 cm\n* IVC\u002FRA TT diagnosed by contrast-enhanced CT \u002F MRI before study treatment\n* unresectable HCC (uHCC) confirmed by a specialized multidisciplinary team\n* liver function of Child-Pugh class A or B\n\nExclusion Criteria:\n\n* with other malignancies\n* prior anti-tumor therapy\n* history of drug allergy\n* autoimmune diseases\n* digestive hemorrhage of any grade\n* insufficient renal, bone marrow, or coagulation function",{"count":138,"type":22},120,"OBSERVATIONAL","The safety, clinical efficacy and prognostic factors of transcatheter arterial chemoembolization (TACE) and\u002For hepatic artery infusion chemotherapy (HAIC) combined with targeted immunotherapy for primary hepatocellular carcinoma (HCC) require further in-depth study. This research aims to evaluate the safety, clinical efficacy and prognostic factors of TACE and\u002For HAIC combined with targeted immunotherapy for hepatocellular carcinoma.\n\nWe are going to compare and analyze local tumor response, survival outcomes, prognostic factors and adverse events. Tumor response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version. Adverse events were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This study intends to include the targeted and immunotherapy applied, mainly including: lenvatinib, sorafenib, apatinib, bevacizumab, etc.; pembrolizumab, carfilzomib, sintilimab and teprotumumab, etc.",[142],"Hepatocellular Carcinoma (HCC)",{"date":144,"type":33},"2026-06-22",{"date":32,"type":22},{"date":147,"type":22},"2028-06-30",{"name":39,"class":40},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":68},"100587217","phase-2-a-trial-of-apatinib-and-adebrelimab-in-combination-with-chemotherapy-in-patients-with-unresectable-icc-100587217","NCT06925516","A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC","Efficacy and Safety of Apatinib Combined With Adebrelimab and GEMOX Regimen Chemotherapy as the First-line Treatment for Unresectable Intrahepatic Cholangiocarcinoma (ICC): A Single-arm, Multicenter, Phase II Study","ACADEMY","Inclusion Criteria:\n\n* 1\\. Provided informed consent and sign the informed consent form;\n* 2\\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);\n* 3\\. Histologically or cytologically confirmed ICC;\n* 4\\. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and\u002For local treatment.\n* 5\\. No previous systematic treatment for advanced ICC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);\n* 6\\. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local therapy can be used as target lesion after the progression is confirmed in accordance with RECIST v1.1)\n* 7\\. Child-Pugh class: Grade A;\n* 8\\. ECOG-PS score: 0-1;\n* 9\\. With a life expectancy of ≥ 12 weeks;\n* 10\\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;\n* 11\\. If subjects have active hepatitis B (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be \\\u003C 500 IU\u002FmL (or must be \\\u003C 2500 copy\u002FmL if copy\u002FmL is the only unit available in the study site) and are willing to receive antiviral therapy throughout the study (treatment in accordance with local standard of care, e.g., entecavir);\n* 12\\. Women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. A negative serum pregnancy test (HCG) must be confirmed within 7 days before starting study treatment. Lactating women are excluded;\n* 13\\. Men with female partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. Men must also agree not to donate sperm during this period. For men whose partners are pregnant, condom use is required without additional contraception;\n\nExclusion Criteria:\n\n* 1\\. Known hepatocellular carcinoma, Combined Hepatocellular and Intrahepatic Cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, fibrolamellar carcinoma of liver;\n* 2\\. Other active malignant tumor except ICC within 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;\n* 3\\. Planning to or previously received organ or allogenic bone marrow transplantation;\n* 4\\. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;\n* 5\\. Previous treatment with Immune Checkpoint Inhibitors: Prior use of any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints), including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies (including topical use).\n* 6\\. Moderate-to-severe ascites with clinical symptoms, i.e., requiring therapeutic puncture or drainage, or Child-Pugh score \\>2, except the subjects with small amount of ascites in radiological examination but free from clinical symptoms; uncontrolled or moderate to severe pleural effusion, pericardial effusion.\n* 7\\. History of gastrointestinal bleeding within 6 months prior to the start of study treatment or clear tendency of gastrointestinal bleeding;\n* 8\\. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment;\n* 9\\. Known genetic or acquired hemorrhage (e.g., coagulation dysfunction) or thrombotic tendency, for example, subject with hemophilia; current or recent (within 10 days prior to the start of study treatment) use of full-dose of oral or intravenous anticoagulant or thrombolytic drug for the purpose of treatment (preventive use of low-dose aspirin or low molecular weight heparin is allowed);\n* 10\\. Current or recent (within 10 days prior to the start of study treatment) use of aspirin (\\> 325 mg\u002Fday, maximum dose for antiplatelet) or dipyridamole, ticlopidine, clopidogrel and cilostazol;\n* 11\\. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment, for example, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;\n* 12\\. Cardiac clinical symptom or disease that is not well controlled;\n* 13\\. Hypertension that cannot be well controlled through antihypertensive drugs, allowing to reach the above parameters by the use of antihypertensive therapy; previous hypertensive crisis or hypertensive encephalopathy;\n* 14\\. Major vascular disease within 6 months prior to the start of study treatment (for example, aortic aneurysm requiring surgical repair or peripheral arterial thrombosis in recent days); Serious, unhealed or splitting wound and active ulcer or untreated bone fracture; Major surgical therapy within 4 weeks prior to the start of study treatment (except diagnosis), or planned major surgery during the study;\n* 15\\. Evidence on intraperitoneal pneumatosis that can not be explained by puncture or recent surgery;\n* 16\\. Previous or current presence of metastasis to central nervous system; Metastatic disease involving main airway or blood vessels (e.g. Vena cava tumor invasion or complete occlusion of the major portal vein due to HCC, the major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein) or high-volume mediastinal tumor mass located in the center (distance from carina \\\u003C30 mm);\n* 17\\. History of hepatic encephalopathy; Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease which required hormonal therapy, or other pulmonary fibrosis that may interfere with the judgement and treatment of immune-related pulmonary toxicity; organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug related pneumonitis, idiopathic pneumonia, subjects with evidence on active pneumonia or serious pulmonary function impairment on thoracic computed tomography (CT) in screening period (previous radiation pneumonitis in the radiation area will be allowed); active tuberculosis;\n* 18\\. Active autoimmune disease or history of autoimmune disease and may relapse (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[with the exception that it can be controlled by hormone replacement therapy\\]). Subjects with skin disease that do not require systemic treatment are eligible, for example, leukoderma, psoriasis, alopecia; subjects with controlled type 1 diabetes by insulin are eligible; subjects with asthma that has been completely resolved in childhood and don't need any treatment are eligible, but subjects with asthma that require a bronchodilator as medical intervention are not eligible;\n* 19\\. Use of immunosuppressive medication within 14 days prior to the start of study treatment, or systemic corticosteroid therapy to achieve the objective of immunosuppression (Prednisone at the dose of \\>10mg\u002Fday or equivalent);\n* 20\\. Known history of hypersensitivity to the active substance or to any other components of each investigational medicinal product;\n* 21\\. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within 2 weeks prior to the start of study treatment (subjects who are treated with antibiotics for prevention, e.g., preventive urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study);\n* 22\\. Congenital or acquired immunodeficiency (e.g., HIV infection);\n* 23\\. Hepatitis B and hepatitis C co-infection;\n* 24\\. Attenuated live vaccine therapy administered within 28 days prior to the start of study treatment, or are expected to receive such vaccines during Adebrelimab treatment or within 60 days after the last dose of Adebrelimab;\n* 25\\. Other factors that may affect the study results or lead to early study termination as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.",{"count":158,"type":22},38,[25],"The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)",[162],"Intrahepatic Cholangiocarcinoma (Icc)",[164,165,166,167,168],"unresectable intrahepatic cholangiocarcinoma","cholangiocarcinoma","GEMOX chemotherapy","Antineoplastic Agents","Tyrosine kinase inhibitors",{"date":170,"type":33},"2026-06-17",{"date":172,"type":33},"2025-04-25",{"date":174,"type":22},"2028-10-01",{"name":39,"class":40},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":68},"100584649","probiotics-for-prevention-of-neratinib-induced-diarrhea-in-breast-cancer-patients-100584649","NCT06892093","Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients","Efficacy and Safety of Probiotics Versus Standard Care in Preventing Diarrhea Induced by Neratinib in Breast Cancer Patients: A Prospective Randomized Controlled Clinical Trial","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1. Female patients aged ≥18 years, diagnosed with HER2-positive breast cancer.\n2. Scheduled to receive Neratinib therapy (monotherapy or in combination), based on clinical guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with an expected survival of at least 3 months.\n4. Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Resolution of any prior treatment-related toxicity to Grade ≤1 (per CTCAE v5.0), with AST and ALT ≤ 2.5 × the upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN.\n6. Adequate bone marrow function, defined as:\n\n   White blood cell count ≥ 3.0 × 10⁹\u002FL Neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum creatinine ≤ 1.5 × ULN\n7. No persistent gastrointestinal symptoms, such as hematochezia, chronic constipation, or abdominal pain.\n8. No evidence of structural gastrointestinal abnormalities confirmed by gastroscopy or other relevant examinations.