[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fudan University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":612},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,522,0,25,[9,45,72,98,118,149,170,198,222,239,265,289,312,339,360,388,408,430,455,477,499,525,547,569,590],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100652821","phase-2-the-study-of-andamertinib-plus-anlotinib-in-patients-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100652821",false,"NCT07780578","The Study Of Andamertinib Plus Anlotinib In Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","A Single Arm, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Andamertinib Combined With Anlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Failed Prior First Line Third Generation EGFR TKI Therapy","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the written informed consent form.\n2. Aged ≥ 18 years, male or female.\n3. Non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically, clinically diagnosed as unresectable and ineligible for curative concurrent chemoradiotherapy, including locally advanced (stage ⅢB\u002FⅢC), metastatic or recurrent (stage Ⅳ) NSCLC.\n4. Harboring EGFR mutations (including exon19 deletions and exon21 L858R mutation), with documented disease progressed following only one prior line of third-generation EGFR-TKI therapy.\n5. At least one measurable lesion per RECIST v1.1. Lesions previously irradiated cannot serve as target lesions unless definitive progression has occurred in the irradiated lesion.\n6. Patients with asymptomatic brain metastases, or brain metastases whose symptoms have stabilized after treatment.\n7. Laboratory values meeting all of the following criteria:\n\n(1) Hemoglobin ≥100g\u002FL (female), ≥110g\u002FL (male). (2) Absolute neutrophil count ≥1.5×10⁹\u002FL. (3) Platelet count ≥100×10⁹\u002FL. (4) Serum creatinine ≤115 μmol\u002FL, or creatinine clearance (CrCl) ≥60mL\u002Fmin (Cockcroft-Gault formula).\n\n(5) Total bilirubin ≤1.5×upper limit of normal (ULN). (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; or ≤5×ULN for patients with liver metastases.\n\n(7) Albumin ≥30g\u002FL. 8. ECOG PS 0-1. 9. Expected survival ≥3 months. 10. Males with reproductive potential and females of child-bearing potential must agree to use effective contraception from the time of informed consent signing until 3 months after the last study drug administration. For females of child-bearing potential, serum pregnancy test must be negative within 7 days prior to the first study drug dose. Women with surgical sterilization or post-menopausal status are exempted.\n\nExclusion Criteria:\n\n1. Diagnosis of other malignant diseases within 3 years prior to first study drug administration, except for radically treated basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, and\u002For radically resected carcinoma in-situ.\n2. Presence of any of the following genetic alterations: ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon14 skipping mutation, MET amplification, RET fusion, KRAS G12C mutation, HER2 mutation, NRG1 fusion.\n3. Central squamous-cell carcinoma with high risk of massive hemoptysis.\n4. Toxicities from prior anti-tumour therapy have not recovered to Grade≤1, except for alopecia, fatigue and other toxicities judged by the investigator to carry low safety risk.\n5. Prior treatment with sunvozertinib.\n6. Major surgery (e.g., intrathoracic, intra-abdominal or pelvic surgery) within 4 weeks before first study drug administration, or resection for brain metastases within 2 weeks, with incomplete recovery from surgical adverse effects. Thoracoscopic biopsy and mediastinoscopy are not considered major surgery; subjects may be enrolled ≥1week after such procedures. Thoracic\u002Fabdominal effusion drainage and needle biopsy are not regarded as surgery.\n7. Severe or uncontrolled systemic diseases, including but not limited to:\n\n(1) Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite treatment; antihypertensive agents may be initiated or adjusted prior to screening).\n\n(2) Positive HIV antibody; or positive HCV antibody plus positive HCV-RNA; or positive HBsAg with HBV-DNA ≥500 IU\u002FmL. Exception: subjects may be enrolled if HBV-DNA decreases to \\\u003C 500 IU\u002FmL and remains so for ≥2 weeks under antiviral therapy during screening, and antiviral therapy must be continued throughout the study. Subjects who require antiviral therapy at screening or in the past must maintain antiviral therapy for the whole study period.\n\n(3) Active keratitis or ulcerative keratitis. (4) Active tuberculosis. (5) Active infection requiring systemic anti-infective therapy within 2 weeks prior to first study drug administration.\n\n(6) Other severe physical or psychiatric illnesses or laboratory abnormalities that, in the investigators opinion, make study drug inappropriate or compromise protocol compliance.\n\n8\\. Any of the following cardiac conditions:\n\n1. Mean QTcF (QTc corrected by Fridericia formula) from three screening ECGs \\>470 ms at rest.\n2. Significant arrhythmias including ventricular arrhythmias, pharmacologically uncontrolled supraventricular\u002Fnodal arrhythmias and other uncontrolled cardiac arrhythmias (e.g., complete left bundle-branch block, grade III atrioventricular block, grade II atrioventricular block, PR interval \\>250 msec).\n3. Risk factors for QTc interval prolongation: e.g., severe hypokalaemia, congenital long-QT syndrome, concomitant use of QTc-prolonging drugs.\n4. New York Heart Association (NYHA) congestive heart failure class ≥3; left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiogram.\n\n9\\. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid therapy; or ongoing medical intervention or active interstitial lung disease at present.\n\n10\\. Coagulopathy or bleeding diathesis: arterial\u002Fvenous thromboembolic events within 6 months before first study drug administration (including myocardial infarction, unstable angina, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, severe deep-vein thrombosis or other serious thromboembolic events); life-threatening bleeding events requiring transfusion, surgery, local intervention or sustained medical treatment; or tumour invasion of major vessels judged by the investigator to confer high bleeding risk.\n\n11\\. Dysphagia, active gastrointestinal disorders, or history of major gastrointestinal surgery that may substantially impair study-drug ingestion or absorption (e.g., ulcerative lesions, inability to swallow oral medication, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome).\n\n12\\. Pleural, pericardial or peritoneal effusion requiring drainage and\u002For associated with dyspnoea within 4 weeks before first study drug administration.\n\n13\\. Any clinically significant systemic disease requiring treatment as judged by the investigator, including but not limited to thyroid disorders (subjects with stable thyroid function on hormone-replacement therapy are eligible), organ transplantation recipients, psychiatric disorders, history of substance abuse, alcoholism or drug addiction.\n\n14\\. Known hypersensitivity to the active substance or excipients of the study drug.\n\n15\\. Pregnant or lactating females. 16. Currently participating in another investigational drug or device trial, or having received other investigational drugs\u002Fdevices within 2 weeks before first study drug administration.\n\n17\\. Cognitive impairment likely to limit understanding and execution of informed consent.\n\n18\\. Any other conditions that may increase risks related to study-drug administration, confound interpretation of study results, poor subject compliance, or render the subject unsuitable for enrolment as judged by the investigator.","ALL","18 Years",{"count":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a single arm study to access the anti-tumor efficacy and safety of Andamertinib plus Anlotinib in patients with locally advanced or metastatic non-small cell lung cancer previously treated with third-generation EGFR-TKI.",[27],"Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line",[29,30,31],"Andamertinib","Anlotinib","Third-generation EGFR-TKI","NOT_YET_RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":21},"2026-09-30",{"date":40,"type":21},"2029-09-30",{"name":42,"class":43},"Fudan University","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100652759","phase-2-selective-coverage-versus-comprehensive-coverage-radiotherapy-in-poorly-differentiated-and-anaplastic-thyroid-cancer-100652759","NCT07777536","Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer","Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer: A Randomized, Controlled, Non-inferiority, Phase 2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Pathologically confirmed as ATC, thyroid cancer containing ATC components, PDTC (in accordance with Turin criteria), or other thyroid cancers with poorly differentiated components, and the MDT considers the biological behavior similar to PDTC.\n* Evaluated by the MDT and proposed to receive external beam radiotherapy, including postoperative R0\u002FR1, R2 gross residual, inoperable local lesion, and local recurrence.\n* ECOG performance status 0-2\n* expected survival ≥ 3 months\n* major organ functions can meet the requirements for radiotherapy and the proposed systemic treatment.\n* The subject voluntarily participates in the study and signs a written informed consent form, willing to follow up according to the protocol and fill in the quality of life scale.\n\nExclusion Criteria:\n\n* Has received radiotherapy to the head and neck or upper mediastinum region in the past, and the target area of this study overlaps significantly with it, and the normal tissue limit cannot be met.\n* Has severe uncontrolled infections, active bleeding, unaddressed airway crises, severe dysfunction of the heart, lungs, liver, kidneys or other diseases that cannot be safely treated with radiotherapy.\n* Pregnant or lactating women; women of childbearing age who do not agree to take effective contraceptive measures.\n* Has other active malignant tumors within 5 years or simultaneously (excluding cured localized tumors such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.)\n* Cannot complete radiotherapy fixation, simulation positioning or follow-up imaging assessment.\n* Other situations that the researcher deems unsuitable for participation in this study.",{"count":53,"type":21},72,[24],"To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer",[57],"Thyroid Cancer",[59,60,61,62,63],"poorly differentiated thyroid cancer","anaplastic thyroid cancer","selective coverage radiotherapy","locoregional control","radiotherapy-related toxicity","RECRUITING",{"date":66,"type":36},"2026-08-20",{"date":68,"type":36},"2026-08-12",{"date":70,"type":21},"2032-07-31",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":44},"100652731","phase-2-induction-pd-1-inhibitor-and-chemotherapy-followed-by-chemoradiotherapy-in-unresectable-or-inoperable-hpv-negative-la-hnscc-100652731","NCT07776340","Induction PD-1 Inhibitor and Chemotherapy Followed by Chemoradiotherapy in Unresectable or Inoperable HPV-negative LA-HNSCC","Induction Chemoimmunotherapy Followed by Concurrent Chemoradiotherapy and Adjuvant Immunotherapy Versus Concurrent Chemoradiotherapy Alone in Unresectable or Inoperable Locoregionally Advanced HPV-Negative Head and Neck Squamous Cell Carcinoma: A Randomized, Controlled, Phase 2 Study","Inclusion Criteria:\n\n* Pathologically confirmed HPV-negative head and neck squamous cell carcinoma (including laryngeal, hypopharyngeal, or oropharyngeal cancer).\n* Loco-regionally advanced (Stage III-IVB) disease according to the 8th edition clinical staging system of the American Joint Committee on Cancer (AJCC)\u002FUnion for International Cancer Control (UICC).\n* Confirmed by a multidisciplinary team (MDT) as not amenable to curative surgery and deemed suitable for definitive concurrent chemoradiotherapy.\n\n\"Not amenable to curative surgery\" includes unresectable disease (anatomic impossibility of resection) or inoperable disease (patient medically unable to tolerate or declining surgical resection).\n\n* ECOG performance status of 0-1.\n* Pre-treatment neutrophils ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 × 10⁹\u002FL; total bilirubin ≤ 1.5 × upper limit of normal (ULN), ALT ≤ 1.5 × ULN, AST ≤ 1.5 × ULN, ALP ≤ 2.5 × ULN; creatinine ≤ 1.5 × ULN.\n* Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (patients on a stable dose of anticoagulant therapy, such as low molecular weight heparin or warfarin, with an INR within the therapeutic range for the anticoagulant, are eligible for screening).\n* Normal pulmonary and cardiac function.\n* Normal myocardial enzyme profile.\n* No prior radiotherapy, chemotherapy, immunotherapy, or biological targeted therapy, or any other antitumor treatment for the current tumor lesion(s).\n* Women of childbearing potential must have a negative pregnancy test (serum) within 7 days before enrollment and must voluntarily use appropriate contraception during the observation period and for 8 weeks after the last treatment; for men, they must be surgically sterile or agree to use appropriate contraception during the observation period and for 8 weeks after the last treatment.\n* Participants must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.\n\nExclusion Criteria:\n\n* Has a history or presence of other malignancies, except for those that have been cured and with no evidence of disease for over 5 years (such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma, etc.).\n* Has active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); excluding autoimmune-mediated hypothyroidism stabilized with thyroid hormone replacement therapy; type I diabetes mellitus stabilized on insulin regimen; vitiligo or childhood asthma\u002Fallergies that have resolved and require no intervention in adulthood.\n* Has uncontrolled cardiac clinical symptoms or diseases, such as: (a) NYHA Class II or above heart failure; (b) unstable angina; (c) myocardial infarction within the past year; (d) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n* Has severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first dose of the study drug, active infection during screening, or unexplained fever \\> 38.5°C before administration (tumor-related fever may be considered for inclusion).\n* Has a history of allergy to any component of anti-PD-1 antibodies, paclitaxel-based drugs, or cisplatin.