[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Affiliated Hospital of Guangdong Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100618099","phase-3-sapylin-versus-dexamethasone-inhalation-for-ccrt-induced-oral-mucositis-in-nasopharyngeal-carcinoma-100618099",false,"NCT07327216","Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma","Efficacy and Safety of Sapylin Versus Dexamethasone Atomized Inhalation for Concurrent Chemoradiotherapy-Induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: A Randomized, Parallel, Non-inferiority Clinical Trial","1. Inclusion Criteria:\n\n   * Stage III-IVa NPC (AJCC 8th edition) diagnosed via pathology in a tertiary hospital;\n   * No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy;\n   * Karnofsky Performance Status score ≥80;\n   * Intact and normal oral mucosa before treatment;\n   * Age 18-75 years;\n   * Voluntary participation and provision of informed consent in person;\n   * Routine blood examination: white blood cell count ≥4.0×109\u002FL, hemoglobin ≥100g\u002FL, neutrophil count ≥1.5×10\\^9\u002FL, and platelet count ≥100×10\\^9\u002FL;\n   * Biochemical examination: total bilirubin ≤1.5×the upper limit of the normal range (ULN), alanine aminotransferase and aspartate aminotransferase ≤2×ULN, and estimated glomerular filtration rate ≥60 mL\u002Fmin.\n2. Exclusion Criteria:\n\n   * With other malignant tumors in the past or present and\u002For distant metastasis during treatment;\n   * Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy;\n   * With a history of asthma, rash, urticaria, and other allergic diseases;\n   * With a history of autoimmune diseases, connective tissue diseases, and diabetes mellitus that significantly affect the healing of the oral mucosa;\n   * With concomitant diseases, such as heart disease, kidney disease, and acute infectious diseases, which are judged by the investigator to seriously endanger the safety of patients or affect the completion of the study;\n   * Who are breastfeeding, pregnant, or planning to become pregnant during the study;\n   * With known allergies to the therapeutic agents and penicillin used in the trial;\n   * Mental or nervous system diseases or poor compliance.","ALL","18 Years","75 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM). These side effects can be so severe that they lower a patient's ability to adhere to treatment, potentially making the CCRT less effective. Studies have shown that a significant number of patients stop treatment early due to this toxicity.\n\nCurrent clinical guidelines from organizations like MASCC\u002FISOO and ESMO agree that preventing RTOM is crucial, but there is currently no specific drug that works for everyone.\n\nThis study aims to investigate a new approach: using Sapylin, a biological immune regulator, delivered through an atomized inhaler. Preliminary research suggests Sapylin delivered this way may enhance the effectiveness of chemotherapy and boost the body's immunity.\n\nThe main purpose of this study is to determine the effect of Sapylin inhalation on the incidence and severity of RTOM, and to evaluate its safety and impact on the overall success of CCRT.\n\nBy participating, you will help researchers find a high-efficiency, low-toxicity method to improve CCRT outcomes and manage RTOM for future NPC patients and specialists.",[27],"Nasopharyngeal Carcinoma (NPC)",[29,30,31,32,33],"Nasopharyngeal carcinoma","radiation-induced oral mucositis","Sapylin","Dexamethasone","atomized inhalation","RECRUITING","2026-03-03",{"date":37,"type":38},"2026-03-04","ACTUAL",{"date":40,"type":38},"2022-08-15",{"date":42,"type":21},"2027-07-01",{"name":44,"class":45},"Affiliated Hospital of Guangdong Medical University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100603438","phase-2-toripalimab-induction-chemotherapy-radiation-therapy-with-omega-3-for-locally-advanced-nasopharyngeal-carcinoma-100603438","NCT07136519","Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma","Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma: A Phase II, Single Arm Clinical Trial","Inclusion Criteria:\n\n* Written informed consent can be provided, and understanding and compliance with research requirements and evaluation schedules are required.\n* On the date of signing the informed consent form, the age range is between 18 and 65 years old (or the legal age specified by local laws).\n* Pathological diagnosis is non keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, i.e. WHO classification II or III).\n* Clinical staging is anyTN2-3M0 or T4N1M0 (AJCC8th\u002FUICC staging).\n* ECOG score is 0-1 points.\n* Hemoglobin (HGB) ≥ 90g\u002FL, white blood cell (WBC) ≥ 4.0 × 109\u002FL, platelet (PLT) ≥ 100 × 109\u002FL.\n* Liver function: ALT and AST\\\u003C2.5 times the upper limit of normal (ULN), total bilirubin\\\u003C2.0 × UL, serum albumin ≥ 28g\u002FL.\n* Renal function: Serum creatinine\\\u003C1.5 × ULN or creatinine clearance rate (CrCl) calculated value ≥ 60mL\u002Fmin (Cockcroft Gault formula).\n* Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).\n* The international normalized ratio (INR) and activated partial thromboplastin time (APTT) are ≤ 1.5 × ULN (unless the subject is receiving anticoagulant treatment and the coagulation parameters (PT\u002FINR and APTT) are within the expected range of anticoagulant treatment at the time of screening).