\n\nExclusion Criteria\n\nParticipants will be excluded if they meet any of the following criteria:\n\n1. Conditions that significantly impair swallowing, digestion, or gastrointestinal drug absorption.\n2. History of chronic gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), gastrointestinal tumors, or malabsorption syndromes.\n3. Severe cardiovascular diseases that may interfere with study treatment, including but not limited to:\n\n   Life-threatening arrhythmias Advanced atrioventricular block Unstable angina Clinically significant pericardial disease Myocardial fibrosis Uncontrolled hypertension\n4. Known hypersensitivity to any component of Neratinib, probiotics, placebo, or loperamide.\n5. Prior participation in any clinical trial involving investigational drugs within 4 weeks prior to enrollment, or chronic use of medications that may induce constipation within 6 months.\n6. Pregnant or lactating women, or those unwilling to use effective contraception during the study period.\n7. Any medical, psychiatric, or social condition that, in the investigator's judgment, could compromise the safety of the participant, interfere with study participation, or confound the study results.",{"count":184,"type":22},308,[115],"This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib.\n\nStudy Design: This is a prospective, randomized controlled clinical trial. Participants will be randomly assigned to either a probiotics intervention group or a placebo-controlled group. Both groups will receive prophylactic loperamide according to the FDA-recommended dosing schedule for neratinib-associated diarrhea.\n\nPrimary Objective: To evaluate the efficacy of probiotics in reducing the incidence and severity of diarrhea in patients receiving Neratinib.\n\nSecondary Objectives: This study will also investigate the effects of probiotics on gut microbiota composition and their potential impact on drug efficacy.\n\nStudy Duration: Enrollment is planned from August 2025 to June 2027 at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University. Both the intervention and control groups will receive treatment for a total of six weeks (two cycles of three weeks each). No post-treatment observation period is included.\n\nEligibility Criteria: Participants must be diagnosed with HER2-positive breast cancer and scheduled to receive Neratinib. Exclusion criteria include patients with severe gastrointestinal disorders or recent probiotic consumption.",[188,189,190],"HER2-positive Breast Cancer","Diarrhea Caused by Drug","Neratinib",[190,192,193,194],"Probiotics","Diarrhea","Breast Cancer",{"date":170,"type":33},{"date":197,"type":33},"2025-08-07",{"date":199,"type":22},"2027-12",{"name":39,"class":40},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":68},"100544140","phase-2-sintilimab-plus-folfiri-as-second-line-therapy-for-patients-with-her2-negative-advanced-gastric-cancer-100544140","NCT06365008","Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer","Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer: a Prospective Single-arm Phase II Study","Inclusion Criteria:\n\n1. Metastatic or locally advanced, unresectable HER2-negative gastric adenocarcinoma confirmed by histology or cytology\n2. Progression or toxicity intolerance of first-line treatment\n3. Patients aged ≥ 18 years\n4. ECOG score 0-2\n5. Estimated life expectancy of at least 12 weeks\n6. Adequate organ and bone marrow function, as follows: Hemoglobin ≥8g\u002Fdl, neutrophil absolute count ≥1000\u002FμL, platelets ≥ 75,000 \u002FμL,Total bilirubin ≤1.5 x upper limit of normal (ULN), alkaline phosphatase, aspartate aminotransferase (AST (SGOT) and alanine aminotransferase (ALT (SGPT)) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN), Serum albumin≥2.8g\u002Fdl, Serum creatinine ≤1.5 x ULN or calculated creatinine clearance \\>50mL\u002Fmin (calculated according to Cockcroft Gault formula)\n7. International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) \\\u003C1.5 x ULN (thromboembolic event must be ruled out if D-dimer is abnormal)\n8. Negative pregnancy test not more than 7 days before enrollment,Pregnancy tests can only be omitted in women who do not have any reproductive potential (e.g., postmenopausal women, i.e. amenorrhea ≥2 years or prior hysterectomy or bilateral oophorectomy). Fertile women and men must consent to the use of appropriate contraception at the time of enrollment and during study participation for at least 3 months after the last treatment\n9. Have sufficient understanding ability and be willing to sign written informed consent\n\nExclusion Criteria:\n\n1. Pregnant and lactating women\n2. The patient has experienced hyperprogression and immunotherapy related grade 3 or above adverse reactions during previous immunotherapy\n3. Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug, the total area of previous bone marrow radiation therapy exceeds 30%; the exception is that if it is not the target lesion, palliative radiotherapy is allowed, and the radiotherapy area must be less than 25% of the bone marrow area\n4. Suffering from other malignant tumors within the past 5 years or simultaneously\n5. Suffering from severe neurological and psychiatric disorders\n6. Patients with uncontrolled or symptomatic brain metastases\n7. Patients with active autoimmune diseases\n8. Immunosuppressive or systemic hormone therapy for immunosuppressive purposes (dose \\>10mg\u002F day prednisone or other therapeutic hormone) within 14 days prior to initiation of study therapy\n9. Allergies to investigational drugs or excipients\n10. Hypertension that cannot be controlled by antihypertensive drugs, coronary heart disease, heart failure, and arrhythmia (QTcF prolongation,\\>450ms in males and\\>470ms in females)\n11. Severe infection in the 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumoniaOral or intravenous administration of therapeutic antibiotics within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics, for example, to prevent urinary tract infections or exacerbation of chronic obstructive pulmonary disease are eligible for study participation)\n12. Patients with congenital or acquired immune deficiency (such as HIV infection)\n13. Have received live attenuated vaccines within 28 days prior to initiation of study treatment, or are expected to require such vaccines during sintilimab treatment or within 60 days after the last administration of sintilimab",{"count":209,"type":22},27,[25],"The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the second-line therapy for patients diagnosed with HER2-negative unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg\u002Fkg for patients with body weight\\\u003C60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg\u002Fm2 intravenous infusion, leucovorin folinate 400mg\u002Fm2 intravenous infusion and fluorouracil 400mg\u002Fm2 intravenous injection followed by 2400mg\u002Fm2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is 5-month progression-free survival (PFS) rate. The investigators estimated that 27 patients were necessary. Secondary endpoints include overall survival, progression-free survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer. Exploratory endpoint is to detect the baseline ctDNA level of patients before initial treatment.",[213],"Unresectable\u002FMetastatic Gastric Cancer",[215,216],"Sintilimab","FOLFIRI",{"date":124,"type":33},{"date":219,"type":22},"2026-06",{"date":221,"type":22},"2036-06",{"name":39,"class":40},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":68},"100642621","phase-3-rhtnk-tpa-for-acute-ischemic-stroke-under-simplified-imaging-in-the-extended-time-window-100642621","NCT07606807","rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window","rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial","SIMPLIFIED","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Presumed acute ischemic stroke of the anterior circulation.\n3. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'.\n4. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).\n5. Limited early ischemic changes on non-contrast CT (NCCT).\n6. Written informed consent signed by patients or their legally authorized representatives.\n\nExclusion Criteria:\n\n1. Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.\n2. Intracranial or subarachnoid hemorrhage identified on baseline NCCT.\n3. Endovascular thrombectomy (EVT) planned at the time of randomization.\n4. Pre-stroke mRS≥2.\n5. Allergy to the test drug and its ingredients.\n6. Severe head trauma or ischemic stroke in the last 3 months.\n7. Intracranial or intraspinal surgery within 3 months before enrollment.\n8. Intracranial tumor or large-size aneurysm found before enrollment.\n9. Gastrointestinal or urinary system hemorrhage within the past 3 weeks.\n10. Active visceral bleeding.\n11. Aortic arch dissection confirmed by examination or medical history.\n12. Infective endocarditis confirmed by examination or medical history.\n13. Platelet count less than 100 × 109 \u002FL.\n14. Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.\n15. Pregnant or lactating women.\n16. Blood glucose \\\u003C50 mg\u002Fdl (2.78mmol\u002FL) or \\>400 mg\u002Fdl (22.2mmol\u002FL) during screening.\n17. Uncontrolled hypertension with persistent systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg, refractory to medical management.\n18. Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness.\n19. Participating in other trials.\n20. Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.",{"count":232,"type":22},750,[234],"PHASE3","The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study. It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).",[237],"Acute Ischemic Stroke",[239,240,241,242,243],"Intravenous Thrombolysis","Extended Time Window","Simplified Imaging","Non-contrast CT","Tenecteplase","2026-06-11",{"date":122,"type":33},{"date":247,"type":22},"2026-08-01",{"date":249,"type":22},"2028-12-01",{"name":39,"class":40},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":258,"sex":77,"minAge":259,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":68},"100499765","phase-4-prolonged-progesterone-to-prevent-preterm-birth-from-ivf---et-100499765","NCT05787509","Prolonged Progesterone to Prevent Preterm Birth From IVF - ET","The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial","Inclusion criteria are: age 20-40 years; meeting the indications for assisted reproductive technology (ART) and undergoing fresh embryo transfer with in vitro fertilization (IVF); singleton pregnancy; and willingness to participate and provide written informed consent.