\n* Prior radiotherapy, chemotherapy, immunotherapy (including PD-1, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, cancer vaccines, etc.), or biological targeted therapy for the current hypopharyngeal\u002Flaryngeal\u002Foropharyngeal cancer.\n* Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.\n* Requirement for systemic treatment with corticosteroids (prednisone equivalent dose \\> 10 mg\u002Fday) or other immunosuppressive agents within 2 weeks prior to the first dose of the study drug, except for topical use to manage local inflammation, prevent allergies, or manage nausea and vomiting. Other special cases should be discussed with the investigator. Inhaled or topical steroids and physiological doses of corticosteroid replacement for adrenal insufficiency (≤ 10 mg\u002Fday prednisone equivalent) are permitted in the absence of active autoimmune disease.\n* Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug.\n* Has a history of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.\n* Has a history of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) or non-infectious pneumonitis.\n* Has a history or CT evidence of active tuberculosis infection, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without formal treatment.\n* Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10⁴ copies\u002FmL) or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).\n* Known history of drug abuse, alcohol abuse, or substance addiction\n* Pregnant or lactating women.\n* Other factors considered by the investigator that may lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring combined treatment, severely abnormal laboratory test values, family or social factors, or any other circumstances that may compromise subject safety or integrity of the study data.","75 Years",{"count":81,"type":21},104,[24],"The goal of this clinical trial is to evaluate if adding chemotherapy and immunotherapy as induction treatment prior to definitive chemoradiotherapy could improve the outcomes of locally advanced HPV-negative head and neck squamous cell that are not amenable to surgery. The study aims to answer:\n\n1. Does this treatment improve the survival outcomes of participants?\n2. How do the tumors of participants response to the treatment?\n3. How is the safety of this treatment? Researchers will compare this treatment (induction chemoimmunotherapy, followed by concurrent chemoradiotherapy, and then immunotherapy as maintenance therapy) to concurrent chemoradiotherapy to see whether it provides additional clinical benefits.",[85],"HPV-unrelated Head and Neck Squamous Cell Carcinoma",[87,88,89,90,91],"Head and Neck Squamous Cell Carcinoma","Programmed Cell Death Receptor 1 (PD-1)","Chemotherapy","Chemoradiotherapy","Induction Treatment",{"date":66,"type":36},{"date":94,"type":21},"2026-09-01",{"date":96,"type":21},"2030-03",{"name":42,"class":43},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":44},"100652659","application-of-ct-linac-based-all-in-one-one-stop-radiotherapy-in-breast-cancer-100652659","NCT07776301","Application of CT-Linac-Based \"All-in-One\" One-Stop Radiotherapy in Breast Cancer","Application of CT-Linac-Based \"All-in-One\" One-Stop Radiotherapy in All-Scenario Breast Cancer Radiotherapy: A Prospective Clinical Study","Inclusion Criteria:\n\n* Histologically or pathologically confirmed breast cancer with definitive indications for radiotherapy (preoperative, postoperative, or radical)\n* ECOG performance status of 0-2\n* Able to remain still and supine on the treatment couch for up to 30 minutes\n* Provision of signed, written informed consent\n* Able to comply with daily follow-ups and blood sample collections\n\nExclusion Criteria:\n\n* Palliative radiotherapy for concurrent distant metastasis\n* Incomplete or ongoing chemotherapy\n* Synchronous multiple primary tumors\n* Current pregnancy or lactation\n* Prior history of radiotherapy to the ipsilateral breast, chest wall, thorax, or regional lymph nodes\n* Severe non-malignant comorbidities (e.g., cardiovascular or pulmonary diseases, systemic lupus erythematosus, scleroderma) resulting in a short life expectancy or inability to tolerate radical radiotherapy\n* Inability or unlikelihood to comply with study follow-up\n* Inability or unwillingness to provide written informed consent",{"count":106,"type":21},225,[108],"NA","This study aims to evaluate and report the clinical adverse events and dosimetric parameters in breast cancer patients undergoing an \"all-in-one (AIO)\" one-stop, fully automated radiotherapy workflow. By systematically tracking these clinical and physical metrics, we seek to establish a standardized clinical protocol for AIO radiotherapy in breast cancer management.",[111],"Breast Cancer",{"date":66,"type":36},{"date":114,"type":36},"2021-08-27",{"date":116,"type":21},"2028-11-27",{"name":42,"class":43},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100652754","phase-2-tactic-rcc-toripalimab-plus-axitinib-induction-with-selective-deferred-cytoreductive-nephrectomy-in-tls-positive-advanced-clear-cell-renal-cell-carcinoma-100652754","NCT07776717","TACTIC-RCC: Toripalimab Plus Axitinib Induction With Selective Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma","Toripalimab Plus Axitinib Induction Therapy With Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma: A Prospective, Single-Arm, Phase II Study (TACTIC-RCC)","TACTIC-RCC","Inclusion Criteria:\n\n1. Age ≥18 years; able to understand the study and provide written informed consent before any study-specific procedure.\n2. Newly diagnosed and previously untreated with systemic anticancer therapy for advanced renal cell carcinoma; the primary renal tumor remains in situ.\n3. Histologically confirmed renal cell carcinoma containing a clear-cell component. Tissue used for diagnosis and TLS screening must be obtained from a core-needle biopsy of the primary renal tumor.\n4. Clinical Stage IV disease according to the AJCC 8th edition, with synchronous distant metastasis confirmed radiologically or pathologically.\n5. At least one RECIST v1.1 measurable metastatic lesion outside the primary renal tumor: non-nodal lesion with longest diameter ≥10 mm or lymph node with short-axis diameter ≥15 mm. If cytoreductive nephrectomy is performed, the investigator anticipates that at least one metastatic lesion can remain available for postoperative longitudinal assessment; clinically necessary local therapy must not be delayed for research purposes.\n6. The primary-tumor biopsy meets specimen-quality requirements and is centrally classified as TLS-positive according to the protocol. Operationally, at least one adequate biopsy core must contain at least one organized lymphoid aggregate showing a relatively well-defined lymphoid structure on H\\&E, an identifiable CD20-positive B-cell domain with an adjacent or surrounding CD3-positive T-cell domain, and organization beyond scattered lymphocytes or a nonspecific small aggregate.\n7. ECOG performance status 0-1 and estimated life expectancy ≥6 months.\n8. Adequate major-organ function according to the central laboratory and applicable prescribing information, including acceptable hematologic, hepatic, renal, thyroid, and coagulation function.\n9. Blood pressure adequately controlled with treatment if necessary; baseline proteinuria within a range considered safe for axitinib by the investigator.\n10. Participants of childbearing potential agree to use effective contraception according to applicable prescribing information and institutional requirements.\n11. Agreement to baseline tissue collection, serial imaging, and serial blood collection. Refusal of optional early\u002Fprogression repeat biopsy or additional omics procedures does not make a participant ineligible.\n\nExclusion Criteria:\n\n1. Prior systemic treatment for advanced renal cell carcinoma with an immune checkpoint inhibitor, VEGF\u002FVEGFR-targeted therapy, mTOR inhibitor, chemotherapy, or other systemic anticancer therapy.\n2. An urgent clinical indication for immediate surgery or local intervention because of uncontrolled bleeding, infection, urinary obstruction, pain, renal-function crisis, or another emergency that prevents safe completion of induction systemic therapy.\n3. A rapidly life-threatening metastatic lesion that, in the investigator's judgment, requires immediate radiotherapy, surgery, or another local treatment before study therapy.\n4. Active central nervous system metastases causing unstable symptoms. Participants with previously locally treated and stable CNS disease who are off corticosteroids or receiving a stable low physiologic\u002Flow dose may be considered individually by the MDT.\n5. Prior organ transplantation, or active autoimmune disease requiring systemic immunosuppressive treatment. Physiologic replacement-dose corticosteroids or local therapy may be permitted according to the protocol.\n6. History of life-threatening immune-related toxicity caused by prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy.\n7. Uncontrolled hypertension, clinically significant cardiovascular disease, recent major arterial or venous thrombosis, active bleeding, a lesion with high bleeding risk, or an uncorrectable coagulation abnormality.\n8. Clinically significant proteinuria, uncontrolled thyroid dysfunction, severe hepatic or renal dysfunction, or another condition that makes toripalimab plus axitinib treatment unacceptably risky.\n9. Active infection requiring systemic treatment. Participants with known active hepatitis B, active hepatitis C, or HIV infection require protocol- and institutional infectious-disease risk assessment. \\[The protocol wording is not an absolute exclusion for all such infections; confirm the final eligibility rule.\\]\n10. Pregnancy or breastfeeding.\n11. Another active malignancy within 5 years, except adequately treated malignancies with very low recurrence risk, such as selected carcinoma in situ or basal\u002Fsquamous cell skin cancers, which may be considered individually.\n12. Severe hypersensitivity to either study drug or any of its excipients.\n13. Inability, in the investigator's judgment, to comply with required visits, oral medication, blood-pressure monitoring, or imaging follow-up.\n14. Investigator\u002FMDT judgment that there is no reasonable possibility that the participant could enter a planned deferred cytoreductive nephrectomy pathway after induction therapy.",{"count":127,"type":21},30,[24],"This prospective, open-label, single-arm Phase 2 study is evaluating toripalimab plus axitinib as induction therapy for adults with newly diagnosed metastatic clear cell renal cell carcinoma whose primary kidney tumor remains in place and whose baseline kidney-tumor core biopsy contains a biopsy-detectable tertiary lymphoid structure (TLS). TLS are organized immune-cell structures that may reflect an active anti-tumor immune environment.\n\nParticipants will receive approximately 12 weeks of toripalimab 240 mg by intravenous infusion every 3 weeks together with axitinib 5 mg by mouth twice daily. At Week 12, an independent multidisciplinary team will review treatment response, performance status, surgical risk, primary-tumor burden, metastatic burden, and the participant's preference to determine whether deferred cytoreductive nephrectomy is clinically appropriate. Surgery is not mandatory, and participants who do not undergo surgery will remain in the study's clinical follow-up cohort.\n\nFor participants who undergo deferred cytoreductive nephrectomy and still have at least one measurable metastatic lesion that has not been locally treated, the main clinical outcome is the proportion who are alive and free from disease progression 24 weeks after surgery. The study will also investigate whether the functional state of TLS in the treated primary kidney tumor and the persistence of TLS-associated T-cell and B-cell clones in blood after surgery are associated with longer control of remaining metastatic disease. Translational analyses may include pathology, multiplex immunofluorescence, T-cell and B-cell receptor sequencing, single-cell or single-nucleus sequencing, spatial transcriptomics, and serial blood sampling.",[131,132],"Metastatic Clear Cell Renal Cell Carcinoma","Advanced Clear Cell Renal Cell Carcinoma",[134,135,136,137,138,139,140,141,142],"Tertiary lymphoid structure","toripalimab","axitinib","deferred cytoreductive nephrectomy","renal cell carcinoma","tumor immune microenvironment","T-cell receptor clonotypes","B-cell receptor clonotypes","spatial transcriptomics","2026-08-17",{"date":66,"type":36},{"date":66,"type":21},{"date":147,"type":21},"2028-12-31",{"name":42,"class":43},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":44},"100652109","phase-2-romiplostim-n01-for-injection-for-secondary-prophylaxis-of-cit-in-breast-cancer-100652109","NCT07771881","Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer","A Prospective Clinical Study on the Efficacy and Safety of Romiplostim N01 for Injection for Secondary Prophylaxis in Breast Cancer Patients With Chemotherapy-Induced Thrombocytopenia (CIT)","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age 18 to 75 years, either sex.\n3. Histologically or pathologically confirmed breast cancer.\n4. Nadir platelet count \\\u003C50×10⁹\u002FL in the previous treatment cycle; OR nadir platelet count ≥50×10⁹\u002FL but \\\u003C75×10⁹\u002FL in the previous chemotherapy cycle, plus at least one high-risk factor for bleeding as defined in the relevant guideline.\n5. Platelet count \\>100×10⁹\u002FL at screening.\n6. No prior exposure to romiplostim\u002Fromiplostim N01.\n7. Prior receipt of one or more antineoplastic therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, and immunotherapy.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n9. Life expectancy of ≥12 weeks.