[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":590},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,77,0,25,[9,47,73,95,121,147,168,192,212,230,258,282,307,327,346,366,384,410,437,461,483,505,529,547,569],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100644680","circulating-cfdna-and-hpv-as-prognostic-biomarkers-for-first-line-recurrent-metastatic-cervical-cancer-100644680",false,"NCT07673211","Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer","A Prognostic Research on First-Line Recurrent and Metastatic Cervical Cancer Using Circulating Cell-Free DNA and Human Papillomavirus Detection","Inclusion Criteria:\n\n1. Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;\n2. Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease);\n3. Received standard first-line therapy (TP\u002FTC regimen plus immunotherapy ± bevacizumab);\n4. Achieved complete response (CR) following standard first-line treatment;\n5. Archived pathological biopsy specimens of recurrent\u002Fmetastatic lesions prior to treatment available in our hospital;\n6. Participated in clinical trials of pharmaceutical therapy for first-line recurrent\u002Fmetastatic cervical cancer conducted at our institution;\n7. Voluntarily participates in this study and provides written informed consent;\n8. Agrees to serial peripheral blood collection at scheduled time points;\n9. Willing to complete scheduled follow-up visits;\n10. Aged ≥ 18 years old.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within the past 2 years;\n2. Pregnant or breastfeeding women;\n3. Severe concomitant diseases, including: cardiovascular diseases (e.g., uncontrolled heart failure, unstable angina, etc.); pulmonary diseases (e.g., severe chronic obstructive pulmonary disease, interstitial pneumonia and other conditions impairing respiratory function); hepatic and renal dysfunction (e.g., decompensated liver cirrhosis, severe renal failure requiring dialysis, etc.);\n4. Refusal to sign informed consent;\n5. Refusal to undergo serial blood collection.","FEMALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","3 Years","OBSERVATIONAL","Primary Objective of this study: To investigate the correlation between longitudinal quantitative dynamics of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA) in peripheral blood and clinical prognosis among patients with recurrent and metastatic cervical cancer who achieved complete response following standard first-line systemic therapy.",[26,27,28],"Cervical Cancer","Recurrent Cervical Cancer","Metastatic Cervical Cancer",[30,31,32,33,34],"Cervical cancer","ctDNA","HPV cfDNA","Complete response","Prognosis","NOT_YET_RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":21},"2026-06",{"date":43,"type":21},"2029-12",{"name":45,"class":46},"Zhejiang Cancer Hospital","OTHER",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100644614","biodistribution-dosimetry-and-safety-of-68ga-ev203-in-hematological-malignancies-100644614","NCT07670949","Biodistribution, Dosimetry, and Safety of 68Ga-EV203 in Hematological Malignancies","A Clinical Translational Study Evaluating the Biodistribution, Radiation Dosimetry, and Safety of 68Ga-EV203 Injection in Patients With Hematological Malignancies","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive) at screening.\n* Able to lie still on the scanning bed for 0.5 hours.\n* Willing to sign informed consent and able to comply with protocol requirements.\n* Histologically\u002Fcytologically confirmed diagnosis of multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or acute myeloid leukaemia (AML) according to the 2022 WHO Classification of Haematolymphoid Tumours.\n\nExclusion Criteria:\n\n* Has claustrophobia or any other condition that prevents tolerance of imaging procedures\n* Has undergone major surgery within 3 months prior to screening, or plans to undergo surgery during the study period.\n* Has received any other radiopharmaceutical imaging agent or therapeutic radiopharmaceutical within 30 days prior to screening.\n* Is pregnant or lactating at screening.\n* Is a woman of childbearing potential or a man who does not agree to use effective contraception during the study (from signing informed consent) and for 3 months after study drug administration.\n* Has a known allergy to alcohol or any component of the investigational product, or has other allergies judged by the investigator to increase the participant's risk.\n* Has clinically significant cardiovascular disease within 6 months prior to screening (e.g., myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled severe arrhythmia).\n* Has uncontrolled hypertension, or a history of coagulopathy or coagulation disorders.\n* Has been diagnosed with another malignancy (other than the target haematological disease) within 5 years prior to 68Ga-EV203 administration.\n* Has received any systemic anti-cancer therapy within 2 weeks prior to planned 68Ga-EV203 administration, or radiotherapy within 8 weeks prior to planned administration.\n* Has any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.","ALL","75 Years",{"count":57,"type":21},30,"INTERVENTIONAL",[60],"NA","The goal of this clinical trial is to evaluate the biodistribution, radiation dosimetry, safety, and time-dependent image quality of \\^68\\^Ga-EV203 injection in patients with hematological malignancies (multiple myeloma, non-Hodgkin lymphoma, or acute myeloid leukaemia), aged 18-75 years, who are able to lie still for 0.5 h and have no contraindications (e.g., pregnancy, recent radiotherapy, etc.).\n\nThe main questions it aims to answer are:\n\nWhat are the biodistribution (organ uptake, %ID, SUV) and radiation absorbed doses (mGy\u002FMBq) of \\^68\\^Ga-EV203 in target organs and the whole body?\n\nWhat is the safety profile of \\^68\\^Ga-EV203, as measured by adverse events and serious adverse events?\n\nHow does the PET\u002FCT image quality differ between the 30-, 60-, 90-, and 120-minute time points after injection?\n\nIf there is a comparison group: Researchers will compare the positive percent agreement (PPA) and positive predictive value agreement (PPrA) of \\^68\\^Ga-EV203 PET\u002FCT against \\^18\\^F-FDG PET\u002FCT to see if the new tracer offers comparable or superior diagnostic performance in detecting CXCR4-positive lesions.\n\nParticipants will:\n\nReceive a single intravenous injection of 74-296 MBq of \\^68\\^Ga-EV203.\n\nUndergo whole-body PET\u002FCT scans at 30 min, 60 min, 90 min, and 120 min post-injection on the same day.\n\nReturn within 3-7 days (but at least 2 days later) for a standard \\^18\\^F-FDG PET\u002FCT scan after fasting for ≥5 h.\n\nAttend a safety follow-up visit at day 8-14 for physical examination, vital signs, and laboratory tests (blood count, coagulation, and biochemistry).",[63],"Hematological Malignancies B","RECRUITING",{"date":66,"type":39},"2026-06-26",{"date":68,"type":39},"2026-06-01",{"date":70,"type":21},"2029-06-01",{"name":45,"class":46},1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":58,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100637333","phase-2-metronomic-oral-paclitaxel-monotherapy-and-combined-immunotherapy-for-advanced-her2-negative-breast-cancer-a-two-stage-dose-exploration-and-expansion-trial-100637333","NCT07602907","Metronomic Oral Paclitaxel Monotherapy and Combined Immunotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose Exploration and Expansion Trial","Inclusion Criteria:\n\n1.Age ≥ 18 years, male or female. 2.Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer, regardless of hormone receptor (HR) status. For patients with HR+\u002FHER2-negative subtype: prior treatment with at least 1 line of CDK4\u002F6 inhibitor plus endocrine therapy is required, and the patient is considered no longer suitable for further endocrine therapy by the investigator.\n\n3.Patients have received 1-4 prior lines of systemic anti-tumor therapy for recurrent or metastatic disease.\n\n1. Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent\u002Fmetastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.\n2. Neoadjuvant or adjuvant therapy is not counted as a treatment line.\n3. Disease recurrence \\>6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.\n4. Disease recurrence \\>12 months after adjuvant therapy is counted as first-line; recurrence ≤12 months is considered continuation of prior therapy, and subsequent regimens start at second-line.\n\n4.Prior treatment with taxane is allowed if both criteria are met:\n\n1. Interval from last dose of taxane to first study dose ≥ 4 weeks;\n2. No unresolved taxane-related Grade ≥3 toxicity in the past. 5.Body surface area (BSA): 1.38 m² ≤ BSA ≤ 1.87 m². 6.ECOG performance status 0-1. 7.At least one measurable lesion per RECIST 1.1. 8.Expected survival ≥ 12 weeks. 9.Adequate bone marrow function: ANC ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL 10.Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN ALT\u002FAST ≤ 2.5 × ULN (no liver metastasis) ALT\u002FAST ≤ 5 × ULN (with liver metastasis) 11.Adequate renal function: Serum creatinine ≤ 1.5 mg\u002FdL Or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) if serum creatinine \\>1.5 mg\u002FdL.\n\n12.Pre-existing peripheral neuropathy \\\u003C Grade 2 (CTCAE v6.0). 13.Known CNS metastases are allowed only if all of the following are met:\n\n1. CNS lesions stable for ≥4 weeks before enrollment, per RANO-BM criteria (no new lesions, target lesion volume change \\\u003C20%, no clear progression of non-target lesions on baseline and follow-up MRI).\n2. No corticosteroid use, or current dexamethasone ≤4 mg\u002Fday (or equivalent), with no dose increase within 7 days before enrollment.\n3. For patients with prior local CNS treatment: no imaging progression after treatment completion; neurologic symptoms stable for ≥2 weeks before first study dose; no steroid or ≤4 mg\u002Fday dexamethasone (or equivalent).\n4. No leptomeningeal disease.\n5. Whole-brain radiotherapy completed \\>14 days before enrollment.\n6. Prior stereotactic radiosurgery is allowed.\n7. Prior CNS surgery completed \\>28 days before enrollment with full recovery. 14.Voluntary participation and signed written informed consent.\n\nExclusion Criteria:\n\n1. Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.\n2. Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).\n3. Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.\n4. Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence\u002Fmetastasis within 12 months after neoadjuvant\u002Fadjuvant therapy.\n5. Patients requiring long-term concomitant use of P-glycoprotein (P-gp) inhibitors or immunosuppressive agents during the study.\n6. Patients receiving long-term treatment with steroids or other immunosuppressive agents (except oral, topical, or local injection).\n7. Patients with myocardial infarction, congestive heart failure, rapidly changing arrhythmia on ECG, severe or unstable angina pectoris, or other serious heart diseases.\n8. Patients with other severe medical diseases (uncontrolled diabetes mellitus and hypertension, chronic obstructive pulmonary disease (COPD), or dyspnea at rest due to any cause).\n9. Patients with a history of drug or alcohol abuse within the past 3 months.\n10. Pregnant or breastfeeding women, or patients who cannot or will not use effective contraceptive methods.\n11. Patients with or suspected of having bile acid excretion disorders.\n12. Active tendency of gastrointestinal bleeding or use of oral vitamin K antagonists (low-dose warfarin and acetylsalicylic acid are allowed as long as INR ≤2.0).\n13. Patients with severe hypersensitivity to the active ingredients or excipients of the study drugs.\n14. History of HIV seropositivity (HIV testing is not mandatory).\n15. Gastrointestinal dysfunction or diseases that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, poorly controlled nausea, vomiting, diarrhea, malabsorption syndrome), except patients with prior gastrectomy.\n16. Patients receiving enteral feeding (e.g., via nasogastric tube, nasointestinal tube, gastrostomy, or jejunostomy).\n17. Patients with visceral crisis, or patients with excessive tumor burden, rapid disease progression who urgently require rapid tumor shrinkage (e.g., conventional maximum tolerated dose chemotherapy) to relieve severe clinical symptoms per investigator assessment.\n18. Patients considered inappropriate for the clinical trial by the investigator.",{"count":80,"type":21},44,[82],"PHASE2","The goal of this clinical trial is to learn if oral paclitaxel solution (metronomic scheduling) works to treat advanced HER2-negative breast cancer in adults. It will also learn about the safety of oral paclitaxel solution alone and combined with toripalimab.\n\nThe main questions it aims to answer are:\n\nWhat is the optimal tolerated dose (OTD) of metronomic oral paclitaxel solution? Does metronomic oral paclitaxel plus toripalimab improve progression-free survival (PFS)? What medical problems do participants have when taking the study treatments? Researchers will evaluate metronomic oral paclitaxel alone (dose-finding) and metronomic oral paclitaxel plus toripalimab (expansion cohort) to see if the regimens work to treat advanced HER2-negative breast cancer.