\n\nExclusion criteria are: age \\>40 years; history of second-trimester miscarriage or cervical insufficiency; ovarian dysfunction or relevant surgical history; uterine malformation; diseases associated with abnormal uterine cavity morphology; abnormal cervical morphology or function, or history of cervical surgery; refractory vaginitis; multiple pregnancy; concomitant severe medical or surgical diseases; participation in another clinical trial within 90 days prior to randomization, or use of an investigational drug within 30 days; inability to complete long-term follow-up or poor compliance; and any other condition that, in the investigator's judgment, may affect trial implementation or outcome evaluation.",true,"20 Years","40 Years",{"count":262,"type":22},100,[264],"PHASE4","To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment",[267],"Preterm Birth","2026-06-08",{"date":244,"type":33},{"date":271,"type":33},"2023-04-01",{"date":273,"type":22},"2029-04-30",{"name":39,"class":40},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":68},"100542188","phase-2-combination-immunotherapy-of-adebrelimab-with-apatinib-and-tegafur-gimeracil-and-oteracil-potassium-capsules-for-immune-rechallenge-therapy-in-esophageal-squamous-cell-carcinoma-100542188","NCT06339619","Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur, Gimeracil and Oteracil Potassium Capsules for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma","Phase II Clinical Study of Adebrelimab Combined With Apatinib and Tegafur, Gimeracil and Oteracil Potassium Capsules in the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Failed First-line Immunotherapy Combined With Chemotherapy","Inclusion Criteria:\n\n1. 18-75 years old, both sexes.\n2. Esophageal squamous cell carcinoma confirmed by histology or cytology with locally advanced unresectable or distant metastasis (according to AJCC 8th edition).\n3. ECOG PS score of 0 \\~ 1.\n4. Expected survival ≥3 months.\n5. Patients who have failed first-line immunotherapy combined with chemotherapy.\n6. At least one measurable or unmeasurable lesion according to RECIST V1.1 criteria (subjects with intracranial lesions alone were excluded from this study).\n7. Ability to swallow investigational drugs .\n8. The functional level of the organ must meet the following requirements. (1) ANC≥1.5×109\u002FL; (2) PLT≥100×109\u002FL; (3) Hb≥90 g\u002FL; (4) Serum albumin ≥30 g\u002FL; (5) TBIL≤1.5×ULN; ALT and AST≤2.5 x ULN; For patients with liver metastases, ALT and AST≤5×ULN; (6) Cr ≤1.5×ULN, or creatinine clearance ≥50mL\u002Fmin as calculated by the Cockcroft-Gault formula; (7) Patients with urinary protein ≥++ should undergo further 24-hour quantitative detection of urinary protein, and the detection result should be\\\u003C1.0g.\n9. Within 7 days prior to enrollment, women of reproductive age must confirm a negative serum pregnancy test and consent to use effective contraception during the study drug use period and within 2 months after the last dose.\n10. Subjects voluntarily participate in the study after fully informed consent and sign the informed consent.\n\nExclusion Criteria:\n\n1. Have been diagnosed with other malignancies within 5 years, excluding: curable carcinoma in situ of the cervix, skin basal cell carcinoma or squamous cell carcinoma, or any other tumor that has been cured .\n2. Patients who had previously received treament of Adebrelimab, Apatinib or Tegafur.\n3. The following conditions occurred in the previous treatment history. (1)Used Chinese medicine anti-tumor treatment within 2 weeks; (2)Received other anti-tumor therapy within 4 weeks, including but not limited to chemotherapy, radiotherapy, and targeted therapy.\n4. Have not recovered from adverse events caused by prior antitumor therapy (i.e., ≤ grade 1 or at baseline).\n5. Subjects who have participated in or are participating in other clinical trials within 4 weeks.\n6. Received major surgery within 4 weeks or anticipated to undergo major surgery during the study period.\n7. Subject is currently using a CYP3A strong inhibitor or inducer, or has discontinued a strong inhibitor for less than 5 half-lives of the medication or discontinued a strong inducer for less than 5 half-lives of the medication or 14 days (whichever is longer) before dosing.\n8. Current need for treatment of central nervous system metastases or uncontrolled central nervous system metastases.\n9. Risk of severe bleeding or esophageal fistula.\n10. Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the drug.\n11. Those with active gastrointestinal ulcers, active gastrointestinal bleeding, or perforation.\n12. Within the 12 months prior to enrollment, individuals with any of the following conditions: myocardial infarction, coronary artery bypass grafting or peripheral artery bypass grafting surgery, congestive heart failure (III-IV graded by New York Heart Association), etc.; unstable angina within the 6 months prior to enrollment.\n13. Within the 12 months prior to enrollment, occurrence of thrombotic events or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, etc., or patients currently receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or other similar medications.\n14. Fridericia-corrected QT interval (QTcF)\\>470 ms; history of congenital long QT syndrome; history of any clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); left ventricular ejection fraction (LVEF) \\\u003C50%.\n15. Those with uncontrollable pleural effusion, pericardial effusion, pelvic effusion, or ascites requiring repeated drainage.\n16. Past or current interstitial lung disease or immune-related pneumonia; currently suffering from drug-induced pneumonia, radiation pneumonia requiring steroid therapy, or clinically symptomatic active pneumonia, or other moderate to severe pulmonary diseases severely affecting lung function.\n17. Active infection during screening, or unexplained fever\\>38.5°C within 2 weeks prior to randomization.\n18. Active hepatitis B or hepatitis C.\n19. Received live vaccines within 4 weeks prior toenrollment and\u002For planned to receive live vaccines after enrollment.\n20. Those with congenital or acquired immunodeficiency (such as HIV-infected individuals).\n21. History of organ transplantation or allogeneic bone marrow transplantation.\n22. Individuals deemed by the investigator to have other serious acute or chronic illnesses unsuitable for participation in the clinical trial.",{"count":21,"type":22},[25],"The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.",[286],"Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma",[288,289,290,291],"immunotherapy rechallenge","ESCC","Adebrelimab","First-line treatment failure","2026-06-02",{"date":294,"type":33},"2026-06-04",{"date":296,"type":33},"2024-03-11",{"date":298,"type":22},"2028-09-01",{"name":39,"class":40},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":19,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":320,"leadSponsor":322,"locationsCount":68},"100637213","phase-2-efficacy-and-safety-of-trastuzumab-rezetecan-or-trastuzumab-deruxtecan-in-advanced-breast-cancer-100637213","NCT07630103","Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer","A Comparison of the Efficacy and Safety of Trastuzumab Rezetecan(SHR-A1811) Versus Trastuzumab Deruxtecan(DS-8201) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab","Inclusion Criteria:\n\n* Female patients aged ≥18 and ≤75 years.\n* Histologically or cytologically confirmed HER2-positive (IHC 3+ and\u002For ISH positive) unresectable or metastatic breast cancer.\n* Prior treatment with trastuzumab and a taxane in the recurrent or metastatic setting. Or recurrence during or within 12 months (disease-free interval, DFI) after completing neoadjuvant\u002Fadjuvant chemotherapy and\u002For anti-HER2 targeted therapy.\n* Documented radiological disease progression (during or after the most recent prior therapy).\n* ECOG Performance Status of 0 or 1.\n* At least one measurable lesion according to RECIST v1.1 criteria.\n* Adequate organ function meeting the following criteria (without the use of any blood components, cytokines, or growth factors for correction within 14 days prior to the first dose):\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Platelet count (PLT) ≥100 × 10⁹\u002FL; Hemoglobin (Hb) ≥90 g\u002FL (9.0 g\u002FdL); Albumin ≥3.0 g\u002FdL;Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5.0 × ULN for patients with liver metastases); Serum creatinine ≤1.5 × ULN OR creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); QTcF interval ≤470 ms; Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography (ECHO) or multigated acquisition scan (MUGA)\n\n* Female subjects of childbearing potential must have a negative pregnancy test at screening and must agree to use highly effective contraception methods from the signing of the informed consent form until 7 months after the last dose of the investigational product.\n* Willing and able to provide written informed consent, with good compliance, and willing to cooperate with follow-up visits and study-related procedures.\n\nExclusion Criteria:\n\n* Patients with known untreated spinal cord compression or active central nervous system (CNS) metastases, except for those who have been treated and have remained stable for at least 1 month and have discontinued corticosteroids for \\>2 weeks.\n* History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* Uncontrolled third-space fluid accumulation (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be managed by drainage or other methods.\n* Having undergone major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biotherapy, or other clinical investigational therapy within 4 weeks prior to the first dose.\n* Prior treatment with an antibody-drug conjugate containing an exatecan derivative (a topoisomerase I inhibitor).\n* Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (at doses \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to the first dose, excluding topical, nasal spray, or inhaled corticosteroids.\n* Presence of any active autoimmune disease or a history of autoimmune disease that may potentially recur.\n* History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* Patients with known or suspected interstitial lung disease (ILD); or presence of other moderate-to-severe pulmonary diseases that may significantly impair respiratory function or interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive\u002Frestrictive lung disease, etc.; and any autoimmune, connective tissue, or inflammatory disorders involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.; or history of pneumonectomy. Patients who experienced ≥Grade 3 ILD during prior treatment with immune checkpoint inhibitors are excluded.\n* Presence of active hepatitis B (HBsAg positive and HBV DNA ≥500 IU\u002FmL), hepatitis C (anti-HCV positive and HCV RNA above the upper limit of normal), or liver cirrhosis; or severe infections requiring systemic antibiotic, antiviral, or antifungal therapy.\n* Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1 (according to NCI-CTCAE v6.0).\n* Known hypersensitivity to any of the study drugs or their excipients.