\n\nExclusion Criteria:\n\n1. Concomitant hematologic disorders;\n2. Prior radiation therapy to long bones or flat bones, or currently receiving\u002Fplanned to receive radiation therapy (local radiation to the breast is permitted);\n3. Serious cardiac clinical symptoms or diseases within 6 months prior to screening;\n4. Thrombotic predisposition or currently receiving thrombolytic and\u002For anticoagulant therapy;\n5. Clinically significant bleeding symptoms within 2 weeks prior to screening, or definitive clinical manifestations of bleeding tendency;\n6. Complications requiring emergency treatment, such as superior vena cava syndrome or spinal cord compression;\n7. Significantly abnormal hepatic function: for patients without hepatic metastasis, ALT\u002FAST \\>3×ULN and TBIL \\>3×ULN; for patients with hepatic metastasis, ALT\u002FAST ≥5×ULN and TBIL ≥5×ULN;\n8. Renal function abnormality: serum creatinine ≥1.5×ULN or eGFR ≤60 mL\u002Fmin (by Cockcroft-Gault formula);\n9. Receipt of romiplostim within 2 to 3 weeks prior to study drug administration;\n10. Known or suspected hypersensitivity or intolerance to romiplostim N01 or its excipients (including cellulose-lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate);\n11. HIV infection;\n12. Participation in any other clinical study of an investigational drug or device within 3 months prior to screening;\n13. Pregnant or lactating women;\n14. Any other condition that, in the investigator's opinion, may affect study results or lead to premature discontinuation of the study.",{"count":157,"type":21},53,[24],"This study aims to evaluate the efficacy and safety of Romiplostim N01 for Injection administered as secondary prophylaxis in breast cancer patients with chemotherapy-induced thrombocytopenia (CIT).",[161],"Thrombocytopenia Chemotherapy Induced","2026-08-14",{"date":164,"type":36},"2026-08-18",{"date":166,"type":21},"2026-08",{"date":168,"type":21},"2030-04",{"name":42,"class":43},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":44},"100651950","phase-2-gelad-based-response-adapted-treatment-for-early-stage-extranodal-nkt-cell-lymphoma-100651950","NCT07768943","GELAD-Based Response-Adapted Treatment for Early-Stage Extranodal NK\u002FT-Cell Lymphoma","A Prospective Multicenter Response-Adapted Treatment Study Based on Early Response Assessment After GELAD Induction Chemotherapy in Early-Stage Extranodal NK\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18 to 75 years, inclusive.\n* Histologically confirmed extranodal NK\u002FT-cell lymphoma, nasal type, according to the 2022 World Health Organization classification.\n* Diagnosis confirmed by institutional or central pathological review. Tumor tissue must be adequate for morphological assessment, immunohistochemistry, and Epstein-Barr virus-encoded RNA in situ hybridization.\n* Lugano 2014 stage IE or IIE disease with a primary site in the upper aerodigestive tract, including but not limited to the nasal cavity, paranasal sinuses, nasopharynx, oropharynx, or oral cavity.\n* At least one disease lesion evaluable by PET\u002FCT at baseline.\n* No previous chemotherapy, radiotherapy, immunotherapy, or other antitumor biological therapy for lymphoma.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Adequate organ function, including:\n\n  * Absolute neutrophil count at least 1.0 x 10\\^9\u002FL.\n  * Platelet count at least 75 x 10\\^9\u002FL.\n  * Hemoglobin at least 90 g\u002FL.\n  * No granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 14 days before enrollment.\n  * Total bilirubin no greater than 1.5 times the upper limit of normal.\n  * Alanine aminotransferase and aspartate aminotransferase no greater than 2 times the upper limit of normal.\n  * Serum creatinine no greater than 1.5 times the upper limit of normal.\n  * Fibrinogen at least 1.5 g\u002FL.\n  * Left ventricular ejection fraction at least 50%.\n* Ability to understand the study and provide written informed consent.\n* Willingness to comply with protocol treatment, follow-up, laboratory testing, imaging assessments, and biospecimen collection.\n\nExclusion Criteria:\n\n* Diagnosis not meeting the 2022 World Health Organization criteria for extranodal NK\u002FT-cell lymphoma or not confirmed after pathological review.\n* Lugano stage III or IV disease or distant organ involvement inconsistent with localized early-stage disease.\n* Primary disease outside the upper aerodigestive tract or predominantly systemic or widespread extranodal disease.\n* Previous lymphoma-directed chemotherapy, radiotherapy, immunotherapy, or other systemic antitumor treatment.\n* Human immunodeficiency virus infection, active hepatitis C virus infection, or hepatitis B virus infection with HBV DNA greater than 10\\^3\u002FmL.\n* History of pancreatitis or pancreatic disease considered unsuitable for pegaspargase treatment.\n* Acute or systemic infection requiring intravenous anti-infective treatment.\n* Severe complications including hemophagocytic lymphohistiocytosis or disseminated intravascular coagulation.\n* Significant organ dysfunction, including respiratory failure, chronic congestive heart failure of New York Heart Association class II or higher, decompensated hepatic or renal dysfunction, uncontrolled hypertension or diabetes despite appropriate treatment, or cardiovascular or cerebrovascular thrombosis or bleeding within the previous 6 months.\n* Active autoimmune disease or another condition considered by the investigator to make immune checkpoint inhibitor treatment unsuitable.\n* Pregnancy or breastfeeding.\n* Participants of reproductive potential who are unwilling to use adequate contraception.\n* Known severe hypersensitivity to any study drug or its excipients.\n* Another active malignancy within the previous 6 months requiring surgery, radiotherapy, or systemic anticancer therapy.\n* Severe psychiatric disorder, poor adherence, or another condition that, in the investigator's judgment, would prevent completion of protocol treatment or follow-up.\n* Current use of another investigational drug or participation in another interventional clinical trial within 4 weeks before enrollment.",{"count":178,"type":21},620,[24],"This prospective, multicenter study evaluates a response-adapted treatment strategy for previously untreated patients with early-stage extranodal NK\u002FT-cell lymphoma of the upper aerodigestive tract.\n\nAll participants receive two cycles of GELAD induction chemotherapy, followed by early response assessment using positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and plasma Epstein-Barr virus (EBV) DNA. Subsequent treatment is determined by the early response.\n\nParticipants with complete metabolic response and negative EBV DNA enter PART A and are randomized 1:1 to standard-dose radiotherapy (50 Gy) or reduced-dose radiotherapy (40 Gy); both groups subsequently receive two additional cycles of GELAD. Participants with partial response and negative EBV DNA enter PART B and receive standard 50 Gy radiotherapy followed by two additional cycles of GELAD. Participants with stable disease, local or regional progressive disease that remains amenable to curative radiotherapy, or partial response with positive EBV DNA enter PART C and receive 50 Gy radiotherapy followed by response-adapted sintilimab consolidation.\n\nThe primary objective of PART A is to determine whether reduced-dose radiotherapy is noninferior to standard-dose radiotherapy with respect to the 24-month progression-free survival rate. The primary objective of PART C is to evaluate the 24-month progression-free survival rate with response-adapted sintilimab consolidation in patients with a high-risk early response.",[182],"Natural Killer\u002FT-cell Lymphoma",[184,185,186,187,188,189,190,191,192],"Extranodal NK\u002FT-cell lymphoma","Early-stage NK\u002FT-cell lymphoma","GELAD","Response-adapted therapy","Radiotherapy de-escalation","Sintilimab","PD-1 blockade","PET\u002FCT","Epstein-Barr virus DNA",{"date":143,"type":36},{"date":94,"type":21},{"date":196,"type":21},"2036-06-30",{"name":42,"class":43},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":205,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":44},"100651683","phase-3-omission-of-adjuvant-radiotherapy-in-low--and-intermediate-risk-ductal-carcinoma-in-situ-after-breast-conserving-surgery-100651683","NCT07762885","Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery","A Prospective, Multicenter, Randomized Phase III Non-Inferiority Trial Evaluating Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk ER-Positive HER2-Negative Ductal Carcinoma In Situ Following Breast-Conserving Surgery","Inclusion Criteria:\n\n1. Female patients aged ≥40 years；\n2. Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions；\n3. Tumor size ≤2.5 cm on final pathology；\n4. Negative surgical margins ≥3 mm, including margins obtained after re-excision；\n5. Estrogen receptor-positive disease (ER ≥10%) with planned endocrine therapy using tamoxifen；\n6. Unifocal lesion；\n7. Absence of comedo necrosis；\n8. Screen-detected disease without bloody nipple discharge or palpable mass；\n9. Clinically node-negative disease；\n10. Patients randomized to the radiotherapy arm must initiate radiotherapy within 3 months after surgery；\n11. Central pathology review by the participating institution required；\n12. Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Known BRCA1 or BRCA2 germline mutation carriers (genetic testing not mandatory)；\n2. Contraindications to radiotherapy, including active connective tissue disease；\n3. Active infection requiring systemic treatment；\n4. Bilateral breast cancer or prior contralateral breast cancer；\n5. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders；\n6. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ；\n7. Prior thoracic radiotherapy；\n8. Pregnant or breastfeeding patients；\n9. Estimated life expectancy ≤5 years；\n10. Poor compliance or inability to adhere to study follow-up requirements.","FEMALE","40 Years",{"count":208,"type":21},636,[210],"PHASE3","This is a prospective, multicenter, randomized, open-label, phase III non-inferiority trial designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in patients with low- and intermediate-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women aged ≥40 years with ER-positive, low- or intermediate-grade DCIS, tumor size ≤2.5 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and screen-detected unifocal disease. Patients will be randomized to postoperative observation alone or adjuvant radiotherapy. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).",[213],"Ductal Carcinoma In Situ, DCIS","2026-08-09",{"date":216,"type":36},"2026-08-13",{"date":218,"type":36},"2026-07-01",{"date":220,"type":21},"2036-06",{"name":42,"class":43},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":205,"minAge":4,"maxAge":206,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":238,"locationsCount":44},"100651672","phase-2-omission-of-adjuvant-radiotherapy-in-young-low-risk-ductal-carcinoma-in-situ-following-breast-conserving-surgery-100651672","NCT07762924","Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery","A Single-Center Prospective Phase II Study Evaluating the Safety of Omission of Adjuvant Radiotherapy in Young Patients With Low-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery","Inclusion Criteria:\n\n1. Female patients aged \\\u003C40 years；\n2. Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions；\n3. Tumor size ≤1 cm on final pathology；\n4. Negative surgical margins ≥3 mm, including margins obtained after re-excision；\n5. Unifocal lesion；\n6. Absence of comedo necrosis；\n7. Screen-detected disease without bloody nipple discharge or palpable mass；\n8. Clinically node-negative disease；\n9. Central pathology review by the participating institution required；\n10. Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory)；\n2. Bilateral breast cancer or prior contralateral breast cancer；\n3. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders；\n4. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ；\n5. Pregnant or breastfeeding patients；\n6. Estimated life expectancy ≤5 years；\n7. Poor compliance or inability to adhere to study follow-up requirements.",{"count":230,"type":21},234,[24],"This is a single-center, prospective phase II clinical study designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in young patients with low-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women younger than 40 years with low- or intermediate-grade DCIS, tumor size ≤1 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and unifocal screen-detected disease. Patients in the radiotherapy omission cohort will undergo close surveillance after surgery, with endocrine therapy permitted according to physician discretion. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).",[213],{"date":216,"type":36},{"date":94,"type":21},{"date":237,"type":21},"2037-02",{"name":42,"class":43},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":44},"100651663","phase-2-dynamic-risk-adapted-ebv-dna-and-mri-guided-de-concurrent-chemotherapy-in-nasopharyngeal-carcinoma-100651663","NCT07762976","Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma","Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study","Inclusion Criteria:\n\n* Age: 18 - 65 years old\n* Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.\n* AJCC\u002FUICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.\n* Baseline plasma EBV-DNA \\> 0, and able to complete dynamic monitoring according to the protocol.\n* ECOG 0 - 1.\n* Main organ functions meet the requirements: neutrophils ≥ 2.0×10\\^9\u002FL, platelets ≥ 100×10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL; ALT\u002FAST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL\u002Fmin.\n* Signed informed consent form, willing to complete the study according to the protocol.\n\nExclusion Criteria:\n\n* Clinical or imaging examinations have confirmed distant metastasis.\n* Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).\n* Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia).\n* Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection.\n* Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose \\> 10mg\u002Fday) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg\u002Fday or only uses inhaled or topical glucocorticoids, participation is allowed.\n* Has a history of active tuberculosis (Mycobacterium tuberculosis infection) in the past year; if active tuberculosis has been fully treated and has been over one year ago, participation is allowed.\n* Has a history of interstitial lung disease.\n* Has received live vaccines within 4 weeks before signing the informed consent form, or is about to receive live vaccines in the near future.\n* Pregnant or lactating women, or reproductive-aged subjects who do not agree to take effective contraceptive measures.\n* Has a history of other malignant tumors within the past 5 years, but the following situations are excluded: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.\n* Cannot take oral medications or have a known severe allergy to capecitabine, tislelizumab, or cisplatin\u002Fgemcitabine.