[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nasopharyngeal-carcinoma-npc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nasopharyngeal-carcinoma-npc":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,48,78,107,129,152,177,200,229,259,283,310,329,353,378,410,438,463,490,512,537,559,580,600,620],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644717","evaluating-the-optimal-timing-of-acupuncture-for-managing-chemoradiation-induced-xerostomia-in-patients-with-head-and-neck-cancers-100644717",false,"NCT07674706","Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers","A Pilot Randomised Trial Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n1. Aged 21 years or older\n2. Oral cavity or oropharyngeal squamous cell carcinoma, or nasopharyngeal carcinoma planned for either curative adjuvant or definitive chemoradiotherapy using intensity-modulated radiation therapy (IMRT).\n\n   Participants who have received prior induction chemotherapy or are planned for adjuvant chemotherapy are not excluded.\n3. Anatomically intact parotid and submandibular glands\n4. Eastern Cooperative Oncology Group performance status of 0 to 2\n5. Able to provide informed consent\n6. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the acupuncture period and for at least 28 days after the last acupuncture.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. History of xerostomia, Sjögren's disease, or another underlying systemic illness known to cause xerostomia\n2. Prior head and neck radiation treatment\n3. Has bleeding disorders (e.g. Hemophilia), or on anticoagulants (e.g. warfarin, low molecular weight heparin and novel oral anticoagulants)\n4. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.\n5. Local skin infections, lymphedema, or severe skin conditions (e.g., psoriasis, eczema) at or near the acupuncture sites\n6. Ongoing active systemic infection\n7. Current use of amifostine or cholinergic agonist medications (pilocarpine, cevimeline) that can affect salivary functions (salivary substitute not prohibited, but if using, they must refrain from using it for at least 24 hours prior to salivary flow assessment)\n8. Concurrent use of alternative medicines (e.g., Chinese Propriety medicines), that could affect salivary function\n9. Is pregnant or expecting to conceive within the projected duration of the trial, starting with the screening visit through 28 days after the last acupuncture treatment\n10. Low body mass index, ie. BMI \\\u003C 15\n11. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, may prevent the patient from cooperating with trial procedures","ALL","21 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","While existing data supports the use of acupuncture to reduce radiation-induced xerostomia, the optimal timing of acupuncture for managing chemoradiation-induced xerostomia remains an area of active investigation. Prior studies have administered acupuncture either in patients who developed xerostomia 12 months after radiation 10 or during the radiation therapy itself 9. The hypothesis is that acupuncture may be more effective in preventing and reducing xerostomia when administered early during CRT, rather than after chronic xerostomia has already set in. Yet, oncologists have concerns about the potentially higher risk of complications, such as infection, associated with acupuncture, especially if administered concurrently with chemoradiotherapy. Therefore, this study aims to conduct this randomised trial to evaluate the impact of early versus delayed acupuncture on patient-reported and objective measures of xerostomia, as well as the safety and tolerability of acupuncture in this setting.\n\nTo our knowledge, this will be the first randomised clinical trial evaluating the optimal timing for incorporating acupuncture to reduce xerostomia in patients undergoing chemoradiation for head and neck cancers. It is also the first study conducted in Singapore to study the role of acupuncture in reducing CRT-induced xerostomia.",[27,28,29,30,31,32],"Xerostomia","Head Cancer","Neck Cancer","Nasopharyngeal Carcinoma (NPC)","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma",[34],"Acupuncture","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":21},"2026-06",{"date":43,"type":21},"2029-06",{"name":45,"class":46},"National University Hospital, Singapore","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100616259","phase-2-becotatug-vedotin-as-adjuvant-therapy-for-high-risk-nasopharyngeal-carcinoma-100616259","NCT07303283","Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma","Single-agent Becotatug Vedotin as Adjuvant Therapy for High-risk Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial","Inclusion Criteria:\n\n1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II\u002FIII).\n2. Eligible patients with high-risk locoregionally advanced NPC, defined as AJCC (9th edition) stage T4N1M0 or Tany N2-3M0 disease, or persistent high-risk features after induction chemotherapy (SD, PD, or detectable plasma EBV DNA).\n3. ECOG performance status ≤1.\n4. Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.\n5. No later than 6 weeks after the completion of the last radiotherapy treatment.\n6. Adequate hematologic (neutrophil count \\> 1.5×10\\^9\u002FL, hemoglobin \\> 90g\u002FL and platelet count \\> 100×10\\^9\u002FL), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \\\u003C 2.5×ULN) and renal function (creatinine clearance \\> 50 ml\u002Fmin)\n7. Patients must be informed of the investigational nature of this study and give written informed consent.\n8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Patients who could not tolerate or were allergic to Becotatug Vedotin.\n2. Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal, or antiviral therapy before randomization, including but not limited to tuberculosis infection.\n3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.\n4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).\n5. Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.\n6. Patients who are known to be intolerant or sensitive to any therapeutic agents.\n7. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \\> 1.5×ULN), and emotional disturbance.","18 Years","65 Years",{"count":58,"type":21},140,[60],"PHASE2","This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).",[30,63,64],"Locoregionally Advanced Nasopharyngeal Carcinoma","Adjuvant Therapy",[66,67,68],"Nasopharyngeal Carcinoma","Adjuvant therapy","Becotatug Vedotin","2026-06-06",{"date":71,"type":39},"2026-06-09",{"date":73,"type":21},"2026-09-01",{"date":75,"type":21},"2033-08-31",{"name":77,"class":46},"Kai Hu",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":47},"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.",{"count":87,"type":21},651,[89],"PHASE3","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.",[30],[64,93,94,95,96],"RAIRI","EBV-DNA","Risk Stratification","response-adapted","RECRUITING","2026-06-03",{"date":100,"type":39},"2026-06-04",{"date":102,"type":39},"2026-05-01",{"date":104,"type":21},"2030-12-31",{"name":106,"class":46},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":114,"enrollmentInfo":115,"targetDuration":117,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":47},"100640114","real-world-rairi-guided-risk-stratification-for-adjuvant-therapy-benefit-after-chemoradiotherapy-in-npc-100640114","NCT07618078","Real-World RAIRI-Guided Risk Stratification for Adjuvant Therapy Benefit After Chemoradiotherapy in NPC","A Prospective, Multicenter, Real-World Observational Study to Evaluate RAIRI-Guided Risk Stratification for Identifying Adjuvant Therapy Benefit After Standard Chemoradiotherapy in Nasopharyngeal Carcinoma","Inclusion Criteria\n\n1. Age 18 to 75 years, male or female.\n2. Histologically or cytologically confirmed EBER-positive non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype.\n3. Non-metastatic nasopharyngeal carcinoma confirmed by multimodal staging, corresponding to stage I-III according to the AJCC 9th edition staging system, or stage I-IVA according to the AJCC 8th edition staging system.\n4. Eastern Cooperative Oncology Group performance status of 0-1.\n5. Availability of complete pretreatment high-quality contrast-enhanced MRI of the nasopharynx and neck, including functional MRI sequences such as diffusion-weighted imaging, and at least one measurable tumor lesion according to RECIST version 1.1.\n6. Availability of pretreatment quantitative plasma cfEBV DNA measurement.\n7. Adequate baseline laboratory function, defined as hemoglobin \\>120 g\u002FL, white blood cell count ≥4 × 10\\^9\u002FL, platelet count ≥100 ×10\\^9\u002FL, and liver and renal function parameters, including ALT, AST, total bilirubin, and serum creatinine, within 1.25 times the upper limit of normal; no severe clinically significant hearing impairment.\n8. Ability to fully understand the nature and follow-up procedures of this observational study, and voluntary provision of written informed consent by the patient or the patient's legally authorized representative.\n9. Agreement to allow the research team to use the patient's clinical data, routine diagnostic imaging data, and residual biospecimens, such as peripheral blood samples and pathological slides, for scientific research analyses.\n10. Adequate major organ function, except for local compression or functional impairment directly attributable to nasopharyngeal carcinoma.\n11. Good expected compliance with follow-up and reliable communication conditions, allowing completion of long-term survival follow-up.\n\nExclusion Criteria\n\n1. Absence of pretreatment plasma cfEBV DNA measurement, or missing key baseline clinical variables required for RAIRI model calculation, such as age, AJCC stage, lactate dehydrogenase level, or central liquefactive necrosis status.\n2. Presence of distant metastatic disease, M1.\n3. History of previous or concurrent malignancy, except for non-melanoma skin cancer or cervical carcinoma in situ that has been successfully treated and has remained disease-free for more than 5 years.\n4. Pregnant or breastfeeding women, or participants of reproductive potential who are unwilling to use effective contraception during the study observation period.\n5. Current participation in another interventional clinical trial involving an investigational drug or medical device.\n6. Severe or uncontrolled comorbidities, including myocardial infarction within the past 6 months, severe unstable arrhythmia, severe cerebrovascular accident, active gastrointestinal ulcer, uncontrolled psychiatric illness, uncontrolled diabetes mellitus, active autoimmune disease, long-term systemic immunosuppressive therapy, active severe infection requiring systemic anti-infective treatment, known history of human immunodeficiency virus infection, hepatitis B surface antigen positivity with HBV DNA \\>1 × 10³ copies\u002FmL or \\>200 IU\u002FmL, or hepatitis C virus antibody positivity with abnormal viral load.