\n* Any other severe physical or mental illness or abnormal laboratory finding that, in the investigator's judgment, may increase the risk associated with study participation, interfere with the study results, or make the patient unsuitable for participation in this study.",{"count":262,"type":22},[25],"This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive advanced\u002Fmetastastic breast cancer",[311],"Advanced Breast Cancer",[313,314,315,316],"ADC","advanced breast cancer","T-DXd","SHR-A1811",{"date":318,"type":33},"2026-06-05",{"date":219,"type":22},{"date":321,"type":22},"2031-12",{"name":39,"class":40},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":341,"leadSponsor":343,"locationsCount":4},"100640552","phase-2-a-phase-ll-interventional-single-arm-study-evaluating-the-efficacy-and-safety-of-inavolisib-plus-ribociclib-and-fulvestrant-in-chinese-patients-with-pik3ca-mutant-hr-positive-her2-negative-locally-advanced-or-metastatic-breast-cancer-100640552","NCT07618390","A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.","Inclusion Criteria:\n\n* Patients must meet all of the following criteria:\n\n  1. Signed informed consent form (ICF).\n  2. Female, aged ≥18 years at the time of signing the ICF.\n  3. Must meet one of the following definitions of postmenopausal status:\n\n     1. Age ≥60 years; OR\n     2. Age \\\u003C60 years with amenorrhea for ≥12 consecutive months in the absence of oral contraceptives, hormone replacement therapy, or gonadotropin-releasing hormone (GnRH) agonists\u002Fantagonists, and with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range per local laboratory assessment; OR\n     3. Documented bilateral oophorectomy performed ≥14 days before Cycle 1 Day 1 (first treatment), with recovery to baseline status.\n\n        For premenopausal or perimenopausal women (i.e., those not meeting postmenopausal criteria), the following is also required:\n     4. Ongoing treatment with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin or leuprorelin) initiated at least 2 weeks before Cycle 1 Day 1 and continued throughout study treatment.\n  4. Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and not amenable to curative surgery or radiotherapy.\n  5. Estrogen receptor (ER)-positive and\u002For progesterone receptor (PR)-positive tumor per ASCO\u002FCAP guidelines, defined as ≥1% of tumor cells showing positive staining on the most recent tumor biopsy.\n  6. HER2-negative per ASCO\u002FCAP guidelines, defined as: HER2 IHC score 0 or 1+, or IHC 2+ with negative ISH (FISH\u002FCISH\u002FSISH), or HER2\u002FCEP17 ratio \\\u003C2.0 on the most recent biopsy, based on local laboratory assessment.\n  7. Biomarker eligibility: PIK3CA mutation status must be determined by PCR or NGS testing of blood or tumor tissue at a local or regional laboratory. Blood samples should represent metastatic disease and be collected after the most recent anticancer therapy; tumor tissue should preferably be from metastatic lesions.\n  8. Disease progression during or within 12 months after completion of adjuvant endocrine therapy (aromatase inhibitor or tamoxifen). If CDK4\u002F6 inhibitor was used in neoadjuvant\u002Fadjuvant setting, time from completion of CDK4\u002F6 inhibitor to progression must be \\>12 months.\n  9. At least one measurable lesion per RECIST v1.1. Patients with only bone metastases are not eligible, even if lesions are measurable.\n  10. Women of childbearing potential must agree to abstinence or use effective non-hormonal contraception (failure rate \\\u003C1% per year) during treatment and for specified post-treatment periods (depending on study drug), and must not donate oocytes.\n  11. ECOG performance status 0-1.\n  12. Life expectancy \\>6 months.\n  13. Adequate hematologic and organ function within 14 days prior to treatment initiation, including:\n\n      ANC ≥1500\u002FμL Hemoglobin ≥9 g\u002FdL Platelets ≥100,000\u002FμL Fasting glucose \\\u003C126 mg\u002FdL and HbA1c \\\u003C6.0% Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome) Albumin ≥2.5 g\u002FdL AST\u002FALT ≤2.5×ULN (≤5×ULN with liver metastases) ALP ≤2.5×ULN (≤5×ULN with liver\u002Fbone metastases) Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault) INR \\\u003C1.5×ULN and aPTT \\\u003C1.5×ULN (with specified exceptions for anticoagulation)\n  14. Ability and willingness to comply with study procedures as judged by the investigator.\n\nExclusion Criteria:\n\n1. Metaplastic breast carcinoma.\n2. Any history of leptomeningeal disease or carcinomatous meningitis.\n3. Prior systemic therapy for metastatic breast cancer (mBC).\n4. Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), except neoadjuvant use ≤6 months.\n5. Prior exposure to PI3K, AKT, or mTOR inhibitors, or any drugs targeting the PI3K-AKT-mTOR pathway.\n6. Requirement for cytotoxic chemotherapy at study entry (e.g., visceral crisis as per local guidelines).\n7. Type 2 diabetes requiring ongoing systemic treatment at enrollment, or history of type 1 diabetes.\n8. Inability or unwillingness to take oral medication or receive intramuscular injections.\n9. Malabsorption syndrome or any condition affecting gastrointestinal absorption.\n10. Untreated or active CNS metastases (progressive disease or requiring anticonvulsants or corticosteroids for symptom control).\n11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage more frequently than every 2 weeks.\n12. Severe infection requiring intravenous antibiotics within 7 days prior to enrollment.\n13. Any concurrent ocular or intraocular disease requiring intervention during the study to prevent or treat potential vision loss.\n14. Active inflammatory or infectious ocular disease, or history of autoimmune\u002Fidiopathic uveitis.\n15. Requirement for daily supplemental oxygen therapy.\n16. Symptomatic active pulmonary disease, including pneumonia.\n17. Active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or current immunosuppressive treatment for such disease.\n18. Any active intestinal inflammation, including diverticulitis.\n19. Symptomatic hypercalcemia requiring ongoing bisphosphonate or denosmab therapy.\n20. Clinically significant active liver disease, including severe hepatic impairment (Child-Pugh B\u002FC), viral hepatitis, cirrhosis, or current alcohol abuse.\n21. Known HIV infection.\n22. Any severe, uncontrolled systemic disease (e.g., significant cardiopulmonary, metabolic, or infectious disease) that may affect study safety or interpretation.\n23. Anticancer therapy within 2 weeks prior to first dose.\n24. Investigational drug use within 4 weeks prior to first dose.\n25. Prior irradiation of ≥25% of bone marrow, or prior stem cell\u002Fbone marrow transplantation.\n26. Unresolved toxicities from prior therapy (except alopecia, hot flashes, or peripheral neuropathy ≤Grade 2).\n27. Other malignancy within 5 years prior to screening, except low-risk cancers (e.g., treated cervical carcinoma in situ, non-melanoma skin cancer, or stage I uterine cancer).\n28. Significant cardiovascular disease, including:\n\n    * Stroke or TIA within 6 months\n    * Myocardial infarction within 6 months\n    * NYHA class III-IV heart failure or clinically significant CHF\n    * Uncontrolled arrhythmias or ventricular arrhythmias requiring treatment\n    * Clinically significant coronary artery disease or unstable angina\n    * QTc prolongation (\\>470 ms using Fridericia formula) or history of long\u002Fshort QT syndrome, Brugada syndrome, or torsades de pointes\n    * Clinically significant ECG abnormalities (e.g., complete LBBB, high-grade AV block)\n    * Evidence of prior myocardial infarction on ECG\n29. Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia).\n30. Chronic use of ≥10 mg\u002Fday prednisone equivalent or other systemic corticosteroids\u002Fimmunosuppressants.\n31. Known hypersensitivity to inavolisib, ribociclib, or fulvestrant components.\n32. Use of strong CYP3A4 inhibitors or inducers within 1 week or 5 half-lives (whichever is longer) prior to treatment initiation.\n33. Pregnancy, breastfeeding, or planning pregnancy during study or within defined post-treatment periods (inavolisib 7 days, ribociclib 21 days, fulvestrant up to 2 years).\n34. Major surgery or significant trauma within 28 days prior to Cycle 1 Day 1, or expected need for major surgery during the study.\n35. Minor surgery within 7 days prior to first dose without adequate recovery (including proper wound healing).",{"count":113,"type":22},[25],"This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in Chinese patients with PIK3CA-mutant, hormone receptor-positive (HR+), HER2-negative (HER2-), endocrine-resistant metastatic breast cancer (mBC). Approximately 160 patients will be enrolled at around 16 centers in China.\n\nThe study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period.\n\nPIK3CA mutation status must be determined in blood or tumor tissue using polymerase chain reaction (PCR)-based assays or next-generation sequencing (NGS) performed in a local clinical laboratory. Patients with locally confirmed PIK3CA mutations who meet all eligibility criteria will be enrolled and receive study treatment with inavolisib, ribociclib, and fulvestrant. Details of the treatment regimen are provided in the Study Treatment section. Study treatment will continue until radiologically confirmed disease progression as determined by the investigator, unacceptable toxicity, withdrawal of informed consent, or study termination, whichever occurs first.\n\nPatients must have measurable disease according to RECIST v1.1. Patients with bone-only metastases are not eligible, even if the lesions are considered measurable. Locally advanced disease must be unsuitable for surgical resection or other local treatment with curative intent.",[194],[334,335,336,337],"breast cancer","PIK3CA-mutant","HER2-negative","HR-positive","2026-05-25",{"date":35,"type":33},{"date":219,"type":22},{"date":342,"type":22},"2028-12",{"name":39,"class":40},{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":350,"enrollmentInfo":351,"targetDuration":353,"studyType":139,"phases":4,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":4},"100637514","artificial-intelligence-based-early-warning-for-distant-metastasis-in-malignant-tumors-100637514","NCT07616011","Artificial Intelligence-Based Early Warning for Distant Metastasis in Malignant Tumors","Inclusion Criteria:\n\n1. Aged ≥ 18 years old;\n2. Diagnosed with malignant tumor confirmed by histopathology;\n3. No distant metastasis detected at baseline enrollment assessment;\n4. Regular imaging examinations for distant metastasis assessment are scheduled in the routine follow-up protocol after enrollment;\n5. Complete baseline clinicopathological data are available;\n6. Patients provide informed consent and permit researchers to collect and analyze their subsequent imaging and clinicopathological data.