\n* Has any other conditions, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illness or family\u002Fsocial factors, which the investigator believes may affect the patient's ability to sign the informed consent form, cooperate and participate in the study, or interfere with the interpretation of the study results.","65 Years",{"count":248,"type":21},148,[24],"This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.",[252],"Nasopharyngeal Carcinoma (NPC)",[254,255,256,257,258,259],"Nasopharyngeal Carcinoma","EBV DNA","MRI","risk-adapted adjuvant therapy","Tislelizumab","capecitabine",{"date":216,"type":36},{"date":166,"type":21},{"date":263,"type":21},"2031-07",{"name":42,"class":43},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":205,"minAge":18,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100651336","phase-3-an-open-label-randomized-phase-iii-study-of-trastuzumab-rezetecan-with-or-without-everolimus-in-first-to-third-line-lar-subtype-tnbc-100651336","NCT07760844","An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus in First to Third Line LAR Subtype TNBC","A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus as First- to Third-Line Treatment for Luminal Androgen Receptor Subtype of Triple-Negative Breast Cancer","SCHBCC-N0117","Inclusion Criteria:\n\n* Inclusion Criteria:\n\n  1. Female patients aged ≥18 years and ≤70 years;\n  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n  3. Life expectancy of at least 3 months;\n  4. Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor \\[ER\\], progesterone receptor \\[PR\\], and human epidermal growth factor receptor 2 \\[HER-2\\] all determined to be negative by pathological testing. Specifically: ER-negative: IHC \\\u003C1%; PR-negative: IHC \\\u003C1%; HER2-negative: IHC -\u002F+ or IHC ++ with FISH\u002FCISH negative. All specimens must be verified as the LAR subtype of the Fudan quadruple molecular classification by the Precision Medicine Center\u002FDepartment of Pathology at the study's participating center);\n  5. Tumor stage: recurrent or metastatic breast cancer; for locally recurrent disease, radical surgical resection must be confirmed by the investigator to be not feasible. Number of prior lines of therapy in the advanced setting ≤2;\n  6. Patients must have at least one lesion (measurable and\u002For non-measurable) that has not been previously irradiated, can be accurately assessed at baseline by CT\u002FMRI, and can be repeatedly evaluated according to RECIST 1.1;\n  7. Adequate major organ function, meeting the following criteria:\n\n     Hematological parameters: hemoglobin (HB) ≥90 g\u002FL (without blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥75×10⁹\u002FL;Biochemical parameters: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN; serum creatinine (Cr) ≤1×ULN, and calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula);\n  8. No prior radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks before study initiation, and recovery from acute toxicities of prior treatment (if surgery was performed, the wound must be completely healed); no peripheral neuropathy or only grade I peripheral neurotoxicity;\n  9. Female subjects of childbearing potential must agree to use a medically accepted contraceptive method during the study treatment period and for at least 3 months after the last dose of study drug;\n  10. Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria will be excluded from this study:\n\n  1. Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;\n  2. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;\n  3. Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;\n  4. Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;\n  5. Pregnant or lactating patients;\n  6. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n  7. Presence of third-space fluid accumulation (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n  8. Participation in another anti-tumor drug clinical trial within 3 weeks before the first use of the study drug;\n  9. Long-term unhealed wounds or incompletely healed fractures;\n  10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or HBV DNA ≥500 IU\u002FmL, or chronic hepatitis with abnormal liver function;\n  11. History of allergic constitution, known allergy to any component of the study drug regimen, or history of allergy to other monoclonal antibodies;\n  12. History of gastrointestinal bleeding within the past 6 months, or clear evidence of a tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active local ulcerative lesions, or fecal occult blood test ≥ (++). Patients with fecal occult blood test (+) should undergo gastroscopy;\n  13. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment;\n  14. Urinalysis showing urine protein ≥ (++), or confirmed 24-hour urine protein quantification \\>1.0 g;\n  15. Hypertension that cannot be controlled to within normal range with antihypertensive medication (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg);\n  16. Prior use of anti-angiogenic agents or prior exposure to an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload","70 Years",{"count":275,"type":21},180,[210],"This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the LAR subtype. A total of 180 patients are planned to be enrolled.",[111,279],"Triple Negative Breast Cancer (TNBC)",[281],"triple negative breast cancer","2026-08-07",{"date":68,"type":36},{"date":285,"type":21},"2026-10-01",{"date":287,"type":21},"2029-03-30",{"name":42,"class":43},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":44},"100605171","the-safety-efficacy-and-immune-response-of-multimodal-thermal-therapy-in-the-treatment-of-malignant-liver-tumors-100605171","NCT07159048","The Safety, Efficacy, and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors","A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Safety, Efficacy and Immune Response of Multimodal Thermal Therapy in the Treatment of Malignant Liver Tumors","Inclusion Criteria:\n\n1. Age of 18-80 years.\n2. Clinical diagnosis or pathologic of hepatocellular carcinoma (HCC) or metastatic liver cancers.\n3. Intrahepatic lesions with a diameter of ≤5cm, and the number of lesions ≤5.\n4. Without extrahepatic metastases; for patients with liver metastases, previously underwent radical resection of the primary lesion without local recurrence.\n5. Child-Pugh score ≤7 (Class A or B).\n6. Performance status 0-1 (Eastern Cooperative Oncology Group classification).\n7. Life expectancy of at least 3 months.\n8. Patients who have previously undergone surgery, chemotherapy, targeted therapy, ablation, vascular interventional therapy (TACE, D-TACE, HAIC), or immunotherapy, with an interval of ≥3 weeks since the last treatment.\n9. The functional level of major organs must meet the following requirements:\n\n(1) Blood Routine: WBC≥3.0×109\u002FL，ANC≥1.5×109\u002FL，PLT≥50×109\u002FL，HGB≥90 g\u002FL. (2) Liver Function: AST ≤5.0×ULN, ALT ≤5.0×ULN, TBIL ≤2.0×ULN. (3) Renal Function: Cr ≤1.5×ULN or CrCl ≥60 mL\u002Fmin. (4) Coagulation Function: INR ≤1.5; APTT ≤1.5×ULN. (5) HBV-DNA: HBV-DNA ≤2×10³ IU\u002FmL (\\*Patients with HBV-DNA \\>2×10³ IU\u002FmL may be enrolled but must receive antiviral therapy.\\*)\n\nExclusion Criteria:\n\n1. Diffuse hepatocellular carcinoma (HCC), or with tumor thrombus in the main portal vein to secondary branches or hepatic veins.\n2. Severe liver atrophy or excessively large tumor volume requiring ablation of ≥1\u002F3 of the liver volume.\n3. Uncorrectable coagulation dysfunction or severe hematologic abnormalities with a high risk of bleeding.\n4. Active bacterial infection or fungal infection.\n5. Previous or coexisting malignancies.\n6. History of solid organ transplant or hepatic encephalopathy.\n7. Current enrollment in another clinical trial or prior exposure to experimental therapies.\n8. Pregnant or breastfeeding, or preparing to pregnant.\n9. Not suitable to participate in clinical trials judged by investigator.","80 Years",{"count":298,"type":21},120,[108],"Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. The feasibility and safety for MTT in the treatment of malignant liver tumors is well-established. This prospective, multi-center, randomized controlled clinical study aimed to explore the ablation-induced immune activating response of MTT in the treatment of malignant liver tumors.",[302,303],"Hepatocellular Carcinoma","Colorectal Cancer Liver Metastasis","2026-08-06",{"date":306,"type":36},"2026-08-10",{"date":308,"type":36},"2025-10-15",{"date":310,"type":21},"2027-10-31",{"name":42,"class":43},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":44},"100651152","phase-2-the-necessity-of-surgery-in-patients-with-mgc-achieving-radiological-response-after-conversion-therapy-100651152","NCT07757165","The Necessity of Surgery in Patients With mGC Achieving Radiological Response After Conversion Therapy","Phase II Randomized Controlled Trial Evaluating the Necessity of Surgery in Patients With Advanced Metastatic Gastric Cancer Achieving Radiological Response After Conversion Therapy","ESMGC","Inclusion Criteria:\n\n1. Age and Informed Consent: The age range is 18 to 75 years (inclusive), and the participant must voluntarily participate in this study and sign the patient informed consent approved by the ethics committee.\n2. Pathological Diagnosis: Gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histological or cytological examination.\n3. Disease Staging: Newly diagnosed, unresectable stage IV disease (according to the 8th edition of the AJCC staging system), confirmed by the multidisciplinary team (MDT) of the research center to be unable to undergo radical surgical resection. The types of metastasis include but are not limited to: unresectable distant lymph node metastasis (such as beyond the abdominal aorta trunk, supraclavicular lymph nodes, etc.); distant organ metastasis (such as liver, lungs, peritoneum, ovaries, etc.).\n4. Conversion Therapy and Efficacy:\n\n   1. Has received 4-6 cycles of first-line standard conversion therapy. The treatment plan should be based on the latest clinical guidelines and molecular typing (such as fluorouracil\u002Fplatinum double or triple drug chemotherapy, combined with anti-HER2 treatment (for HER2-positive patients) or immune checkpoint inhibitors (PD-1\u002FPD-L1 inhibitors, such as when CPS ≥ 5 or MSI-H, etc.).\n   2. After conversion therapy, according to the RECIST 1.1 standard, confirmed by the independent imaging assessment committee (IRC) or at least two senior radiologists, the efficacy reaches complete response (CR) or partial response (PR).\n5. Surgical Feasibility Assessment: Re-evaluated by the MDT of the research center (must include senior gastrointestinal surgeons, oncologists, and radiologists), it is considered that all known lesions (primary and metastatic lesions) can be technically achieved R0 resection, and the patient is expected to be safely and tolerably able to undergo surgery.\n6. Physical Condition: Eastern Cooperative Oncology Group (ECOG) performance status score (PS) of 0 or 1.\n7. Good Organ Function (measured within 14 days before randomization), meeting the following laboratory test value standards:\n\n   1. Hematological System:\n\n      Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet count (PLT) ≥ 100 × 10⁹\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL\n   2. Liver Function:\n\n      Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (if liver metastasis, then ≤ 5 × ULN)\n   3. Renal Function:\n\n   Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 50 mL\u002Fmin (Cockcroft-Gault formula)\n8. Female patients of childbearing age must have a negative serum pregnancy test within 7 days before randomization, and all patients (regardless of gender) must agree to take effective contraceptive measures during the study and within 6 months after treatment.\n\nExclusion Criteria:\n\n1. Pathological type: Other pathological types, such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, gastrointestinal stromal tumor (GIST), etc.\n2. Treatment and efficacy:\n\n   1. During the conversion therapy, disease progression (PD) was confirmed after assessment.\n   2. Previously received systemic anti-tumor treatment for advanced gastric cancer (except for conversion therapy).\n   3. Previously received radical radiotherapy for the stomach or metastatic lesions.\n3. Surgical contraindications:\n\n   1. According to MDT assessment, there are residual lesions that cannot be surgically removed (such as diffuse peritoneal metastasis that cannot achieve satisfactory tumor reduction, extensive liver metastasis that cannot preserve sufficient functional liver tissue, etc.).\n   2. There are severe internal medical comorbidities that significantly affect surgical safety, and the anesthesiology and surgical physicians have evaluated that the surgical risk is extremely high, for example:\n\n   Uncontrolled heart failure (NYHA cardiac function class III-IV), unstable angina or myocardial infarction within 6 months.\n\n   Severe chronic obstructive pulmonary disease (COPD) or other severe respiratory diseases, which are expected to be intolerant to general anesthesia.\n\n   Uncontrollable severe infection.\n4. Past and coexisting disease history:\n\n   1. In the past 5 years, had other active malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, etc.\n   2. Had any uncontrolled severe clinical problems (such as severe mental or neurological diseases) that affected the compliance with the protocol or interfered with the interpretation of the research results.\n5. Laboratory test abnormalities: Any serious and uncontrolled laboratory test abnormalities were found. The investigator considered that participating in this study would bring significant risks.\n6. Pregnancy and lactation: Pregnant or lactating women.