\n7. Any personal, social, geographic, or psychiatric condition that, in the investigator's judgment, would make it impossible for the participant to complete regular follow-up visits and assessments.","75 Years",{"count":116,"type":21},900,"3 Years","OBSERVATIONAL","This prospective, multicenter, real-world observational study aims to evaluate whether a response-adapted individualized risk index, the RAIRI model, can identify patients with non-metastatic nasopharyngeal carcinoma who may or may not benefit from adjuvant therapy after standard chemoradiotherapy. Patients will receive standard treatment according to routine clinical practice. After completion of chemoradiotherapy and assessment at approximately 1 month after radiotherapy, longitudinal multimodal response data, including plasma cfEBV DNA dynamics and MRI-based tumor response, will be incorporated into the RAIRI model to estimate the predicted 5-year progression-free survival. Patients will be stratified into a RAIRI low-risk group, defined as predicted 5-year PFS ≥85%, and a RAIRI high-risk group, defined as predicted 5-year PFS \\\u003C85%.\n\nWithin each RAIRI risk stratum, outcomes will be compared between patients who receive adjuvant systemic therapy, mainly PD-1 inhibitor-based adjuvant immunotherapy, and those who undergo routine surveillance without adjuvant systemic therapy. The primary endpoint is 3-year failure-free survival. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, complete response rate after chemoradiotherapy, distribution of RAIRI risk groups, adverse events, late toxicities, and longitudinal health-related quality of life.",[30],[93,94,64,95,96],"2026-06-01",{"date":98,"type":39},{"date":125,"type":39},"2026-01-01",{"date":127,"type":21},"2031-12-31",{"name":106,"class":46},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100638676","a-multicenter-prospective-phase-iii-clinical-study-of-proton-intensity-modulated-radiotherapy-versus-photon-intensity-modulated-radiotherapy-for-untreated-non-metastatic-nasopharyngeal-carcinoma-100638676","NCT07578727","A Multicenter, Prospective, Phase III Clinical Study of Proton Intensity-modulated Radiotherapy Versus Photon Intensity-modulated Radiotherapy for Untreated Non-metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Diagnosed by histology and\u002For cytology as non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, i.e., WHO type II or III).\n2. Clinical stage: T1-4N0-3M0, I-III stage (AJCC 9th edition).\n3. Age: ≥ 18 years old, ≤ 70 years old.\n4. Gender: No restrictions.\n5. ECOG ≤ 1.\n6. Good organ function:\n\n   Normal bone marrow function: WBC ≥ 4×109\u002FL, Platelet ≥ 100×109\u002FL, HGB ≥ 90g\u002FL Total bilirubin, AST, ALT ≤ 2.0× upper limit of normal value; Creatinine clearance rate ≥ 60ml\u002Fmin or Creatinine ≤ 1.5× upper limit of normal value.\n7. The patient has signed the informed consent form and is willing and able to comply with the study visit schedule, treatment plan, laboratory tests and other research procedures.\n\nExclusion Criteria:\n\n1. The patient has a poor general condition and is in a state of poor health; or the patient has already experienced metastasis.\n2. The patient has an uncontrolled severe infectious disease.\n3. The patient has severe diseases or complications in the heart, lungs, liver, kidneys or other systems, and the investigator judges that they cannot complete the clinical trial.\n4. There are implants such as artificial ears or dentures within the radiotherapy range, and the investigator judges that they are not suitable for proton therapy.\n5. The patient has a history of radiotherapy in the head and neck region.\n6. The patient has mental illness, drug abuse or alcohol dependence.","70 Years",{"count":137,"type":21},504,[24],"Proton therapy for nasopharyngeal carcinoma can reduce radiotherapy-related toxic reactions, and some retrospective studies have found that proton therapy improves the survival of patients with nasopharyngeal carcinoma. However, high-level prospective clinical evidence is still lacking. This study aims to investigate the efficacy and side effects of proton therapy compared with photon intensity-modulated radiotherapy for nasopharyngeal carcinoma through a multicenter, prospective, phase III clinical trial, providing more high-quality evidence-based medical evidence for proton therapy of nasopharyngeal carcinoma.",[30],[142,143],"proton therapy","nasopharyngeal carcinoma","2026-05-13",{"date":146,"type":39},"2026-05-15",{"date":102,"type":21},{"date":149,"type":21},"2028-12-30",{"name":151,"class":46},"Guangzhou Concord Cancer Center",{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":47},"100636596","phase-2-taurine-for-the-prevention-and-treatment-of-radiation-induced-oral-mucositis-in-patients-with-nasopharyngeal-carcinoma-100636596","NCT07567742","Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma","Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: a Single-center, Open-label, Randomized Phase 2 Clinical Trial","Inclusion Criteria:\n\n1. Age 18-70 years.\n2. Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).\n3. Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.\n4. Scheduled to receive radical intensity-modulated radiotherapy (IMRT).\n5. No prior history of anti-cancer treatment.\n6. ECOG performance status 0-1; adequate organ function within 2 weeks before enrollment; Hematology: hemoglobin \\> 90 g\u002FL; absolute neutrophil count \\> 1.5×10⁹\u002FL; platelet count \\> 100×10⁹\u002FL. Biochemistry: total bilirubin ≤ 1.5×ULN; ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; creatinine clearance ≥ 50 mL\u002Fmin.\n7. For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal.\n8. Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.\n\nExclusion Criteria:\n\n1. Known intolerance or hypersensitivity to taurine or its excipients.\n2. Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).\n3. Prior history of malignant tumor.\n4. Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)\n5. History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.\n6. Unwilling to stop smoking, drinking alcohol, or chewing betel nut.\n7. Presence of severe active comorbidities.