\n\nParticipants will:\n\nReceive metronomic oral paclitaxel solution (one of two dose levels) once daily or three times weekly After OTD is determined, receive metronomic oral paclitaxel plus toripalimab every 3 weeks Visit the clinic regularly for safety checks, blood tests, and tumor imaging Keep records of treatment compliance and health-related quality of life",[85,86],"Advanced Breast Cancer","HER2-negative Breast Cancer","2026-05-21",{"date":89,"type":39},"2026-05-22",{"date":91,"type":21},"2026-05-30",{"date":93,"type":21},"2029-05-07",{"name":45,"class":46},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":105,"studyType":23,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":72},"100639053","a-prospective-observational-study-of-senaparib-in-the-treatment-of-epithelial-ovarian-cancer-100639053","NCT07586449","A Prospective Observational Study of Senaparib in the Treatment of Epithelial Ovarian Cancer","Evaluation of Safety and Effectiveness of Senaparib in Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer: A Prospective Observational Real-World Study","RESO","Inclusion Criteria:\n\n* Sign informed consent and voluntarily join the study;\n* Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology;\n\n  -≥ 18 years old;\n* The investigator determined that the patient could receive senaparib monotherapy or combination therapy;\n* For patients with fertility, effective contraceptive methods should be used during the study period and within 90 days after the last administration of senaparib\n\nExclusion Criteria:\n\n* There is evidence that the patient is a pregnant or lactating woman;\n* Participating in any research with intervention measures other than routine -clinical practice;\n* The researcher judges other situations that are not suitable for inclusion in the study;",{"count":104,"type":21},500,"6 Years","Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis.\n\nThis observational study is to evaluate the safety and efficacy of senaparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment。",[108],"Ovarian Cancer (OvCa)",[110,111,112],"senaparib","real word study","ovarian cancer","2026-05-08",{"date":115,"type":39},"2026-05-14",{"date":117,"type":21},"2026-06-10",{"date":119,"type":21},"2030-12-31",{"name":45,"class":46},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":58,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":72},"100634357","phase-2-car-t-combined-with-asct-in-the-treatment-of-relapsedrefractory-large-b-cell-lymphoma-with-high-risk-factors-100634357","NCT07538635","CAR-T Combined With ASCT in the Treatment of Relapsed\u002FRefractory Large B-cell Lymphoma With High-risk Factors.","A Single-arm, Single-center, Open-label Clinical Study on the Efficacy and Safety of CAR-T Combined With ASCT in the Treatment of Relapsed\u002FRefractory Large B-cell Lymphoma With High-risk Factors.","CAR-T+ASCT","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL)\n3. Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline\n4. Meet one of the following clinical high-risk factors or molecular biological high-risk factors:\n\n   1. Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line immunochemotherapy; or relapse after autologous hematopoietic stem cell transplantation (ASCT); or central nervous system involvement at the time of disease relapse or progression\n   2. Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement\n5. ECOG 0 to 2\n6. Eligible for high-dose chemotherapy\u002Fautologous hematopoietic stem cell transplantation (HDCT\u002FASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy\n7. Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg\u002FdL; serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 30 mL\u002Fmin\n8. Left ventricular ejection fraction (LVEF) ≥ 40%\n9. Life expectancy ≥ 3 months\n\nExclusion Criteria:\n\n1. Patients who have previously received any CD19-targeted therapy\n2. Patients with CD19 negativity confirmed by immunohistochemistry (IHC)\n3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities\n4. Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases\n5. History of human immunodeficiency virus (HIV) infection\n6. Pregnant or lactating patients",{"count":130,"type":21},20,[82],"This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed\u002Frefractory large B-cell lymphoma with high-risk factors.",[134],"High-risk R\u002FR LBCL",[136,137,138,139],"CART","ASCT","R\u002FR LBCL","high-risk factors",{"date":141,"type":39},"2026-05-13",{"date":143,"type":39},"2026-04-20",{"date":145,"type":21},"2028-02-29",{"name":45,"class":46},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":58,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100635608","phase-2-ultra-low-dose-radiation-therapy-followed-by-orelabrutinib-as-first-line-treatment-for-stage---malt-lymphoma-100635608","NCT07554898","Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma","Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma: A Prospective, Multicenter Phase Ⅱ Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, all genders eligible;\n2. Histopathologically confirmed MALT lymphoma (extranodal marginal zone lymphoma) with at least one measurable lesion outside the spleen, with any diameter \\> 1.0 cm;\n3. No prior systemic anti-tumor therapy after diagnosis (including chemotherapy, targeted therapy, rituximab, etc.).\n\n   Note: For patients with primary gastric MALT lymphoma, Helicobacter pylori (HP) must be negative or the patient must have failed standard HP eradication therapy. Patients with MZL who progressed or relapsed after local treatment (including surgery, Helicobacter pylori eradication, and hepatitis C treatment) are eligible for enrollment.\n4. ECOG performance status score of 0-1;\n5. Presence of treatment indications as judged by the investigator (including symptoms, cytopenias, risk of end-organ damage, bulky disease, or persistent progression);\n6. Adequate major organ function, meeting the following criteria:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelets ≥ 75 × 10⁹\u002FL, hemoglobin ≥ 75 g\u002FL; If bone marrow involvement is present: ANC ≥ 1.0 × 10⁹\u002FL, platelets ≥ 50 × 10⁹\u002FL, hemoglobin ≥ 50 g\u002FL;\n   2. Total bilirubin ≤ 1.5 × ULN, AST or ALT ≤ 2 × ULN, serum creatinine ≤ 1.5 × ULN, serum amylase ≤ ULN;\n   3. International Normalized Ratio (INR) ≤ 1.5 × ULN.\n7. Expected survival ≥ 3 months;\n8. Voluntarily provide written informed consent before screening.\n\nExclusion Criteria:\n\n1. Current or history of other malignant tumors, except for those who have achieved complete remission after radical treatment;\n2. Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;\n3. Patients with other tumors who have not recovered from non-hematologic toxicities of prior anti-tumor therapy to ≤ Grade 1 (except for alopecia);\n4. Uncontrolled or significant cardiovascular diseases, including:\n\n   1. Congestive heart failure of New York Heart Association (NYHA) Class II or above, unstable angina, myocardial infarction within 6 months before the first dose of the study drug, or arrhythmias requiring treatment at screening, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);\n   3. History of clinically significant QTc interval prolongation, or QTc interval at screening \\> 470 ms for females or \\> 450 ms for males;\n   4. Subjects with symptomatic coronary artery disease requiring medication;\n   5. Uncontrolled hypertension (despite lifestyle modification and use of a reasonable and tolerable maximum dose of 3 or more antihypertensive drugs \\[including diuretics\\] for more than 1 month, blood pressure still not reaching target, or blood pressure can only be effectively controlled with 4 or more antihypertensive drugs);\n5. Active bleeding within 2 months before screening, or currently receiving anticoagulant drugs, or considered by the investigator to have a clear bleeding tendency;\n6. Urine protein ≥ 2+ and 24-hour urine protein quantification ≥ 2 g\u002F24 hours;\n7. History of deep vein thrombosis or pulmonary embolism within the past 6 months;\n8. History of organ transplantation or allogeneic hematopoietic stem cell transplantation;\n9. Major surgery within 6 weeks before screening or minor surgery within 2 weeks before screening. Major surgery is defined as surgery performed under general anesthesia; however, diagnostic endoscopic procedures are not considered major surgery. Insertion of vascular access devices is exempt from this exclusion criterion;\n10. HIV\u002FAIDS or other serious infectious diseases;\n11. Patients with severe pulmonary function impairment due to pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or other conditions;\n12. Previous treatment with BTK inhibitors, BCR pathway inhibitors (e.g., PI3K, Syk), or BCL-2 inhibitors;\n13. Subjects with drug abuse or alcohol abuse;\n14. Pregnant or lactating women, or subjects of childbearing potential who are unwilling to use contraceptive measures;\n15. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this trial.",{"count":20,"type":21},[82],"This is a prospective, multicenter Phase 2 clinical trial named the MALT-RO study, evaluating ultra-low-dose radiation therapy followed by orelabrutinib as first-line treatment for adults with Stage I-II MALT lymphoma. The study aims to determine the efficacy and safety profile of this sequential regimen. Eligible participants aged 18 years or older with histologically confirmed MALT lymphoma, measurable lesions, no prior systemic anti-lymphoma therapy, adequate organ function, and an ECOG performance status of 0-1 will receive 4Gy ultra-low-dose radiation (2Gy daily for 2 consecutive days) followed by oral orelabrutinib 150mg once daily for up to 6 cycles (28 days per cycle). Patients with partial response or stable disease after 6 cycles may continue orelabrutinib monotherapy for up to 12 cycles or until disease progression. All participants will undergo regular safety monitoring, tumor assessments, and long-term follow-up every 3 months to evaluate treatment durability. This treatment strategy is designed to improve efficacy and achieve more favorable outcomes compared with standard approaches for MALT lymphoma, while minimizing treatment-related toxicities such as long-term organ damage, xerostomia, cataracts, and other complications related to conventional standard-dose radiation, thereby offering a well-tolerated, convenient, targeted therapeutic option for patients with MALT lymphoma under strict ethical oversight in accordance with the Declaration of Helsinki and Chinese Good Clinical Practice guidelines.",[158],"MALT Lymphoma","2026-05-05",{"date":161,"type":39},"2026-05-11",{"date":163,"type":21},"2026-04-16",{"date":165,"type":21},"2029-01-01",{"name":45,"class":46},2,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":54,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":58,"phases":177,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":72},"100626906","phase-2-safety-and-efficacy-of-umbilical-cord-blood-therapy-for-cancer-therapy-induced-thrombocytopenia-ctit-100626906","NCT07441720","Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT)","Inclusion Criteria:\n\n1. Aged 12 to 65 years at the time of signing the informed consent, regardless of gender.\n2. Meets the diagnostic criteria for cancer treatment-induced thrombocytopenia (CTIT):Peripheral blood platelet count \\\u003C 100 × 10⁹\u002FL; Prior definite exposure to a chemotherapy agent (or tumor-targeted therapy, immunotherapy, or other anti-tumor drugs) known to cause thrombocytopenia, with gradual improvement of thrombocytopenia-related symptoms\u002Fsigns or normalization of platelet count after discontinuation of the offending drug; Presence or absence of bleeding tendency, such as petechiae, purpura, unexplained epistaxis, or even severe organ\u002Ftissue hemorrhage;\n3. No significant hepatic or renal impairment: ALT and AST ≤ 2.5 × upper limit of normal (ULN), serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 1.25 × ULN;\n4. Karnofsky Performance Status (KPS) score ≥ 60 (see Appendix 1), Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2);\n5. Estimated life expectancy of more than 3 months.\n\nExclusion Criteria:\n\n1. Other causes of thrombocytopenia, in particular exclusion of underlying diseases or comorbidities such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia (ITP), hypersplenism, or bone marrow infiltration by tumor cells;\n2. Use of non-anti-tumor medications known to cause thrombocytopenia (including but not limited to sulfonamides and other drugs);\n3. Pseudothrombocytopenia induced by ethylenediaminetetraacetic acid (EDTA) anticoagulant;\n4. Uncontrolled malignant tumor, hypertension, or diabetes mellitus;\n5. Active infection, including but not limited to known HIV positivity, active hepatitis B or C, or syphilis;\n6. Poor compliance;\n7. Known allergy or hypersensitivity to any component of the study intervention (umbilical cord blood or related products);\n8. Participation in another clinical trial within 1 month prior to enrollment or current participation in another clinical trial;\n9. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical study.","12 Years","65 Years",{"count":7,"type":21},[82],"This study is a prospective, single-center, open-label, single-arm clinical trial to assess the safety and efficacy of umbilical cord blood in cancer treatment-induced thrombocytopenia (CTIT) patients. It plans to recruit subjects aged 12 to 65 years old with CTIT. The study involves intravenous infusion of umbilical cord blood, with platelet transfusion as supportive therapy if necessary. The trial consists of three phases: screening (baseline assessments and enrollment), treatment (umbilical cord blood infusion), and follow-up (blood routine tests at Days 3, 7, 14, and 28 post-treatment to record platelet counts, first response time, maximum and minimum values, and calculate efficacy rates while observing changes in thrombocytopenia grading). A total of 25 subjects will be enrolled, and they will undergo evaluation for safety and efficacy based on treatment-related adverse events, GVHD incidence, and hematological improvements.",[180,181],"Thrombocytopenia","Cancer Treatment-induced Thrombocytopenia",[183,184,185],"Umbilical cord blood","Cancer treatment-induced thrombocytopenia","CTIT",{"date":161,"type":39},{"date":188,"type":39},"2026-02-28",{"date":190,"type":21},"2027-12-30",{"name":45,"class":46},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":58,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":72},"100634358","phase-1-a-phase-ii-clinical-study-evaluating-the-effectiveness-of-injectable-nc527-x-in-intraoperative-imaging-for-patients-with-solid-tumors-100634358","NCT07538648","A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors","Inclusion criteria:\n\n1. 