\n7. Other: Known to have a severe allergic history to any drugs (chemotherapy drugs, targeted drugs, immunotherapies, anesthetics, etc.) used in the study protocol. The investigator believed that there were any other situations that were not suitable for participating in this clinical study.",{"count":321,"type":21},126,[24],"The core of this study lies in directly addressing the most pressing clinical uncertainty in the current field: For patients with advanced metastatic gastric cancer who have achieved significant radiological remission after conversion therapy, should the addition of radical surgical intervention on top of the best medical treatment bring clear survival benefits to these patients? Answering this question is of extreme importance and urgency, directly affecting the treatment decisions, quality of life, and survival outcomes of a large number of patients.",[325],"Advanced Metastatic Gastric Cancer",[327,328,329,330],"Advanced metastatic gastric cancer","Conversion therapy","Radiological response","Surgery","2026-08-05",{"date":333,"type":36},"2026-08-11",{"date":335,"type":36},"2025-11-01",{"date":337,"type":21},"2030-10-30",{"name":42,"class":43},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100650861","phase-3-apex-stroke-calm-ich-domain-100650861","NCT07752719","APEX-STROKE CALM-ICH Domain","Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM) Domain of the APEX-STROKE Adaptive Platform Trial","CALM-ICH","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Symptom onset or last known well≤ 6 hours before randomization;\n3. Traditional Chinese Medicine syndrome consistent with heat-toxin internal accumulation: at least two of high fever, flushed face, restlessness, dry mouth, or rapid pulse;\n4. No surgical plan at the time of randomization;\n5. All corresponding eligibility criteria must be met according to the randomization setting:\n\n   * If randomized in the prehospital (ambulance) setting: AI model predicts ICH, FAST score ≥ 2 and GCS ≥ 8;\n   * If randomized in the emergency department: brain imaging confirms ICH, hematoma volume ≥ 10 mL, NIHSS score ≥ 8, and GCS score≥ 7;\n6. Provide written informed consent by patient (or approved surrogate)\n\nExclusion Criteria:\n\n1. Severe comorbid disease likely to interfere with trial treatment, follow-up, or outcome assessment, such as severe heart failure;\n2. History of epilepsy or seizure-like attack;\n3. Pregnancy or lactation;\n4. Subjects meeting any of the following criteria in the corresponding randomization setting shall be excluded:\n\nIf randomized in the prehospital (ambulance) setting: blood glucose \\\u003C2.8 mmol\u002FL; head trauma within the previous 7 days; If randomized in the emergency department: severe hepatic or renal dysfunction, defined as serum creatinine ≥ 2 mg\u002FdL or ALT\u002FAST \\>3 times the upper limit of normal; secondary cause of hemorrhage, including arteriovenous malformation or other structural abnormality.",{"count":348,"type":21},1100,[210],"In this domain of APEX-STROKE, participants with acute intracerebral hemorrhage (ICH) who are considered suitable for non-surgical management and who meet the eligibility criteria for this domain will be randomized in a 1:1 ratio to receive either Angong Niuhuang pills (ANP) or matching placebo, both in addition to guideline-based standard care. The matching placebo is the control condition and is not counted as a domain intervention.\n\n• Intervention: Angong Niuhuang pills (ANP) in addition to guideline-based standard care.\n\nANP should be initiated as soon as possible after randomization in the ambulance or emergency department setting, with subsequent treatment continued for a total of 14 days according to the domain-specific intervention schedule.\n\n• Control condition: matching placebo in addition to guideline-based standard care.",[352,353],"Stroke","Intracerebral Hemorrhage","2026-08-04",{"date":282,"type":36},{"date":94,"type":21},{"date":358,"type":21},"2030-02-28",{"name":42,"class":43},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":367,"sex":205,"minAge":368,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":385,"leadSponsor":387,"locationsCount":4},"100608362","evaluation-of-a-vaccine-chatbot-on-hpv-vaccine-confidence-and-hesitancy-100608362","NCT07200570","Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy","Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy: a Randomized Controlled Trial and Implementation Science Study","Inclusion Criteria:\n\n* Female, aged 15 to 45 years, inclusive.\n* Not previously vaccinated against HPV.\n* Reports no contraindications to HPV vaccination.\n* Has no mental, visual, or reading impairments that would preclude cooperation with study activities.\n* Is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Male.\n* Age under 15 or over 45 years.\n* Has a history of prior HPV vaccination.\n* Has a known contraindication to HPV vaccination.\n* Unable to comply with study procedures.\n* Is unwilling or unable to provide informed consent.",true,"15 Years","45 Years",{"count":371,"type":21},1800,[108],"The goal of this clinical trial is to learn if a chatbot powered by artificial intelligence works to improve HPV vaccination among females aged 15 to 45 in China. A randomized controlled trial and implementation science study will be conducted targeting females as participants. The main questions it aims to answer are:\n\n1. Does the vaccine chatbot influence women's confidence, literacy, hesitancy, and uptake of the HPV vaccine.\n2. What are the public acceptance of chatbot and the facilitators and barriers to its implementation in a real-world setting.\n\nResearchers will compare a group of women who use the chatbot with a group who do not use it to see if the chatbot is effective at helping women feel confident and willing to get vaccinated against HPV.\n\nParticipants will:\n\n1. Be recruited and randomly allocated into one of two groups. One group will be invited to use the HPV vaccine chatbot and the other group will not get access to the vaccine chatbot until the end of the trial.\n2. Complete a questionnaire survey on their confidence, literacy, and hesitancy on the HPV vaccine.\n3. Have their vaccination status checked at the end of trial.",[375],"HPV Vaccine",[377,378,379,380,381],"HPV","vaccine confidence","chatbot","randomised controlled trial","implementation science","2026-07-31",{"date":354,"type":36},{"date":166,"type":21},{"date":386,"type":21},"2026-11",{"name":42,"class":43},{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":44},"100613556","titan-hcc-neoadjuvant-and-adjuvant-ql1706-with-tace-in-resectable-hepatocellular-carcinoma-beyond-milan-criteria-100613556","NCT07268131","TITAN-HCC: Neoadjuvant and Adjuvant QL1706 With TACE in Resectable Hepatocellular Carcinoma Beyond Milan Criteria","Neoadjuvant TACE Plus Iparomlimab and Tuvonralimab （QL1706）and Adjuvant QL1706 in Resectable BCLC Stage A\u002FB Hepatocellular Carcinoma Patients Beyond Milan Criteria: the TITAN-HCC Phase II Trial","TITAN-HCC","Inclusion Criteria:\n\n* Age ≥18 years, male or female\n* Patients with histologically or pathologically confirmed hepatocellular carcinoma (HCC), or Patients meeting the clinical diagnostic criteria for hepatocellular carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD)\n* BCLC stage A or B hepatocellular carcinoma deemed amenable to curative-intent surgery after multidisciplinary consultation, yet exceeding Milan criteria\n* Eligible for the TACE procedure predefined by the study center, with no contraindications\n* Child-Pugh score ≤7\n* ECOG PS ≤1\n* Measurable disease per RECIST 1.1 criteria\n* Life expectancy \\>12 weeks\n* Adequate organ function meeting the following laboratory values: Hematological: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL Platelet count (PLT) ≥75×10⁹\u002FL Hemoglobin (HGB) ≥90 g\u002FL Hepatic: Total bilirubin (TBIL) ≤3× upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN Serum albumin ≥28 g\u002FL Note: Patients may be enrolled if values stabilize after standard liver support therapy for ≥1 week, as assessed by the investigator. Renal: Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula) Coagulation: International normalized ratio (INR) ≤2×ULN or Activated partial thromboplastin time (APTT) ≤2×ULN\n* Willing and able to provide written informed consent prior to any study-related procedures\n\nExclusion Criteria:\n\n* Patients with histopathologically confirmed variant hepatocellular carcinoma (HCC) subtypes, including: Fibrolamellar hepatocellular carcinoma Sarcomatoid hepatocellular carcinoma Mixed hepatocellular-cholangiocarcinoma\n* Prior local therapy targeting the index lesion(s), including but not limited to: Transarterial chemoembolization (TACE) Transarterial embolization (TAE) Transarterial radioembolization (TARE) Hepatic arterial infusion chemotherapy (HAIC) Radiofrequency ablation (RFA) Cryoablation High-intensity focused ultrasound (HIFU) Radiation therapy\n* Prior systemic anti-cancer therapy for hepatocellular carcinoma, including but not limited to: Molecular targeted agents (e.g., tyrosine kinase inhibitors, anti-angiogenic drugs) Conventional chemotherapy Immunotherapy: Immune checkpoint inhibitors (e.g., PD-1\u002FPD-L1\u002FCTLA-4 inhibitors) Immune checkpoint agonists Cellular immunotherapy (e.g., CAR-T, NK cell therapy) Biological therapy: Cancer vaccines Cytokines (e.g., interferons, interleukins) Growth factor inhibitors\n* Presence of portal vein tumor thrombus, hepatic vein or inferior vena cava tumor thrombus, or distant metastasis\n* History of bleeding events within 6 months prior to initial treatment, including but not limited to: Acute hemorrhage from esophageal or gastric varices caused by portal hypertension AND\u002FOR 6. Untreated or inadequately treated\n* Clinically significant cardiovascular or cerebrovascular disease, including any of the following within 3 months prior to initial treatment: Congestive heart failure (NYHA Class ≥II) Myocardial infarction Cerebrovascular accident (stroke\u002FTIA) Unstable arrhythmia Unstable angina OR 8. History of congenital long QT syndrome OR 9. Screening ECG showing QTc interval \\>500 ms (calculated by Fridericia's formula)\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years prior to initial treatment, with the following exceptions: Non-systemic replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal\u002Fpituitary insufficiency)\n* Known HIV-positive status or history of active acquired immunodeficiency syndrome (AIDS)\n* History of allogeneic stem cell transplantation or solid organ transplantation\n* History of other active malignancies within 5 years prior to initial treatment, except for those with negligible risk of metastasis or death (e.g., 5-year overall survival rate \\>90%), including: Adequately treated carcinoma in situ of the cervix Non-melanoma skin cancer Localized prostate cancer (Gleason score ≤6, treated if required) Superficial bladder cancer (Ta\u002FTis, non-invasive)\n* Women who are pregnant or breastfeeding\n* Concurrent participation in another clinical trial, unless: It is a non-interventional study (e.g., observational\u002Fregistry study), OR The patient is in the follow-up phase of an interventional trial, defined as: ≥4 weeks since last dose in the prior trial, OR ≥5 half-lives of the investigational drug (whichever is shorter)\n* Systemic corticosteroid (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 2 weeks prior to initial treatment, with the following exceptions: Adrenal replacement therapy (prednisone ≤10 mg\u002Fday or equivalent) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption Short-term corticosteroid prophylaxis for hypersensitivity reactions (e.g., premedication for CT scans)\n* Any clinical or laboratory abnormality or compliance issue deemed by the investigator to render the patient unsuitable for enrollment in this clinical study",{"count":127,"type":21},[108],"This is a single-arm, single-center, prospective trial designed to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with ipalimab\u002Ftuvonralimab (QL1706) in the peri-operative setting for resectable hepatocellular carcinoma exceeding the Milan criteria, and to explore biomarkers predictive of therapeutic response.",[400],"Hepatocellular Carcinoma (HCC)","2026-07-30",{"date":382,"type":36},{"date":404,"type":36},"2025-12-09",{"date":406,"type":21},"2029-10-31",{"name":42,"class":43},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100648945","ai-guided-turbt-for-bladder-cancer-100648945","NCT07727343","AI-Guided TURBT for Bladder Cancer","Evaluation of the Efficacy and Safety of an AI Navigation Planning System in Transurethral Resection of Bladder Tumor: A Prospective, Randomized, Controlled, Single-Center Study","AITURBT","Inclusion Criteria:\n\n* Age between 18 and 75 years, male or female.\n* Clinical or imaging diagnosis of non-muscle invasive bladder cancer (NMIBC) according to international diagnostic standards (CT, MRI, ultrasound, cystoscopy).\n* Medically fit for TURBT surgery, with normal or essentially normal renal, cardiopulmonary, and hepatic function.\n* Willing and able to provide written informed consent (signed by the patient or a legally authorized representative).\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Severe dysfunction of other vital organs (heart, lungs, kidneys, etc.).\n* Imaging evidence of distant metastases.\n* Severe infection or active inflammation.\n* Psychiatric disorders or inability to comply with study procedures.\n* Any other condition deemed by the investigator as inappropriate for participation.",{"count":417,"type":21},170,[108],"This prospective, randomized, controlled, single-center study evaluates whether an AI navigation planning system used during Transurethral Resection of Bladder Tumor (TURBT) can improve recurrence-free survival in patients with non-muscle invasive bladder cancer. Participants are randomized to receive either standard TURBT surgery or standard TURBT with AI-assisted real-time tumor identification and resection margin guidance. The primary outcome is recurrence-free survival, with secondary outcomes including surgical duration, intraoperative blood loss, perioperative bleeding, and complication rates. The study aims to provide high-level evidence on the clinical utility of AI-assisted surgical navigation in bladder cancer treatment.",[421],"Bladder Cancer","2026-07-23",{"date":424,"type":36},"2026-07-27",{"date":426,"type":21},"2026-08-01",{"date":428,"type":21},"2028-11-30",{"name":42,"class":43},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":454,"locationsCount":44},"100483497","phase-1-gq1001-combined-with-pyrotinib-for-treatment-with-her2-positive-metastatic-breast-cancer-100483497","NCT05575804","GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer","Phase Ib\u002FII Study of GQ1001 and Pyrotinib in HER2 Positive Metastatic Breast Cancer Patients Who Had Failed Previous Anti-HER2 Treatment（GRACE）","Inclusion Criteria:\n\n1. Having provided written informed consent, and be able to follow clinical trial protocol.\n2. Men or women aged 18-75.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1，life expectancy greater than 3 months.\n4. Left ventricular ejection fraction (LVEF) ≥50%.