\n8. Severe dysfunction of heart, brain, lung, or other vital organs.\n9. Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders.\n10. Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors.\n11. Any other condition deemed inappropriate by the investigator.",{"count":160,"type":21},130,[60],"This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.",[164,30],"Oral Mucositis (Ulcerative) Due to Radiation",[166,66,167],"Radiation-induced Oral Mucositis","Taurine","2026-04-30",{"date":170,"type":39},"2026-05-05",{"date":172,"type":21},"2026-05-06",{"date":174,"type":21},"2029-03-30",{"name":176,"class":46},"Sun Yat-sen University",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":47},"100636415","phase-2-evaluating-ivonescimab-in-pd-1-resistant-recurrent-or-metastatic-nasopharyngeal-carcinoma-100636415","NCT07565389","Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma","Phase II Open-label Study Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma","AK112","Inclusion Criteria:\n\n* Participant is eligible to be included in the study only if all the following criteria are met:\n\n  1. The participant (or legally acceptable representative if applicable) provides written consent for the trial.\n  2. Participant is at least 21 years of age on the day of signing informed consent\n  3. Has a locally or centrally determined histologically or cytologically confirmed diagnosis of Epstein Barr Virus (EBV)-positive nasopharyngeal carcinoma Note: The EBV status is to be determined by the EBV-encoded small RNA in situ hybridization (EBER in situ hybridization \\[ISH\\]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required. If EBV status by EBER ISH assay has not been previously determined, tumour tissue from archival tissue may be submitted for EBV determination.\n  4. Has recurrent or metastatic (R\u002FM) disease not amenable to curative local therapy (surgery or radiation)\n  5. Must have seen at least 1 prior line of systemic treatment and has progressed on prior platinum-based chemotherapy and anti-PD1 therapy in the R\u002FM setting OR Progressed within 6 months of previous multimodal therapy containing platinum-based chemotherapy and anti-PD1 therapy in the locally advanced setting.\n  6. Has measurable disease based on iRECIST.\n  7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  8. Has an adequate organ function as defined in the following table (table 1). Specimens must be collected within 10 days prior to the start of study treatment\n  9. Willing to provide blood and tumour tissue samples (newly obtained biopsy if clinically feasible or archival specimen) to support exploratory biomarker analysis.\n\nExclusion Criteria:\n\n* Participant is excluded from the study if ANY of the following criteria apply:\n\n  1. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.\n  2. Has prior anti-angiogenic therapy in the R\u002FM setting or within 6 months as part of multimodality therapy in the locally advanced setting. \\[Applies to cohort A only\\]\n  3. Has tumour that encases major arteries which in the opinion of the investigator carries high risk of vessel wall dehiscence.\n  4. Has a condition requiring systemic steroid therapy (\\> 10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.\n\n     Note: Inhaled or topical steroids and adrenal replacement doses \\\u003C10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted if \\\u003C or = 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.\n  5. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n     Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n  6. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n  7. Has hypersensitivity to ivonescimab or any of its components.\n  8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n     Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.\n  9. Has an active infection requiring systemic therapy, or serious non-healing wound, ulcer or bone fracture.\n  10. Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of ≥ 3 anti-hypertensive drugs or systolic blood pressure greater than 150 mmHg).\n  11. Recent cardiovascular thromboembolic event, such as the following:\n\n      1. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 4 weeks before enrolment\n      2. Symptomatic pulmonary embolism ≤ 4 weeks before enrolment\n      3. Any history of acute myocardial infarction ≤ 6 months before enrolment\n      4. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before enrolment\n      5. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before enrolment\n      6. Any history of cerebrovascular accident ≤ 6 months before enrolment\n  12. Persistent proteinuria of NCI-CTCAE Grade 3 or higher (\\> 3.5 g\u002F24 hours, measured by urine protein\u002Fcreatinine ratio on a random urine sample).\n  13. Clinically significant bleeding (NCI-CTCAE Grade 3 or higher) within 30 days prior to start of study medication.\n  14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n  15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n  16. Is pregnant, breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.\n  17. A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to randomization\u002Fallocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n      Note: If 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.\n  18. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.\n  19. Known active Hepatitis B (defined as hepatitis B viral load detected) or Hepatitis C virus (defined as HCV RNA \\[qualitative\\] detected) infection. Patients on anti-virals but with undetectable Hepatitis B or C viral loads are not excluded.