\n\nExclusion Criteria:\n\n1. Concurrent presence of two or more primary malignant tumors;\n2. Presence of any medical or social factors that may interfere with completion of routine imaging follow-up.","95 Years",{"count":352,"type":22},10000,"4 Years","Early detection and timely intervention of distant metastasis are essential for improving the prognosis of patients with malignant tumors. However, current clinical methods have notable limitations. Conventional imaging can only detect macroscopic metastatic lesions, failing to seize the optimal intervention window before metastasis occurs or during the micrometastasis stage. Previous research has adopted artificial intelligence to break the constraints of traditional imaging and realized subclinical early warning of distant metastasis based on retrospective data. On this basis, the present study aims to systematically validate the predictive performance and generalizability of the model in real-world clinical settings via a prospective cohort. This study intends to establish an organ-specific, non-invasive and cost-effective pan-cancer tool for early warning of distant metastasis. It can gain critical time for clinical intervention, help reduce the incidence of distant metastasis and ultimately optimize patient prognosis.",[356],"Malignant Tumor With Metastasis",{"date":358,"type":33},"2026-05-29",{"date":35,"type":22},{"date":361,"type":22},"2036-12-31",{"name":39,"class":40},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":68},"100639879","ultrasound-monitoring-of-clipped-lymph-nodes-to-predict-axillary-response-after-chemotherapy-in-breast-cancer-100639879","NCT07596472","Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer","A Prospective Diagnostic Clinical Study Based on Longitudinal Multimodal Ultrasound Evaluation of Clipped Lymph Nodes to Assess Axillary Pathological Response After Neoadjuvant Chemotherapy in Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n\nClinical stage of breast cancer: T1-T4, N1-N3, M0.\n\nAxillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy.\n\nIndicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen.\n\nThe biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement.\n\nCompletion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available.\n\nUnderwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound.\n\nSigned informed consent and willingness to complete all scheduled follow-ups.\n\nExclusion Criteria:\n\n* Bilateral breast cancer.\n\nPatients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only.\n\nPrior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment.\n\nPresence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult.\n\nPregnant or lactating women.\n\nPoor image quality on ultrasound or other imaging modalities.\n\nInability to provide informed consent due to psychological, family, or social factors",{"count":371,"type":22},150,"This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. In this study, patients with biopsy-proven metastatic axillary lymph nodes will have a metallic clip placed in the positive node before chemotherapy. During and after treatment, the clipped lymph node will be monitored by ultrasound, including gray-scale imaging, shear wave elastography, and contrast-enhanced ultrasound. The changes in the morphological and functional features of the clipped node will be analyzed to establish a predictive model for axillary pathological complete response. The results are expected to help identify patients who may safely avoid unnecessary axillary lymph node dissection and improve individualized surgical decision-making.",[194,374,375,376],"Axillary Lymph Node Metastasis","Neoadjuvant Chemotherapy","Pathological Complete Response","2026-05-13",{"date":379,"type":33},"2026-05-19",{"date":381,"type":22},"2026-05-20",{"date":383,"type":22},"2027-05-20",{"name":39,"class":40},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":77,"minAge":259,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100637079","phase-1-tocilizumab-for-the-treatment-of-refractory-granulomatous-lobular-mastitis-100637079","NCT07595900","Tocilizumab for the Treatment of Refractory Granulomatous Lobular Mastitis","Efficacy and Safety of Tocilizumab in the Treatment of Refractory Granulomatous Lobular Mastitis: A Two-Center, Single-Arm Clinical Trial","Inclusion Criteria:\n\n1. Females aged 20 to 50 years;\n2. Clinically diagnosed (combined with pathology) with non-lactational granulomatous mastitis (cessation of lactation for more than 6 months);\n3. M-Activity-Score ≥ 2;\n4. Steroid-refractory NL-GLM or intolerant to steroid therapy.\n5. Female subjects of childbearing potential agree to use highly effective contraception starting at least 7 days before the first dose until 16 weeks after dosing. Pregnancy tests for female subjects of childbearing potential must be negative within 7 days before the first dose.\n\nExclusion Criteria:\n\n1. Bilateral mastitis occurring simultaneously or sequentially within six months.\n2. Clinical diagnosis (combined with pathological findings) of periductal mastitis.\n3. History of lymphoproliferative disorder; or presence of signs or symptoms suggestive of a possible lymphoproliferative disorder (including lymphadenopathy or splenomegaly); or active primary or recurrent malignancy; or clinically significant malignancy with a remission duration of less than 5 years.\n\n   1. Patients with carcinoma in situ of the cervix may participate if successfully treated with no evidence of recurrence or metastasis for at least 3 years.\n   2. Patients with basal cell or squamous cell carcinoma of the skin may participate if successfully treated with no evidence of recurrence for at least 3 years.\n4. Patients who are pregnant.\n5. Current or recent severe viral, bacterial, fungal, or parasitic infection, including but not limited to:\n\n   1. Symptomatic herpes zoster infection within 12 weeks prior to screening.\n   2. History of disseminated\u002Fcomplicated herpes zoster (e.g., multidermatomal involvement, herpes zoster ophthalmicus, CNS involvement, or postherpetic neuralgia).\n   3. Symptomatic herpes simplex at the time of enrollment.\n   4. Active or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n   5. Household contact with an individual with active tuberculosis (TB) and not having received appropriate and documented TB prophylaxis.\n   6. Evidence of active TB, or history of active TB without appropriate and documented treatment.\n   7. Clinically significant infection within 4 weeks prior to enrollment, or having received intravenous antibiotic therapy for an infection.\n   8. Any other active or recent infection within 4 weeks prior to enrollment that, in the investigator's judgment, would pose an unacceptable risk to the patient.\n\n   Note: Recent viral upper respiratory tract infections or uncomplicated urinary tract infections should not be considered clinically significant.\n6. Patients with hepatic or renal insufficiency, gastrointestinal ulcer, active hepatitis, active rheumatic autoimmune disease, active tuberculosis, or poorly controlled psychiatric disorders.\n7. Cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that, in the investigator's judgment, makes the patient unsuitable for enrollment.\n8. History of hypersensitivity to tocilizumab.\n9. Previous treatment with tocilizumab (a single prior dose may be exempted upon investigator's assessment).\n10. Any major surgery within 8 weeks prior to screening, or requirement for major surgery during the study period, which, in the investigator's judgment, would pose an unacceptable risk to the patient.\n11. Presence of the following laboratory abnormalities, or any other laboratory value outside the reference range deemed by the investigator to pose an unacceptable risk for participation:\n\n    1. AST or ALT ≥ 2 × upper limit of normal (ULN)\n    2. Alkaline phosphatase (ALP) ≥ 2 × ULN\n    3. Total bilirubin (TBL) ≥ 1.5 × ULN\n    4. Hemoglobin \\\u003C 9.0 g\u002FdL\n    5. Total white blood cell count \\\u003C 2.5 × 10⁹ cells\u002FL\n    6. Neutropenia (absolute neutrophil count \\[ANC\\] \\\u003C 1.2 × 10⁹ cells\u002FL)\n    7. Lymphopenia (lymphocyte count \\\u003C 0.75 × 10⁹ cells\u002FL)\n    8. Thrombocytopenia (platelets \\\u003C 100 × 10⁹\u002FL)\n    9. Estimated glomerular filtration rate (eGFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m² (based on the CKD-EPI equation) Note: The above abnormalities may be retested during the screening period, with eligibility determined based on the retest results.\n12. Administration of a live or attenuated vaccine within 6 weeks prior to the first dose, or planned administration during the treatment period or within 6 weeks after the last dose.\n13. Body weight ≥ 100 kg.","50 Years",{"count":394,"type":22},31,[51,25],"Non-Lactational Granulomatous Lobular Mastitis (NL-GLM) is an inflammatory disease of unknown etiology, characterized clinically by local breast masses, accompanied by redness and swelling of the overlying skin, sinus tract formation, and other symptoms. Currently, there is no universally accepted standard treatment for this condition; previous expert consensus or practice guidelines have mostly recommended systemic glucocorticoid therapy as the primary treatment approach. Our team's preliminary research has confirmed that local glucocorticoid injection achieves efficacy equivalent to systemic administration but with better safety, making it a first-line treatment option for NL-GLM. However, in our preliminary studies and literature reports, we found that some patients still exhibit glucocorticoid dependence or resistance (i.e., refractory NL-GLM) after receiving either local or systemic glucocorticoid therapy. The lack of high-quality evidence to support subsequent-line treatments has become a major bottleneck in clinical management. Additionally, some patients cannot tolerate glucocorticoid therapy due to its adverse effects. Research has shown that the IL-6 inflammatory pathway is significantly activated in the lesion tissues and peripheral blood of NL-GLM patients, and the IL-6 inhibitor tocilizumab has demonstrated efficacy in various autoimmune diseases. Based on this, this study intends to conduct a dual-center, single-arm clinical trial to systematically evaluate the efficacy and safety of tocilizumab in the treatment of refractory NL-GLM. The aim is to fill the treatment gap, provide high-level evidence for clinical practice, and ultimately improve patient outcomes.",[398,399],"Granulomatous Lobular Mastitis","Granulomatous Mastitis",{"date":379,"type":33},{"date":35,"type":22},{"date":403,"type":22},"2028-10-30",{"name":39,"class":40},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":68},"100640771","phase-2-adebrelimab-combined-with-neoadjuvant-chemoradiotherapy-for-esophageal-squamous-cell-carcinoma-100640771","NCT07595770","Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma","A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma","ANCRE","Inclusion Criteria:\n\n* \\- 1. Provided informed consent and sign the informed consent form;\n* 2\\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);\n* 3\\. Pathological confirmed ESCC;\n* 4\\. Patients assessed by thoracic oncologists as resectable without distant metastasis\n* 5\\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;\n* 6\\. Have at least one assessable lesion according to the RECIST V1.1\n* 7\\. ECOG-PS score: 0-1;\n* 8\\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;\n* 9\\. With a life expectancy of ≥ 6 weeks;\n* 10\\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;\n\nExclusion Criteria:\n\n* 1\\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy\n* 2\\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons\n* 3\\. Simultaneously developing tumors in other parts of the body\n* 4\\. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and\u002For AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)\n* 5\\. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses\\>10 mg\u002Fday or oral prednisone for more than 2 weeks\n* 6\\. Severe allergy to immune preparations\n* 7\\. Abnormal coagulation function: (PT\\>16s, APTT\\>53s, TT\\>21s, Fib\\\u003C1.5 g\u002FL), bleeding tendency or during thrombolytic or anticoagulant therapy\n* 8\\. Pregnancy or lactation period\n* 9\\. Other situations as judged by investigators not suitable for inclusion.;",{"count":414,"type":22},37,[25],"This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.",[418],"Esophageal Squamous Cell Carcinoma (ESCC)",[420,421,422,423],"chemotherapy","radiotherapy","immune checkpoint inhibitors","adebrelimab",{"date":379,"type":33},{"date":426,"type":22},"2026-05-22",{"date":428,"type":22},"2029-10-01",{"name":39,"class":40},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":260,"maxAge":19,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100640943","an-exploratory-study-on-triple-inhaler-therapy-in-patients-with-early-lung-function-impairment-100640943","NCT07595796","An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment","Efficacy Evaluation of Budesonide\u002FGlycopyrronium Bromide\u002FFormoterol Inhalation Aerosol in Symptomatic Preserved Ratio Impaired Spirometry (PRISm): A Single-arm Multicenter Clinical Trial","BGF-PRISm","Inclusion Criteria:\n\n1. Age 40-75 years;\n2. Smoking history ≥10 pack-years;\n3. Pulmonary function test showing 0.7 ≤ FEV1\u002FFVC \\\u003C 0.8 and FEV1 \\\u003C 80% predicted;\n4. Presence of at least one chronic respiratory symptom (e.g., cough, sputum, dyspnea) lasting ≥3 months;\n5. Voluntarily sign a written informed consent form, be able to understand the study objectives, and comply with follow-up requirements;\n6. The investigator assesses that the subject is able to complete the 12-week treatment and follow-up and has good medication adherence.\n\nExclusion Criteria:\n\n1. Concomitant Respiratory Diseases: (1) Diagnosed asthma, bronchiectasis, interstitial lung disease, active tuberculosis, or lung cancer. (2) Meeting the diagnostic criteria for chronic obstructive pulmonary disease (COPD) (post-bronchodilator FEV1\u002FFVC \\\u003C 0.7). (3) Acute respiratory infection or exacerbation within 4 weeks prior to enrollment.\n2. Cardiovascular Disease Risks: (1) Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg). (2) Myocardial infarction, unstable angina, malignant arrhythmia, or cardiac insufficiency (NYHA class ≥III) within the past 6 months. (3) Long-term use of beta-blockers or antiarrhythmic drugs.\n3. Drug-Related Contraindications: (1) Allergy to budesonide, glycopyrronium bromide, formoterol, or excipients of the inhalation aerosol. (2) Use of long-acting bronchodilators (LABA, LAMA), inhaled corticosteroids, or immunosuppressants within 4 weeks prior to enrollment.\n4. Other Systemic Diseases: (1) Severe hepatic or renal insufficiency (ALT\u002FAST \\> 3 times the upper limit of normal, or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²). (2) Uncontrolled diabetes (HbA1c \\> 9%) or hyperthyroidism.\n5. Special Populations and Compliance Issues: (1) Pregnant or lactating women, or women planning pregnancy without using effective contraception. (2) History of substance abuse, psychiatric disorders, or cognitive impairment that may affect study compliance. (3) The investigator deems the subject unsuitable for participation for other reasons (e.g., life expectancy \\\u003C 1 year, inability to complete follow-up).",{"count":439,"type":22},23,[115],"Preserved Ratio Impaired Spirometry (PRISm) is characterized by a normal forced expiratory volume in one second (FEV1)\u002Fforced vital capacity (FVC) ratio but an FEV1 below 80% of the predicted value. It has a population prevalence of approximately 10% and is associated with marked symptoms, a high risk of acute exacerbations, and increased mortality. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines PRISm as a pre-chronic obstructive pulmonary disease (COPD) state, and 20%-30% of patients with PRISm will progress to COPD. Currently, no evidence-based therapy exists for PRISm; management is mainly symptomatic relief, and there is an urgent need for evidence-based support. This single-arm clinical trial preliminarily evaluates the efficacy and safety of budesonide\u002Fglycopyrronium\u002Fformoterol inhalation aerosol in symptomatic patients with PRISm. Symptomatic smokers who meet the diagnostic criteria for PRISm and have an FEV1\u002FFVC ratio ≥0.7 and \\\u003C0.8 are enrolled and treated with budesonide\u002Fglycopyrronium\u002Fformoterol inhalation therapy for 12 weeks. The primary endpoint is the change from baseline in FEV1; secondary endpoints include symptom score (COPD Assessment Test, CAT) and quality of life (St George's Respiratory Questionnaire, SGRQ); safety is assessed by recording adverse events (e.g., cardiovascular events); and exploratory analyses examine the association between biomarkers (e.g., peripheral blood eosinophil count, serum IgE level) and treatment efficacy. The study aims to preliminarily explore the efficacy and safety of budesonide\u002Fglycopyrronium\u002Fformoterol inhaler therapy for PRISm. Early intervention may delay the progression from PRISm to COPD, reduce the burden of chronic respiratory disease, and have important clinical translational value and public health significance.",[443],"Preserved Ratio Impaired Spirometry (PRISM)",[443],{"date":379,"type":33},{"date":35,"type":22},{"date":448,"type":22},"2028-02-29",{"name":39,"class":40},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":472},"100539248","methotrexate-combined-with-tofacitinib-in-rheumatoid-arthritis-100539248","NCT06301373","Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis","Methotrexate Combined With Tofacitinib in the Treatment of Active Rheumatoid Arthritis With a Myeloid-stromal Pathotype: a Randomized, Controlled, Open Label, Multicenter Clinical Study","Inclusion Criteria:\n\n* Patients were diagnosed according to the 1987 American College of Rheumatology or 2010 American College of Rheumatology\u002FEuropean League Against Rheumatism criteria\n* Patients had moderate or high disease activity\n* Patients had a synovial biopsy and with a myeloid-stromal pathotype\n* Patients with good compliance, willing to participate in this study and sign an informed consent form\n\nExclusion Criteria:\n\n* Patient received conventional synthetic disease modifying anti-rheumatic drugs treatment in the first 12 weeks of randomization\n* Patient received biologic agents treatment in the first 6 months of randomization\n* Patient received Janus kinase inhibitor treatment before randomization\n* Patient with serious diseases under control (such as diabetes), serious respiratory diseases, serious chronic gastrointestinal diseases (such as active or recurrent gastrointestinal ulcers), serious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any disease that can cause hemolysis or erythrocyte instability (such as malaria, hemolytic anemia)\n* Patients with moderate to severe congestive heart failure (New York Heart Association grade III or IV), or recent (within 6 months prior to screening) cerebrovascular accident, myocardial infarction, coronary stent implantation, or uncontrolled hypertension\n* Patients with blood routine WBC\\\u003C4.0 × 109\u002FL, and\u002For Hb\\\u003C90g\u002FL, and\u002For Plt\\\u003C100 × 109\u002FL during the screening period\n* Patients with active chronic liver disease or abnormal liver function, AST, ALT, GGT, and TBIL are more than twice the upper limit of normal during the screening period\n* Patients with estimated glomerular filtration rate \\\u003C30ml\u002Fmin during screening period\n* Patients with history of symptomatic herpes zoster infection (within the first 12 weeks of randomization), recurrent or disseminated (even if only once) herpes zoster or disseminated (even if only once) herpes simplex infection\n* Chest X-ray or CT examination indicates active tuberculosis, or latent tuberculosis (T-SPOT or TB-IGRA positive) without prophylactic tuberculosis treatment for at least 4 weeks\n* Patients woth hepatitis C virus ribonucleic acid (HCV-RNA) testing are higher than the lower limit of detection; Or positive for Treponema pallidum antibody (TP Ab); Or human immunodeficiency virus antibody (HIV Ab) positive during the selected period\n* Patients with hepatitis B surface antigen positive without prophylactic antiviral treatment\n* Patients with history of lymphoproliferative diseases, or possibly various signs or symptoms of lymphoproliferative diseases\n* Patients with any active malignant tumors or history of malignant tumors within the first 5 years, except for skin squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ that has been treated and considered cured\n* Patients with history of thromboembolism, including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc., or high risk factors prone to thromboembolism (such as obesity, smoking, abnormal coagulation function, diabetes, long-term use of estrogen or use of compound hormonal contraceptives or hormone replacement therapy, long-term braking, etc., which are comprehensively judged by the investigator according to clinical evaluation)\n* Patients with undergone major surgery within the first 4 weeks of randomization, or is expected to undergo major surgery after enrollment; Or a history of chronic pain that may affect the evaluation of the study; Or have received organ transplantation before\n* Patients with history of mental illness, alcoholism, drug or other substance abuse\n* Pregnant women, lactating women, and men or women who plan to conceive in the near future\n* The researchers believe that there are any other factors that may affect the progress or evaluation of the results of this study","65 Years",{"count":459,"type":22},130,[115],"Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy.\n\nThis project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48.