\n5. Histopathological and\u002For cytological confirmed Her2-positive locally advanced or metastatic breast cancer (IHC3+, or IHC2+ and ISH+), \\*ISH: Fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of HER2 gene copy number to CEP17 signal number ≥2.0. When the immunohistochemical (IHC) result is 3+, ISH testing is not required. When the IHC result is 2+, ISH testing should be performed to confirm HER2 positivity.\n6. Failure for at least 1 line of standard systemic treatment for metastatic disease. Meet one of the following conditions:\n\n   1. Recurrent within 12 months after completing or during neoadjuvant\u002F adjuvant therapy (the regimens contain trastuzumab or its biosimilar with pertuzumab or not).\n   2. Received at least one treatment with trastuzumab or its biosimilar ±pertuzumab (monotherapy or in combination with other drugs) for recurrent or metastatic disease.\n7. Having at least one measurable lesion according to RECIST 1.1.\n8. Previous exposure to taxanes.\n9. During the screening period and the first 7 days before treatment, the following indicators confirm appropriate organ functions:\n\n   1. Hematology: WBC≥3.0×109\u002FL；NE≥1.5×109\u002FL；Hb≥90 g\u002FL；Plt≥100×109\u002FL;\n   2. Liver function: Total bilirubin ≤ 1.5 x the upper limit of normal; AST and ALT ≤ 2.5 x the upper limit of normal, ≤ 5.0 x the upper limit of normal in the presence of liver metastases;\n   3. Kidney function: Serum creatinine ≤1.5 x the upper limit of normal;\n   4. Coagulation function: prothrombin time and activated partial thromboplastin time ≤1.5 x the upper limit of normal.\n10. Adequate wash-out periods:\n\n    1. Major surgery ≥4 weeks;\n    2. Radiotherapy ≥4 weeks (Palliative stereotactic radiotherapy without abdominal involvement radiotherapy: ≥2 weeks);\n    3. Autologous transplantation: ≥3 months\n    4. targeted therapy or chemotherapy≥4 weeks;\n    5. Radioactive particle therapy: ≥3 months\n    6. Nuclide therapy: ≥3 months\n    7. Hormone therapy: ≥2 weeks, or based on judgement on the breast cancer\n    8. Participants from the investigators' judgment;\n    9. Endocrine therapy: ≥4weeks;\n    10. Chemotherapy or targeted therapy: 5-fluorouracil-based preparations, folinic acid preparations, and\u002For Weekly paclitaxel: ≥2 weeks;\n    11. Tyrosine kinase inhibitor: ≥2 weeks (or 5 half-lives)\n    12. In the case of a decline period, the longer one shall prevail;\n    13. Nitrosoureas or mitomycin C: ≥6 weeks\n    14. Immunotherapy ≥4 weeks;\n    15. Potent CYP3A4 inhibitor≥3\\*t1\u002F2 weeks;\n    16. Any investigational agents≥4 weeks.\n11. Female subjects who are capable of bearing children must have negative urine or serum pregnancy test results within 7 days before randomization, and must commit to using contraception throughout the study period and continue to do so for 7 months after the study ends.\n\nExclusion Criteria:\n\n1. Clinical symptomatic brain metastasis is defined as untreated and symptomatic, or requiring steroid or anticonvulsant treatment to control related symptoms. Patients with asymptomatic brain metastasis, or with stable clinical symptoms and no need for steroid hormone and other treatments for brain metastasis for ≥28 days, can be enrolled.\n2. Have previously been treated with: another antibody-drug conjugate (ADC) consisting of DM1 or its derivative，pyrotinib and capecitabine，except for the following situations:\n\n   1. During (neo)adjuvant therapy, received pyrotinib, and the participants who have experienced recurrence or metastasis more than 6 months after the last treatment and have not received pirlotinib since then are allowed to be enrolled;\n   2. Participants who have received pirlotinib treatment during the recurrent and metastatic stage, discontinued the medication due to reasons other than disease progression, and have progressed more than 6 months after discontinuation are allowed to be enrolled;\n   3. Participants who have received treatment with ADC drugs with different small molecule toxins (such as DS-8201, GQ1005, SHR-A1811, etc.) are eligible for enrollment. Such patients are also allowed to have received pirlotinib treatment during the recurrent or metastatic stage, and those who have progressed after more than 6 months of pirlotinib treatment are also eligible for enrollment.\n3. Have other malignant tumors within 5 years before signing the informed consent form ( except for cured skin basal cell carcinoma and cervical carcinoma in situ).\n4. Have a medical history of myocardial infarction or clinically significant heart diseases, including but not limited to,\n\n   1. symptomatic congestive heart failure (CHF) (NYHA classes II-IV), or serious cardiac arrhythmia which required to therapy;\n   2. Having a history of myocardial infarction or unstable angina pectoris within 6 months prior to the initial treatment,\n   3. Have a corrected QT interval (QTc) prolongation to \\> 450 milliseconds (ms) in males and \\> 470 ms in females.\n5. Have clinically significant acute and chronic pulmonary diseases (e.g. interstitial lung disease (ILD), lung infection, pulmonary fibrosis, and severe radiation pneumonitis), participants with a history of ILD\u002Fnon-infectious pneumonia requiring hormone therapy, or suspected of having lung diseases based on imaging examination at screening, with imaging suggesting miliary disseminated metastasis, subjects with specific pulmonary complications including but not limited to any potential lung diseases (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or other conditions that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to enrollment in the study), or subjects requiring oxygen therapy.\n6. History of allergic reaction to any component of GQ1001.\n7. The toxicity of previous anti-cancer therapy has not recovered to ≤1 as specified in CTCAE v5.0 (except for hair loss); e.g. chronic grade 2 toxicity might be determined per the investigator's judgment.\n8. The cumulative dose of anthracyclines or equivalent\\>500 mg\u002Fm2.\n9. Uncontrollable infections require intravenous antibiotics, antiviral drugs, or antifungal drugs.\n10. Hepatitis B virus (HBV) infection (including hepatitis B surface antigen \\[HBsAg\\] positive or hepatitis B core antibody \\[HBcAb\\] positive and HBV DNA positive); HIV, syphilis, hepatitis C antibody positive, or other severe and fatal viral or bacterial diseases, except for patients with stable hepatitis B (HBV viral copy number below the upper limit of reference value) after drug treatment and cured hepatitis C patients (HCV viral copy number below the detection limit of assay method).\n11. Per the investigator's judgment, participants with any history or current evidence of concomitant disease treatment or laboratory abnormalities may interfere with the trial results, as well as their participation and compliance.\n12. Lactating women or women who have confirmed pregnancy through a pregnancy test within 7 days prior to their first treatment.\n13. Male or female subjects unwilling to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for 7 months following the last dose of the study drug infusion.\n14. Other circumstances that are deemed not appropriate for the study.\n15. Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug administration and absorption.",{"count":438,"type":21},32,[440,24],"PHASE1","The aim of this trial is to study the safety, pharmacokinetics and preliminary efficacy of the HER2-targeted antibody-drug conjugate GQ1001 in combination with pyrotinib in patients with HER2-positive metastatic breast cancer patients who had failed previous anti-HER2 treatment.",[443],"Advanced\u002F Metastatic Her-2 Positive Breast Cancer",[445,446,447],"HER2-ADC","pyrotinib","Advanced\u002F Metastatic Her-2 positive Breast Cancer","2026-07-22",{"date":450,"type":36},"2026-07-24",{"date":452,"type":36},"2022-10-01",{"date":147,"type":21},{"name":42,"class":43},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":296,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":44},"100572814","phase-2-the-efficacy-and-safety-of-narlumosbart-in-combination-with-stereotactic-body-radiation-therapy-to-improve-the-efficacy-of-first-line-chemotherapy-combined-with-immunotherapy-in-patients-with-bone-metastases-from-advanced-non-small-cell-lung-cancer-100572814","NCT06738160","The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer","Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy Followed by First-line Chemotherapy Combined With Immunotherapy in Advanced Driver Gene-negative Non-small Cell Lung Cancer Patients With Bone Metastases: A Phase II, Single-arm, Single-center Clinical Trial Protocol","Inclusion Criteria:\n\n* Signed informed consent prior to the implementation of any trial-related procedures;\n* Age 18-80 years old;\n* Histologically or cytologically confirmed stage IV NSCLC according to the TNM Classification of Malignant Tumours, 9th edition；\n* Histologically confirmed bone metastases requiring local radiotherapy；\n* Patients who have not undergone systemic drug therapy for lung cancer (including chemotherapy, targeting, immunotherapy, etc.);\n* Driver genes (EGFR, ALK, ROS-1) negative in adenocarcinoma patients (genetic testing not required for squamous cell carcinoma) ;\n* At least one evaluable non-bone lesion (refer to RECIST1.1);\n* Bone metastases other than the lesions to be radiotherapy do not require local treatment (surgery or radiotherapy) intervention after evaluation;\n* ECOG score 0-1 points;\n* Expected survival time \\> 3 months;\n* Adequate organ function, defined as meeting all of the following laboratory criteria within 14 days prior to enrollment: 1) ANC ≥1.5×10⁹\u002FL (no G-CSF); 2) Platelets ≥100×10⁹\u002FL (no transfusion); 3) Haemoglobin ≥9 g\u002FdL (no transfusion\u002FEPO); 4) Bilirubin ≤1.5×ULN; 5) AST\u002FALT ≤2.5×ULN (≤5×ULN if liver metastases); 6) Creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin; 7) INR\u002FPT ≤1.5×ULN; 8) TSH within normal limits (or FT3\u002FFT4 normal if TSH abnormal); 9) Cardiac enzymes (troponin I, CK-MB) ≤ ULN (isolated abnormalities not clinically significant are permitted).\n\nExclusion Criteria:\n\n* The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;\n* The lesion is an isolated lesion and can be treated radically;\n* Patients who need surgical treatment after the evaluation of the study are not allowed to enroll;\n* The radiotherapy lesion to be treated has been treated with radiotherapy or the lesion to be treated cannot be treated with radiotherapy after evaluation;\n* Presence of active brain metastases;\n* Other malignancies within 5 years (except cured non-melanoma skin cancer or carcinoma in situ);\n* Prior treatment with anti-PD-1, anti-PD-L1, or RANKL-targeting agents;or used investigational device treatment within 4 weeks prior to the first dose;\n* Active autoimmune disease requiring systemic therapy;\n* Presence of clinically uncontrollable pleural effusion\u002Fascites effusion (subjects who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled);\n* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Presence of active bone metabolism disease (Paget bone disease, Cushing's syndrome, and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper\u002Fhypothyroidism, hyperparathyroidism\u002Fhypoparathyroidism;\n* Those who are known to be allergic to the active ingredients or excipients such as sintilimab, pemetrexed, nalusopaimab, carboplatin, cisplatin, paclitaxel, etc., of the drug in this study;\n* Have not recovered adequately from toxicity and\u002For complications induced by any of the interventions (i.e., ≤ grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment);\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory department of the research center);\n* Hypocalcemia cannot be improved after treatment;\n* Previous or current osteomyelitis or osteonecrosis of the jaw; Dental surgery or oral surgery that does not heal; Acute dental or jaw disease requiring oral surgery; Those who plan to undergo invasive dental surgery during the study;\n* Use of any of the following anti-bone metabolizing agents within 6 months prior to enrollment: Parathyroid hormone (PTH) or derivatives; Calcitonin; Osteoprotein; Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1);\n* Pregnant or lactating women;\n* Presence of any serious or uncontrollable systemic disease, such as:\n\n  1. Resting ECG has major abnormalities in rhythm, conduction or morphology and severe symptoms that are difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation;\n  2. unstable angina, congestive heart failure, New York Heart Association (NYHA) classification ≥ grade 2 chronic heart failure;\n  3. myocardial infarction within 6 months prior to enrollment;\n  4. unsatisfactory blood pressure control;\n  5. History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current presence of clinically active interstitial lung disease;\n  6. active tuberculosis;\n  7. Presence of active or uncontrolled infection requiring systemic therapy;\n  8. Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. poorly controlled diabetes mellitus (fasting blood glucose (FBG) \\>10mmol\u002FL);\n  11. Those whose urine routine showed a urine protein ≥++, and confirmed that the 24-hour urine protein was \\> 1.0 g;\n  12. Subjects with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other conditions that are considered by the investigator to be unsuitable for enrollment in the opinion of the investigator are not suitable for participation in this study.",{"count":463,"type":21},27,[24],"Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases.\n\nMethods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg\u002Ftime, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy\u002F3F is used for spinal metastases, and 30Gy\u002F5F or 35Gy\u002F5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR\u002FPR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR\u002FPR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%.\n\nWangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.",[467,468,469],"NSCLC","Stereotactic Body Radiation Therapy (SBRT)","Immunotherapy","2026-07-21",{"date":422,"type":36},{"date":473,"type":36},"2025-02-15",{"date":475,"type":21},"2028-12-30",{"name":42,"class":43},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":498,"locationsCount":4},"100648157","phase-2-fulvestaciclib-combined-with-anti-her2-and-endocrine-therapy-for-hrher2-advanced-breast-cancer-100648157","NCT07716046","Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+\u002FHER2+ Advanced Breast Cancer","Efficacy and Safety of Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for First-line Maintenance or Upfront Chemo-Free Treatment in HR+\u002FHER2+ Advanced Breast Cancer: A Multicenter, Open-label, Randomized Controlled Phase II Study","FACET","Inclusion Criteria:\n\n* Age ≥ 18 years, with inoperable locally advanced or recurrent\u002Fmetastatic breast cancer not amenable to curative-intent therapy.