1\\. Voluntarily sign a written informed consent form;\n2. 2\\. Male and female individuals aged 18 years or above;\n3. 3\\. Patients with solid tumors that have been diagnosed by imaging tests or confirmed by pathology and who are scheduled for surgical removal;\n4. 4\\. The ECOG score ranges from 0 to 1;\n5. 5\\. During the trial period, the subjects used effective contraceptive methods and continued to use contraception for another 3 months after the medication was completed.\n6. 6\\. Be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol and complete this trial.\n\nExclusion criteria:\n\n1. 1\\. Has a history of allergic reactions to similar products, contrast agents, or fluorescent lamps, or is known to be allergic to the study drug or any other components.\n2. 2\\. 28 days prior to the first administration, the subject had received a similar drug (such as indocyanine green for injection);\n3. 3\\. Within one month prior to the first administration, participants were enrolled in another clinical study (including observational or non-interventional clinical studies);\n4. 4\\. Within 28 days prior to the first administration, had received a live attenuated vaccine;\n5. 5\\. Within one month prior to the first administration, had undergone major surgical procedures (as defined by the investigators);\n6. 6\\. The subjects had previously undergone allogeneic stem cell or solid organ transplantation;\n7. 7\\. Within 28 days prior to the first administration, there were adverse reactions caused by previous treatments that had not recovered to grade 1 or below according to CTCAE 5.0 criteria (pigmentation, hair loss; adverse reactions that the investigator deemed safe can be included);\n8. 8\\. The laboratory test results during the screening period indicated that the subjects did not have good organ function: a. Hematology (Blood transfusion within 14 days before the screening laboratory tests and treatment with blood components or granulocyte colony-stimulating factor need to be excluded) i. Absolute neutrophil count \\\u003C 1.5 × 109\u002FL (1,500\u002Fmm3); ii. Platelet count \\\u003C 75 × 109\u002FL; iii. Hemoglobin \\\u003C 9.0 g\u002FdL; b. Liver i. Serum total bilirubin (TBil) \\> 1.5 × ULN; for subjects with liver metastasis or those with evidence of or suspected Gilbert's disease, TBil \\> 3 × ULN; ii. AST and ALT \\> 2.5 × ULN, for subjects with liver metastasis, AST and ALT \\> 5 × ULN; c. Kidney: Serum creatinine \\> 1.5 × ULN; or glomerular filtration rate estimated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI formula, see Appendix 2) \\\u003C 60 mL\u002F(min \\* 1.73m2); d. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) \\> 1.5 × ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT\u002FINR and APTT) are within the expected range for anticoagulant treatment at the time of screening);\n9. 9\\. Patients with primary central nervous system tumors or those with symptomatic central nervous system metastases (meningeal metastases, regardless of whether they are symptomatic or not, must be excluded);\n10. 10\\. Within 6 months prior to the first administration of the drug, the following cardiovascular diseases occurred: symptomatic heart failure with a New York Heart Association (NYHA) classification of 2 or above (see Appendix 3), left ventricular ejection fraction (LVEF) \\\u003C 50%, unstable arrhythmia or unstable angina pectoris, myocardial infarction requiring treatment, pulmonary embolism, uncontrolled hypertension (this protocol defines uncontrolled hypertension as although the optimal antihypertensive treatment is adopted, but after treatment, systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg, and the investigator assesses it to have clinical significance). Note: Three 12-lead electrocardiograms indicating QTc interval prolongation \\> 450 milliseconds (ms) (for males) or 470 ms (for females) must be excluded; For atrial fibrillation or paroxysmal supraventricular tachycardia that requires treatment but is assessed by the investigator to be stable, it can be considered for inclusion.\n11. 11\\. Within 4 weeks prior to the first administration of the drug, there was a history of severe infection or an active infection occurred within 2 weeks.\n12. 12\\. The following disease-infected individuals are present: Human Immunodeficiency Virus (HIV) infection; Active hepatitis B virus carriers \\[Hepatitis B Surface Antigen (HBsAg) positive, and hepatitis B virus DNA (HBV-DNA) test result \\> 200 IU\u002FmL or 103 copies\u002FmL\\]; Hepatitis C virus carriers \\[HCV antibody and viral RNA (HCV-RNA) test results are positive\\]; Treponema pallidum antibody positive and RPR positive individuals;\n13. 13\\. Female subjects who have tested positive for pregnancy during the screening period, are currently breastfeeding, or plan to become pregnant or give birth during the course of this trial; Male subjects whose spouses have a pregnancy plan within the last 3 months.\n14. 14\\. Any other diseases, medical conditions or abnormalities, metabolic disorders, physical examination results, clinical laboratory test results that prohibit the use of the study drug, may affect the interpretation of the results, or may place the subjects at a high risk of treatment complications, or according to the investigator's judgment, are not suitable for using the study drug.",{"count":199,"type":21},400,[201],"PHASE1","Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X",[204],"Cancer","2026-04-13",{"date":143,"type":39},{"date":208,"type":39},"2025-12-24",{"date":210,"type":21},"2027-06-30",{"name":45,"class":46},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":72},"100627942","a-study-on-the-efficacy-and-safety-of-switching-between-two-targeted-strategies-hpchemotherapy-and-hpychemotherapy-after-treatment-progression-in-her-2-positive-advanced-or-metastatic-breast-cancer-100627942","NCT07455188","A Study on the Efficacy and Safety of Switching Between Two Targeted Strategies, HP+Chemotherapy and HPy+Chemotherapy, After Treatment Progression in HER-2 Positive Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form with good compliance.\n2. Female, aged 18 years or older.\n3. Histologically confirmed diagnosis of HER2-positive advanced or metastatic breast cancer.\n4. Metastatic lesions confirmed by MRI\u002Fcontrast-enhanced CT, with at least one measurable lesion according to RECIST 1.1 criteria.\n5. For patients previously treated with trastuzumab or tyrosine kinase inhibitors (TKIs) in the early-stage setting, recurrence must have occurred more than 1 year after the completion of prior treatment.\n6. ECOG performance status score of 0-2.\n7. Eligible patients meeting the treatment criteria specified in this study protocol may be included. This includes:Patients whose prior first-line and second-line treatments both align with the requirements of this protocol；Patients currently receiving second-line treatment whose prior first-line treatment aligns with the requirements of this protocol；The above populations may have previously received or not received trastuzumab and\u002For pertuzumab, small-molecule tyrosine kinase inhibitors (e.g., pyrotinib, etc.), and may include patients with brain metastases, among others.\n\n   \\-\n\nExclusion Criteria:\n\n1. Known allergy to the drugs involved in this trial or their excipients.\n2. Current or recent use of medications that may affect the metabolism or efficacy of pyrotinib or trastuzumab, such as strong CYP3A4 inhibitors (e.g., itraconazole, fluconazole, etc.), strong CYP3A4 inducers (e.g., rifampicin, efavirenz, etc.), or other drugs that may influence the plasma concentration of these two agents.\n3. Pregnant or lactating women.\n4. Major surgery within 4 weeks prior to the start of study drug administration, with incomplete recovery. Minor procedures such as tumor biopsy, thoracentesis, or venous catheter placement are permitted.\n5. Presence of severe systemic diseases and\u002For uncontrolled infections.\n6. Concurrent conditions considered by the investigator to pose a serious risk to patient safety or interfere with the patient's ability to complete the study (e.g., severe hypertension, diabetes, thyroid disorders, concurrent hepatitis B\u002FC, or other active infections).\n7. History of other malignancies.\n8. Psychiatric illness, cognitive impairment, or inability to comply with the trial protocol and follow-up.\n9. Other conditions deemed by the investigator to render the participant unsuitable for inclusion.",{"count":219,"type":21},600,"This study adopts a multicenter, natural selection, observational design, and plans to enroll patients with HER-2 positive advanced or metastatic breast cancer treated at approximately 20 research centers nationwide. Patients with de novo stage IV disease or those with recurrent metastatic breast cancer who have not previously received trastuzumab, as well as patients with brain metastases, will be included for separate stratified efficacy analysis and will not be included in the overall analysis. The study plans to enroll effective data from 600 HER-2 positive advanced or metastatic breast cancer patients, who will be naturally allocated in a 1:1 ratio to either Group A (switching from HP + chemotherapy to HPy + chemotherapy) or Group B (switching from HPy + chemotherapy to HP + chemotherapy), with each group comprising approximately 300 patients. If first-line treatment fails, patients will switch to the alternative regimen in second-line treatment. All patients will continue treatment until disease progression, intolerable toxicity, or other reasons lead to discontinuation, with the number of treatment cycles recorded. The study is divided into three phases: screening\u002Fbaseline period, treatment period (treatment period 1 + treatment period 2), and survival follow-up period. If patients develop intolerance to taxanes during treatment, clinicians may select alternative chemotherapy regimens such as vinorelbine, capecitabine, or eribulin based on clinical judgment. During the treatment period, patients will be followed up every two cycles, during which clinical data will be collected, including disease status assessments, laboratory tests, study drug usage, concomitant medications, and adverse events. After chemotherapy completion or treatment discontinuation, subsequent maintenance therapy, such as continued dual-targeted maintenance, may be administered by clinicians based on clinical needs until disease progression or intolerable toxicity occurs. Survival follow-up will be conducted every three months (for up to three years), with patient survival status recorded.",[222],"Breast Cancer","2026-03-02",{"date":225,"type":39},"2026-03-06",{"date":227,"type":39},"2025-03-01",{"date":119,"type":21},{"name":45,"class":46},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":58,"phases":240,"briefSummary":241,"conditions":242,"keywords":246,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":72},"100624996","phase-2-thiotepa-in-combination-with-pirtobrutinib-a-btk-inhibitor-and-sintilimab-a-pd-1-inhibitor-for-frail-or-relapsedrefractory-primary-or-secondary-central-nervous-system-lymphoma-100624996","NCT07416890","Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","A Prospective, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Histopathologically confirmed relapsed primary central nervous system lymphoma (PCNSL) of B-cell lineage, or secondary central nervous system lymphoma (SCNSL) with a previously confirmed B-cell origin primary lesion but without evidence of active extracranial systemic involvement.\n2. The patients or their legal guardians provide voluntary written informed consent.\n3. Age\\>=18 years, both male and female.\n4. Karnofsky Performance Status (KPS) score\\>=40.\n5. Patients deemed unsuitable for methotrexate (MTX)-based systemic chemotherapy (\"unfit\"), including but not limited to: patients assessed as unsuitable for chemotherapy or frail according to a simplified Geriatric Assessment (sGA) criteria; patients with contraindications to MTX (e.g., renal insufficiency, serous cavity effusions, oral mucositis, etc.); or patients who refuse high-dose methotrexate (HD-MTX) chemotherapy.\n6. Life expectancy of greater than 3 months, as judged by the investigator.\n7. Patients with parenchymal lesions (\\>10\\*10mm ) on contrast-enhanced cranial MRI or those with leptomeningeal disease only, require cytological examination of cerebrospinal fluid (CSF) to confirm the presence of lymphoma cells and\u002For imaging findings consistent with CSF results. These assessments must be completed within 14 days prior to enrollment.\n8. If the patients have received prior anti-tumor therapy, all treatment-related non-hematologic toxicities must have recovered to Grade 1 or baseline (according to NCI CTCAE version 5.0, with the exception of alopecia).\n9. Bone marrow and organ function must meet the following criteria (without transfusion, G-CSF support, or corrective therapy within 14 days prior to informed consent):\n\n   1. Hematological: Absolute neutrophil count (ANC) \\>=1.5\\*10\\^9\u002FL (1500\u002Fmm\\^3), platelets \\>=75\\*10\\^9\u002FL, hemoglobin\\>=8 g\u002FdL (If bone marrow is involved, then platelets\\>=50\\*10\\^9\u002FL, ANC \\>=1.0\\*10\\^9\u002FL, and hemoglobin\\>=7 g\u002FdL are acceptable).\n   2. Hepatic: Total bilirubin \\\u003C=1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=2.5 × ULN.\n   3. Renal: Serum creatinine \\\u003C=1.5 × ULN or estimated creatinine clearance \\>=60 mL\u002Fmin.