[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cancer Institute and Hospital, Chinese Academy of Medical Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":566},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,217,0,25,[9,47,75,96,118,143,162,182,200,231,254,280,302,322,340,363,381,405,424,443,460,482,497,524,547],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100621133","phase-1-safety-tolerability-and-preliminary-efficacy-of-neuk203-13-in-refractory-neuroendocrine-tumor-patients-100621133",false,"NCT07366658","Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroendocrine Tumor Patients","A Study to Explore the Safety, Tolerability, and Preliminary Efficacy of NEUK203-13 Injection in Patients With Neuroendocrine Tumors Who Have Failed Systemic Therapy","NEUK203-13","Inclusion Criteria:\n\n* 1\\. Understand and voluntarily sign the Informed Consent Form (ICF);\n* 2\\. Aged ≥ 18 years and \\\u003C 75 years at the time of signing the ICF, regardless of gender;\n* 3\\. Pathologically confirmed neuroendocrine tumors, including small cell lung cancer (SCLC), etc.;\n* 4\\. Previous failure or intolerance to systemic therapy, or recurrence after remission: among them, patients with small cell lung cancer must have received at least platinum-based chemotherapy with or without PD-1\u002FPD-L1 inhibitors in previous treatments, with imaging evidence of disease progression after treatment;\n* 5\\. Must provide tissue samples for biomarker analysis, preferably newly obtained tissues. For patients unable to provide newly obtained tissues, 4 unstained sections of archived formalin-fixed, paraffin-embedded (FFPE) tissues can be provided (at least 1 patient with high DLL3 expression shall be enrolled in each dose group: high expression is defined as positive staining in ≥ 50% of tumor cells; preference is given to enrolling DLL3-positive patients);\n* 6\\. Have at least one measurable lesion as the target lesion (per RECIST v1.1 criteria);\n* 7\\. Expected survival ≥ 3 months;\n* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* 9\\. Have adequate bone marrow reserve and organ function within 7 days before the first administration of NEUK203-13 Injection:\n* 10\\. Sufficient bone marrow function (no supportive therapy within 14 days before the first administration): hemoglobin (Hb) ≥ 90 g\u002FL, platelets (PLT) ≥ 75 × 10⁹\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n* 11\\. Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), total bilirubin (TBIL) \\\u003C 1.5 × ULN;\n* 12\\. Renal function: serum creatinine (Scr) ≤ 1.5 × ULN and creatinine clearance rate (Ccr) ≥ 60 mL\u002Fmin (calculated according to the Cockcroft-Gault formula); Coagulation function: prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 2.0;\n* 13\\. Female patients of childbearing potential or male patients whose partners are of childbearing potential agree to use highly effective contraceptive measures from any dose administration in the study until 6 months after the last dose of the study.\n\nExclusion Criteria:\n\n* 1\\. Mixed carcinoma with non-neuroendocrine tumor components;\n* 2\\. Active brain metastases (patients with stable disease for 3 months after treatment without the need for continued glucocorticoid therapy are eligible for enrollment); known leptomeningeal metastases; isolated central nervous system (CNS) disease progression without evidence of progression outside the CNS;\n* 3\\. A history of hypersensitivity to interleukin-2 (IL-2), fludarabine, cyclophosphamide, tocilizumab, or any component of the infusion product formulation; or patients with a history of specific allergic disorders (asthma, rubella, eczematous dermatitis);\n* 4\\. Prior receipt of any of the following treatments:\n* 5\\. Any systemic antineoplastic therapy within 4 weeks or 5 half-lives prior to the first administration of NEUK203-13 Injection, whichever is shorter;\n* 6\\. Radiotherapy not involving the thoracic cavity within 2 weeks prior to the first administration of NEUK203-13 Injection, or radiotherapy involving the thoracic cavity within 4 weeks prior to the first administration of the study drug, whichever is longer;\n* 7\\. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study;\n* 8\\. Prior vaccination with an antineoplastic vaccine, or receipt of a live vaccine within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 9\\. Major surgery or severe trauma within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 10\\. Failure of toxicities from prior antineoplastic therapy to resolve to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia) or to the level specified in the inclusion\u002Fexclusion criteria, whichever is more stringent;\n* 11\\. Active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); exceptions include patients with vitiligo, patients with a history of childhood asthma\u002Fallergies that have resolved completely and require no intervention in adulthood, patients with autoimmune-mediated hypothyroidism receiving a stable dose of thyroid replacement hormone, and patients with type 1 diabetes receiving a stable dose of insulin;\n* 12\\. A history of immunodeficiency, including positive HIV test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;\n* 13\\. Severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first administration of NEUK203-13 Injection, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicating active pulmonary inflammation; or presence of signs and symptoms of infection requiring oral or intravenous antibiotic therapy within 2 weeks prior to the first administration of the study drug (except for prophylactic antibiotic use);\n* 14\\. Tuberculosis infection identified by medical history or CT examination; Active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay), or positive syphilis test results (including positive RPR or TPPA);\n* 15\\. Prior diagnosis of any other malignant tumor, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or adequately treated localized prostate cancer;\n* 16\\. Pregnant or lactating women;\n* 17\\. Uncontrolled concurrent diseases, including but not limited to: documented cerebrovascular events (stroke or transient ischemic attack) within 6 months prior to the first administration of the study drug, symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 50%, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmias, severe chronic gastrointestinal disease with diarrhea, or severe dyspnea requiring oxygen therapy;\n* 18\\. A definite history of neurological or psychiatric disorders that, in the investigator's judgment, may affect the patient's cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.; or psychiatric illnesses\u002Fsocial conditions that may affect study compliance, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent;\n* 19\\. Other factors judged by the investigator that may force the patient to terminate the study prematurely, such as severely abnormal laboratory test results, and\u002For family or social factors that may affect patient safety or the collection of trial data.","ALL","18 Years","75 Years",{"count":22,"type":23},9,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase I clinical trial being conducted in humans for the first time, aiming to evaluate a novel cell therapy called NEUK203-13 Injection for the treatment of patients with advanced small cell lung cancer (SCLC) who have failed systematic therapy or late stage neuroendocrine tumors(NETs). The primary goal of the study is to determine the safety and tolerability of this new therapy and to preliminarily observe its anti-tumor effects.\n\nNEUK203-13 Injection is an \"off-the-shelf\" CAR-NK cell therapy developed based on induced pluripotent stem cell (iPSC) technology, targeting the DLL3 protein highly expressed in SCLC or other neuroendocrine tumors(NETs) .\n\nPrimary Objective Primary Endpoint aims to evaluate safety and tolerability Secondary Endpoints aim to preliminarily observe efficacy and investigate the pharmacokinetics of the drug in the body.\n\nTwo pre-set dose levels are planned, with an enrollment of 7-9 patients. Treatment Regimen\n\n1. Lymphodepletion Conditioning: Chemotherapy (Cyclophosphamide + Fludarabine) before cell infusion to clear lymphocytes in the body.\n2. Cell Infusion: NEUK203-13 is administered via intravenous infusion, d1，d4 and d7 for three doses.\n3. Supportive Medication: Concurrent use of IL-2 (Interleukin-2) d1, d4, d7 and d10 to support NK cell persistence.\n\nTarget Patient Population Patients with advanced SCLC who have progressed after prior platinum-based chemotherapy or late stage neuroendocrine tumors(NETs) and have a relatively good performance status.\n\nKey Monitoring Focus Close monitoring of risks specific to cell therapy, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).\n\nIn short, this study represents the first clinical exploration of NEUK203-13 Injection in patients with advanced small cell lung cancer or other neuroendocrine tumors(NETs). Its primary focus is on safety, while simultaneously gathering preliminary signals on whether the therapy can control tumors, thereby laying the foundation for subsequent clinical development.",[29,30],"SCLC, Extensive Stage","Neuroendocrine Tumors",[32,33],"Car-NK cells","iPSC","RECRUITING","2026-06-23",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":38},"2026-02-20",{"date":42,"type":23},"2027-01-20",{"name":44,"class":45},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":19,"maxAge":20,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100644748","a-phase-ii-study-of-radiation-therapy-to-treat-refractory-breast-cancer-100644748","NCT07672743","A Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer","A Prospective Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Locally advanced or recurrent metastatic breast cancer, pathologically confirmed;\n* At least one extracranial measurable lesion suitable for radiotherapy;\n* Signature of informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactation women;\n* Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.","FEMALE",{"count":56,"type":23},29,[58],"NA","For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.",[61],"Breast Cancer",[63,64,65],"breast cancer","radiotherapy","spatially fractionated radiation therapy","NOT_YET_RECRUITING","2026-06-22",{"date":69,"type":38},"2026-06-29",{"date":71,"type":23},"2026-06-30",{"date":73,"type":23},"2027-12-31",{"name":44,"class":45},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":46},"100644063","characterization-of-multi-omics-landscapes-and-ai-pathological-prediction-model-for-long-term-survival-in-nsclc-immunotherapy-100644063","NCT07668037","Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy","Characterization of Multi-Omics Landscapes in Long-Term Survival Following Immunotherapy and Development of an AI Pathological Prediction Model for Long-Term Survival Based on H&E-Stained Images in Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC).\n* Patients derived from real-world data of multiple centers (including Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital of Shanxi, Chinese Academy of Medical Sciences \\[Shanxi Cancer Hospital\\]; and other participating centers) or from completed phase III clinical trials (e.g., Choice-01, Rationale-307, Rationale-304).\n* Patients who received first-line or later-line immune checkpoint inhibitor (ICI) monotherapy or ICI-based combination therapy.\n* Patients with complete clinical information and available follow-up data.\n\nExclusion Criteria:\n\n* Patients whose systemic therapy did not include an immunotherapy regimen.\n* Patients lost to follow-up.",{"count":83,"type":23},600,"OBSERVATIONAL","This study is a retrospective, multicenter, observational cohort study in patients with advanced or locally advanced non-small cell lung cancer (NSCLC). The aim of this study was to establish a long-term survival (LTS) versus short-term survival (STS) real-world cohort, to systematically characterize the multi-omics landscapes, and to develop and validate an artificial intelligence (AI) pathological prediction model based on routine H\\&E-stained images for predicting immune microenvironment features and long-term survival outcomes following immunotherapy.",[87,88,89],"Non-Small Cell Carcinoma of Lung","Immunotherapy","Advanced Non-Small Cell Lung Cancer",{"date":37,"type":38},{"date":92,"type":38},"2026-05-01",{"date":94,"type":23},"2030-05-01",{"name":44,"class":45},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":24,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":46},"100642039","phase-2-efficacy-and-safety-of-postoperative-concurrent-chemoradiotherapy-for-extrahepatic-cholangiocarcinoma-and-gallbladder-carcinoma-a-multicenter-prospective-phase-ii-study-100642039","NCT07636824","Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study","Inclusion Criteria:\n\n* Aged 18-80 years\n* Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma\n* Postoperative pathology with ≥1 high-risk factor for recurrence\n\n  1. Narrow resection margin (\\\u003C1 cm), including R1 resection\n  2. Positive circumferential resection margin\n  3. T stage ≥ T3-4\n  4. Positive regional lymph nodes\n* Postoperative liver function: Child-Pugh grade A5-B7\n* No recurrence or metastasis before postoperative radiotherapy\n* ECOG performance status 0-2\n* Expected survival \\>3 months\n* Routine blood tests: Neutrophils ≥1.0×10⁹\u002FL, hemoglobin ≥80 g\u002FL, platelets ≥100×10⁹\u002FL\n* Liver function: Total bilirubin \\\u003C1.5×upper limit of normal (ULN), plus one of the following:\n\n  1. ALT and AST ≤2.5×ULN\n  2. ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction)\n* Renal function: Creatinine and blood urea nitrogen ≤2.5×ULN\n* Voluntary participation and signed informed consent\n\nExclusion Criteria:\n\n* History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ)\n* Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders)\n* Prior abdominal radiotherapy\n* Post-organ transplantation\n* Symptomatic moderate-severe ascites within 4 months postoperatively\n* ≥4 months since surgery","80 Years",{"count":104,"type":23},92,[106],"PHASE2","This is a multicenter, open-label, single-arm, prospective Phase II clinical trial. The study enrolls patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma who have undergone curative resection and harbor high-risk recurrence factors, including: 1) narrow resection margin (including R1 resection); 2) positive circumferential resection margin; 3) T stage ≥ T3-4; 4）positive regional lymph nodes. All patients will receive postoperative concurrent chemoradiotherapy (CCRT) with intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). The high-risk volumes of the primary tumor bed and metastatic lymph node beds will be irradiated to 48-60 Gy in 20-25 fractions. Retroperitoneal and intra-abdominal lymph nodes will receive 50-57.5 Gy in 20-25 fractions, and lymphatic drainage regions will be treated to 40-45 Gy in 20-25 fractions. During radiotherapy, concurrent oral capecitabine will be administered at a dose of 1,600 mg\u002Fm² on Days 1-14, every 21 days for 2 cycles. Following the completion of radiotherapy, maintenance oral capecitabine will be continued at 2,000 mg\u002Fm² on Days 1-14, every 21 days for 6 cycles. For patients intolerant to capecitabine, S-1 will be substituted: concurrent S-1 40-50 mg twice daily on Days 1-28, every 42 days for 1 cycle, followed by maintenance S-1 40-60 mg twice daily on Days 1-28, every 42 days for 3 cycles.\n\nThe primary study endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary study endpoints include the 2-year overall survival (OS) rate, locoregional control rate, and incidence of grade ≥3 adverse events.\n\nA total of 92 patients are planned for enrollment in this trial.",[109],"Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma","2026-06-21",{"date":112,"type":38},"2026-06-24",{"date":114,"type":38},"2026-06-16",{"date":116,"type":23},"2029-05-30",{"name":44,"class":45},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":54,"minAge":19,"maxAge":20,"enrollmentInfo":125,"targetDuration":4,"studyType":24,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":46},"100599440","phase-3-hypofractionated-vs-conventional-rt-after-prosthetic-breast-reconstruction-100599440","NCT07084519","Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction","Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction","Inclusion Criteria:\n\n* Female, aged 18-75 years\n* Karnofsky Performance Status ≥60\n* Histopathologically confirmed invasive breast adenocarcinoma\n* Total mastectomy \\[with or without nipple-areolar complex preservation\\] + axillary dissection\u002Fsentinel lymph node biopsy + implant\u002Fexpander placement R0 resection with negative margins\n* pT3 or N2-3 disease; or pT1-2N1\n* No distant metastasis\n* Completed standard neoadjuvant\u002Fadjuvant chemotherapy cycles\n* ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to chest wall or nodal regions\n* Pregnancy or lactation\n* T4 stage disease\n* Autologous breast reconstruction of the irradiated breast\n* Pre-radiotherapy local\u002Fregional\u002Fdistant metastasis\n* Grade ≥3 implant-related adverse events irreversible before radiotherapy\n* Bilateral breast cancer requiring bilateral radiotherapy\n* Concurrent\u002Fsecondary malignancy with disease-free interval \\\u003C5 years \\[except non-melanoma skin cancer, papillary\u002Ffollicular thyroid cancer, or cervical carcinoma in situ\\]\n* Active collagen vascular disease, e.g., SLE, scleroderma\n* Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders",{"count":126,"type":23},506,[128],"PHASE3","This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.\n\nStudy Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.\n\nIntervention:\n\nHFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy\u002Ffraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy\u002Ffraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)",[61,131,132],"Breast Reconstruction","Radiation Oncology",[63,134,135],"prosthetic breast reconstruction","hypofractionated radiotherapy","2026-06-17",{"date":67,"type":38},{"date":139,"type":38},"2026-03-27",{"date":141,"type":23},"2030-12-31",{"name":44,"class":45},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":24,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":161,"locationsCount":4},"100642582","phase-2-ovv-01-injection-combined-with-ak112-injection-for-the-treatment-of-patients-with-advanced-soft-tissue-sarcoma-sts-100642582","NCT07650838","OVV-01 Injection Combined With AK112 Injection for the Treatment of Patients With Advanced Soft Tissue Sarcoma (STS)","A Single-Arm, Open-Label, Multicenter Clinical Study Evaluating the Safety and Efficacy of OVV-01 Injection Combined With AK112 Injection in Patients With Advanced Soft Tissue Sarcoma (STS)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures;\n2. Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.\n3. Histologically\u002Fcytologically confirmed metastatic or recurrent unresectable soft tissue sarcoma, currently failing standard therapy (disease progression, recurrence, or intolerance to treatments such as chemotherapy, radiotherapy, or targeted therapy) or lacking standard treatment options. Participants must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies). Subjects must have demonstrated failure or intolerance to anthracycline-based standard chemotherapy regimens. For specific histologic subtypes lacking standard effective chemotherapy options (e.g., alveolar soft part sarcoma), subjects may have previously received targeted therapy (e.g., anti-angiogenic agents such as anlotinib, pazopanib) with failure or intolerance.\n4. Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions with a longest diameter ≥10 mm and lymph node lesions with a shortest diameter ≥15 mm on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound\u002FCT\u002For endoscopic guidance.\n5. ECOG performance status of 0-2, with an estimated survival of at least 12 weeks.\n6. Sufficient organ and hematopoietic function:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 75 × 10⁹\u002FL (no platelet transfusion or thrombopoietin (TPO) therapy within 2 weeks prior to first dose); Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 2 weeks); Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CCr) ≥ 50 mL\u002Fmin; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; for patients with liver metastases, AST and ALT \\\u003C 5 × ULN; Serum total bilirubin (TBIL) ≤ 2 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for at least six months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with known brain metastases and\u002For clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled);\n2. Subjects who received radiotherapy to the target lesion within the past 2 months;\n3. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;\n4. Lesions intended for injection with a maximum diameter \\>100 mm;\n5. Participants who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;\n6. Participants scheduled for or who have previously undergone tissue\u002Forgan transplantation;\n7. Participants with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL; Patients with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at screening, and HBV-DNA above the lower limit of detection; patients with positive HCV antibody at screening and HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;\n8. Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.\n9. Subjects requiring therapeutic anticoagulant therapy during the study period.\n10. Subjects with uncontrolled active infection of ≥Grade 3 severity according to CTCAE v5.0 that is clinically significant;\n11. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose; received nitrosourea or mitomycin C within 6 weeks prior to first dose; palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to first dose);\n12. Uncontrolled hypertension, pulmonary hypertension, or unstable angina; myocardial infarction, coronary artery bypass grafting, or stent placement within 6 months prior to dosing; history of chronic heart failure at New York Heart Association (NYHA) functional class III-IV; Severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia deemed by the investigator as not affecting the trial), including QTcF ≥450 ms in males or ≥470 ms in females (calculated using Fridericia's formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to enrollment;\n13. Active autoimmune disease or history of autoimmune disease with potential for recurrence;\n14. Requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to first dose or during the study period;\n15. Tumors located in high-risk areas (including mucosal regions, proximity to airways, major vessels, or spinal cord) that may cause obstruction or compression due to tumor enlargement, erode major vessels due to necrosis, encase major vascular structures (e.g., carotid artery), tumors adjacent to critical neurovascular structures, or other tumors deemed unsuitable for intratumoral injection;\n16. Subjects requiring administration of any live vaccine during the screening or treatment period;\n17. Subjects with a history of allergy to the study drug, immunotherapy, or any component of related medications;\n18. Subjects with psychiatric disorders, alcoholism, inability to abstain from smoking, drug addiction, or substance abuse;\n19. Pregnant or lactating women;\n20. Adverse reactions to prior antitumor therapy not yet recovered to Grade 1 (CTCAE 5.0) (excluding alopecia);\n21. Severe uncontrolled medical conditions, or other circumstances deemed by the investigator to potentially interfere with study treatment, rendering the subject unsuitable for participation;\n22. Other conditions deemed by the investigator to preclude eligibility.",{"count":151,"type":23},40,[106],"The efficacy of OVV-01 injection in combination with AK112 injection in subjects with advanced soft tissue sarcoma was evaluated using ORR as the primary endpoint.",[155],"Soft Tissue Sarcoma (STS)","2026-06-14",{"date":114,"type":38},{"date":159,"type":23},"2026-08-01",{"date":73,"type":23},{"name":44,"class":45},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":46},"100641209","phase-1-prospective-randomized-controlled-clinical-study-of-acupoint-application-with-gutong-plaster-in-the-treatment-of-moderate-to-severe-cancer-pain-100641209","NCT07657390","Prospective Randomized Controlled Clinical Study of Acupoint Application With Gutong Plaster in the Treatment of Moderate to Severe Cancer Pain","A Prospective Randomized Controlled Clinical Trial of Acupoint Application With Gutong Plaster for Moderate to Severe Cancer Pain","Inclusion Criteria:\n\n1. The subject has signed the informed consent form.\n2. Age ≥ 18 years, including males and females.\n3. According to the investigator's assessment, the subject has relatively stable cancer pain and requires continuous analgesic medication (estimated treatment duration ≥ 2 weeks).\n4. Estimated life expectancy ≥ 3 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.\n6. Adequate organ function.\n7. Patients with moderate to severe cancer pain, defined as 4 ≤ NRS (Numeric Rating Scale) score ≤ 8.\n\nExclusion Criteria:\n\n1. Known allergy to any active ingredient or excipient of the study drug, or a history of allergy to other opioids and their related components.\n2. Persistent pain caused by other diseases or unknown causes.\n3. Subjects presenting with urgent symptoms such as intestinal obstruction\u002Fperforation, spinal cord compression, or pathological fracture.\n4. History of severe psychiatric disorders, such as schizophrenia and depression.\n5. Patients currently receiving chemotherapy or still in the chemotherapy reaction period (patients in the chemotherapy interval may be included. That is, patients who have completed chemotherapy for more than 1 week can be enrolled, or patients who have just finished chemotherapy may be enrolled at the investigator's discretion).\n6. Patients who have received radiotherapy to the pain area within 4 weeks before enrollment (those who have received radiotherapy to areas other than the pain area may be included), or those who plan to receive radiotherapy to the pain area during the study.\n7. Other conditions deemed unsuitable for participation in this study by the investigator, such as poor compliance.",{"count":170,"type":23},198,[26,106],"This clinical trial aims to evaluate the efficacy and safety of acupoint application with Gutong Plaster for treating moderate to severe cancer pain in patients aged ≥18 years with moderate to severe cancer pain (NRS 4-8), ECOG 0-3, life expectancy ≥3 months. The main questions it aims to answer are:\n\nDoes acupoint application with Gutong Plaster improve the response rate (CR + PR) in patients with moderate to severe cancer pain? Does Gutong Plaster reduce pain intensity (NRS score) and opioid consumption in cancer pain patients? Researchers will compare patients receiving oxycodone plus Gutong Plaster to patients receiving oxycodone plus placebo simulant to see if Gutong Plaster provides better pain relief and lower opioid use.\n\nParticipants will:\n\nReceive standard treatment with oxycodone prolonged-release tablets Be randomly assigned to receive Gutong Plaster or placebo simulant via acupoint application twice daily for 14 days Undergo pain assessment, quality of life evaluation, safety laboratory tests, and follow-up at specified time points",[174],"Cancer Pains",{"date":176,"type":38},"2026-06-18",{"date":178,"type":38},"2025-12-25",{"date":180,"type":23},"2026-12-31",{"name":44,"class":45},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":24,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":199,"locationsCount":46},"100641182","predictive-value-of-tumor-microenvironment-petct-for-response-and-prognosis-in-aggressive-lymphoma-a-multicenter-study-100641182","NCT07657494","Predictive Value of Tumor Microenvironment PET\u002FCT for Response and Prognosis in Aggressive Lymphoma: A Multicenter Study","The Predictive Value of Tumor Microenvironment PET\u002FCT Imaging for Treatment Response and Prognosis in Aggressive Lymphoma: A Multicenter Clinical Study","Inclusion Criteria:\n\n* Histologically confirmed aggressive lymphoma.\n* Baseline PET\u002FCT showing moderate to high FDG uptake in lymphoma lesions.\n* No previous history of malignant tumors.\n* No significant cardiac, hepatic, or renal dysfunction.\n* Expected survival of at least 6 months and ability to complete follow-up.\n\nExclusion Criteria:\n\n* Low FDG uptake on baseline PET\u002FCT.\n* Lymphoma lesions have been surgically removed, with no positive lesions available for evaluation.\n* Active or uncontrolled chronic inflammation or infection.\n* Uncontrolled diabetes mellitus.\n* Incomplete clinical data or loss to follow-up.\n* Refusal to sign the informed consent form.\n* Inability to lie supine for 30 minutes.",{"count":190,"type":23},94,[58],"This multicenter study aims to evaluate the predictive value of tumor microenvironment PET\u002FCT imaging for treatment response and prognosis in patients with aggressive lymphoma. Eligible patients with histologically confirmed aggressive lymphoma will undergo FAPI PET\u002FCT imaging, and selected patients who are candidates for immunotherapy will undergo Grazytracer PET\u002FCT imaging. These imaging methods are intended to assess fibroblast activation protein expression and granzyme B activity in lymphoma lesions, reflecting cancer-associated fibroblasts and cytotoxic T-cell activity in the tumor microenvironment. The study will explore optimal imaging assessment criteria and develop clinical-pathological-imaging models to predict treatment response, prognosis, and the relationship between tumor heterogeneity and refractory or relapsed disease.",[194],"Aggressive Lymphoma",{"date":176,"type":38},{"date":197,"type":38},"2024-07-11",{"date":180,"type":23},{"name":44,"class":45},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":24,"phases":210,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":46},"100641175","connectome-guided-navigation-for-eloquent-area-tumor-surgery-trial-100641175","NCT07657403","CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial","A Prospective, Randomized, Controlled Superiority Trial of Connectome-Guided Navigation-Assisted Microsurgical Resection for Functional Preservation in Eloquent-Area Brain Tumors","CONNECT Trail","Inclusion Criteria:\n\n1. Patients clinically diagnosed with brain tumors involving language areas, motor areas, or major functional brain networks, including the default mode network, central executive network, dorsal attention network, or ventral attention network.\n2. Karnofsky Performance Status (KPS) score of 70 or higher.\n3. Preoperative MRI demonstrating a spatial relationship between the tumor and major white matter tracts, such as the corticospinal tract or arcuate fasciculus.