\n* Histologically or cytologically confirmed hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. HR+ is defined as estrogen receptor (ER) and\u002For progesterone receptor (PR) positivity with ≥1% of invasive tumor cells positive by immunohistochemistry (IHC). HER2+ is defined as IHC 3+ or IHC 2+ with in situ hybridization (ISH) positivity.\n* No prior systemic therapy for advanced breast cancer, including endocrine therapy, chemotherapy, anti-HER2 therapy, or any CDK4\u002F6 inhibitor.\n* Patients may have received neoadjuvant or adjuvant therapy. If prior endocrine therapy was received in the neoadjuvant\u002Fadjuvant setting, the disease-free interval from completion of endocrine therapy to randomization must be ≥12 months. If prior anti-HER2 therapy was received, the disease-free interval from completion of anti-HER2 therapy to randomization must be ≥6 months.\n* Patients with stable central nervous system (CNS) metastases (meeting all the following criteria: no disease progression on screening imaging after local therapy; at least 3 weeks from completion of local CNS therapy to Cycle 1 Day 1; no requirement for medication to control symptoms) or asymptomatic CNS metastases are eligible.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Any menopausal status. Postmenopausal status is defined as: a. bilateral oophorectomy; b. age ≥60 years; c. age \\\u003C60 years with amenorrhea for \\>1 year in the absence of chemotherapy, tamoxifen, toremifene, or ovarian function suppression, and with serum FSH and estradiol levels within the postmenopausal range. For patients \\\u003C60 years on tamoxifen or toremifene with amenorrhea, serum FSH and estradiol levels must be within the postmenopausal range on consecutive measurements.\n* At least one evaluable lesion per RECIST 1.1 (measurable and\u002For non-measurable lesion).\n* For women of childbearing potential: negative serum or urine pregnancy test within 7 days prior to randomization, and agreement to use adequate contraception during study treatment and for 6 months after the last dose of fulvestaciclib.\n* Voluntarily sign the informed consent form (ICF), understand the study, and be willing to comply with all study procedures and follow-up.\n* Adequate bone marrow and organ function defined as:\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Hemoglobin ≥90 g\u002FL (no red blood cell transfusion within 14 days prior to randomization); Platelet count ≥75 × 10⁹\u002FL; Serum total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN (or ≤5 × ULN in the presence of liver metastases); Serum creatinine ≤1 × ULN or calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula); Baseline left ventricular ejection fraction (LVEF) ≥50%.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer.\n* Leptomeningeal disease.\n* Active brain metastases (patients with asymptomatic brain metastases, or clinically stable and not requiring steroids or other CNS-directed therapy for ≥4 weeks are eligible).\n* Diagnosis of any other malignancy, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that has been definitively treated.\n* Known severe hypersensitivity to any component of the study drugs.\n* Myocardial infarction within 6 months prior to first dose; uncontrolled cardiac arrhythmias (QTc interval ≥470 ms by Fridericia's formula); New York Heart Association (NYHA) Class III-IV cardiac insufficiency; LVEF \\\u003C50% on echocardiography; or clinically significant pleural effusion, pericardial effusion, or ascites requiring intervention.\n* Dysphagia, active gastrointestinal disease, major gastrointestinal surgery, malabsorption syndrome, or any other condition that may interfere with the absorption of study drugs.\n* Known active infection, including hepatitis B (HBsAg positive with HBV DNA ≥1×10⁴ copies\u002FmL or ≥2000 IU\u002FmL), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection.\n* Major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody therapy, or other systemic antitumor therapy within 30 days prior to the first dose, or any therapy that the investigator considers may interfere with the efficacy of study drugs.\n* Concurrent use of other investigational drugs or therapies.\n* Planned or prior organ or bone marrow transplantation.\n* Known history of substance abuse or drug addiction.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.",{"count":486,"type":21},240,[24],"This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4\u002F6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and pertuzumab, HP) and endocrine therapy (ET) in hormone receptor-positive (HR+) and HER2-positive advanced breast cancer (ABC).\n\nPatients with HR+\u002FHER2+ ABC without prior systemic therapy for advanced disease are randomized in a 1:1:1 ratio into three arms, stratified by visceral metastasis status (yes vs. no) and metastatic type (de novo vs. recurrent).\n\nArm A: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive fulvestaciclib + HP + ET as maintenance therapy.\n\nArm B: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive HP + ET alone (without fulvestaciclib) as maintenance therapy.\n\nArm C (exploratory): Patients receive upfront fulvestaciclib + HP + ET as first-line therapy without induction chemotherapy (chemo-free).\n\nFor premenopausal\u002Fperimenopausal patients, ovarian function suppression (OFS) is added in all arms. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.\n\nThe primary endpoint is investigator-assessed progression-free survival (PFS) comparing Arm A versus Arm B. Secondary endpoints include PFS (Arm A vs. Arm C), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR), cumulative incidence of central nervous system (CNS) metastases, safety, and patient-reported outcomes (PROs).",[111,490,491,492],"HER2-positive Breast Cancer","Hormone Receptor-positive Breast Cancer","HR+\u002FHER2+ Breast Cancer","2026-07-20",{"date":470,"type":36},{"date":285,"type":21},{"date":497,"type":21},"2032-12-31",{"name":42,"class":43},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":514,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":44},"100608920","phase-3-dvbcg-in-her2-expressing-bcg-nave-high-risk-nmibc-100608920","NCT07207824","DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC","A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer","HERO","Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with \\>50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).\n3. Complete resection of all Ta\u002FT1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.\n4. HER2 expression (IHC 1+\u002F2+\u002F3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.\n5. Unwillingness or ineligibility to undergo radical cystectomy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.\n7. Signed informed consent form (ICF).\n\nExclusion Criteria\n\n1. Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.\n2. Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.\n3. History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).\n4. Prior therapy with any other type of HER2-targeted inhibitor.\n5. Major surgery within 2 weeks prior to randomization.\n6. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.",{"count":508,"type":21},182,[210],"The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.",[512,513],"Bladder (Urothelial, Transitional Cell) Cancer","NMIBC",[513,515,516,517],"disitamab vedotin","HER2","BCG","2026-07-17",{"date":470,"type":36},{"date":521,"type":36},"2025-12-01",{"date":523,"type":21},"2030-12-01",{"name":42,"class":43},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":206,"maxAge":79,"enrollmentInfo":532,"targetDuration":4,"studyType":22,"phases":534,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":44},"100647619","phase-4-efficacy-and-safety-of-canagliflozin-in-the-treatment-of-type-2-diabetes-with-mild-cognitive-impairment-100647619","NCT07711171","Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment","Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment- a Prospective, Randomized, Single-blind, Controlled, Single-center, Head-to-head Clinical Cohort Study","Inclusion Criteria:\n\n* age: 40-75 years old;\n* HbA1c: 7.0 - 10.0%;\n* Moca scale total score between 20-26 (duration of education is more than 10 years) or total score between 20 and 25 (duration of education is less than 10 years);\n* sign informed consent;\n\nExclusion Criteria:\n\n* left-handedness;\n* duration of diabetes is less than 6 years;\n* inability to complete central nervous system magnetic resonance imaging;\n* alcohol or drug addiction history;\n* use of other oral hypoglycemic drugs within 90 days prior to enrollment except for metformin;\n* Family or past history of neurological or psychiatric disorders, pancreatitis, medullary thyroid cancer and multiple endocrine adenomatosis;\n* History of recurrent urinary tract infection and malignant tumor;\n* History of severe gastrointestinal diseases and gastroenteric surgery;\n* Pregnancy\u002Flactation status;\n* Abnormal liver function (liver enzyme index is more than 2.5 times the upper limit of the reference range) or abnormal kidney function (estimated glomerular filtration rate is less than 45ml\u002Fmin); Type 1 diabetes; other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, which are likely to cause loss of follow-up, according to the judgment of the researchers;",{"count":533,"type":21},60,[535],"PHASE4","The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients, and early intervention is of great significance. Central nervous system insulin resistance plays a key role in the pathogenesis of cognitive dysfunction in diabetic patients. Central insulin resistance observed by functional magnetic resonance imaging (fMRI), may serve as an alternative endpoint for assessing cognitive function. Sodium glucose cotransporter 2 inhibitor (SGLT2i) may improve cognitive impairment by improving central insulin resistance.",[538,539],"Type 2 Diabetes Mellitus","Cognitive Impairment","2026-07-14",{"date":518,"type":36},{"date":543,"type":36},"2024-08-19",{"date":545,"type":21},"2026-10-30",{"name":42,"class":43},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":296,"enrollmentInfo":554,"targetDuration":4,"studyType":556,"phases":4,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":566,"leadSponsor":568,"locationsCount":44},"100647388","real-world-study-of-young-patients-with-solid-tumors-in-china-100647388","NCT07708935","Real-World Study of Young Patients With Solid Tumors in China","A Multicenter Real-World Study on the Diagnosis, Treatment, and Long-Term Survival of Young Patients With Malignant Solid Tumors in China","Inclusion Criteria:\n\n1. Confirmed Diagnosis: Patients with malignant solid tumors confirmed by histopathological or cytological examination. The primary tumor types of interest include, but are not limited to, breast cancer, malignant melanoma, and multiple primary tumors.\n2. Age and Cohort Definitions:\n\n   2.1. Young Cohort (Core Population): Patients aged ≤40 years at the time of initial diagnosis of a malignant tumor.\n\n   2.2. Older Control Cohort: Patients aged \\>40 years at the time of initial diagnosis of a malignant tumor. Patients will be selected proportionally according to the incidence of each tumor type and propensity score matching principles.\n3. Eligible Time Window: The initial diagnosis or receipt of antitumor treatment at the participating center must have occurred between January 1, 2010, and May 31, 2026.\n4. Treatment History: Patients must have received at least one standard antitumor treatment at a participating study center, including but not limited to curative or palliative surgery, neoadjuvant or adjuvant systemic therapy, and first-line or later-line chemotherapy, targeted therapy, or immunotherapy for advanced disease.\n5. Availability of Multimodal Data:\n\n5.1. Relatively complete clinical records must be available, including baseline demographic characteristics, medical records, treatment regimens, and follow-up records.\n\n5.2. Baseline imaging data must be available, such as CT, MRI, or PET-CT scans. 5.3. Pathological tissue samples, such as formalin-fixed, paraffin-embedded (FFPE) blocks or unstained slides, must be available to support subsequent digital pathology and radiomic feature extraction.\n\nExclusion Criteria:\n\n1. Uncertain Diagnosis: Patients with an inconclusive histopathological or cytological diagnosis, or without clear documentation of tumor stage according to the TNM staging system.\n2. Severe Missingness of Core Data: Patients with substantially incomplete clinical records, such as missing documentation of key treatment regimens, absence of any baseline imaging assessment, or no follow-up records whatsoever due to loss to follow-up.\n3. Potential Confounding From Multiple Primary Malignancies: Patients with a concurrent malignancy or a history of another malignancy within the previous 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma, to avoid confounding the analysis of survival outcomes, including overall survival (OS) and progression-free survival (PFS).\n4. Deemed Unsuitable by the Investigator: Patients considered by the investigator, based on clinical judgment, to have other conditions that make them unsuitable for inclusion in this study.",{"count":555,"type":21},12000,"OBSERVATIONAL","To evaluate organ preservation rates, fertility preservation, and long-term quality of life after treatment among young patients.",[559],"Cancer",[561],"Young Patients with Malignant Solid Tumors","2026-07-13",{"date":564,"type":36},"2026-07-16",{"date":382,"type":21},{"date":567,"type":21},"2027-12-31",{"name":42,"class":43},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":205,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":577,"studyType":556,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":44},"100647182","granzyme-b-pet-predicting-immunotherapy-efficacy-in-tnbc-100647182","NCT07705438","Granzyme B-PET: Predicting Immunotherapy Efficacy in TNBC","Study on Using Granzyme B-PET Imaging to Predict the Efficacy of Immunotherapy in Locally Advanced and Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically confirmed unresectable locally advanced or metastatic breast cancer, with immunohistochemistry (IHC) results indicating negativity for ER, PR, and Her-2. If pathology from a metastatic lesion is available, its histology will take precedence.