\n   4. Coagulation: INR \\\u003C=1.5 × ULN; PT and APTT \\\u003C=1.5 × ULN (unless the subject is receiving anticoagulant therapy and, at screening, PT and APTT are within the anticipated therapeutic range for the anticoagulant regimen).\n10. For the subjects of reproductive age women and fertile men, during the entire study period and within 3 months after the interruption of treatment, they must not have any conception plans with their partners. During the entire study period and within 3 months after the interruption of treatment, one of the following measures must be taken for effective contraception: abstinence, physical contraception (such as sterilization or condoms), and the use of hormonal contraceptive drugs (w hich must start at least 3 months before the first administration upon enrollment). For male subjects, sperm donation is prohibited from the start of treatment until 3 months after the cessation of treatment.\n11. Willingness and ability to undergo multiple MRI\u002FCT scans and an expected ability to undergo lumbar puncture.\n\nAbility to swallow oral medication without difficulty.\n\nExclusion Criteria:\n\n1. The patients with secondary central nervous system lymphoma (SCNSL) who have lesions outside the CNS and require systemic treatment.\n2. Received chemotherapy, radiotherapy, immunotherapy or antibody-based treatments for anti-tumor purposes within 4 weeks prior to the first administration (or within 5 half-lives), those who had used small molecule targeted drugs or traditional Chinese medicine with anti-tumor indications within 2 weeks, and those who had received monoclonal antibody conjugate drug treatments within 10 weeks.\n3. Receipt of any vaccine (including but not limited to vaccines for COVID-19, influenza, pneumonia, shingles, hepatitis B, etc.) within 4 weeks before taking the medicine for the first time.\n4. Concurrent enrollment in another interventional clinical study, or less than 4 weeks between the last dose of prior clinical trial treatment and the first dose in this study.\n5. Previous treatment with thiotepa, PD-1 inhibitors, or BTK inhibitors is not excluded by default but requires benefit-risk assessment by the investigator. Subjects with a history of Grade \\>=3 immune-related adverse events (per NCI CTCAE v5.0) attributed to these agents are excluded.\n6. History of active bleeding within 4 weeks before the first dose; need for therapeutic anticoagulation during the study (e.g., warfarin or vitamin K antagonists); or any condition associated with elevated bleeding risk or coagulopathy per investigator judgment (e.g., high-risk esophageal varices, active ulcer disease).\n7. Treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers is required within 2 weeks before the first administration or during the study period.\n8. Concurrent presence of other malignant tumors requiring antineoplastic treatment.\n9. Having uncontrolled or significant cardiovascular diseases, including (but not limited to):\n\n   1. Any of the following conditions occurring within 6 months before the first administration: congestive heart failure with New York Heart Association class \\>= 3, myocardial infarction, unstable angina pectoris, arrhythmia requiring treatment at screening, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);\n   3. A history of clinically significant QTc interval prolongation, second-degree type II atrioventricular block, third-degree atrioventricular block, or a QTc interval \\> 470ms (for females) and \\> 450ms (for males);\n   4. Atrial fibrillation (EHRA class\\>= 2b);\n   5. Poorly controlled hypertension, which is deemed unsuitable for study participation by the investigator.\n10. Active uncontrolled infection requiring intravenous antimicrobial treatment.\n11. Patients with active chronic hepatitis B, active chronic hepatitis C, or syphilis. Patients who test positive for hepatitis B surface antigen or hepatitis C virus antibody during the screening period must undergo further tests for HBV DNA titer (which must not exceed 1000 IU\u002Fml) and HCV RNA (which must not exceed the lower detection limit of the assay) before being eligible for enrollment in the trial. Hepatitis B virus carriers, patients with hepatitis B stabilized after drug treatment, and patients with cured hepatitis C may be enrolled.\n12. Patients with a known history of HIV infection and\u002For AIDS.\n13. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or total gastrectomy.\n14. Autologous transplantation within 3 months, or organ or allogeneic stem cell transplantation within 6 months, before signing the informed consent form.\n15. Pregnancy or lactation.\n16. Stroke or intracranial hemorrhage within 6 months before first dosing, excluding post-surgical sequelae of intracranial bleeding.\n17. History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or similar conditions, deemed by the researcher as rendering the subject unsuitable for participation in the trial.\n18. Participants whom the investigator considers unsuitable for the study due to existing kidney, nerve\u002Fmental, liver, or endocrine diseases, or for any other reason judged by the researcher.\n19. Exclude patients with active autoimmune disease or a history of it, including but not limited to: immune-related neurologic disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, SLE, connective-tissue disease, scleroderma, inflammatory bowel disease (Crohn's or ulcerative colitis), hepatitis, TEN, Stevens-Johnson syndrome, antiphospholipid syndrome.\n\n    Note: allow subjects with vitiligo, eczema, type 1 diabetes, or endocrine disorders (e.g., thyroiditis on physiologic steroid replacement). Subjects with rheumatoid arthritis\u002Fother arthropathies, Sjögren's syndrome, controlled celiac disease, or psoriasis treated only topically, and those seropositive (ANA, anti-thyroid antibodies, etc.) must be assessed for target-organ involvement and need for systemic therapy; if neither is present, they may be enrolled.\n20. Major surgery within 28 days prior to the first study dose, as determined by the investigator.","80 Years",{"count":239,"type":21},24,[82],"This is a prospective, single-Arm, phase II clinical study evaluating the efficacy and safety of thiotepa in combination with pirtobrutinib (a BTK Inhibitor) and sintilimab (a PD-1 Inhibitor) for frail or relapsed\u002Frefractory primary or secondary central nervous system lymphoma.It includes screening phase， induction therapy phase, and maintenance therapy phase.The screening period is defined as within 14 days prior to the first dose.Induction Treatment Phase: Enrolled subjects will receive a combination regimen of thiotepa, pirtobrutinib, and sintilimab. Treatment is administered in 21-day cycles for up to 6 cycles. Patients who achieve a disease response may proceed to consolidation therapy with either autologous hematopoietic stem cell transplantation or whole-brain radiotherapy at the investigator's discretion.Maintenance Treatment Phase: For patients who do not receive consolidation therapy with autologous transplantation or whole-brain radiotherapy, maintenance treatment with pirtobrutinib plus sintilimab will be initiated (for up to 1 year). Patients who receive any consolidation therapy will not proceed to maintenance treatment.Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria. The trial will monitor patient survival data, objective response rate (ORR), and safety parameters.Upon discontinuation of study treatment or completion of the 1-year treatment period, subjects will enter the follow-up phase. During follow-up, radiographic assessments (contrast-enhanced CT of the involved site is recommended) will be performed according to the following schedule: every 3 months for the first 2 years, every 6 months from Year 3 to Year 5, and annually after 5 years, until the end of the follow-up period. For subjects who have not withdrawn consent, survival information (including date and cause of death, subsequent anti-tumor therapies, etc.) will be collected every 3 months via telephone and\u002For clinical visit.",[243,244,245],"Pirtobrutinib","Sintilimab","Central Nervous System Lymphoma",[247,248,249],"pirtobrutinib","sintilimab","central nervous system lymphoma","2026-02-11",{"date":252,"type":39},"2026-02-18",{"date":254,"type":21},"2026-02-10",{"date":256,"type":21},"2030-08-05",{"name":45,"class":46},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":72},"100576409","to-investigate-the-real-world-efficacy-and-safety-of-sacituzumab-govitecan-for-her2-negative-metastatic-breast-cancer-patients-in-china-100576409","NCT06784921","To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.","Real-World Patient Characteristics, Treatment Patterns, and Outcomes for Patients With HER2 Negative Metastatic Breast Cancer Treated With Sacituzumab Govitecan: A Retrospective Trial in China（SACIT-OUT）","SACIT-OUT","Inclusion Criteria:\n\nLocal recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.\n\nHER2-negative breast cancer(according to 2018 ASCO\u002FCAP HER2 test guideline). 18-75 years old. ECOG PS 0～2. life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.1. received at least two cycles of SG. Signed informed\n\nExclusion Criteria:\n\nPatients who did not receive sacituzumab govitecan treatment for two or more cycles Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.\n\nFemale patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial History of neurological or psychiatric disorders Researchers believe that patients are not suitable for any other situation in this study.",{"count":267,"type":21},200,"To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.",[270],"Breast Cancer Metastatic",[272,273],"Breast cancer","Sacituzumab Govitecan","2026-01-14",{"date":276,"type":39},"2026-01-16",{"date":278,"type":39},"2025-02-01",{"date":280,"type":21},"2026-12-30",{"name":45,"class":46},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":289,"targetDuration":4,"studyType":58,"phases":291,"briefSummary":292,"conditions":293,"keywords":297,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":72},"100619350","phase-2-sacituzumab-tirumotecan-plus-third-generation-tki-withwithout-radiotherapy-for-egfr-mutant-nsclc-brain-metastases-100619350","NCT07343479","Sacituzumab Tirumotecan Plus Third-Generation TKI With\u002FWithout Radiotherapy for EGFR-Mutant NSCLC Brain Metastases","A Clinical Study of Sac-TMT for Injection Combined With Third-Generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) ± Radiotherapy in Subjects With EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer and Brain Metastasis Who Have Failed Prior EGFR-TKI Treatment","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF), regardless of gender;\n* Histologically or cytologically confirmed non-squamous NSCLC, and metastatic (Stage IV);\n* Confirmed EGFR sensitizing mutation including exon 19 deletion (19-Del) or exon 21 point mutation (L858R);\n* Subject has previously received EGFR-TKI therapy for locally advanced or metastatic disease and has experienced radiological PD;\n* Subjects with new or previously diagnosed brain metastasis confirmed by contrast-enhanced cranial MRI;\n* ECOG performance status scale of 0 or 1;\n* Life expectancy ≥ 12 weeks;\n* Adequate organ and bone marrow function;\n\nExclusion Criteria:\n\n* Tumor histology or cytology confirms combined small cell lung cancer (SCLC), neuroendocrine carcinoma, carcinosarcoma components, or squamous cell carcinoma;\n* Known leptomeningeal metastases;\n* Other malignant tumors within 3 years prior to the first dose (except for tumors cured by local treatment, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, etc.);\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>470 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention;\n* Uncontrolled systemic diseases as judged by the investigators;\n* Clinically severe pulmonary impairment due to concurrent lung disorders, including but not limited to any underlying lung disorder (e.g., pulmonary embolism within 3 months before the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, sicca syndrome, sarcoidosis, etc.), or prior pneumonectomy;\n* Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage;\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease;\n* Active infection requiring systemic therapy;\n* Active hepatitis B \\[hepatitis B surface antigen (HBsAg) positive, requiring hepatitis B virus deoxyribonucleic acid (HBV-DNA) testing; HBV-DNA ≥500 IU\u002FmL or above the lower limit of detection, whichever is higher\\] or hepatitis C \\[hepatitis C antibody positive, and hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection\\];\n* Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;\n* History of allogeneic tissue\u002Fsolid organ transplant.",{"count":290,"type":21},45,[82],"This is a prospective, open-label, multi-center, single-arm clinical trial",[294,295,296],"NSCLC (Advanced Non-small Cell Lung Cancer)","EGFR Gene Mutations","Brain Metastasis",[298],"NSCLC with brain metastasis","2026-01-06",{"date":301,"type":39},"2026-01-15",{"date":303,"type":21},"2026-05-01",{"date":305,"type":21},"2029-12-20",{"name":45,"class":46},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":58,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":72},"100618355","phase-2-a-phase-ii-clinical-study-evaluating-entinostat-with-or-without-anlotinib--fulvestrant-for-the-treatment-of-hormone-receptor-hr--positive-human-epidermal-growth-factor-receptor-2-her-2--negative-advanced-breast-cancer-that-relapsed-or-progressed-after-endocrine-therapy-100618355","NCT07330544","A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy","A Phase II Clinical Study Evaluating Entinostatwit h or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy","Inclusion Criteria:\n\n1. Sign an informed consent form;\n2. Female, aged 18 or above;\n3. The patient's Eastern Tumor Collaboration Group (ECOG) physical status is 0-1;\n4. The patient's expected survival time is ≥3 months;\n5. Breast cancer patients diagnosed as HR-positive and HER-2 negative by tumor histopathological and molecular pathological typing (based on the most recent report); 1) Hormone receptor positive refers to estrogen receptor (ER) positive, progesterone receptor (PR) negative or positive (≥1% positive staining cells are considered receptor positive); 2) HER-2 negative means: the immunohistochemical result of the pathological specimen test is 0 or 1+; Or an immunohistochemical result of 2+ and a negative ISH or FISH test.