\n\nExclusion Criteria:\n\n* Nasopharyngeal cancer patients with recurrence and distant metastasis.\n* Pathology shows keratinized squamous cell carcinoma (WHO classification type I).\n* Patients who have undergone radiotherapy or systemic chemotherapy before.\n* Pregnant or lactating women who are in the reproductive period and have not taken effective contraceptive measures.\n* HIV positive.\n* Have suffered from other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ).\n* Patients who have been treated with immune checkpoint inhibitors (CTLA-4, PD-1, PD-L1, etc.).\n* Patients with immunodeficiency diseases and a history of organ transplantation.\n* Patients who have been treated with high-dose corticosteroids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.\n* Patients with significantly impaired heart, liver, lung, kidney, and bone marrow function.\n* Simultaneously using other investigational drugs or in other clinical trials.\n* Refusal or inability to sign the informed consent form for participation in the trial.\n* Individuals with personality or mental disorders, without civil capacity or with limited civil capacity.\n* hepatitis B B surface antigen (HBsAg) is positive and the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) is ≥ 1000 cps\u002Fml.\n* Patients with positive HCV antibody test results are only eligible for this study if their HCV RNA polymerase chain reaction test results are negative.\n* Patients who have experienced any bleeding events with a severity rating of 3 or above in CTCAE5.0 within the first 4 weeks of screening and are deemed to have a high risk of bleeding by the researchers.\n* If there have been any arterial\u002Fvenous thrombotic events within the 6 months prior to the start of screening, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n* Patients with hypertension who cannot be reduced to the normal range through antihypertensive medication (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg); Based on the average of BP readings obtained from ≥ 2 measurements, there has been a history of hypertensive crisis or hypertensive encephalopathy.\n* Past or current inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); History of previous or existing gastrointestinal perforation and\u002For fistula.\n* Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB should undergo chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs.\n* Other serious, uncontrolled internal medical conditions and infections, or other contraindications to treatment, or any condition that researchers believe may pose a risk to receiving the study drug treatment, or interfere with the evaluation of the study drug, subject safety, or analysis of the study results.","65 Years",{"count":56,"type":21},30,[58],"PHASE2","The aim of this study is to evaluate the efficacy, adverse reactions, nutritional status analysis, and quality of life analysis of Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3 in the treatment of locally advanced nasopharyngeal carcinoma.",[27],[62,63],"Toripalimab","Omega-3","NOT_YET_RECRUITING","2025-08-20",{"date":67,"type":38},"2025-08-22",{"date":67,"type":21},{"date":70,"type":21},"2029-12-31",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":18,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":46},"100588404","jy231jy231-injection-for-the-treatment-of-relapsedrefractory-b-cell-lymphoma-leukemia-100588404","NCT06940960","JY231(JY231) Injection for the Treatment of Relapsed\u002FRefractory B Cell Lymphoma\u002F Leukemia","An Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-Cell Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 12-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   1. Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   2. Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   3. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;\n   4. In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    1. Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    2. Grass aminotransferase (AST) ≤3 times ULN;\n    3. Total bilirubin ≤1.5 times ULN;\n    4. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    5. Indoor oxygen saturation ≥ 92%;\n    6. Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    7. There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    1. Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    2. Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    3. Platelet≥50.000\u002Fmm3;\n    4. Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    1. Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    2. Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    3. Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    4. Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    5. CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    1. Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    2. Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    3. The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n16. Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.","12 Years",{"count":81,"type":21},20,[83],"NA","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002F leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[86,87],"B Acute Lymphoblastic Leukemia","B-Non Hodgkin Lymphoma","2025-06-05",{"date":90,"type":38},"2025-06-10",{"date":92,"type":38},"2025-05-30",{"date":94,"type":21},"2027-12",{"name":44,"class":45},""]