\n\n      Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n  20. History of having received a live virus vaccination (e.g., yellow fever, MMR, nasal flu, chicken pox or Zostavax) within 4 weeks prior to the first dose of trial treatment. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.",{"count":186,"type":21},42,[60],"This study is designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy.",[30],[191],"Ivonescimab","2026-04-27",{"date":194,"type":39},"2026-05-04",{"date":196,"type":21},"2026-05",{"date":198,"type":21},"2031-05",{"name":45,"class":46},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":4},"100635453","pseudomembrane-removal-for-post-rt-nasopharyngeal-necrosis-100635453","NCT07552883","Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis","Endoscopic Nasopharyngeal Pseudomembrane Removal for Prevention of Radiation-Induced Nasopharyngeal Necrosis After Re-irradiation in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Multicenter Interventional Study","EPoRN","Inclusion Criteria:\n\n* Voluntarily sign the informed consent form.\n* Age between 18 and 80 years.\n* ECOG performance status ≤ 2.\n* Prior radical radiotherapy with total dose ≥ 66 Gy.\n* Imaging or histopathology confirmed local recurrence and\u002For retropharyngeal lymph node recurrence, with or without cervical lymph node recurrence.\n* Re-irradiation with single dose \\\u003C 2.3 Gy and total dose ≥ 50 Gy.\n* Presence of pseudomembrane reaction on nasopharyngeal mucosa during or after re-irradiation.\n* Expected survival \\> 1 year.\n* Induction chemotherapy, immunotherapy, concurrent chemotherapy, adjuvant chemotherapy, or radiotherapy alone are all permitted.\n\nExclusion Criteria:\n\n* History of other malignancies within the past 5 years, except cured non-melanoma skin cancer or carcinoma in situ of the cervix.\n* Severe uncontrolled systemic diseases (e.g., uncontrolled infection, severe cardiovascular disease, uncontrolled diabetes).\n* Pregnant or breastfeeding women.\n* Known allergy to any equipment or medication used during endoscopy.\n* Inability to tolerate endoscopic procedure due to anatomical or medical reasons.\n* Concurrent participation in another interventional clinical trial.\n* Any condition that, in the investigator's judgment, would interfere with study compliance or outcome assessment.","80 Years",{"count":210,"type":21},40,[24],"This study aims to evaluate the effectiveness and safety of endoscopic nasopharyngeal pseudomembrane removal in reducing radiation-induced nasopharyngeal necrosis in patients with recurrent nasopharyngeal carcinoma who have received re-irradiation. This is a prospective, single-arm, multicenter interventional study. Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic pseudomembrane removal. Based on published literature, the 2-year incidence of radiation-induced nasopharyngeal necrosis after re-irradiation is approximately 40%. This study expects to reduce the incidence to 20%. The primary outcome measure is the 2-year incidence of nasopharyngeal necrosis after re-irradiation. Secondary outcome measures include: necrosis-free survival, overall survival, progression-free survival, local regional recurrence-free survival, distant metastasis-free survival, as well as safety and adverse events. A total of 40 participants will be enrolled from multiple hospitals in China.",[30,214,215],"Radiation Injuries","Necrosis",[217,218,219,220,221],"recurrent NPC","re-RT","radiation necrosis","pseudomembrane","endoscopy","2026-04-20",{"date":192,"type":39},{"date":168,"type":21},{"date":226,"type":21},"2031-04-30",{"name":228,"class":46},"Jiangxi Provincial Cancer Hospital",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":241,"conditions":242,"keywords":246,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":47},"100611947","phase-1-integrating-allogeneic-nk-cells-in-high-risk-advanced-stage-iii-iv-nasopharyngeal-cancer-patients-100611947","NCT07247201","Integrating Allogeneic NK Cells in High-risk Advanced Stage III-IV Nasopharyngeal Cancer Patients","Phase 1\u002F2 Trial Integrating Allogeneic NK Cells in High-risk Advanced Stage III-IV Nasopharyngeal Cancer Patients","AlloNK1","Inclusion Criteria:\n\n* Diagnosed with NPC Stage III-IVA\u002FB (T1-4, N1-3, M0)\n* Able to tolerate convectional CRT\n* Detectable EBV level at diagnosis\n* Adequate organ function ANC ≥ 1500\u002FµL Platelet count ≥ 100,000\u002FµL Creatinine clearance ≥60ml\u002Fminute Total bilirubin ≤ 1.5 x upper limit normal (ULN) AST ≤ 2 x upper limit normal ALT ≤ 2 x upper limit normal\n* ECOG performance status of 0-1\n\nExclusion Criteria:\n\n* History of Autoimmune Disease or any condition resulting in immunocompromised state (e.g., Drug induced)\n* ECOG performance status above or equal to 2\n* Poor Organ Function\n* Lactating or pregnant\n* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study.",{"count":238,"type":21},31,[240,60],"PHASE1","This clinical trial aims to determine whether Natural Killer (NK) cell therapy administered in combination with concurrent chemoradiotherapy (CRT) can reduce recurrence in patients with advanced nasopharyngeal cancer (NPC), and to identify the highest safe and tolerable dose of allogeneic NK cells. Allogeneic NK cells, derived from healthy donors, have demonstrated good tolerability in cancer patients.\n\nThe primary research questions are:\n\n1. What is the maximum tolerated dose (MTD) of allogeneic NK cells when administered with CRT in NPC patients?\n2. Can the addition of allogeneic NK cells to standard CRT reduce the proportion of NPC patients with detectable plasma EBV-DNA from 30% to 10%?\n\nPhase 1: Participants will receive one of five escalating doses of allogeneic NK cells with CRT to determine the MTD.\n\nPhase 2: Participants will receive the established MTD NK dose together with CRT.