\n6. The subject has received at least one line of endocrine therapy as well as CDK 4\u002F6 inhibitor therapy at an unresectable stage of locally advanced recurrence or metastasis; Or disease recurrence occurred during ET combined with CDK4\u002F6 inhibitors as adjuvant therapy or within 12 months after the end of treatment.\n7. The subject has not received chemotherapy or ADC therapy for metastatic disease\n8. At least one measurable target lesion was evaluated by the investigator in accordance with RECIST 1.1\n9. No known active brain metastases or leptomeningeal disease\n10. The patient must have adequate organ function within 1 week (7 days) prior to the initiation of study administration, as defined below:\n\n    * Hematology: Hemoglobin (HgB) ≥80 g\u002FL, platelet count ≥100×109 \u002FL, absolute neutrophil count ≥1.0×10 \u002FL.\n\nNote: Platelet transfusion is not allowed within 3 days before these laboratory tests, red blood cell transfusion is not allowed within 14 days, and hematopoietic growth factor (pegylated G-CSF, 14 days for erythropoietin) is not allowed within 7 days. No blood transfusion or use of auxiliary white blood cell, platelet increase drugs such as cytokines or erythropoietin drugs within 2 weeks prior to the screening test\n\n* Renal function: Serum creatinine (Cre) ≤1.5× upper limit of normal (ULN), or glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2. Urine protein \\\u003C2+ or 24-hour urine protein quantification \\\u003C1g\n* Liver function: Total bilirubin ≤1.5×ULN; If Gilbert syndrome is present, total bilirubin ≤3 mg\u002FdL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; If there is liver metastasis, both ALT and AST should be ≤5×ULN; Alkaline phosphatase (ALP) ≤2.5×ULN; If there is bone metastasis, it should be ≤5×ULN.\n\n  9\\. Echocardiography shows left ejection fraction (LVEF) ≥50% and QTc interval ≤480 ms.\n\n  10\\. Female patients in the premenopausal or perimenopausal period who agree to use the concomitant luteinizing hormone-releasing hormone (LHRH) agonist can be enrolled. Those who meet any of the following criteria may be considered to have reached menopause, but those who do not meet the criteria for being considered premenopausal or perimenopausal:\n* Having undergone bilateral oophorectomy in the past;\n* Age ≥60 years;\n* Age \\\u003C60 years old, natural menopause ≥12 months, no chemotherapy, tamoxifen, torremifen or ovarian function castration during this period, blood follicle-stimulating hormone (FSH) and estradiol (E2) levels within postmenopausal range (judged in combination with the reference range of the research center); 11. Patients who are fertile must agree to use recognized effective methods of contraception (including condoms with inactivated sperm, vaginal separators, oral or injectable contraceptives, etc.) or abstain from sexual activity during their participation in the study and for 3 months after the cessation of study treatment.\n\nExclusion Criteria:\n\n* Patients should not be enrolled if any of the following conditions occur:\n\n  1. Symptomatic visceral metastases or other conditions, visceral crisis, or the investigator deems it inappropriate to use endocrine therapy;\n  2. The patient has a past or present central nervous system metastases, or leptomeningeal disease, brain metastases;\n  3. Previous use of selective estrogen receptor degraders (SERD, such as fulvestrant) or histone deacetylase (HDAC) inhibitors (such as entectamine, chidamide, etc.) or small molecule multi-target tyrosine kinase inhibitors (such as apatinib, anlotinib, etc.) or PAM pathway inhibitors (such as PI3K inhibitor Alpelisib, AKT inhibitor Capivasertib, MTOR inhibitor everolimus, etc.\n  4. Known allergy to SERD, entinostat, or other drugs with a benzamide structure (such as typapride, remopilib, cloprapride, etc.), anlotinib;\n  5. Pregnant or lactating women;\n  6. Coexisting with other malignant tumors, unless radical treatment has been administered and there is no evidence of recurrence or metastasis;\n  7. There is pericardial effusion requiring drainage, pleural effusion with obvious clinical symptoms or ascites;\n  8. Other circumstances that the investigator deems unsuitable for inclusion.",{"count":315,"type":21},118,[82],"* This study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+\u002FHER2- with recurrent or progressive advanced breast cancer treated with CDK4\u002F6 inhibitors;\n* The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entestasta + fluvestrus group (Group 1) or the anlotinib + entestasta + fluvestrus group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first.\n* During the study period, efficacy evaluations will be conducted every 8 weeks in accordance with the Solid Tumor Efficacy Evaluation Criteria (RECIST) v1.1 until disease progression, the initiation of a new anti-tumor treatment by the subject, or the withdrawal of informed consent, whichever occurs first.\n* Continuous safety evaluations will be conducted during the study treatment period. All subjects who have received at least one study treatment will be required to undergo end-of-treatment visits and safety follow-up visits within 7 days and 30±2 days after the last study treatment, respectively.\n* The end of the study was defined as the occurrence of disease progression or the end of the study treatment in all subjects, or the early termination of the study for other reasons, whichever occurred first.",[222],"2026-01-04",{"date":321,"type":39},"2026-01-09",{"date":323,"type":39},"2025-11-24",{"date":325,"type":21},"2028-11-26",{"name":45,"class":46},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":334,"targetDuration":4,"studyType":58,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":72},"100617977","phase-2-perioprative-study-of-ibi363-in-patients-with-mhc-ii-negative-locally-advanced-gastric-cancer-100617977","NCT07325630","Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer","IBI363 Combined Chemotherapy for Perioperative Treatment of MHC-II-Negative Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Single-Center, Single-Arm Phase II Clinical Study","Key Inclusion Criteria:\n\n1. Patients voluntarily enrolled in this study and signed informed consent forms;\n2. Age 18-75 years;\n3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;\n4. MHC-II negative, with \\\u003C5% tumour cells displaying staining \\\u003C2+ (grade 2 or stronger);\n5. Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and\u002For laparoscopy (per AJCC 8th Edition staging);\n6. No prior antineoplastic therapy for current disease (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy);\n7. Scheduled for surgical intervention following completion of neoadjuvant therapy;\n8. Able to swallow tablets orally;\n9. ECOG performance status 0-1;\n10. Expected survival ≥6 months.\n\nKey Exclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within 6 months prior to, during, or after the last dose of the investigational medicinal product.\n2. Known signs of active bleeding from a lesion.\n3. Patients with known dMMR\u002FMSI-H status.\n4. Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets.\n5. Subjects with unresolved Grade \\>1 toxicity related to any prior antineoplastic therapy (excluding persistent Grade 2 alopecia, anaemia, peripheral neuropathy, electrolyte abnormalities correctable with treatment, or endocrine abnormalities controlled and stable with hormone replacement therapy).\n6. Known dihydropyrimidine dehydrogenase (DPD) deficiency (or prior fluorouracil-containing therapy resulting in Grade 3 or higher mucositis).\n7. Known hypersensitivity to any monoclonal antibody or component of the chemotherapy agents (capecitabine, oxaliplatin) (resulting in Grade 3 or higher hypersensitivity reaction).\n8. History of epileptic seizures, active, newly diagnosed, or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases.\n9. Clinically significant cardiovascular or cerebrovascular disease.",{"count":20,"type":21},[82],"This is a phase 2 study designed to evaluate the safety and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) or S-1 and oxaliplatin (SOX) in perioprative treatment of locally advanced MHC-II-negative gastric and gastroesophageal junction adenocarcinoma.",[338],"IBI363 + Chemotherapy",{"date":340,"type":39},"2026-01-08",{"date":342,"type":39},"2025-11-03",{"date":344,"type":21},"2027-12-31",{"name":45,"class":46},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":58,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":72},"100614841","phase-2-phase-ii-trial-of-albumin-bound-paclitaxel-combined-with-nedaplatin-tp-via-hepatic-arterial-infusion-for-advanced-breast-cancer-patients-with-liver-metastases-after-failure-of-standard-therapy-100614841","NCT07284836","Phase II Trial of Albumin-Bound Paclitaxel Combined With Nedaplatin (TP) Via Hepatic Arterial Infusion for Advanced Breast Cancer Patients With Liver Metastases After Failure of Standard Therapy","Inclusion Criteria:\n\n* Patients with liver metastases from breast cancer pathologically confirmed via surgery or biopsy.\n\n  * Advanced breast cancer patients with imaging-confirmed visceral tumor burden solely confined to liver metastases.\n\n    * Patients who have previously failed at least two lines of standard therapy (including endocrine therapy, chemotherapy, or targeted therapy), or those for whom researchers determine that local therapy would yield greater benefit.\n\n      * Age 18-70 years.\n\n        * ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2. • 0: Fully active, without any restrictions; • 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work; • 2: Ambulatory and capable of all self-care but unable to carry out any work activities.\n\n          * Liver function score (e.g., Child-Pugh) Class A-B.\n\n            • Class A (5-6 points): Good hepatic reserve, well tolerated to surgery, low incidence of postoperative complications and mortality;\n\n            • Class B (7-9 points): Moderately impaired hepatic reserve, poorly tolerated to surgery, increased postoperative complications and mortality;\n\n            • Class C (≥10 points): Severely impaired hepatic reserve, very poorly tolerated to surgery, high risk of postoperative complications and mortality; surgery is generally not recommended.\n\n            ⑦ Adequate organ function.\n\n            • Hemoglobin ≥90 g\u002FL, white blood cells ≥3.5×10⁹\u002FL, neutrophils ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL;\n\n            • Serum creatinine ≤1.0×upper normal limit (UNL), and creatinine clearance \\>60 mL\u002Fmin;\n\n            • Alanine aminotransferase (ALT) ≤1.5×UNL, aspartate aminotransferase (AST) ≤1.5×UNL, alkaline phosphatase (ALP) ≤1.5×UNL;\n\n            • Total bilirubin (TBIL) ≤1.5×UNL;\n\n            • No severe abnormalities on electrocardiogram, left ventricular ejection fraction (LVEF) ≥50%;\n\n            • Absence of other severe medical conditions or comorbidities that would preclude tolerance to the clinical trial intervention.\n            * Signed informed consent, indicating understanding of the trial's purpose, risks, and potential benefits.\n\nExclusion Criteria:\n\n1. History of other malignancies.\n2. Breast and chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or visceral metastases outside the liver.\n3. Tumor volume ≥70% of liver volume.\n4. History of heart failure (NYHA class \\>I), myocardial infarction, unstable angina, stroke, or poorly controlled arrhythmia.\n5. Active infection, severe allergic reactions, or autoimmune diseases, including but not limited to:\n\n   * Active tuberculosis (TB), currently receiving or having received anti-TB treatment within the past year;\n   * HIV infection (HIV1\u002F2 antibody positive);\n   * Active hepatitis B or hepatitis C virus infection;\n   * History of systemic lupus erythematosus, rheumatoid arthritis, chronic lymphocytic thyroiditis, hyperthyroidism, polyarteritis nodosa, autoimmune hemolytic anemia, etc.\n6. Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period.\n7. Uncontrolled hypertension, diabetes, or other serious diseases.\n8. Severe uncontrolled dysfunction of the liver, kidneys, lungs, or other vital organs.\n9. Pregnant or lactating patients.\n10. History of mental illness.\n11. Known allergy to albumin-bound paclitaxel, nedaplatin, or related drugs.\n12. Current participation in another clinical trial.","70 Years",{"count":57,"type":21},[82],"Study Objective: To Evaluate the Efficacy of Albumin-Bound Paclitaxel Combined with Nedaplatin via Hepatic Arterial Infusion as Later-Line Therapy for Breast Cancer Patients with Liver Metastases After Failure of Standard Treatment.\n\nOutcome Measures：Primary Outcome: Liver Progression-Free Survival (LPFS) Secondary Outcomes:Liver Objective Response Rate (LORR)、Progression-Free Survival (PFS) and Overall Survival (OS)\n\nParticipants will:\n\n* Albumin-bound paclitaxel + nedaplatin (TP) regimen is administered via hepatic arterial infusion chemotherapy on Day 1 of each cycle.