\n4. No other neurological disease or underlying condition that may cause neurological dysfunction.\n5. No prior treatment for a brain tumor in the same region, such as radiotherapy.\n6. Tumor not extensively adherent to multiple critical network nodes.\n7. Planned craniotomy for tumor resection and provision of written informed consent by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Pathologically or clinically suspected non-neoplastic brain lesion.\n2. Multifocal tumors.\n3. Incomplete evaluation data.\n4. Withdrawal from the study by the patient or legally authorized representative for any reason.\n5. Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.",{"count":209,"type":23},200,[58],"This study is designed for patients with brain tumors located in eloquent brain areas involved in language, motor, or major functional brain networks. The purpose of the study is to determine whether connectome-guided navigation-assisted microsurgical resection can better preserve neurological function after surgery than conventional tractography-guided surgery.\n\nParticipants who meet the study criteria will be assigned to one of two surgical planning strategies. In the experimental group, patients will undergo preoperative diffusion tensor imaging and resting-state functional MRI for individualized brain network reconstruction, and these data will be integrated with intraoperative navigation and neurophysiological monitoring to guide the resection boundary. In the control group, surgery will be guided by conventional DTI tractography-assisted navigation.\n\nThe main outcome is the rate of postoperative functional preservation. Other outcomes include extent of tumor resection, postoperative complications, time to neurological recovery, overall survival, and quality of life. Patients will be evaluated before surgery and followed after surgery with clinical examinations, neurological assessments, and MRI at prespecified time points.",[213,214],"Brain Neoplasms","Eloquent Area Brain Tumors",[216,217,218,219,220,221,222,223,224],"Connectome-guided surgery","Eloquent area brain tumor","Brain network navigation","Diffusion tensor imaging","DTI tractography","Resting-state fMRI","Functional preservation","Microsurgical resection","Intraoperative neurophysiological monitoring",{"date":176,"type":38},{"date":227,"type":38},"2025-11-01",{"date":229,"type":23},"2028-12-31",{"name":44,"class":45},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":24,"phases":241,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100641305","early-phase-1-inhaled-mrna-immunotherapy-for-patients-with-advanced-lung-cancer-or-pulmonary-metastatic-solid-tumors-100641305","NCT07657611","Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors","A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors","BMD-PLAT","Inclusion Criteria:\n\n1. Male or female patients aged ≥ 18 years.\n2. Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.\n3. Presence of at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function, including hematologic, hepatic, and renal function.\n6. Ability to understand and sign the informed consent form.\n7. Expected survival of at least 12 weeks.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug.\n2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).\n3. Prior allogeneic stem cell or solid organ transplantation.\n4. Current use of other investigational agents within 4 weeks before the first dose of study treatment.\n5. Active autoimmune disease requiring systemic immunosuppressive therapy.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.",{"count":240,"type":23},60,[242],"EARLY_PHASE1","This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.",[245,246,247],"Neoplasms","Solid Tumors","Neoplasm Metastasis",{"date":176,"type":38},{"date":250,"type":23},"2026-06-10",{"date":252,"type":23},"2029-12",{"name":44,"class":45},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":24,"phases":263,"briefSummary":264,"conditions":265,"keywords":269,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":46},"100641388","early-phase-1-qh101-cell-injection-in-patients-with-brain-brain-spinal-meninges-and-spinal-cord-metastatic-malignant-solid-tumors-100641388","NCT07656103","QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors","Exploratory Clinical Study of Dose Escalation for QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors Three Dose Groups Are Established: 1×10⁷ enTCR Vδ2T Cells Per Infusion (Low Dose), 3×10⁷ enTCR Vδ2T Cells Per Infusion (Medium Dose), and 6×10⁷ enTCR Vδ2T Cells Per Infusion (High Dose). The Dose Escalation Rules Are as Follows: The First Enrolled Subject Receives Low-dose Cell Infusion. If no Dose-limiting Toxicity (DLT) Events Occur After Infusion, the Second Enrolled Subject Receives Medium-dose Infusion; the Medium and Hig","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. ECOG ≤2 or KPS ≥60;\n3. Life expectancy ≥8 weeks as assessed by the investigator;\n4. Pathologically and\u002For histologically confirmed malignant tumors with brain, meningeal, and spinal cord metastases that have failed standard therapy or lack standard treatment options may be considered for enrollment;\n5. Intracranial metastases must meet the following characteristics:\n\n   Unresectable by craniotomy for solitary\u002Ffocal (≤3 lesions)\u002Fmultiple (\\>3 lesions) intracranial metastases; or inoperable leptomeningeal or spinal cord metastases; Inclusion Criteria Intracranial lesions that progressed after standard treatment, including whole-brain radiotherapy\u002Fstereotactic radiosurgery (WBRT\u002FSRS), and are not suitable for repeat radiotherapy;\n6. For brain\u002Fspinal cord parenchymal metastases, contrast-enhanced MRI must show at least one measurable lesion (according to iRANO criteria); for patients with meningeal lesions only, those deemed likely to benefit from this study by investigator judgment may also be considered for inclusion (efficacy assessed using RANO-LM criteria);\n7. Basic normal bone marrow reserve function and normal hepatic and renal function (laboratory tests must meet the following criteria prior to first QH101 administration):\n\n   White blood cell count (WBC) ≥ 3 × 10⁹\u002FL; Lymphocyte count (LY) ≥ 0.8 × 10⁹\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Platelet count (PLT) ≥ 90 × 10⁹\u002FL; Alanine aminotransferase (ALT) \\& aspartate aminotransferase (AST) \\\u003C 1.5×ULN; Serum creatinine (Cr) \\\u003C 1.5×ULN; Total bilirubin \\\u003C 1.5×ULN; PT \\& APTT ≤ 1.25×ULN.\n8. Pregnancy test must be negative for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;\n9. Ability to understand trial requirements and procedures, and willingness to participate in the clinical study as required;\n10. Signing of the trial informed consent form.\n\nExclusion Criteria:\n\n1. Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;\n2. Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;\n3. Patients with metastases in the brainstem and high cervical spinal cord, including midbrain, pons, medulla oblongata, and C1\u002F2 segments of the cervical spinal cord;\n4. Patients with significant mass effect from intracranial lesions and signs of increased intracranial pressure (such as severe headache, projectile vomiting, papilledema, altered consciousness, or imaging showing significant edema, midline shift ≥1 cm, compression of peribrain cisterns such as suprasellar cistern, quadrigeminal cistern, interpeduncular cistern, or ambient cistern);\n5. Patients with primary or secondary epilepsy\u002Fepileptic syndrome that is difficult to control with medication;\n6. Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric\u002Fsocial conditions limiting patient compliance with study requirements;\n7. Known psychiatric disorders or substance abuse disorders that may affect compliance with trial requirements;\n8. Currently receiving any other investigational treatments;\n9. Diagnosed with an immunodeficiency;\n10. Patients with active infections requiring systemic treatment;\n11. Inability to undergo magnetic resonance imaging (MRI);\n12. Severe cardiovascular damage: history of New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction or stroke within 6 months after first dosing, or clinically significant arrhythmias requiring treatment at screening;\n13. Allergic to immunotherapy or related cellular therapies;\n14. Previously received CAR-T or other cellular immunotherapies;\n15. Other reasons that the investigator considers make the patient unsuitable for participation in this study.",{"count":262,"type":23},7,[242],"QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence.",[266,267,268],"Brain Metastasis","Meningeal Metastasis","Spinal Cord Metastasis",[270,271,272,273],"TCR","BTN","γδT","allogeneic cell therapy",{"date":176,"type":38},{"date":276,"type":23},"2026-05-31",{"date":278,"type":23},"2027-05-31",{"name":44,"class":45},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":24,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":46},"100641261","phase-1-platform-study-of-vsv-based-recombinant-oncolytic-viruses-for-the-treatment-of-advanced-malignant-tumors-100641261","NCT07656116","Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors","A Phase I Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand this study, and agree to comply with the protocol and complete all trial procedures\n2. Be at least 18 years of age at the time of signing the ICF, with no gender restrictions.\n3. Patients with advanced solid tumors confirmed by histopathological\u002Fcytological examination of primary and\u002For metastatic lesions.\n4. Patients who have failed standard therapy, lack a standard last-line treatment option, or are medically ineligible for standard therapy.\n5. Subjects with an ECOG performance status of 0-2 and an estimated survival of ≥12 weeks.\n6. Adequate organ and hematopoietic function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FLPlatelet count ≥ 75 × 10⁹\u002FL (no platelet transfusion or thrombopoietin (TPO) therapy within 2 weeks prior to first dose)Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 2 weeks)Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CCr) ≥ 50 mL\u002Fmin Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN for patients with liver metastases, AST and ALT \\\u003C 5 × ULN， Serum total bilirubin (TBIL) ≤ 2 × ULN， International Normalized Ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of reproductive potential must agree to use reliable contraception during the trial and for at least 6 months after the last dose. Translated with DeepL.com (free version)\n\nExclusion Criteria:\n\n1. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, and subjects with malignancies within the scope of the indication.\n2. Lesions intended for injection with a maximum diameter \\>100 mm；\n3. Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks；\n4. Subjects scheduled for or who have previously undergone tissue\u002Forgan transplantation；\n5. Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL Patients with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at screening, with HBV-DNA above the lower limit of detection patients with positive HCV antibody at screening and HCV-RNA above the lower limit of detection subjects with positive syphilis serology\n6. Subjects requiring antiviral medication during the study period or within 5 half-lives of antiviral medication at the time of first dosing.\n7. Subjects requiring therapeutic anticoagulant medication during the study period.\n8. Subjects with uncontrolled active infection of ≥Grade 3 severity according to CTCAE v5.0 that is clinically significant\n9. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer) Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to first dose Received nitrosourea or mitomycin C within 6 weeks prior to first dose Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to first dose)\n10. Uncontrolled hypertension, pulmonary hypertension, or unstable angina myocardial infarction, coronary artery bypass grafting, or stenting within 6 months prior to dosing history of chronic heart failure at New York Heart Association (NYHA) functional class III-IV Severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia deemed by the investigator to have no impact on the trial), including QTcF ≥ 450 ms in males or ≥ 470 ms in females (calculated using Fridericia's formula) cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to enrollment",{"count":288,"type":23},27,[26],"To evaluate the safety and tolerability of combined administration of VSV injection solutions carrying different targets via multiple routes for treating advanced malignant solid tumors.",[292],"Advanced Solid Tumor",[294,295],"oncolytic virus","immunotherapy",{"date":176,"type":38},{"date":298,"type":38},"2026-01-29",{"date":300,"type":23},"2027-01-31",{"name":44,"class":45},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":54,"minAge":19,"maxAge":20,"enrollmentInfo":309,"targetDuration":4,"studyType":24,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":46},"100641101","risk-stratified-hypofractionated-radiotherapy-after-breast-conserving-surgery-for-early-breast-cancer-100641101","NCT07657442","Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer","A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer","Inclusion Criteria:\n\n* ECOG performance status score of 0 to 2.\n* Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.\n* Clinical stage cT0-2N0M0.\n* Underwent breast-conserving surgery.\n* Negative surgical margins greater than 2 mm.\n\nExclusion Criteria:\n\n* Regional lymph node metastasis.\n* Distant metastasis.\n* Bilateral breast cancer.\n* Prior thoracic radiotherapy.\n* Life expectancy of less than 5 years.\n* Lactating or pregnant women.",{"count":310,"type":23},649,[58],"This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.",[314,61],"Early Stage Breast Carcinoma",[63,64],{"date":176,"type":38},{"date":318,"type":23},"2026-06-15",{"date":320,"type":23},"2032-12-31",{"name":44,"class":45},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":24,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":338,"leadSponsor":339,"locationsCount":46},"100641775","phase-1-ovv-01-intravenous-and-intratumoral-injection-combined-with-ak112-for-the-treatment-of-advanced-solid-tumors-100641775","NCT07650825","OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors","A Single-Arm, Open-Label Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of OVV-01 Administered Intravenously and Intratumorally in Combination With AK112 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. At least 18 years of age at the time of signing the ICF; gender is not restricted.\n2. Patients with advanced solid tumors confirmed by histopathological\u002Fcytological examination of the primary and\u002For metastatic lesions, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, hepatocellular carcinoma, gastric cancer, etc.\n3. Patients with advanced disease who have failed standard therapy, lack standard treatment options, or are medically ineligible for standard therapy. Patients must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies).\n4. Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions ≥10 mm in longest diameter and lymph node lesions ≥15 mm in shortest diameter on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound\u002FCT\u002For endoscopic guidance.\n5. ECOG performance status of 0-1, with an estimated survival of at least 12 weeks.\n6. Sufficient organ and hematopoietic function.\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with known brain metastases and\u002For clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled);\n2. Subjects who underwent radiotherapy to the target lesion within the past 2 months (may be enrolled if the radiotherapy site progressed);\n3. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;\n4. Largest diameter of lesions for injection \\>100 mm;\n5. Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;\n6. Subjects scheduled for or who have previously undergone tissue\u002Forgan transplantation;\n7. Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL; Patients screening positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection, or screening positive for HCV antibody with HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;\n8. Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.\n9. Subjects requiring therapeutic anticoagulant therapy during the study period.\n10. Subjects with uncontrolled active infection ≥ Grade 3 according to CTCAE v5.0 that is clinically significant;\n11. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to the first dose; Received nitrosourea or mitomycin C within 6 weeks prior to the first dose; Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to the first dose);",{"count":330,"type":23},30,[26],"This study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with advanced solid tumors.",[334],"Advanced Solid Tumors",[294,295],{"date":114,"type":38},{"date":159,"type":23},{"date":300,"type":23},{"name":44,"class":45},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":46},"100641219","phase-1-cib-in-vivo-car-t-lentiviral-injection-in-patients-with-advanced-malignant-tumors-100641219","NCT07657585","CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors","A Phase 1, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years.\n2. At least one measurable target lesion according to RECIST version 1.1 at screening.\n3. Histologically or cytologically confirmed advanced or metastatic malignant tumor, with positive target expression confirmed by validated assay methods.\n4. Patients who have failed prior standard systemic therapy (including but not limited to VEGF-targeted tyrosine kinase inhibitors and\u002For immune checkpoint inhibitors), or are intolerant to standard therapy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Expected survival time ≥ 3 months as assessed by the investigator.\n7. Adequate organ function at baseline (no growth factor support or transfusion within 14 days prior to screening):\n\n   a. Bone marrow function: i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; ii. Hemoglobin (Hb) ≥ 90 g\u002FL; iii. Platelet count (PLT) ≥ 75 × 10⁹\u002FL. b. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤ 5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN.\n\n   c. Renal function: Serum creatinine ≤ ULN or creatinine clearance rate ≥ 80 mL\u002Fmin.\n8. For female patients of childbearing potential, serum β-HCG test result must be negative within 7 days prior to enrollment.\n9. Patients must agree to use effective contraception from the signing of the informed consent form (ICF) until at least 90 days after the end of the study.\n10. Voluntarily sign the informed consent form (ICF) and be able to understand and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Asymptomatic untreated brain metastases; symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence of uncontrolled CNS\u002Fmeningeal metastases that are considered unsuitable for enrollment by the investigator.\n2. Presence of clinically significant cardiovascular, pulmonary, neurological, or systemic disease at baseline that may increase study participation risk or interfere with safety assessments.\n3. Presence of severe chronic or active infection at baseline, including:\n\n   1. Active hepatitis B (HBsAg positive with HBV DNA \\> ULN);\n   2. Active hepatitis C (anti-HCV positive with detectable HCV RNA);\n   3. Known history of or positive test for human immunodeficiency virus (HIV);\n   4. Systemic anti-infective therapy required within 4 weeks prior to first administration, including hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.\n4. History of active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) or receipt of long-term systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive agents within 4 weeks prior to first administration.\n5. Prior allogeneic tissue or solid organ transplantation.\n6. Evidence of severe immunodeficiency, such as primary immunodeficiency (e.g., severe combined immunodeficiency, SCID) or concurrent opportunistic infections.\n7. Prior gene therapy using lentiviral or retroviral vectors.\n8. Prior treatment with drugs targeting the same antigen.\n9. Requiring therapeutic anticoagulation that cannot be discontinued prior to administration.\n10. History of severe cardiovascular disease, including:\n\n    1. NYHA class ≥ II congestive heart failure;\n    2. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    3. Corrected QT interval (QTcF) \\> 470 ms or long QT syndrome;\n    4. Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade ≥ 3 cardiovascular events within 6 months prior to first administration;\n    5. Uncontrolled hypertension.\n11. Prior anti-tumor therapy within 4 weeks or 5 half-lives (whichever is longer) prior to first administration, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy; prior oral small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer); prior palliative radiotherapy within 14 days; prior participation in other anti-tumor clinical trials within 4 weeks; prior use of any anti-tumor traditional Chinese medicine within 2 weeks.\n12. Pregnant or breastfeeding women, or women of childbearing potential who refuse to use effective contraception during the study period.\n13. Any other disease or laboratory abnormality that, in the investigator's opinion, makes the patient unsuitable for participation in this study.",{"count":348,"type":23},91,[26],"This is an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors.\n\nThe study will enroll patients with histologically or cytologically confirmed advanced solid tumors that have progressed on or are intolerant to standard therapies. A \"3+3\" dose-escalation design will be used, with planned dose levels including 1×10⁵ TU\u002Fkg, 3×10⁵ TU\u002Fkg, 1×10⁶ TU\u002Fkg, 3×10⁶ TU\u002Fkg, 1×10⁷ TU\u002Fkg, and 3×10⁷ TU\u002Fkg. The primary objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) based on dose-limiting toxicities (DLTs) observed within 28 days after administration. Secondary objectives include evaluating adverse events, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic parameters of the study drug.",[352],"Advanced Malignant Solid Tumors",[334,354,355,356],"In Vivo CAR-T","Phase 1 Study","Dose Escalation",{"date":176,"type":38},{"date":359,"type":23},"2026-07-01",{"date":361,"type":23},"2028-05-31",{"name":44,"class":45},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":24,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":46},"100607330","the-application-of-symptoms-management-program-based-on-the-patient-reported-outcome-after-esophagectomy-100607330","NCT07187154","The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy","Inclusion Criteria:\n\n* The patient is aware and able to communicate in Mandarin;\n* There are smartphones；\n* Proficient in using WeChat mini programs.\n* Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.\n\nExclusion Criteria:\n\n* Have cognitive impairment or psychiatric illness;\n* Refusal to participate",{"count":370,"type":23},300,[58],"1. Research methods Constructed the \"Manual for Graded Management of Postoperative Symptoms of Esophageal Cancer\" and developed continuous care Procedures.\n2. Randomised controlled studies were conducted to verify the effects of the procedure.",[374],"Esophageal Cancer",{"date":114,"type":38},{"date":377,"type":38},"2026-05-02",{"date":379,"type":23},"2027-02-01",{"name":44,"class":45},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":102,"enrollmentInfo":388,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":390,"conditions":391,"keywords":394,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":46},"100616498","distribution-and-analysis-of-metastatic-lymph-nodes-in-colorectal-cancer-patients-diamond-100616498","NCT07306390","Distribution and Analysis of Metastatic Lymph Nodes in Colorectal Cancer Patients (DIAMOND)","DIAMOND","Inclusion Criteria:\n\n* Aged between 18 and 80 years\n* Pathologically confirmed adenocarcinoma of the colon or rectum\n* Underwent radical resection for colorectal cancer with a D3 lymphadenectomy and lymph nodes were submitted for pathological examination according to standardized station-based and distance-based protocol\n* No distant metastasis or distant metastasis within 6 months after surgery\n* No history of other malignant tumors or severe systemic diseases\n* No immune diseases or inflammatory bowel diseases\n* Non-emergency surgery\n* With complete clinicopathological and follow-up data\n\nExclusion Criteria:\n\n* Pathologically confirmed benign tumors or non-adenocarcinoma malignancies\n* Underwent local excision or palliative resection\n* Regional lymph nodes were not dissected or submitted for pathological examination according to the unified station-based or distance-based protocol\n* With distant metastasis or distant metastasis within 6 months after surgery\n* Dual or multiple primary colorectal cancers or concurrent other malignant tumors\n* Had a previous diagnosis of immune diseases or inflammatory bowel disease such as ulcerative colitis or Crohn's disease\n* Underwent emergency surgery\n* Had incomplete clinicopathological or follow-up data",{"count":389,"type":23},1200,"The goal of this observational study is to learn about the spatial distribution and significance of metastatic lymph nodes in colorectal cancer patients. The main question it aims to answer is:\n\n* What is the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer?\n* Can the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer guide clinical practice? Participants should undergo regular follow-up examinations for at least 5 years after the surgery.",[392,393],"Colon Cancer","Rectal Cancer",[395,396,397],"Colorectal Cancer","Lymph Node Metastasis","Spatial Distribution","2026-06-07",{"date":400,"type":38},"2026-06-09",{"date":359,"type":23},{"date":403,"type":23},"2028-01-31",{"name":44,"class":45},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":411,"targetDuration":413,"studyType":84,"phases":4,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":46},"100580611","a-prospective-multicenter-observational-cohort-study-to-evaluate-the-efficacy-and-safety-of-a-novel-anti-tumor-drug-as-a-radiosensitizer-in-patients-with-advanced-breast-cancer-brain-metastasis-100580611","NCT06839547","A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug as a Radiosensitizer in Patients With Advanced Breast Cancer Brain Metastasis.","Inclusion Criteria:\n\n1. Males or females who are at least 18 years of age on the day of signing the informed consent form.\n2. Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology.\n3. Patients who are planned to receive, currently receiving, or have completed intracranial radiotherapy after discussion by a multidisciplinary team (MDT) at the stage of brain metastasis.\n4. Patients who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. These drugs include:\n\n   ADC drugs (such as T-DXd, T-DM1, etc.), CDK4\u002F6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), Novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1\u002FPD-L1 inhibitors, etc.\n5. Patients with a traceable medical history during the treatment period.\n6. Patients who are able to sign the informed consent form to participate in the study.\n\nExclusion Criteria:\n\n1. The subject has leptomeningeal metastasis.\n2. If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.\n3. The subject has not signed the informed consent form.\n4. Pregnant or breastfeeding women.\n5. Other situations deemed by the investigator as unsuitable for inclusion in the study.",{"count":412,"type":23},100,"2 Years","A prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.",[416],"Advanced Breast Cancer Brain Metastasis","2026-06-06",{"date":250,"type":38},{"date":420,"type":38},"2025-03-01",{"date":422,"type":23},"2028-09-10",{"name":44,"class":45},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":442,"locationsCount":46},"100585922","phase-2-evaluate-the-efficacy-and-safety-of-adebrelimab-combined-with-chemotherapy-with-or-without-radiotherapy-as-neoadjuvant-treatment-for-her2-negative-locally-advanced-breast-cancer-100585922","NCT06908668","Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer","A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged between 18 and 70 years old.\n2. Pathologically confirmed as invasive breast cancer, with immunohistochemical staining indicating HER2 negativity, as specifically referenced in the guidelines of the American Society of Clinical\n3. Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP).\n4. Clinical stage II-III, patients who are planned to undergo neoadjuvant treatment to downstage for surgery or who wish to have breast-conserving surgery after neoadjuvant treatment.\n5. The breast tumor is suitable for SBRT (stereotactic body radiotherapy) (tumor distance from the skin \\> 5 mm, without invasion of the ribs or intercostal muscles).\n6. No distant metastasis detected by clinical examination combined with imaging studies (including but not limited to liver ultrasound, chest CT, bone scan, PET-CT).\n7. Adequate organ function (hemoglobin ≥ 100 g\u002FL, white blood cells ≥ 3×10⁹\u002FL, neutrophils ≥ 1.5×10⁹\u002FL, platelets ≥ 80×10⁹\u002FL; creatinine ≤ 132 μmol\u002FL; alanine aminotransferase\u002Faspartate aminotransferase ≤ 2.5×upper normal limit \\[UNL\\]).\n8. Capable of undergoing breast magnetic resonance imaging (MRI) scans. Eligible for follow-up conditions.\n9. The subject is able to sign the informed consent form to participate in the study.\n10. Women of childbearing age are not pregnant, not breastfeeding, and are using effective contraception.\n\nExclusion Criteria:\n\n1. Prior receipt of chest radiotherapy, chemotherapy, or immunotherapy.\n2. History of other malignancies, with the exception of adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid cancer.\n3. Patients with active fibroconnective tissue diseases, risk of active autoimmune diseases, or a history of autoimmune diseases that may involve the central nervous system, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, and autoimmune neuropathies (e.g., Guillain-Barré syndrome). The following exceptions apply: Type I diabetes mellitus, stable hypothyroidism on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic therapy, and autoimmune diseases caused by B cells or anti-self-antigen antibodies.\n4. Pulmonary disease defined as ≥ Grade 3 according to the NCI-CTCAE v5.0; history of interstitial lung disease (ILD) requiring corticosteroid treatment (including pulmonary fibrosis or radiation pneumonitis), or current ILD or ≥ Grade 2 radiation pneumonitis.\n5. Severe comorbidities or active diseases:\n\n   a) History of severe cardiovascular and cerebrovascular diseases, including but not limited to: i. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or third-degree atrioventricular block; ii. QT interval prolongation at rest (QTc \\> 450 msec in males or \\> 470 msec in females); iii. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to the first dose; iv. Presence of heart failure with New York Heart Association (NYHA) functional class ≥ II.\n\n   b) Poorly controlled diabetes for \\> 1 month: fasting blood glucose \\> 10 mmol\u002FL, or postprandial 2-hour blood glucose \\> 13 mmol\u002FL.\n\n   c) Poorly controlled psychiatric disorders with an episode or exacerbation within the past 6 months.\n\n   d) Active infection. e) Positive for human immunodeficiency virus (HIV) antibodies. Other diseases that are not suitable for immunotherapy, or a history of other malignancies.\n6. Presence of severe internal medical conditions that may affect radiotherapy or immunotherapy.\n7. Pregnant or breastfeeding women.\n8. History of allergy to components of radiotherapy or immunotherapy.","70 Years",{"count":433,"type":23},170,[106],"A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined with Chemotherapy with or without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer",[437],"HER2-Negative Locally Advanced Breast Cancer",{"date":250,"type":38},{"date":440,"type":38},"2025-03-31",{"date":422,"type":23},{"name":44,"class":45},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":24,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":458,"leadSponsor":459,"locationsCount":46},"100580612","phase-2-evaluating-the-efficacy-and-safety-of-pd-l1-monoclonal-antibody-combined-with-vex-metronomic-chemotherapy-and-concurrent-or-delayed-radiotherapy-in-patients-with-advanced-her2-negative-breast-cancer-with-brain-metastasis-100580612","NCT06839560","Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis","A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis","Inclusion Criteria:\n\n1. Males or females who are at least 18 years of age on the day of signing the informed consent form.\n2. Patients with metastatic HER2-negative breast cancer brain metastasis, with clear clinical documentation; specific criteria refer to the guidelines of the American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP).\n3. Patients who have received no more than one line of chemotherapy during the metastatic stage of breast cancer.\n4. Patients with brain metastasis should not require immediate local therapy during the trial and meet at least one of the following criteria:\n\n   1. The patient has not previously received intracranial radiotherapy.\n   2. The patient has not previously undergone surgery for intracranial metastases; if surgery was performed, the surgical lesion is not the target for the planned radiotherapy, or it is the target lesion and has recurred after surgery.\n5. The patient must have at least one measurable intracranial lesion, with the longest diameter baseline accurately measurable by magnetic resonance imaging (MRI) as ≥10 mm and suitable for precise repeated measurement according to RECIST 1.1 in combination with RANO criteria. Measurable extracranial lesions are not required.\n6. Patients with suspected or confirmed leptomeningeal metastasis should be excluded.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, assessed within 10 days before the start of study treatment.\n8. Patients may have previously received anthracycline (e.g., doxorubicin, epirubicin) and\u002For taxane (e.g., paclitaxel, docetaxel) therapy, specifically including:\n\n   1. Before breast cancer recurrence, the patient received anthracycline and\u002For taxane during adjuvant or neoadjuvant treatment.\n   2. The patient experienced treatment failure during or after anthracycline and\u002For taxane-based chemotherapy.\n   3. In the judgment of the investigator, the patient is not suitable for anthracycline and\u002For taxane-based chemotherapy as a first-line treatment regimen.\n9. Female patients are not pregnant, not breastfeeding, and agree to use necessary contraceptive measures.\n10. The patient is able to sign the informed consent form to participate in the study.\n11. The patient has adequate organ function, as detailed in Table 1 of the study protocol; all screening laboratory tests should be completed within 10 days before the start of study treatment.\n\nExclusion Criteria:\n\n1. The subject has leptomeningeal metastasis.\n2. If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.\n3. Malabsorption syndrome, or the disease significantly affects gastrointestinal function; or after subtotal gastrectomy, or after proximal small bowel resection, which may affect the absorption of oral metronomic chemotherapy agents.\n4. The subject has dysphagia or is unable to swallow tablets.\n5. Known history of another invasive malignancy that is progressing or requires active treatment within the past 5 years. (Subjects with a history of cutaneous basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ of the breast treated with curative intent, or in situ cervical cancer are not excluded.)\n6. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or targeted drugs acting on another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).\n7. Diagnosis of immunodeficiency or receiving long-term systemic corticosteroid therapy (daily dose exceeding 10 mg prednisone equivalent) or any form of immunosuppressive therapy within 7 days before the first dose of study treatment.\n8. Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressive agents).\n9. History of pneumonia requiring steroid treatment (non-infectious) or current pneumonia.\n10. Positive urine pregnancy test within 72 hours before the first dose of study treatment.\n11. Active infection requiring systemic treatment.\n12. Known history of active tuberculosis.\n13. Echocardiogram performed at screening confirms left ventricular ejection fraction (LVEF) \\\u003C50% or below the institutional lower limit of normal.\n14. Other significant cardiac disease, such as: myocardial infarction, acute coronary syndrome, or history of coronary artery angioplasty\u002Fstent placement\u002Fbypass surgery within the past 6 months; New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or history of NYHA Class III or IV CHF.\n15. Known history of human immunodeficiency virus (HIV) infection.\n16. Known history of hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\]) or known active hepatitis C virus infection (defined as detectable HCV RNA \\[qualitative\\]).",{"count":451,"type":23},102,[106],"A Prospective, multicenter, randomized controlled phase II study to evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy and concurrent or delayed radiotherapy in patients with advanced HER2-negative breast cancer with brain metastasis",[455],"Brain Metastasis From Advanced HER2-negative Breast Cancer",{"date":250,"type":38},{"date":420,"type":38},{"date":422,"type":23},{"name":44,"class":45},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":24,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":481},"100575386","phase-2-phase-ii-clinical-trial-of-pd-l1-in-combination-with-vinorelbine--cyclophosphamide--capecitabine-vex-metronomic-chemotherapy-with-or-without-radiotherapy-for-advanced-triple-negative-breast-cancer-100575386","NCT06771609","Phase II Clinical Trial of PD-L1 in Combination With Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy With or Without Radiotherapy for Advanced Triple-negative Breast Cancer.","Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy With or Without Radiotherapy in Advanced Triple-negative Breast Cancer: a Prospective, Multicenter, Randomized Controlled Phase II Clinical Trial.","Subjects are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female who is 18 years of age or older on the day of signing the informed consent form.\n2. Subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the \"American Society of Clinical Oncology - College of American Pathologists (ASCO\u002FCAP) guidelines.\"\n3. Have received less than or equal to 1 line of chemotherapy for metastatic breast cancer;\n4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 10 days before the start of study treatment;\n5. Subjects must have at least one measurable lesion present; specific reference to the \"Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\" guidelines;\n6. Subjects may have previously received treatment with anthracyclines (e.g., doxorubicin, epirubicin) and\u002For taxanes (e.g., paclitaxel, docetaxel) as follows: a) The subject has used anthracyclines and\u002For taxanes during adjuvant and\u002For neoadjuvant therapy before breast cancer recurrence. b) The subject has experienced treatment failure during or after chemotherapy based on anthracyclines and\u002For taxanes. c) According to the investigator's judgment, the Subject is not suitable for anthracyclines and\u002For taxanes-based chemotherapy as a first-line treatment option.\n7. Female subjects are not pregnant, not lactating, and agree to use necessary contraceptive measures.\n8. Subjects are able to sign an informed consent form to participate in the study.\n9. Have appropriate organ function, as detailed in Table 1; all screening laboratory tests should be completed within 10 days before the start of study treatment.",{"count":468,"type":23},150,[106],"Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.",[472],"Advanced Triple-negative Breast Cancer",[474,475,64],"advanced triple-negative breast cancer","PD-L1 in combination with VEX metronomic chemotherapy",{"date":250,"type":38},{"date":478,"type":38},"2024-09-10",{"date":422,"type":23},{"name":44,"class":45},2,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":488,"targetDuration":413,"studyType":84,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":496,"locationsCount":46},"100575790","a-prospective-multicenter-observational-cohort-study-assessing-the-efficacy-and-safety-of-radiotherapy-sensitized-immunotherapy-in-advanced-breast-cancer-100575790","NCT06776861","A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer","Inclusion Criteria:\n\nSubjects are eligible for inclusion in the study only if all the following criteria apply:\n\n1. Men or women who are 18 years of age or older on the day of signing the informed consent;\n2. Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;\n3. Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;\n4. Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing radiotherapy;\n5. Patients with a traceable medical history during treatment;\n6. Subjects who are able to sign an informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI scan;\n2. Have not signed the informed consent form;\n3. Pregnant or lactating women;\n4. Other conditions deemed unsuitable for inclusion in the study by the investigator.",{"count":468,"type":23},"A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.",[491],"Advanced Breast Cancer",{"date":400,"type":38},{"date":494,"type":38},"2024-09-24",{"date":422,"type":23},{"name":44,"class":45},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":24,"phases":508,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":522,"leadSponsor":523,"locationsCount":46},"100638056","phase-3-rairi-model-guided-adjuvant-therapy-in-nasopharyngeal-carcinoma-100638056","NCT07590024","RAIRI Model-Guided Adjuvant Therapy in Nasopharyngeal Carcinoma","Individualized Adjuvant Therapy Decision-Making for Locoregionally Advanced Nasopharyngeal Carcinoma Guided by Response-Adapted Individualized Risk Index (RAIRI): A Multicenter, Randomized, Controlled Phase III Study","RAIRI-NPC","Inclusion Criteria\n\n1. Age 18-65 years, regardless of sex.\n2. Histologically confirmed EBER-positive, non-metastatic, non-keratinizing nasopharyngeal carcinoma.\n3. AJCC 9th edition stage II-III disease \u002F AJCC 8th edition stage III-IVA disease, excluding T3-T4N0 and T3N1 disease; or baseline EBV DNA \\>4,000 copies\u002FmL.\n4. Eastern Cooperative Oncology Group performance status score of 0-1.\n5. Availability of complete baseline pretreatment imaging data, including nasopharyngeal and neck MRI with functional MRI sequences, and at least one measurable tumor lesion.\n6. Availability of pretreatment baseline plasma cfEBV-DNA measurement.\n7. Patients must meet the following laboratory criteria: hemoglobin \\>120 g\u002FL and white blood cell count ≥4 × 10⁹\u002FL.\n8. Platelet count ≥100 × 10⁹\u002FL; liver and renal function parameters within 1.25 times the upper limit of normal; and no hearing impairment.\n9. Ability to understand the study and provision of written informed consent.\n10. Agreement to allow the use of personal data and biological samples, including blood and tissue samples, for research purposes.\n11. Adequate function of major organs, except for abnormalities related to nasopharyngeal carcinoma.\n12. Ability and willingness to comply with scheduled follow-up.\n\nExclusion Criteria\n\n1. Absence of pretreatment cfEBV-DNA data or other essential baseline characteristic data.\n2. AJCC 8th edition stage I-II or IVB disease \u002F AJCC 9th edition stage I or IV disease, or T3-4N0 or T3N1 disease.\n3. History of other malignancies, except stage I non-melanoma skin cancer or carcinoma in situ of the cervix.\n4. Pregnant or lactating women, or women of childbearing potential who are not using contraception.\n5. Current participation in another investigational drug trial.\n6. Severe comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, active ulcer disease, psychiatric illness, uncontrolled diabetes mellitus, active autoimmune disease, ongoing systemic immunosuppressive therapy, active infection requiring systemic treatment, history of human immunodeficiency virus infection, positive hepatitis B surface antigen, hepatitis B virus DNA \\>1 × 10³ copies\u002FmL or \\>200 IU\u002FmL, or positive hepatitis C virus antibody.\n7. Inability to comply with regular follow-up.","65 Years",{"count":507,"type":23},651,[128],"This study aims to evaluate a personalized approach for treating patients with locoregionally advanced nasopharyngeal carcinoma (NPC). Currently, many high-risk patients receive additional treatment (adjuvant therapy) after standard chemoradiotherapy to prevent the cancer from returning. However, some patients may not actually need this extra treatment and could safely avoid its side effects.\n\nThis trial uses a novel risk prediction model called the Response-Adapted Individualized Risk Index (RAIRI). The RAIRI model evaluates how a patient's tumor and blood markers (such as Epstein-Barr Virus DNA) respond during and immediately after their initial chemoradiotherapy.\n\nIn this study, patients will be randomly assigned to one of two groups:\n\n1. Standard Treatment Group: All patients will receive standard adjuvant therapy (either a PD-1 inhibitor or capecitabine) after completing their initial chemoradiotherapy.\n2. RAIRI-Guided Group (Experimental): Patients will be evaluated using the RAIRI model after initial chemoradiotherapy. Only those identified as \"high-risk\" by the model will receive adjuvant therapy. Those identified as \"low-risk\" will be exempted from adjuvant therapy and will undergo regular observation.\n\nThe main goal of this study is to determine if using the RAIRI model to exempt low-risk patients from adjuvant therapy is as safe and effective as giving adjuvant therapy to everyone, measured by how long patients live without the disease returning or progressing.",[511],"Nasopharyngeal Carcinoma (NPC)",[513,514,515,516,517],"Adjuvant Therapy","RAIRI","EBV-DNA","Risk Stratification","response-adapted","2026-06-03",{"date":520,"type":38},"2026-06-04",{"date":92,"type":38},{"date":141,"type":23},{"name":44,"class":45},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":24,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":546,"locationsCount":46},"100452168","phase-2-preoperative-imrt-with-anlotinib-and-penpulimab-for-localized-sarcoma-spare-01-100452168","NCT05167994","Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma （SPARE-01）","Preoperative Intensity-Modulated Radiotherapy (IMRT) Combined With Concurrent Anlotinib Hydrochloride and Penpulimab for Localized Extremity or Trunk Sarcoma","SPARE-01","Inclusion Criteria:\n\n* Age older than 18-yo\n* Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.\n* ECOG 0-3\n* Histology reviewed by reference pathologist\n* Lesion can be assessed\n* Can tolerate radiotherapy and Anlotinib\n* Agree contraception.\n* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed\n\nExclusion Criteria:\n\n* No gross tumor post-resection in other center.\n* Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.\n* Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.\n* Benign histology\n* Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)\n* STS can be cured by extensive operation alone.\n* Previous irradiation to the same area\n* Radiological evidence of distant metastases\n* Other contraindications, can't tolerate operation or other treatment needed in this study.\n* Neoadjuvant chemotherapy given or planned.",{"count":330,"type":23},[106],"To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.",[536,537,538,539,540,541],"Sarcoma,Soft Tissue","Extremity","Trunk","Anlotinib","Intensity-modulated Radiotherapy","Major Wound Complications",{"date":520,"type":38},{"date":544,"type":38},"2020-05-01",{"date":73,"type":23},{"name":44,"class":45},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":102,"enrollmentInfo":554,"targetDuration":4,"studyType":24,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":563,"leadSponsor":565,"locationsCount":46},"100638189","early-phase-1-study-of-wenyang-tongbi-formula-in-the-treatment-of-chemotherapy-induced-polyneuropathy-100638189","NCT07626528","Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy","A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy","Inclusion Criteria:\n\n* Age: Patients aged between 18 and 80 years (inclusive).\n* Life Expectancy: An anticipated survival time of ≥ 3 months.\n* Performance Status \\& Organ Function: A Karnofsky Performance Status (KPS) score ≥ 60 and adequate organ function.\n* Diagnosis: Histopathologically or cytologically confirmed breast cancer or colorectal cancer.\n* Chemotherapy Regimen: Currently undergoing chemotherapy containing taxanes or oxaliplatin.\n* Neurotoxicity Grade: Presence of Grade ≥ 2 peripheral neurotoxicity (according to NCI-CTCAE criteria) induced by chemotherapy.\n* TCM Syndrome Differentiation: Conforming to the \"Yang Deficiency and Collateral Obstruction with Toxin-Stasis Accumulation Pattern\" as defined in the Guidelines for Clinical Research of New Traditional Chinese Medicines.\n\nExclusion Criteria:\n\n* Allergy History: Known hypersensitivity to the active ingredients or excipients of the study drug\u002Fplacebo; history of allergic constitution; or a history of allergies to ≥ 3 substances.\n* Comorbidities: Presence of severe psychiatric disorders; or pre-existing conditions such as diabetic neuropathy, hypothyroidism, renal insufficiency, radiculopathy, Charcot-Marie-Tooth disease, or Guillain-Barré syndrome.\n* Concomitant Medications: Use of Chinese patent medicines or herbal decoctions specifically for CIPN within 30 days prior to enrollment.\n* Compliance: Inability to adhere to the treatment protocol or difficulty in accurately assessing one's own general condition.\n* Pregnancy \\& Lactation: Pregnant or lactating women.",{"count":555,"type":23},144,[242],"This clinical trial aims to evaluate the efficacy of Wenyang Tongbi Granules (a patented Traditional Chinese Medicine prescription) in treating chemotherapy-induced peripheral neuropathy (CIPN). The study compares Wenyang Tongbi Granules with mecobalamin tablets, a standard clinical medication, to determine whether the TCM intervention yields superior outcomes in sensory and motor function of the limbs, as well as overall systemic status, among patients presenting with paresthesia and pain during chemotherapy.\n\nMethods: Participants who develop hand-foot paresthesia or pain during chemotherapy will receive either Wenyang Tongbi Granules or mecobalamin tablets daily for a continuous period of 42 days. Evaluations will be conducted on Day 1, Day 21, and Day 42. Outcome measures include the severity and duration of limb paresthesia, as well as changes in TCM-specific syndromes. Additionally, blood samples will be collected to assess variations in serum levels of multiple cytokines, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), before and after the intervention.",[559],"Chemotherapy-induced Peripheral Neuropathy","2026-06-02",{"date":520,"type":38},{"date":359,"type":23},{"date":564,"type":23},"2028-11-01",{"name":44,"class":45},""]