\n\nThis project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines.",[463],"Rheumatoid Arthritis","2026-05-08",{"date":466,"type":33},"2026-05-12",{"date":468,"type":33},"2024-09-01",{"date":470,"type":22},"2029-12-31",{"name":39,"class":40},5,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":129},"100623737","phase-3-ribociclib-in-hormone-receptor-positive-her2-negative-early-breast-cancer-with-residual-disease-after-neoadjuvant-chemotherapy-100623737","NCT07400523","Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy","Ribociclib Plus Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy: an Open-label, Multicenter, Randomized, Phase III Trial","Inclusion Criteria:\n\n* Willingness for study participation with written informed consent\n* Female with age at least 18 years\n* Histologically confirmed unilateral or bilateral primary invasive breast cancer\n* Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion\n* Histologically confirmed hormone receptor-positive (≥1% ER and\u002For PR positive stained cells) and HER2-negative (IHC 2+ with FISH-negative or IHC 0-1+) assessed preferably on core biopsy of the breast or tissue from post-neoadjuvant residual invasive disease, or if no other tissue is available the residual tumor of the lymph node can be assessed. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable\n* Histologically confirmed Ki67 expression assessed preferably on core biopsy or post-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable\n* QTc interval \\\u003C 450 msec with mean resting heart rate 50-99 beats\u002Fmin (determined by ECG)\n* Patients must have received neoadjuvant chemotherapy of at least 18 weeks. This period must include 6 weeks of a taxane-containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant treatment, a total treatment period of less than 18 weeks is also eligible)\n* Adequate surgical treatment including resection of all clinically evident disease and ipsilateral axillary lymph node dissection. Histologically complete resection (R0) of the invasive and ductal in situ tumor is required in case of breast conserving surgery as the final treatment. No evidence of gross residual disease (R2) is required after total mastectomy (R1 resection is acceptable). Axillary dissection is not required in patients with a negative sentinel-node biopsy before (pN0, pN+\\[mic\\]) or after (ypN0, ypN+\\[mic\\]) neoadjuvant chemotherapy\n* Less than 16 weeks interval since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) at date of randomization\n* Completion of adjuvant radiotherapy according to standard guidelines (e.g. NCCN) is strongly recommended. If radiotherapy is not performed the reason for this needs to be documented in the eCRF\n* No clinical evidence for locoregional or distant relapse during or after preoperative chemotherapy. Local progression during chemotherapy is not an exclusion criterion\n* c\u002FpT3N0; c\u002FpT2N0 with MammaPrint high-risk, G3, G2+Ki67 ≥20%, or lymphovascular invasion\n* Eastern Cooperative Oncology Group performance status 0 or 1\n* Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion)\n* Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer\n* The patient must be accessible for scheduled visits, treatment and follow-up. Patients registered on this trial must be treated at the participating center which could be the Principal or a Co- investigator's site\n\nExclusion Criteria:\n\n* c\u002FpN+\n* Known severe hypersensitivity reactions to compounds similar to ribociclib or to aromatase inhibitor\n* Inadequate organ function immediate prior to randomization including: Hemoglobin \\\u003C10g\u002FdL (100g\u002FL); ANC \\\u003C 2000\u002Fmm³ (\\\u003C 2.0 x 10\\^9\u002FL); Platelets \\\u003C100,000\u002Fmm³ (\\\u003C 100 x 10\\^9\u002FL); AST or ALT \\>1.5 x upper limit of normal (ULN); alkaline phosphatase \\> 2.5 x ULN, total serum bilirubin \\> 1.25 x ULN; serum creatinine \\>1.25 x ULN or estimated creatinine clearance \\\u003C 60 mL\u002Fmin as calculated using the method standard for the institution; severe and relevant co-morbidity that would interact with the participation in the study\n* Evidence for infection including wound infections, Human Immunodeficiency Virus (HIV) or any type of Hepatitis\n* The cumulative dose of doxorubicin is more than 450mg\u002Fm² or epirubicin is more than 900mg\u002Fm²\n* Uncontrolled electrolyte disorders (eg, hypocalcemia, hypokalemia, hypomagnesemia)\n* Any of the following within 6 months of randomization: myocardial infarction, severe\u002Funstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade ≥2, atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism\n* Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection\n* Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix\n* Current severe acute or uncontrolled chronic systemic disease (e.g. diabetes mellitus) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study\n* Recent (within the past year) or active suicidal behavior\n* Pregnancy or lactation period. Women of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment and for 90 days after discontinuation. A serum pregnancy test must be negative in premenopausal women or women with amenorrhea of less than 12 months\n* Major surgery within 2 weeks prior to randomization\n* 10 weeks or more have passed since completion of radiotherapy at day of randomization and 16 weeks interval since the date of final surgery have passed\n* Prior treatment with any CDK4\u002F6 inhibitor\n* Patients treated within the last 7 days prior to randomization and\u002For concurrent use of drugs known to be strong CYP3A4 inhibitors or inducers\n* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to randomization",{"count":481,"type":22},446,[234],"This is a multi-center, open-lable, prospective, randomized phase III clinical trial to investigate the efficacy and safety of adjuvant ribociclib combined with aromatase inhibitor in hormone receptor-positive, HER2-negative early breast cancer with residual disease after neoadjuvant chemotherapy",[194],"2026-04-27",{"date":487,"type":33},"2026-04-28",{"date":489,"type":33},"2026-02-10",{"date":491,"type":22},"2031-02-10",{"name":39,"class":40},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":514},"100600248","neoadjuvant-oral-paclitaxel-plus-subcutaneous-pertuzumabtrastuzumab-in-patients-with-her2-positive-breast-cancer-100600248","NCT07095023","Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab\u002FTrastuzumab in Patients With HER2-positive Breast Cancer","A Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Neoadjuvant Oral Paclitaxel Plus Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-positive Breast Cancer","OPTIMAL-BC","Inclusion Criteria:\n\nAged 18-75 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).\n\nBaseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n\nThe functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):\n\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase and aspartate aminotransferase (ALT\u002FAST) ≤1.5×ULN\n* Blood urea nitrogen and serum creatinine ≤1.5×ULN\n* Creatinine clearance (Ccr) ≥50 ml\u002Fmin (Cockcroft-Gault formula) Signature of informed consent\n\nExclusion Criteria:\n\n* History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and\u002For incisional biopsy of the primary tumor and\u002For axillary lymph nodes.\n\nPrior systemic therapy for breast cancer. History of life-threatening hypersensitivity reactions or known hypersensitivity to any component of the investigational drug.\n\nParticipation in another clinical trial of a drug or medical device within 4 weeks prior to the first dose and\u002For receipt of investigational drug\u002Fdevice during the trial.\n\nMajor surgery within 28 days prior to the first dose or planned major surgery during the study period.\n\nHistory of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ.\n\nActive tuberculosis or other severe infectious diseases requiring systemic treatment, including but not limited to bacteremia, severe pneumonia, and other serious infections.\n\nHistory of immunodeficiency or autoimmune diseases, including but not limited to HIV infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.\n\nHistory of cardiovascular or cerebrovascular diseases, including:\n\n* Unstable angina;\n* Clinically significant arrhythmias requiring medication;\n* Myocardial infarction within the past 6 months;\n* Heart failure or second-degree or higher atrioventricular block;\n* Cerebral infarction (excluding lacunar infarction) or cerebral hemorrhage within the past 6 months.\n\nPoorly controlled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite regular medication), or history of hypertensive crisis or hypertensive encephalopathy.\n\nUnsuitability for oral administration of the investigational drug, as judged by the investigator, including:\n\n* Clinically significant or uncontrolled congenital or acquired gastrointestinal diseases;\n* Diseases that may affect drug administration, gastric entry, or absorption (e.g., intestinal obstruction, Crohn's disease, ulcerative colitis).\n\nPregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception during the study and for 6 months after the last dose.",{"count":502,"type":22},112,[115],"The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.",[506],"Breast Cancers",{"date":508,"type":33},"2026-04-29",{"date":510,"type":33},"2025-08-15",{"date":512,"type":22},"2029-06-30",{"name":39,"class":40},9,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":4},"100635599","a-single-center-retrospective-study-to-improve-the-visibility-of-breast-tissue-marker-clips-in-breast-tissue-and-axillary-lymph-nodes-using-the-color-doppler-twinkling-artifact-100635599","NCT07554781","A Single-Center, Retrospective Study to Improve the Visibility of Breast Tissue Marker Clips in Breast Tissue and Axillary Lymph Nodes Using the Color Doppler Twinkling Artifact","A Single-Center, Retrospective Study on Enhancing the Visibility of Breast Tissue Marker Clips in Breast Tissue and Axillary Lymph Nodes Using the Twinkling Artifact Feature in Color Doppler Ultrasound","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Presence of suspicious breast lesions confirmed by ultrasound.\n* Successful implantation of a breast tissue marker clip with accurate radiological documentation.\n* Availability of preoperative breast ultrasound examinations (including B-mode and Color Doppler) performed using either a GE-10 or Siemens ultrasound system.\n* Confirmation of clip placement via mammography, surgical specimen morphology, or same-day post-implantation ultrasound.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* History of ipsilateral breast malignancy or surgery.\n* Presence of other metal implants potentially interfering with imaging.