\n* Tumor response will be assessed every 6 weeks (±7 days) according to RECIST 1.1 criteria until disease progression is determined by the investigator.",[357,358],"Hepatic Artery Infusion","Liver Metastasis of Breast Cancer","2025-12-15",{"date":361,"type":39},"2025-12-16",{"date":278,"type":39},{"date":364,"type":21},"2028-01-31",{"name":45,"class":46},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":58,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":72},"100614926","phase-2-efficacy-and-safety-of-distamab-vedotin-combined-with-carboplatin-for-advanced-ovarian-cancer-in-the-first-line-treatment-100614926","NCT07285941","Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment","Inclusion Criteria:\n\n* Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;\n* Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;\n* HER2 expression: IHC 2+ or 3+;\n* Had not received chemotherapy before enrollment;\n* ECOG PS ≤ 2;\n* Expected survival period ≥ 3 months;\n* Adequate organ function. During the screening period, the following criteria should be met (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g\u002FdL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelets ≥ 100 × 109\u002FL; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); When there is no liver metastasis, ALT and AST ≤ 2.5 × ULN, and when there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin according to the Cockcroft-Gault formula;\n* Non-pregnant women;\n* Signed a written informed consent form before the trial.\n\nExclusion Criteria:\n\n* Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);\n* The subject had central nervous system diseases or brain metastases;\n* Had previously experienced grade II or above peripheral neuropathy;\n* Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;\n* Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);\n* Had known allergies to the study-related drugs or their excipients or was intolerant to them;\n* Was participating in other clinical trials at the same time;\n* Subjects judged by the researcher to be unsuitable for this study.",{"count":130,"type":21},[82],"Ovarian cancer exhibits the highest mortality rate among gynecological malignancies. Currently, the combination of paclitaxel and carboplatin remains the standard first-line chemotherapy regimen for neoadjuvant or postoperative treatment of ovarian cancer. However, conventional paclitaxel, due to the addition of polyoxyethylated castor oil solubilizer, may induce various adverse reactions beyond chemotherapeutic toxicity, such as hypersensitivity, toxic renal injury, neurotoxicity, and cardiovascular toxicity. Therefore, exploring optimized treatment regimens to provide patients with new therapeutic options is imperative.\n\nHER2 is a protein encoded by the ERBB2 gene that regulates cell survival, proliferation, and differentiation. HER2 gene amplification and\u002For protein overexpression are observed in 18%-35% of mucinous ovarian cancers. A meta-analysis involving over 5,000 ovarian cancer cases revealed that HER2 overexpression correlates with reduced overall survival (OS) and progression-free survival (PFS), suggesting its potential as a biomarker for poor prognosis.\n\nThe emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48). Preliminary results from the PRaG3.0 trial presented at the 2023 ASCO Annual Meeting showed an ORR of 66.7% in six HER2-expressing gynecological cancer patients treated with RC48 combined with radiotherapy and immune checkpoint inhibitors (ICIs). Updated data from the RC48-C018 study demonstrated an ORR of 36.4%, median duration of response (mDoR) of 5.52 months, mPFS of 4.37 months, and 12-month OS rate of 66% in 22 cervical cancer patients. RC48 exhibited promising efficacy and manageable safety in recurrent\u002Fmetastatic HER2-expressing (IHC 1+\u002F2+\u002F3+) cervical cancer.\n\nRegarding safety, the GOG-158 study reported pronounced hematologic toxicity with carboplatin-paclitaxel in advanced ovarian cancer: grade 3\u002F4 leukopenia (\\>50%), thrombocytopenia (\\>30%), and neutropenia (\\>80%). Conversely, a retrospective study of RC48 combined with platinum ± bevacizumab in HER2-mutated NSCLC patients showed an ORR of 71.4% with no dose reductions or discontinuations due to adverse events. Thus, RC48-platinum combinations may offer a lower-toxicity alternative. Thus the investigators designed this trial to evaluate the efficacy and safety of RC48 combined with carboplatin in HER2-expressing advanced ovarian cancer.",[376,377],"Ovarian Cancer","HER2","2025-12-02",{"date":361,"type":39},{"date":381,"type":39},"2025-01-04",{"date":364,"type":21},{"name":45,"class":46},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":392,"targetDuration":4,"studyType":58,"phases":394,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":167},"100608064","an-in-vivo-ct-imaging-study-of-gma-tulip-i-gel-and-lma-supreme-glam-ii-100608064","NCT07196696","An in Vivo CT Imaging Study of GMA-Tulip, I-gel, and LMA Supreme (GLAM-II)","An in Vivo CT Imaging Study After Insertion of the LMA Supreme, I-gel, and GMA-Tulip Airway Devices Under General Anesthesia (GLAM-II)","GLAM-II","Inclusion Criteria:\n\n* Aged 18-75 years, scheduled for CT interventional therapy;\n* Aged 18-75 years, scheduled for CT interventional therapy;\n* Body Mass Index (BMI) \\\u003C30 kg\u002Fm²;\n* Good communication and cooperation, with voluntary signing of the informed consent form.\n\nExclusion Criteria:\n\n* Presence of head\u002Fneck or airway anatomical abnormalities (e.g., laryngeal cartilage malformation, Grade III tonsillar hypertrophy, tongue hypertrophy, cervical spine malformation) that may affect laryngeal mask insertion or CT imaging evaluation;\n* Current participation in other clinical studies.",{"count":393,"type":21},9,[60],"Laryngeal masks are core devices for supraglottic airway management, and the accuracy of their anatomical position directly impacts ventilation safety and the incidence of complications. Despite their wide clinical application, gaps remain in understanding their in vivo anatomical characteristics. This study aims to evaluate the in vivo anatomical features (e.g., insertion depth, anatomical alignment, tissue compression) of three laryngeal masks (LMA Supreme, I-gel, GMA-Tulip) using CT scanning in anesthetized patients undergoing CT interventional therapy, providing anatomical evidence for optimized laryngeal mask selection and complication prevention.",[397],"Supraglottic Airway Device",[399,400,401,402],"GMA-Tulip","I-gel","LMA-Supreme","Supraglottic airway device",{"date":404,"type":39},"2025-11-25",{"date":406,"type":39},"2025-10-12",{"date":408,"type":21},"2025-12-31",{"name":45,"class":46},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":418,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":420,"conditions":421,"keywords":423,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":72},"100613264","real-time-dynamic-imaging-study-of-normal-pharyngolaryngeal-structures-during-barium-swallow-glam-iii-100613264","NCT07264322","Real-Time Dynamic Imaging Study of Normal Pharyngolaryngeal Structures During Barium Swallow (GLAM-III)","Observational Imaging Study on Real-Time Dynamic Changes of Normal Pharyngolaryngeal Structures During Barium Swallow in Patients Undergoing Routine Barium Meal Examination","GLAM-III","Inclusion Criteria:\n\n* Aged 18-75 years;\n* No history of pharyngolaryngeal surgery, trauma, or congenital malformation;\n* No swallowing dysfunction, pharyngolaryngeal inflammation, or neurological diseases affecting swallowing;\n* No recent use of drugs that affect muscle function (e.g., muscle relaxants, anticholinergics);\n* Barium meal examination confirms unobstructed oropharyngeal-esophageal pathway;\n* Normal pharyngolaryngeal anatomical structure (confirmed by preliminary imaging review);\n* Scheduled to undergo routine barium meal examination at Zhejiang Cancer Hospital for clinical diagnosis.\n\nExclusion Criteria:\n\n* Presence of diseases that may compress pharyngolaryngeal structures (e.g., goiter, mediastinal mass);\n* Allergy to barium sulfate or other components of the barium suspension.",{"count":419,"type":21},3,"The integrity and functional stability of pharyngolaryngeal anatomical structures are critical for airway management, and the dynamic changes of key structures (e.g., pyriform sinus, cricoid cartilage lamina) during swallowing directly relate to the design and clinical safety of laryngeal masks. This observational study aims to investigate the real-time dynamic changes and physiological movement patterns of normal pharyngolaryngeal structures during barium swallow using routine barium meal examination imaging. The findings will provide anatomical and physiological evidence for optimizing laryngeal mask design and improving its anatomical fit with the pharynx and larynx.",[422],"Barium Meal Examination",[424,425,426,427,428],"Barium Swallow","Pharyngolaryngeal Dynamic Changes","Pyriform Sinus","Cricoid Cartilage Lamina","Laryngeal Mask Design","2025-11-23",{"date":431,"type":39},"2025-12-04",{"date":433,"type":39},"2025-09-10",{"date":435,"type":21},"2025-12-30",{"name":45,"class":46},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":443,"sex":54,"minAge":18,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":58,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":72},"100612344","lcms-based-metabolic-analysis-explores-the-effect-of-american-ginseng-on-urine-and-plasma-in-healthy-individuals-100612344","NCT07252362","LCMS-Based Metabolic Analysis Explores the Effect of American Ginseng on Urine and Plasma in Healthy Individuals","* 18 to 45 years old;\n\n  * The subjects were fully informed about the research process and signed the informed consent form (the subjects had no abnormalities in routine physical examinations, no previous medical history, and no history of drug allergies); ③ During the trial, they were required to have a light diet and were prohibited from consuming alcoholic and caffeinated beverages;",true,"45 Years",{"count":130,"type":21},[60],"Researchers will use LCMS Metabolic Analysis to Explore the Effect of American Ginseng on Urine and Plasma in Healthy Individuals\n\nParticipants will:\n\n* Take 3 grams of American Ginseng powder every day for 14 days\n* Collect the fasting urine samples at the following times at the hospital: On the first day, on the 7th day after taking the medicine, and on the 14th day after taking the medicine.\n* Collect the fasting Serum samples at the following times at the hospital: On the first day and on the 14th day after taking the medicine.\n* Have their any adverse effects monitored and evaluated throughout the study.",[449],"The Impact of American Ginseng on the Metabolomics of Urine and Plasma in Healthy Individuals",[451,452],"American ginseng","metabolomics","2025-11-18",{"date":455,"type":39},"2025-11-26",{"date":457,"type":39},"2023-11-11",{"date":459,"type":21},"2026-03-30",{"name":45,"class":46},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":468,"targetDuration":4,"studyType":58,"phases":470,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":72},"100611080","phase-3-firstline-sequential-ag-and-mfolfox-combined-with-serplulimab-and-bevacizumab-versus-ag-chemotherapy-alone-in-advanced-pancreatic-cancer-100611080","NCT07235930","Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer","Nab-Paclitaxel\u002FGemcitabine Followed by mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Previously Untreated Advanced Pancreatic Cancer: A Randomized, Controlled, Multicenter Phase III Trial","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the study and sign the informed consent;\n2. ≥18 years of age and ≤75 years of age on the day of signing the informed consent form, regardless of gender;\n3. Pancreatic ductal adenocarcinoma confirmed by pathologic histology or cytology;\n4. No prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer;\n5. Measurable lesions at baseline according to RECIST 1.1 criteria; if the subject has only 1 measurable lesion at baseline, the area of the lesion must not have received radiotherapy in the past or there must be evidence of significant progression of the lesion after completion of radiotherapy treatment;\n6. the ECOG physical status score was 0 or 1 and the Expected survival ≥12 weeks;\n7. No serious organic diseases of the heart, lungs, brain and other organs;\n8. Adequate organ function\n\n   1. Bone Marrow Function: (no transfusion within 14 days prior to screening, no use of granulocyte colony stimulating factor \\[G-CSF\\], no use of drug correction) : i. Hemoglobin ≥90g\u002FL; ii. Leukocytes ≥ 4.0 x 109\u002FL, Neutrophils ≥1.5×109\u002FL; iii. Platelet ≥80×109\u002FL;\n   2. Coagulation function: PT or APTT ≤ 1.5 x ULN in subjects not receiving anticoagulation; if subjects are receiving anticoagulation, as long as the PT is within the range of the anticoagulant drug formulation;\n   3. liver function: (no albumin infusion within 14 days prior to screening): Serum total bilirubin ≤ 1.5 x ULN (with biliary obstruction, allowing enrollment of subjects undergoing biliary drainage or in the midst of stenting therapy who have a total bilirubin ≤ 2.5 x ULN). In subjects without liver metastasis, Aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.5×ULN; In subjects with liver metastasis, ALT and AST≤5×ULN, but without elevated bilirubin;\n   4. Renal function: serum creatinine ≤1.5 x ULN, creatinine clearance (CCr) ≥50 mL\u002Fmin, urinary protein \\\u003C2+ (if urinary protein ≥2+, 24-hour (h) urinary protein quantification can be carried out, and 24h urinary protein quantification \\\u003C1.0 g can be enrolled)\n   5. Heart function: New York College of Cardiology (NYHA) rating \\\u003C 3; Left ventricular ejection fraction ≥50%;\n9. Male or female patients of childbearing potential will voluntarily use an effective method of contraception, such as a double-barrier contraceptive method, condoms, oral or injectable contraceptives, and an intrauterine device (IUD), for the duration of the study and up to 6 months after the last study dose. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, artificially menopausal or sterilized;\n10. Subject's ability and willingness to comply with visits, treatment plans, laboratory tests, and other study-related processes as specified in the study protocol.\n\nExclusion Criteria:\n\n1. subjects with clear brain metastases on imaging or with meningeal metastases;\n2. untreated spinal compression fractures not treated by surgery and\u002For radiotherapy; treated spinal compression fractures require disease stabilization for at least 2 weeks prior to enrollment;\n3. high risk of gastrointestinal or abdominal bleeding as evaluated by the Investigator;\n4. uncontrolled cancer pain; narcotic analgesics not at a stable dose at enrollment;\n5. previous treatment with vascular endothelial growth factor (VEGFR) inhibitors or previous treatment with immune checkpoint inhibitors;\n6. antitumor treatment with chemotherapy, small molecule inhibitors, immunotherapy (e.g., interleukin, interferon, or thymosin) within 28 days prior to enrollment in this study, and herbal medicine with antitumor indications within 14 days prior to dosing;\n7. major surgical procedures \\[such as transabdominal, transthoracic and other major surgeries; excluding diagnostic puncture such as ultrasonic endoscopy-guided pancreatic fine-needle aspiration biopsy (EUS-FNB), percutaneous hepatic perforation biopsy, peripheral venous catheterization, and biliary stent implantation\\] or invasive treatments or operations with incomplete healing of the surgical incision, local anti-tumor treatment such as hepatic artery interventional embolization, hepatic metastasis cryo-ablation, radiofrequency ablation and other local anti-tumor treatments. radiofrequency ablation and other local antitumor therapy;\n8. have received radical radiotherapy within 3 months prior to study entry; palliative radiotherapy 2 weeks prior to dosing is permitted, and the dose of radiotherapy meets local standards of care for palliative care;\n9. required systemic corticosteroid (\\>10 mg\u002Fday prednisone or equivalent of other corticosteroid for ≥7 consecutive days) or immunosuppressive therapy within 14 days prior to enrollment in this study; with the exception of inhaled or locally applied hormones, or physiologic replacement doses of hormone therapy due to adrenal insufficiency; short-term (≤7 days) corticosteroids are allowed for prophylaxis (e.g., contrast allergy) or treatment of Non-autoimmune conditions (eg, delayed hypersensitivity reactions caused by exposure to allergens) ;\n10. subjects with uncorrectable albumin decline (serum albumin \\\u003C3.0 g\u002FdL) 14 days prior to enrollment in this study; and\n11. a 10% or greater weight loss in comparison to the weight loss at the time of ICF signing within 72 hours prior to enrollment in this study; and\n12. within 72 hours prior to study entry, the subject's ECOG physical status score increases by ≥1 point compared to the ICF score; 13. within 28 hours prior to study entry, the subject's ECOG physical status score increases by ≥1 point compared to the ICF score; and\n13. has received a live vaccine (including live attenuated vaccine) within 28 days prior to enrollment in this study;\n14. previous or current interstitial pneumonia\u002Fpneumatosis, unless determined by the investigator to be inactive and not requiring hormonal therapy; and\n15. pre-existing or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatous disease with polyangiitis), Graves' disease, rheumatoid arthritis, hypopituitarism, uveitis, autoimmune hepatitis, systemic sclerosis ( Scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome). The following conditions are excluded: type I diabetes mellitus, hypothyroidism stabilized by hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic therapy;\n16. a combination of other malignancies within the last 5 years, except cured squamous skin cancer, basal cell carcinoma, non-basal invasive bladder cancer, and prostate\u002Fcervical\u002Fbreast cancer in situ;\n17. hepatic metastases comprising more than 50% of the total liver volume;\n18. uncontrolled comorbidities, including but not limited to the following\n\n    1. Active HBV or HCV infection; (Note: HBV DNA and\u002For HCV RNA testing is required for subjects who are HBsAg positive and\u002For HCV antibody positive at Screening. Subjects who are negative for HBV DNA ≤500 IU\u002FmL (or ≤2000 copies\u002FmL) and\u002For HCV RNA are eligible for enrollment; HBsAg-positive subjects are required to have their HBV DNA monitored during the course of treatment);\n    2. Known history of HIV infection or AIDS;\n    3. Active syphilis;\n    4. Active tuberculosis;\n    5. Active or uncontrolled serious infection (≥ CTCAE grade 2 infection);\n    6. Medication-uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg;), symptomatic cardiac insufficiency (NYHA II-IV), unstable angina pectoris or myocardial infarction within 6 months, or the presence of a prolonged QTc or risk of torsades de pointes (baseline QTc\\>470 msec (women)\u002F450 msec (men) \\\u003C Fridericia method correction\\>, hypokalemia, long QT syndrome, atrial fibrillation with heart rate \\>100 bpm at rest or severe cardiac valvular disease, history of medically significant arrhythmias);\n19. unrecovered toxicity from prior antitumor therapy to CTCAE ≤ Grade 1 (NCI-CTCAE v5.0), except for baldness (any grade allowed) and peripheral neuropathy (recovery to ≤ Grade 2 required);\n20. history of prior allogeneic bone marrow or organ transplantation;\n21. prior history of allergic reaction, hypersensitivity reaction, intolerance to investigational drugs or similar medications; prior significant allergy to drugs or foods or other substances (e.g., severe allergic reaction, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia)\n22. pregnant and\u002For lactating women;\n23. other conditions that, in the opinion of the investigator, would affect the safety of or adherence to treatment with the study medication, including alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, the presence of serious laboratory test abnormalities, moderate to large amounts of plasmapheresis such as pleural fluid, pericardial effusion, ascites, and other concomitant familial or social factors, which would affect the safety of the patient;",{"count":469,"type":21},292,[471],"PHASE3","A randomized, multicenter, Phase III trial evaluating the efficacy and safety of first-line Sequential AG-mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab versus AG chemotherapy alone in advanced pancreatic cancer. The primary endpoint is Overall Survival (OS). Approximately 292 patients will be enrolled in China.",[474],"Non-Resectable Pancreas Carcinoma","2025-11-17",{"date":477,"type":39},"2025-11-19",{"date":479,"type":21},"2025-11-15",{"date":481,"type":21},"2029-07-01",{"name":45,"class":46},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":490,"targetDuration":4,"studyType":58,"phases":492,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":4},"100606584","early-phase-1-study-on-safety-and-efficacy-of-ucb-mncs-for-radiation-induced-lung-injury-100606584","NCT07177456","Study on Safety and Efficacy of UCB-MNCs for Radiation-induced Lung Injury","Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Radiation-induced Lung Injury","Inclusion Criteria:\n\n1. Ages 18-75 years,with no restriction on gender;\n2. History of chest radiotherapy;\n3. Diagnosed with grade 2-3 radiation-induced lung injury according to CTCAE 4.0 classification criteria in \"Diagnosis and Treatment of Radiation-induced Lung Injury\";\n4. Inadequate response to conventional treatment for two weeks, with no relief or progressive worsening of symptoms;\n5. Well-controlled tumor for ≥3 months;\n6. No significant liver or kidney dysfunction: ALT, AST ≤ 3 times the upper limit of normal, serum Cr and BUN ≤ 2 times the upper limit of normal;\n7. Expected survival ≥ 3 months;\n8. Informed consent signed voluntarily by the patient;\n9. Willing and able to receive treatment and follow-up as required by the protocol, and able to comply with basic treatment as directed by the physician.\n\nExclusion Criteria:\n\n1. Severe cardiac insufficiency (such as NYHA class III or IV), uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg);\n2. Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;\n3. ECOG score ≥2;\n4. Currently participating in or participated in other clinical trials within 4 weeks;\n5. History of allergies or known allergy to the study preparation;\n6. Patients with psychiatric disorders who cannot cooperate with treatment; (7) Pregnant or lactating women.",{"count":491,"type":21},10,[493],"EARLY_PHASE1","This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for radiation-induced lung injuryr (RILI) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating RILI .",[496],"Radiation-induced Lung Injury","2025-09-16",{"date":499,"type":39},"2025-09-17",{"date":501,"type":21},"2025-10-01",{"date":503,"type":21},"2026-12-31",{"name":45,"class":46},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":512,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":4},"100606850","a-real-world-study-on-the-compliance-of-ofs-assisted-endocrine-therapy-for-hormone-receptor-positivehr-premenopausal-breast-cancer-100606850","NCT07180914","A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer","A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for HR+ Premenopausal Breast Cancer","Inclusion Criteria:\n\n1. Female breast cancer patients who were premenopausal at the time of surgery.\n2. Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III.\n3. HR-positive (defined as ER ≥ 10% and\u002For progesterone receptor(PR) ≥ 10%).\n4. Patients who have undergone radical mastectomy and are planning to receive OFS treatment.\n5. Have received (neo)adjuvant chemotherapy and radiotherapy.\n6. Eastern Cooperative Oncology Group Performance Status(ECOG PS) score of 0-1.\n7. Complete medical records.\n8. Willing to accept long-term follow-up.\n9. Any adverse events that occurred during adjuvant chemotherapy (if applicable) have recovered or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment.\n\nExclusion Criteria:\n\n1. Simultaneously participating in another blinded clinical study.\n2. Presence of other active malignant tumors or multiple primary cancers.\n3. Pregnant or lactating women.\n4. Other conditions that the investigator deems unsuitable for inclusion in the study.\n5. Planning to use systemic therapies not described in the study cohort during the endocrine therapy phase (such as, but not limited to, chemotherapy, Antibody-Drug Conjugates(ADCs), or immunotherapy).",{"count":513,"type":21},300,"The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens.\n\nThe main questions it aims to answer are:\n\n1. What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy?\n2. What is the impact of OFS treatment duration on patient prognosis?\n\nParticipants, who are already receiving OFS treatment as part of their regular medical care, will have their demographic data, treatment status, clinical outcomes, and adverse events collected over time.",[516],"Breast Cancer Females",[518,519,520],"OFS","Hormone receptor positive","Early-stage breast cancer","2025-09-12",{"date":523,"type":39},"2025-09-18",{"date":525,"type":21},"2025-10-10",{"date":527,"type":21},"2029-12-31",{"name":45,"class":46},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":536,"targetDuration":4,"studyType":58,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":546,"locationsCount":72},"100606411","early-phase-1-study-on-safety-and-efficacy-of-ucb-mncs-for-chronic-radiation-enteritis-100606411","NCT07175207","Study on Safety and Efficacy of UCB-MNCs for Chronic Radiation Enteritis","Study on the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in the Treatment of Chronic Radiation Enteritis","Inclusion Criteria:\n\n1. Aged 18-75 years, with no restriction on gender;\n2. History of pelvic and abdominal radiotherapy;\n3. Patients diagnosed with chronic radiation-induced intestinal injury (CRII) via colonoscopy and pathological examination (≥3 months after the end of radiotherapy);\n4. Diagnosed with grade 2-3 radiation-induced intestinal injury based on the clinical symptom assessment (RTOG classification) in Expert Consensus on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Radiation-Induced Intestinal Injury in China;\n5. Poor response to conventional treatment for two weeks, with symptoms showing no remission or progressive aggravation;\n6. Well-controlled tumor for ≥3 months;\n7. No significant abnormalities in liver and renal function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); serum creatinine (Cr) and blood urea nitrogen (BUN) ≤ 2 times the upper limit of normal (ULN);\n8. Expected lifespan of the subject ≥ 3 months;\n9. The patient is informed of the study details and voluntarily signs the informed consent form;\n10. Willing and able to receive treatment and complete follow-up in accordance with the protocol requirements, and able to adhere to the doctor's advice for basic treatment.