\n\n   ER and PR negativity is defined as: ER \\\u003C1% positive and PR \\\u003C1% positive, OR ER \\\u003C10% with weak positivity and PR \\\u003C10% with weak positivity.\n\n   Her-2 negativity is defined as: an IHC score of 0 or 1+; or an IHC score of 2+ with a negative FISH test result. For patients with an IHC score of 0 or 1+, a FISH test is optional but must be negative if performed.\n3. Decision by the clinician to treat with a regimen containing an immune checkpoint inhibitor (ICI), with the patient scheduled to receive at least 2 cycles of treatment.\n\n   3.1. If the patient intends to participate in an ongoing clinical trial involving an ICI at our department, they must meet the inclusion and exclusion criteria of that specific trial. ICIs involved in clinical trials at our department include, but are not limited to, Pembrolizumab, Sintilimab, Toripalimab, and QL1706.\n\n   3.2. For patients not enrolled in a clinical trial, they must have PD-L1 positive status (CPS ≥ 1), and the intended drug must be Toripalimab, as approved by the National Medical Products Administration (NMPA).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Evidence of radiological or objective disease progression during or after the most recent systemic therapy prior to study entry, or intolerance to the toxicity of prior treatment.\n6. Life expectancy of ≥ 12 weeks at the time of screening.\n7. Presence of at least one measurable lesion that has not been previously irradiated. The lesion must have a longest diameter of ≥10 mm at baseline as measured by CT or MRI (for lymph nodes, the short axis must be ≥15 mm). In cases where only bone lesions are present, lytic or mixed lytic-blastic bone lesions that can be assessed by CT, MRI, or X-ray are acceptable.\n8. Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to randomization.\n9. Adequate organ and bone marrow function within 14 days prior to randomization. The most recently obtained results for all parameters listed below must be used to meet the eligibility criteria:\n\n   1. Hemoglobin ≥ 9 g\u002FdL\n   2. Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm³\n   3. Platelet count ≥ 100,000\u002Fmm³\n   4. At baseline, Total Bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) if no liver metastases are present, or \\\u003C 3 × ULN for patients with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases.\n   5. ALT and AST ≤ 3 × ULN, or \\\u003C 5 × ULN for patients with liver metastases.\n   6. Serum albumin ≥ 2.5 g\u002FdL\n   7. Creatinine clearance ≥ 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n   8. International Normalized Ratio (INR) or Prothrombin Time (PT), and Partial Thromboplastin Time (PTT) or activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN.\n10. From the screening period through the entire study treatment period and for 7 months after the last dose of study treatment, female patients must not donate or retrieve oocytes (eggs) for personal use. Breastfeeding must be avoided during this period. If oocyte preservation is desired, it should be completed prior to randomization in this study.\n\nExclusion Criteria:\n\n1. Uncontrolled concomitant diseases, including but not limited to: persistent or active infection; uncontrolled or significant cardiovascular disease; severe chronic gastrointestinal conditions associated with diarrhea; or psychiatric\u002Fsocial conditions that may limit compliance with study requirements, significantly increase the risk of adverse events (AEs), or impair the patient's ability to provide written informed consent.\n2. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   1. History of myocardial infarction or symptomatic Congestive Heart Failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV) within 6 months prior to randomization. Patients with troponin levels above the upper limit of normal (ULN) (as defined by the manufacturer) at screening without any symptoms related to myocardial infarction should undergo a cardiology consultation prior to randomization to rule out myocardial infarction.\n   2. Uncontrolled hypertension.\n   3. Uncontrolled and\u002For clinically significant arrhythmias.\n3. History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis requiring steroid treatment, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis on imaging at screening that cannot be ruled out.\n4. Use of immunosuppressive medications within 14 days prior to the first dose of the study drug, with the exception of intranasal and inhaled corticosteroids, or systemic corticosteroids at a dose of less than 10 mg\u002Fday of prednisone or its equivalent.\n5. Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within three months prior to randomization, severe asthma, severe Chronic Obstructive Pulmonary Disease \\[COPD\\], restrictive lung disease, significant pleural effusion), and\u002For any autoimmune, connective tissue, or inflammatory diseases with concomitant pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), and\u002For prior lung resection.\n6. Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals.\n7. Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be eligible. Subjects may be included if their brain metastases have been treated, they are no longer symptomatic, do not require corticosteroids or anticonvulsants, and have recovered from the acute toxic effects of radiotherapy.\n8. Active primary immunodeficiency, known Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B or Hepatitis C infection. For patients with positive Hepatitis C antibody, only those who are negative for HCV RNA by polymerase chain reaction (PCR) are eligible for enrollment.\n9. Unresolved toxicity from prior anticancer therapy, defined as toxicity that has not resolved to ≤ Grade 1 or baseline (with the exception of alopecia).\n\n   Note: Subjects with chronic, stable Grade 2 toxicity (defined as not having worsened for at least 3 months prior to enrollment and being manageable with standard therapy) that the investigator deems related to prior anticancer therapy may be enrolled. Examples include chemotherapy-induced neuropathy or fatigue; residual toxicity from prior immunosuppressive therapy such as Grade 1 or 2 endocrinopathy.\n10. Female patients who are pregnant or breastfeeding, or are planning to become pregnant.\n11. Known history of severe hypersensitivity reaction to the active substance, excipients in the drug formulation, or other monoclonal antibodies.\n12. History of another primary malignancy within the last 3 years, with the exception of: adequately resected non-melanoma skin cancer, curatively treated carcinoma in-situ, other solid tumors that have been cured, or contralateral breast cancer.\n13. Substance abuse or any other medical condition, such as a psychiatric illness, that in the investigator's judgment could interfere with the patient's participation in or the evaluation of the results of the clinical study.",{"count":127,"type":21},"1 Year","This study plans to enroll 30 patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who are scheduled to receive at least two cycles of a regimen containing an immune checkpoint inhibitor (ICI). All ICI treatments must be administered in accordance with current clinical indications. For patients who intend to participate in a clinical trial involving an ICI, they must meet the eligibility criteria of that specific trial protocol.\n\nAfter screening and enrollment, participants will undergo a \\[68Ga\\]Ga-DOTA-GSI PET\u002FCT (Granzyme B PET\u002FCT) scan before initiating the ICI-containing regimen and again after Cycle 2 (C2). Participants will continue the ICI regimen until disease progression, with tissue biopsies performed as needed.\n\nBy integrating patients' baseline clinical characteristics, treatment outcomes, and prognostic information, this study aims to conduct a comprehensive analysis. The objective is to investigate whether the following factors, as assessed by Granzyme B PET\u002FCT, can serve as early predictors of response to immunotherapy in patients with advanced breast cancer: baseline Granzyme B expression levels, immunotherapy-activated Granzyme B levels after C2, and the heterogeneity of Granzyme B expression at baseline and after C2.",[580,581,582],"Triple Negative Breast Cancer","Immune Checkpoint Inhibitor","Granzyme B PET\u002FCT",{"date":584,"type":36},"2026-07-15",{"date":586,"type":36},"2025-05-28",{"date":588,"type":21},"2027-05-28",{"name":42,"class":43},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":44},"100606989","phase-2-skb264-plus-inetetamab-in-her2-positive-metastatic-breast-cancer-patients-progressing-after-t-dxd-treatment-100606989","NCT07182721","SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment","A Phase II, Single-Arm, Single-Center, Prospective Study of SKB264 Plus Inetetamab in HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients Progressing After T-DXd Treatment","SHINE-HER","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. Patients with histologically or cytologically confirmed breast cancer who meet the following criteria:\n\n   1. Unresectable locally advanced or metastatic breast cancer.\n   2. Pathologically confirmed HER2-positive breast cancer, regardless of hormone receptor (HR) status. HER2 positivity is defined as: IHC 3+, or IHC 2+ and FISH positive.\n   3. Prior treatment for unresectable locally advanced or metastatic disease must have included the following anti-HER2 therapies: trastuzumab deruxtecan (T-DXd) and trastuzumab (or a trastuzumab biosimilar). Patients who received T-DXd and trastuzumab (or a biosimilar) in the (neo)adjuvant setting and experienced recurrence or metastasis during or within 12 months of completing therapy are eligible. Additionally, prior treatment regimens must have included a taxane.\n   4. Documented disease progression or unacceptable toxicity after the last line of therapy for unresectable locally advanced or metastatic disease.\n3. ECOG performance status of 0-2, with a life expectancy of \\> 3 months.\n4. At least one measurable target lesion according to RECIST v1.1 criteria.\n5. Adequate organ and bone marrow function, as defined below:\n\n   1. Complete Blood Count: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL.\n   2. Liver Function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN. For patients with liver metastases, ALT and AST ≤ 5.0 × ULN.\n   3. Renal Function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n   4. Coagulation Function: International Normalized Ratio (INR) ≤ 1.5 × ULN and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n   5. Echocardiogram: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n   6. 12-lead ECG: QT interval corrected by Fridericia's formula (QTcF) \\\u003C 470 ms for females and \\\u003C 450 ms for males.\n6. Voluntarily agrees to participate in the study by signing the informed consent form (ICF), and is willing and able to comply with follow-up procedures.\n\nExclusion Criteria:\n\n1. Meningeal metastases confirmed by MRI or lumbar puncture.\n2. Presence of spinal cord compression or clinically active central nervous system (CNS) metastases (defined as untreated or symptomatic metastases, or those requiring corticosteroids or anticonvulsants to control associated symptoms). Patients with previously treated brain metastases may be enrolled, provided they are clinically stable for at least 4 weeks, have no imaging evidence of progression, and at least 2 weeks have passed since the completion of brain radiotherapy and the discontinuation of corticosteroids or anticonvulsants for this indication.\n3. Presence of third-space fluid accumulation (e.g., significant pleural effusion) that cannot be controlled by drainage or other methods.\n4. Prior treatment with inetetamab or any TROP-2 antibody-drug conjugate (ADC).\n5. Receipt of whole-brain radiotherapy, chemotherapy, biologic targeted therapy, immunotherapy, surgery, endocrine therapy, or other investigational drugs within 2 weeks prior to the first dose of study treatment.\n6. Concurrent treatment with any other anti-cancer therapy.\n7. Known history of hypersensitivity to any component of the study drugs. Permanent discontinuation of prior trastuzumab or its biosimilars due to any toxicity.\n8. Severe or uncontrolled cardiac disease requiring treatment, including:\n\n   1. Congestive heart failure of New York Heart Association (NYHA) Class 3 or 4.\n   2. Unstable angina pectoris uncontrolled by medication.\n   3. Myocardial infarction within 6 months prior to the first dose of study treatment.\n   4. Severe arrhythmia requiring medical treatment (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia).\n   5. History of symptomatic congestive heart failure or a Left Ventricular Ejection Fraction (LVEF) \\\u003C40% during previous trastuzumab therapy.\n9. Presence of any severe concomitant disease that, in the investigator's judgment, could jeopardize patient safety or interfere with study completion (e.g., uncontrolled severe diabetes, hypertension, autoimmune diseases), or any other condition deemed unsuitable for enrollment by the investigator.\n10. Toxicity from prior anti-cancer therapy that has not resolved to NCI-CTCAE v5.0 Grade ≤1 or baseline level (with the exception of Grade 2 alopecia, pigmentation, or other toxicities such as simple laboratory abnormalities that the investigator considers to pose no safety risk).\n11. History of other malignancies within the past 5 years, with the exception of curatively treated carcinoma in-situ, basal cell or squamous cell skin carcinoma, or papillary thyroid carcinoma after curative resection.\n12. History of immunodeficiency, including a positive HIV test, active Hepatitis B or C, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n13. Known history of neurological or psychiatric disorders, including epilepsy or dementia.\n14. Female patients of childbearing potential who are pregnant or breastfeeding. A negative serum pregnancy test is required within 7 days prior to randomization. Patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 7 months after the last dose of study drug.\n15. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.",{"count":599,"type":21},48,[24],"This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.",[603,604,605],"HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer","SKB264","Inetetamab",{"date":584,"type":36},{"date":608,"type":36},"2025-09-30",{"date":610,"type":21},"2029-02-01",{"name":42,"class":43},""]