\n* Suspicious mammographic microcalcifications in the target lesion.",{"count":523,"type":22},86,"This single-center, retrospective study aims to evaluate the utility of the color Doppler twinkling artifact feature in improving the visibility of breast tissue marker clips within breast tissue and axillary lymph nodes. The study population will consist of approximately 86 female patients (with 110 clips) who have undergone placement of breast tissue marker clips and have corresponding preoperative imaging data from GE-10 or Siemens ultrasound systems between October 2024 and October 2025. The primary endpoint is the proportion of subjects whose implanted clips exhibit the characteristic \"twinkling artifact\" on color Doppler ultrasound imaging, reported with a 95% confidence interval.",[194],"2026-04-23",{"date":487,"type":33},{"date":529,"type":22},"2026-05",{"date":531,"type":22},"2027-05",{"name":39,"class":40},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":19,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":550,"locationsCount":68},"100635136","endoscopic-skin-sparing-vs-conventional-mastectomy-for-wound-complications-in-bc-100635136","NCT07548762","Endoscopic Skin-Sparing vs. Conventional Mastectomy for Wound Complications in BC","A Multicenter, Randomized, Controlled, Open-Label Study Comparing Endoscopic Skin-Sparing Mastectomy With Conventional Mastectomy for Wound Complications in Patients With Breast Cancer","Inclusion Criteria:\n\n* Female patients aged 18 to 75 years\n* Pathologically confirmed invasive breast cancer\n* Clinical stage cT1-4a N0-3 M0\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Unilateral breast cancer\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Hematological and renal function with the following parameters: White blood cell count ≥ 3.0 × 10⁹\u002FL; Neutrophil count ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n* No planned breast reconstruction\n\nExclusion Criteria:\n\n* Tumor invasion of the skin\n* Diffuse malignant microcalcifications\n* Breast cancer during pregnancy or lactation\n* History of another primary malignancy\n* Severe cardiopulmonary, hepatic or renal dysfunction, or other significant systemic diseases",{"count":541,"type":22},258,[115],"This randomized, open-label study compares endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in female patients with unilateral invasive breast cancer (T1-4aN0-3M0). The primary objective is to evaluate differences in postoperative wound complications and patient satisfaction, with secondary outcomes including breast appearance and oncological safety.\n\nEligible patients have a breast volume ≤ cup C and no\u002Fmild ptosis (grade I-II). A total of 258 participants (129 per group) will be enrolled across multiple centers and randomized by site.\n\nThis study aims to provide evidence for selecting optimal endoscopic surgical strategies, address the evidence gap for E-SSM without immediate reconstruction, and advance the precision of breast cancer surgery.",[194],"2026-04-21",{"date":526,"type":33},{"date":548,"type":33},"2025-12-05",{"date":342,"type":22},{"name":39,"class":40},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":77,"minAge":18,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":566,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":575},"100584465","phase-3-phase-iii-trial-of-camrelizumabapatiniberibulin-vs-physicians-choice-chemotherapy-in-advanced-triple-negative-breast-cancer-100584465","NCT06889688","Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer","A Multicenter, Phase III, Randomized Controlled Trial Comparing Camrelizumab Plus Apatinib and Eribulin Versus Physician's Choice Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. The subject voluntarily agrees to participate in this study and signs an informed consent form (ICF).\n2. Female subjects aged ≥18 and ≤70 years on the date of signing the ICF.\n3. Pathologically confirmed advanced triple-negative breast cancer (TNBC), defined as ER-negative (IHC ER-positive percentage \\\u003C1%), PR-negative (IHC PR-positive percentage \\\u003C1%), and HER2-negative (IHC-\u002F+, or IHC++ but FISH\u002FCISH-), with at least one measurable lesion per RECIST v1.1 criteria.\n4. Patients who have received at least 1 and up to 4 lines of prior systemic therapy for metastatic or locally advanced unresectable triple-negative breast cancer (TNBC) with disease progression. Prior systemic therapy (including at least 1 line of chemotherapy and neoadjuvant\u002Fadjuvant chemotherapy) must include at least a taxane or anthracycline. Subjects who relapse within 6 months after completion of neoadjuvant\u002Fadjuvant chemotherapy are considered as having failed first-line therapy.\n5. Capable of swallowing tablets.\n6. ECOG performance status of 0-1.\n7. Expected survival ≥12 weeks.\n8. Adequate function of vital organs, meeting the following criteria (without the use of blood products or growth factors during the screening period): Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL. Platelet count ≥100×10⁹\u002FL. Hemoglobin ≥9 g\u002FdL. Serum albumin ≥3 g\u002FdL. Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be assessed; subjects with normal T3 and T4 levels are eligible). Total bilirubin ≤1.0×ULN (for subjects with Gilbert's syndrome or liver metastases, total bilirubin ≤1.5×ULN). ALT and AST ≤1.5×ULN (for subjects with liver metastases, ≤3×ULN). Alkaline phosphatase (ALP) ≤2.5×ULN. Renal function within 7 days prior to the first dose: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin.\n9. Women of childbearing potential agree to use highly effective contraception starting at least 7 days prior to the first dose and continuing for 24 weeks after the last dose. A negative serum pregnancy test is required within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n1. Subjects with untreated active brain metastases or leptomeningeal metastases.\n2. Participation in any other interventional clinical trial within 28 days prior to the first dose.\n3. History of severe allergic reactions to other monoclonal antibodies.\n4. Receipt of other antitumor therapies within 28 days prior to the first dose.\n5. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n6. Prior treatment with CTLA-4, Tim-3, or LAG-3 antibodies, or T-cell co-stimulatory therapies (previous use of PD-1 or PD-L1 antibodies is allowed).\n7. Prior treatment with anti-angiogenic agents or eribulin chemotherapy.\n8. Presence of any active autoimmune disease or a history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Subjects with vitiligo, or childhood asthma that has fully resolved without intervention in adulthood, may be included. Subjects with asthma requiring medical intervention with bronchodilators are excluded.\n9. Uncontrolled cardiac clinical symptoms or diseases, including: Heart failure classified as NYHA Class II or higher. Unstable angina. Myocardial infarction within the past year. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n10. Urinalysis indicating proteinuria ≥++ or confirmed 24-hour urinary protein ≥1.0 g.\n11. Known hereditary or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism).\n12. Congenital or acquired immunodeficiency (e.g., HIV infection).\n13. Receipt of a live vaccine within 4 weeks prior to or during the study period.\n14. Allergy or contraindication to the investigational drugs.\n15. Underwent surgery within 3 months prior to enrollment or anticipated need for major surgical procedures during the study period.","70 Years",{"count":560,"type":22},246,[234],"This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.",[564,565],"Breast Cancer Stage IV","Triple -Negative Breast Cancer",[567,58],"Advanced Triple-Negative Breast Cancer","2026-04-19",{"date":526,"type":33},{"date":571,"type":33},"2025-02-21",{"date":573,"type":22},"2029-06-01",{"name":39,"class":40},7,{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":68},"100603539","phase-3-optimizing-reperfusion-by-intra-arterial-thrombolysis-as-adjunct-to-endovascular-treatment-for-medium-vessel-occlusion-100603539","NCT07137832","OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion","OPtimizing REperfusion by Intra-Arterial ThRomboLysis as Adjunct to Endovascular Treatment for Medium Vessel Occlusion (PEARL-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial","PEARL-MeVO","Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Clinical diagnosis of acute ischemic stroke.\n3. CT angiography (CTA) or MR angiography (MRA) confirmed primary isolated medium vessel occlusion (i.e. an occlusion of the co-\u002Fnon-dominant M2, the M3\u002FM4 segment of the MCA, the A1\u002FA2\u002FA3 segment of the ACA, or the P1\u002FP2\u002FP3 segment of the PCA).\n4. Baseline NIHSS ≥6.\n5. Treatment (arterial puncture) can be initiated 5.1 Within 6 hours of last known well (LKW) OR 5.2 Within 6 to 24 hours of LKW AND evidence of salvageable brain tissue on CT perfusion or perfusion-diffusion MRI (ischemic core volume \\\u003C50mL, hypo-perfused tissue volume to ischemic core volume ratio \\>1.4, mismatch volume \\>10mL). Hypo-perfused tissue is defined as Tmax \\>6s on CT perfusion or perfusion MRI. Ischemic core is defined as rCBF \\\u003C30% on CT perfusion or ADC \\\u003C620μm2\u002Fs on diffusion MRI.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Evidence of intracranial hemorrhage.\n2. Pre-stroke mRS score ≥ 2.\n3. Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \\\u003C6 at randomization.\n4. The intervention procedure is unlikely to be completed as assessed by the investigator.\n5. Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis.\n6. Suspected arterial dissection.\n7. Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast.\n8. Known genetic or acquired bleeding disposition or anticoagulant factors deficiency.\n9. Coagulation disorder with INR \\>1.7 or use of new oral anticoagulants within 48 hours prior to symptom onset.\n10. Platelet count \\\u003C50×10\\^9\u002FL.\n11. Any active or recent bleeding (gastrointestinal, urinary tract bleeding, etc.), or previous parenchymal organ surgery or biopsy in the last 1 month.\n12. Systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg, refractory to treatment.\n13. Known severe renal insufficiency with glomerular filtration rate \\\u003C30 ml\u002Fmin or blood creatinine \\>220 μmol\u002FL (2.5 mg\u002Fdl).\n14. Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma).\n15. Anticipated life expectancy \\\u003C6 months due to advanced disease (e.g., malignancy, severe cardiopulmonary disease, etc.).\n16. Women who are pregnant or breastfeeding.\n17. Participation in other clinical trials.\n18. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and\u002For comply with study procedures and\u002For follow-up due to psychiatric disorders, cognitive or emotional impairment).",{"count":585,"type":22},530,[234],"PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of intra-arterial thrombolysis as adjunct to endovascular treatment in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.",[237],"2026-04-14",{"date":591,"type":33},"2026-04-16",{"date":593,"type":33},"2025-10-09",{"date":595,"type":22},"2028-12-31",{"name":39,"class":40},""]