\n\nExclusion Criteria:\n\n1. Severe cardiac insufficiency (e.g., NYHA classification Grade Ⅲ or Ⅳ) and uncontrolled hypertension with medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg);\n2. Positive results for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2;\n4. Currently participating in another clinical trial or having participated in another clinical trial within 4 weeks;\n5. Patients with an allergic diathesis or known allergy to the preparation used in this trial;\n6. Patients with comorbid mental illness who are unable to cooperate with treatment;\n7. Pregnant or lactating women.",{"count":491,"type":21},[493],"This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for chronic radiation enteritis (CRE) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating CRE.",[540,541],"Chronic Radiation Induced Intestinal Injury","Chronic Radiation Enteritis","2025-09-09",{"date":497,"type":39},{"date":501,"type":21},{"date":503,"type":21},{"name":45,"class":46},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":555,"targetDuration":4,"studyType":58,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":4},"100605453","phase-2-scrt-followed-by-ak112-in-pmmrmss-mid-low-rectal-cancer-100605453","NCT07162714","SCRT Followed by AK112 in pMMR\u002FMSS Mid-low Rectal Cancer","Short-Course Radiotherapy Followed by Ivonescimab (AK112) in pMMR\u002FMSS Mid-Low Rectal Cancer: An Exploratory Phase II Clinical Study.","STAR","Inclusion Criteria:\n\n1. Aged between 18 and 75 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1;\n3. Histopathologically confirmed rectal adenocarcinoma, without any prior anti - tumor treatment; The status of MMR\u002FMSI is detected by IHC\u002FPCR in pathological biopsy to clarify that the patient's classification is pMMR\u002FMSS;\n4. The lower border of the lesion is ≤ 7 cm from the anal verge as determined by fibrocolonoscopy or digital rectal examination;\n5. Baseline magnetic resonance staging is cT2 - 4 and\u002For N+, excluding any of cT4b, N2, positive mesorectal fascia (MRF+), extramural venous invasion (EMVI+), lateral lymph node metastasis, and distant metastasis (according to the 8th edition of the AJCC Cancer Staging Manual);\n6. Able to accept the treatment plan during the study period;\n7. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Uncontrolled epilepsy, history of central nervous system disorders or psychiatric conditions that, in the investigator's judgment, may interfere with the ability to provide informed consent or affect compliance with oral medication.\n2. Prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies.\n3. Clinically significant active cardiac disease, including symptomatic coronary artery disease, congestive heart failure (New York Heart Association \\[NYHA\\] Class II or higher), severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.\n4. Immunosuppressive therapy following organ transplantation.\n5. History of other malignancies within the past 5 years (excluding adequately treated non-melanoma skin cancer or carcinoma in situ).\n6. Severe uncontrolled recurrent infections or other significant uncontrolled comorbidities.\n7. Baseline laboratory values failing to meet the following criteria:Hemoglobin ≥80 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelets ≥100×10\\^9\u002FL; ALT\u002FAST ≤2.5×upper limit of normal (ULN); Alkaline phosphatase (ALP) ≤2.5×ULN; Total bilirubin \\\u003C1.5×ULN; Serum creatinine \\\u003C1×ULN\n8. Active gastrointestinal diseases (e.g., gastric\u002Fduodenal ulcers, ulcerative colitis), unresected tumors with active bleeding, or other conditions deemed by the investigator to pose risks of gastrointestinal bleeding or perforation.\n9. Active bleeding or bleeding predisposition.\n10. Pregnancy or lactation.\n11. Hypersensitivity to any component of the investigational drug(s).",{"count":57,"type":21},[82],"Primary Objectives： Evaluate the complete response rate (CR rate) and safety of short - course radiotherapy combined with ivonesimab (AK112) in patients with pMMR\u002FMSS mid - low rectal cancer.\n\nSecondary Objectives： Evaluate treatment - related toxic reactions, the quality of life, long - term prognosis (local control \\[LC\\], disease - free survival \\[DFS\\] and overall survival \\[OS\\]).\n\nPatients will :\n\nReceive Radiotherapy: Pelvic IMRT or VMAT, DT 25Gy\u002F5Fx. One week after radiotherapy, begin treatment with Ivorsimab (AK112) at a dose of 20mg\u002Fkg by intravenous drip on day 1. One cycle is 21 days, and a total of 6 cycles are to be carried out.\n\nEvaluate the curative effect after 3 cycles of treatment. Patients with progressive disease (PD) will withdraw from the study, and other treatment plans will be adjusted in a timely manner. Patients with CR\u002FPR\u002FSD will continue treatment for another 3 cycles. Conduct a comprehensive assessment after 6 cycles of treatment. Patients who achieve cCR can choose the watch - and - wait approach. For patients who do not achieve cCR, TME surgery is recommended. Decide whether to perform adjuvant chemotherapy based on the postoperative pathological findings.",[559,560,561],"Rectal Cancer","Radiation","AK112","2025-09-06",{"date":542,"type":39},{"date":565,"type":21},"2025-09-01",{"date":567,"type":21},"2028-12-31",{"name":45,"class":46},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":576,"targetDuration":4,"studyType":58,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":72},"100555244","phase-2-neoadjuvant-chemoradiotherapy-followed-by-immunotherapy-and-surgery-for-resectable-esophageal-squamous-cell-carcinomacris-2-trial-100555244","NCT06509568","Neoadjuvant ChemoRadiotherapy Followed by Immunotherapy and Surgery for Resectable Esophageal Squamous Cell Carcinoma（CRIS-2 Trial）","Comparison of Neoadjuvant Chemoradiotherapy Followed by Immunotherapy With Neoadjuvant Chemoimmunotherapy in the Treatment for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multi-center, Phase II Randomized Clinical Study","Inclusion Criteria:\n\n1. Age and Consent: Subjects must be male or female, aged ≥18 and ≤75 years at the time of signing the informed consent form.\n2. Performance Status: Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, or a Karnofsky Performance Status (KPS) score of ≥80.\n3. Histological Confirmation: Histologically confirmed thoracic esophageal squamous cell carcinoma (ESCC), with the upper boundary of the lesion not exceeding the thoracic inlet.\n4. Resectability: Subjects must have resectable or potentially resectable T3-4aN0 or T2-4aN+ ESCC, as per the AJCC\u002FUICC 8th edition clinical staging (cTNM).\n5. Lesion Length: The length of the esophageal lesion must be \\\u003C8 cm.\n6. Surgical Eligibility: Subjects must have no contraindications for surgical procedures.\n7. Organ Function: Subjects must have good cardiopulmonary function and other organ functions to tolerate chemoradiotherapy and surgery.\n\n   a. Hematology (without the use of any blood components and cell growth factor support treatment within 7 days before the start of study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL (1500\u002Fmm\\^3). ii. Platelet count ≥ 100×10\\^9\u002FL (100000\u002Fmm\\^3). iii. Hemoglobin ≥ 90 g\u002FL. b. Renal Function: i. Calculated creatinine clearance\\* (CrCl) ≥ 50 mL\u002Fmin.\n\n   \\*CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL\u002Fmin) = (140 - age) × weight (kg) × F \u002F (SCr (mg\u002FdL) × 72), where F = 1 for males and 0.85 for females; SCr = serum creatinine. ii. Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g. c. Liver Function: i. Serum total bilirubin (TBiL) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN; for subjects with liver metastasis, AST and ALT ≤ 5 × ULN.\n\n   iii. Serum albumin (ALB) ≥ 28 g\u002FL. d. Coagulation Function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy and INR and APTT are within the expected therapeutic range).\n\n   e. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 60%.\n8. Female Subjects of Childbearing Potential: Must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test is inconclusive, a serum pregnancy test will be required, and the serum result will be definitive). If a female subject of childbearing potential engages in sexual activity with an unsterilized male partner, she must use highly effective contraception from the start of screening and agree to continue using it for 120 days after the last dose of the study drug. Decisions regarding contraception discontinuation after this period should be discussed with the investigator.\n9. Male Subjects with Female Partners of Childbearing Potential: Must use effective contraception from the start of screening until 120 days after the last dose of the study drug. Decisions regarding contraception discontinuation after this period should be discussed with the investigator.\n10. Compliance: Subjects must be adequately informed and sign the informed consent form. They must also be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1. Cervical esophageal cancer (lesion located in the cervical esophagus).\n2. Metastasis to cervical lymph nodes or lymph nodes around the celiac artery.\n3. Invasion of the trachea or aorta.\n4. Hoarseness caused by the esophageal tumor.\n5. Esophageal fistula or a tendency to develop an esophageal fistula.\n6. Pregnant or lactating patients.\n7. Severe, poorly controlled diabetes mellitus.\n8. Inability to use the stomach for esophageal replacement due to previous surgeries.\n9. Previous receipt of chemoradiotherapy.\n10. Allergy or contraindication to taxane drugs.\n11. Inability to provide informed consent due to psychological, familial, or social reasons.\n12. History of malignancies other than esophageal cancer.\n13. Inability to tolerate chemoradiotherapy due to severe cardiac, pulmonary, hepatic, renal dysfunction, hematologic diseases, or cachexia; BMI \\\u003C 18.5.\n14. Active autoimmune disease, history of autoimmune disease (including but not limited to colitis, hepatitis, hyperthyroidism, etc.), history of immune deficiency (including positive HIV test), or other congenital or acquired immune deficiency disorders, organ transplantation, or allogeneic bone marrow transplantation.\n15. Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10\\^4 copies\u002FmL), active hepatitis C (positive hepatitis C antibody with HCV-RNA levels above the detection limit).\n16. History of immunodeficiency; positive HIV antibody test; currently on long-term systemic corticosteroids or other immunosuppressants.\n17. Severe infections within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infections requiring systemic anti-infective therapy within 2 weeks before the first dose (excluding antiviral treatment for hepatitis B or C).\n18. Known active tuberculosis (TB); suspected active TB should be ruled out by clinical examination; known active syphilis infection.\n19. Receipt of live or attenuated live vaccines within 30 days prior to the first dose or planned receipt of such vaccines during the study period (inactivated vaccines are allowed).\n20. History of interstitial lung disease or non-infectious pneumonitis.\n21. History of myocarditis, cardiomyopathy, malignant arrhythmias; unstable angina requiring hospitalization, myocardial infarction, congestive heart failure (NYHA class 2 or above), or vascular disease (e.g., aneurysms at risk of rupture) within 12 months prior to the first dose; or other cardiac conditions that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).\n22. Known psychiatric disorders, drug abuse, alcoholism, or a history of substance abuse.\n23. Local or systemic diseases caused by non-malignant tumors; or diseases or symptoms secondary to tumors that may lead to high medical risk and\u002For uncertainty in survival assessment, such as tumor leukemoid reaction (white blood cell count \\> 20×10\\^9\u002FL), cachexia (e.g., known weight loss of more than 10% in the 3 months prior to screening).\n24. Any condition that the investigator believes may pose a risk to the subject's participation in the study, interfere with the evaluation of the study drug, or affect the interpretation of study results.",{"count":577,"type":21},92,[82],"Based on our previous single-arm Phase Ib study (CRIS trial, NCT06303583), we observed that neoadjuvant chemoradiotherapy followed by immunotherapy (nCRIT) significantly increased the pathological complete response (pCR) rate, achieving approximately 60% in locally advanced esophageal squamous cell carcinoma(ESCC). We plan to initiate a multicenter, prospective, randomized phase II trial designed to compare the efficacy and safety of neoadjuvant chemoimmunotherapy (nCIT) versus neoadjuvant chemoradiotherapy followed by immunotherapy (nCRIT) in treating esophageal squamous cell carcinoma. The primary study population includes patients with operable or potentially operable thoracic ESCC classified as cT3-4aN0 or T2-4aN+ based on endoscopy, enhanced chest and abdominal CT, and whole-body PET scans. Eligible participants are aged 18-75 years with an ECOG performance status of 0-1. Qualified patients will be randomly assigned in a 1:1 ratio to either the nCRIT group or the nCIT group.\n\nPatients in the nCRIT group will receive neoadjuvant concurrent chemoradiotherapy: radiation therapy will be administered using IMRT or VMAT with involved-field irradiation at a dose of PTV 41.4 Gy\u002F23 fractions\u002F31 days. Chemotherapy will consist of weekly administration of paclitaxel (albumin-bound) 50 mg\u002Fm² and carboplatin (AUC=2) for five weeks, given on the days of radiotherapy. Patients who do not progress on CT and meet immunotherapy criteria will receive fixed-dose tislelizumab (200 mg IV) on days 8 and 29 after chemoradiotherapy, followed by minimally invasive esophagectomy four weeks after completing immunotherapy.\n\nPatients in the nCIT group will receive two cycles of TC chemotherapy combined with immunotherapy, specifically paclitaxel (albumin-bound) 100 mg\u002Fm² on days 1, 8, 15 or 260mg\u002Fm² d1, carboplatin (AUC=5) on days 1, and tislelizumab (200 mg) on days 1. Minimally invasive esophagectomy will be performed 4-6 weeks after completing chemotherapy, and adjuvant immunotherapy is recommended for one year after surgery.\n\nThe primary endpoint of the study is the pathological complete response (pCR). Secondary endpoints include treatment safety, CT imaging response rate, R0 resection rate, major pathological response (MPR), 2-year event-free survival (EFS), 2-year overall survival (OS) in the intention-to-treat (ITT) population, and analysis of treatment failure reasons.",[581],"Esophageal Squamous Cell Carcinoma","2025-08-23",{"date":584,"type":39},"2025-08-29",{"date":586,"type":39},"2024-08-01",{"date":588,"type":21},"2027-08-01",{"name":45,"class":46},""]