\n\nParticipants will undergo regular safety monitoring, side-effect assessment, measurement of plasma EBV-DNA levels, and surveillance for disease recurrence.",[30,243,244,245],"Minimal Residual Disease","Recurrent Nasopharyngeal Carcinoma","Maximum Tolerated Dose",[247,248,249,245],"Advanced Nasopharyngeal Cancer","Epstein-Barr Virus DNA","Allogeneic NK Cells","2026-03-24",{"date":252,"type":39},"2026-03-30",{"date":254,"type":21},"2026-04",{"date":256,"type":21},"2026-09",{"name":258,"class":46},"Singapore General Hospital",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":47},"100628258","phase-3-becotatug-vedotin-plus-sintilimab-in-locoregionally-advanced-npc-100628258","NCT07459296","Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC","Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form in writing.\n2. Aged 18-70 years, male or non-pregnant female.\n3. Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).\n4. Staged as anyT N2-3 or T4N1 (9th AJCC\u002FUICC staging) without distant metastasis.\n5. ECOG performance status score of 0-1.\n6. Hemoglobin (HGB) ≥ 90 g\u002FL, neutrophil count ≥ 1.5×10⁹\u002FL, and platelet (PLT) count ≥ 100×10⁹\u002FL.\n7. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN.\n8. Normal renal function: Creatinine clearance rate ≥ 60 ml\u002Fmin (calculated using the Cockcroft-Gault formula).\n9. Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug.\n\nExclusion Criteria:\n\n1. Aged \\> 70 years or \\\u003C 18 years.\n2. Patients with recurrent or distant metastatic nasopharyngeal carcinoma.\n3. Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).\n4. Patients who have previously received radiotherapy or systemic chemotherapy.\n5. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\> 1000 copies\u002FmL or 200 IU\u002FmL.\n6. Positive for hepatitis C virus antibody (anti-HCV).\n7. Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).\n8. Patients who received systemic glucocorticoids (equivalent to prednisone \\> 10 mg\u002Fday) or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Patients who received systemic glucocorticoids equivalent to prednisone ≤ 10 mg\u002Fday, inhaled or topical glucocorticoids are eligible for enrollment.\n9. Patients with a history of active tuberculosis within the past year; patients with active tuberculosis that has been adequately treated for more than one year are eligible for enrollment. Patients with a history of other malignant tumors (except cured basal cell carcinoma or carcinoma in situ of the cervix).\n10. Patients with a history of interstitial lung disease.\n11. Patients who received live vaccines within 30 days prior to signing the informed consent form or plan to receive live vaccines in the near future.\n12. Pregnant or lactating females.\n13. Patients with a history of other malignant tumors within the past 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.\n14. Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab.\n15. Patients with known history of HIV infection.\n16. Any other conditions deemed by the investigator to potentially affect the patient's ability to sign the informed consent form, cooperate with and participate in the study, or interfere with the interpretation of results, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illnesses, or family\u002Fsocial factors.",{"count":267,"type":21},266,[89],"This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.",[30],[66,68,272,273],"Sintilimab","Concurrent Chemoradiotherapy","2026-03-13",{"date":276,"type":39},"2026-03-16",{"date":278,"type":21},"2026-03-05",{"date":280,"type":21},"2032-04-01",{"name":282,"class":46},"First Affiliated Hospital of Guangxi Medical University",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":114,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":47},"100618099","phase-3-sapylin-versus-dexamethasone-inhalation-for-ccrt-induced-oral-mucositis-in-nasopharyngeal-carcinoma-100618099","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.",{"count":291,"type":21},180,[89],"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.",[30],[296,297,298,299,300],"Nasopharyngeal carcinoma","radiation-induced oral mucositis","Sapylin","Dexamethasone","atomized inhalation","2026-03-03",{"date":303,"type":39},"2026-03-04",{"date":305,"type":39},"2022-08-15",{"date":307,"type":21},"2027-07-01",{"name":309,"class":46},"Affiliated Hospital of Guangdong Medical University",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":114,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":47},"100622833","phase-2-scipibaimab-combined-with-tislelizumab-in-patients-with-first-line-treatment-failed-recurrentmetastatic-nasopharyngeal-carcinoma-100622833","NCT07388758","Scipibaimab Combined With Tislelizumab in Patients With First-Line Treatment-Failed Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","Efficacy and Safety of Scipibaimab Combined With Tislelizumab in the Treatment of Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma Who Have Failed First-line Treatment: a Multicenter, Single-arm, Non-randomized, Open-label Phase II Clinical Study","Inclusion Criteria:\n\n* 1\\. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and\u002For radiation therapy.\n* 2\\. Age ≥ 18 years and ≤ 75 years, both genders.\n* 3\\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n* 4\\. Life expectancy of at least 3 months.\n* 5\\. Have failed for first-line platinum-based chemotherapy.\n* 6\\. Have failed for prior treatment with PD-1 antagonists +\u002F- chemotherapy.\n* 7\\. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.\n* 8\\. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet count ≥ 75×109\u002FL; Hemoglobin ≥ 9 g\u002FdL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN ; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml\u002Fmin (Cockcroft-Gault formula); serum albumin ≥28 g\u002FL; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine \\[FT3\\] or free Thyroxine \\[FT4\\] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN.\n* 9\\. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative.\n\n  10\\. Written informed consent.\n\nExclusion Criteria:\n\n* 1.Known history of hypersensitivity to any components of the Tislelizumab formulation, or other monoclonal antibody.\n* 2.Prior therapy with any anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody, anti-IgE monoclonal antibody, or other monoclonal antibodies\u002Fbiological agents.\n* 3.There was a history of severe bleeding, and any bleeding events with a serious grade of 3 or more in CTCAE5.0 occurred within 4 weeks before screening.\n* 4.Before treatment, MRI showed that the tumor may have invaded important blood vessels (such as enclosing the internal carotid artery \u002F vein), nasopharyngeal necrosis, or researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment.\n* 5.Patients with abnormal blood coagulation and bleeding tendency (14 days before signing informed consent: INR is within the normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues. On the premise that the INR \\\u003C 1.5, low-dose warfarin (1mg orally, once a day) or low-dose aspirin (daily dose not more than 100mg) is allowed for preventive purposes.\n* 6.Arteriovenous thrombosis occurred within one year before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by intravenous catheterization due to early chemotherapy) and pulmonary embolism.\n* 7\\. Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix.\n* 8\\. Join another clinical study at the same time, received any research drug within 4 weeks before the first administration of the drug.\n* 9\\. Patients with any active autoimmune disease or a documented history of autoimmune disease such as pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;\n* 10\\. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses \\> 10 mg\u002Fday prednisone or equivalent are prohibited within 2 weeks before study drug administration.\n* 11\\. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease.\n* 12\\. Be known to have active tuberculosis.\n* 13\\. Hepatitis B virus (HBV) \\>2000 IU\u002Fml or DNA ≥ 1×10\\^4\u002Fml; or hepatitis C virus (HCV) RNA ≥ 1×10\\^3\u002Fml).\n* 14\\. Has an active infection requiring systemic therapy.\n* 15\\. Has known active central nervous system metastases.\n* 16\\. Severe, uncontrolled angiocardiopathy (heart failure \\> class II NYHA, unstable angina, myocardial infarction within past 1 year, supraventricular or ventricular arrhythmia which need medical intervention, or QT interval male ≥ 450 ms, female ≥ 470 ms.).\n* 17\\. Have been vaccinated with anti-tumor vaccines or have been vaccinated with live vaccines within 4 weeks before screening.\n* 18\\. Pregnant or nursing.\n* 19\\. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.",{"count":5,"type":21},[60],"This study aims to explore the efficacy and safety of scipibaimab combined with tislelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line therapy.",[30],"2026-02-04",{"date":323,"type":39},"2026-02-05",{"date":325,"type":21},"2026-02",{"date":327,"type":21},"2029-02",{"name":176,"class":46},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":47},"100600765","phase-2-iparomlimab-and-tuvonralimab-combined-with-nimotuzumab-in-recurrent-or-metastatic-npc-after-first-line-treatment-failure-a-single-arm-phase-iia-clinical-trial-100600765","NCT07101744","Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial","Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic Nasopharyngeal Carcinoma After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial","Inclusion Criteria:\n\n1. ECOG performance status score of 0-1;\n2. Age 18 to 70 years;\n3. Histologically confirmed nasopharyngeal carcinoma;\n4. Patients with locoregional recurrence unsuitable for surgery or radiotherapy, or those who developed distant metastasis after standard comprehensive treatment, or initially diagnosed with metastatic nasopharyngeal carcinoma, provided they have experienced treatment failure with first-line cisplatin-based regimens (± PD-1 monoclonal antibody);\n5. Availability of nasopharyngeal + neck MRI data prior to enrollment, with at least one measurable lesion (excluding bone metastases);\n6. Willingness to provide archived tumor tissue specimens or undergo a biopsy to collect tumor tissue for PD-L1 expression level testing;\n7. Laboratory test results within 7 days prior to enrollment meeting the following criteria:\n\n   Hematology: Absolute neutrophil count (ANC) ≥ 2.0 × 10\\^9\u002FL, hemoglobin (Hb) ≥ 9.0 g\u002FdL, platelets (PLT) ≥ 100 × 10\\^9\u002FL;\n\n   Liver function: Total bilirubin \\\u003C 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 1.5 × ULN;\n\n   Renal function: Serum creatinine \\\u003C 1.5 × ULN.\n8. Voluntary participation with signed informed consent form.\n\nExclusion Criteria:\n\n1. History of other malignancies (except adequately treated non-melanoma skin cancer, in situ carcinoma, or other cancers cured ≥5 years prior);\n2. Comorbidities requiring long-term immunosuppressive therapy or systemic\u002Flocal corticosteroids at immunocompromising doses;\n3. Immunodeficiency diseases or history of organ transplantation (including but not limited to: interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.);\n4. HIV-positive status; HBsAg-positive with detectable HBV DNA ≥1000 copies\u002FmL; or HCV antibody-positive;\n5. High-dose glucocorticoid use within 4 weeks prior;\n6. Pregnant\u002Flactating women or individuals of reproductive potential without effective contraception;\n7. Laboratory test abnormalities beyond protocol-defined thresholds within 7 days before enrollment;\n8. Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function;\n9. Uncontrolled comorbidities or active infections;\n10. Concurrent participation in other clinical trials or receipt of investigational drugs;\n11. Unwillingness or inability to provide written informed consent;\n12. Other contraindications to study treatment;\n13. Psychiatric disorders or cognitive impairment limiting legal competency.",{"count":337,"type":21},41,[60],"This study aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent\u002Fmetastatic nasopharyngeal carcinoma (NPC). It is expected to investigate a novel therapeutic regimen with improved efficacy and enhanced safety for recurrent\u002Fmetastatic NPC, thereby providing robust evidence-based medical support for the application of dual-target immune checkpoint inhibitors in nasopharyngeal carcinoma therapy",[30,341],"First-line Treatment Failure Nasopharyngeal Carcinoma",[30,343,344],"Nimotuzumab","Iparomlimab and Tuvonralimab","2026-01-21",{"date":347,"type":39},"2026-01-23",{"date":349,"type":39},"2025-10-17",{"date":351,"type":21},"2030-07-16",{"name":176,"class":46},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":47},"100619122","phase-3-proton-vs-photon-imrt-in-locally-advanced-nasopharyngeal-carcinoma-a-phase-iii-trial-100619122","NCT07340515","Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial","A Prospective, Randomized, Open-Label, Multicenter Phase III Clinical Study Comparing Intensity-Modulated Proton Therapy and Intensity-Modulated Photon Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Age 18 to 70 years\n* Histologically confirmed nasopharyngeal carcinoma (WHO type II or III)\n* High-risk locoregionally advanced disease defined as clinical stage T4 or N3, M0, according to the AJCC staging system\n* No prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Adequate organ function as defined in the study protocol\n* Eligible to receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy as specified in the protocol\n* Ability to understand and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis (M1 disease)\n* Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma\n* Active autoimmune disease requiring systemic therapy\n* Uncontrolled infection or severe comorbidities that may affect treatment tolerance\n* Pregnancy or breastfeeding\n* Known allergy, hypersensitivity, or contraindication to study medications as defined in the protocol\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation",{"count":361,"type":21},300,[89],"This multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma.\n\nAll patients receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy and are randomized 1:1 to IMPT or IMRT during the concurrent treatment phase.\n\nThe primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.",[30],[366,367,368,66,369],"Proton Therapy","IMPT","Intensity-Modulated Proton Therapy","Chemoradiotherapy","2026-01-13",{"date":372,"type":39},"2026-01-14",{"date":374,"type":21},"2025-12-15",{"date":127,"type":21},{"name":377,"class":46},"Man Hu",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100618224","phase-3-reduced-dose-versus-conventional-dose-intensity-modulated-radiation-therapy-for-locally-advanced-nasopharyngeal-carcinoma-with-remission-after-induction-chemotherapy-and-immunotherapy-100618224","NCT07328841","Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy","Reduced-Dose Versus Conventional-Dose Intensity-Modulated Radiation Therapy in Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy: A Multicenter, Phase III Clinical Trial","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO classification Type II or Type III).\n2. Clinical stage: AJCC 8th edition staging: T4N0-2M0, T1-4N3M0 (stage IVa); AJCC 9th edition staging: T4N0-2M0, T1-4N3M0 (stage III).\n3. After 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, the efficacy is assessed as PR or CR by nasopharyngoscopy and enhanced MRI of nasopharynx + neck, with EBV DNA reduced to zero or below the lower limit of detection.\n4. Age: 18-70 years old.\n5. PS\u002FECOG score (performance status score of 0 or 1).\n6. Adequate organ function:\n\n   1. Hematology: White blood cell count ≥ 4000\u002FμL, neutrophil count ≥ 2000\u002FμL, hemoglobin ≥ 9 g\u002FdL, platelet count ≥ 100000\u002FμL;\n   2. Liver function: Bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 × ULN are eligible), AST and ALT ≤ 1.5 × ULN, and alkaline phosphatase ≤ 1.5 × ULN; albumin ≥ 3 g\u002FdL;\n   3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin calculated by the Cockcroft-Gault formula.\n   4. Proteinuria: Urine protein\u002Fcreatinine ratio (UPC ratio) \\\u003C 1.0. For those with UPC ratio ≤ 0.5, no further examination is required; for those with UPC ratio \\> 0.5, further testing showing 24-hour urine protein \\\u003C 1000 mg is eligible.\n\n   Note: The UPC ratio of random urine is an estimate of 24-hour urine protein quantification, and the two have a good correlation. The UPC ratio can be calculated using the following formulas:\n\n   i. Urine protein\u002Furine creatinine (if both protein and creatinine are in mg\u002FdL); ii. (Urine protein) × 0.088\u002Furine creatinine (if urine creatinine is in mmol\u002FL).\n\n   e) Coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n7. Patients have signed the informed consent form and are willing and able to comply with the study's scheduled visits, treatment plans, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n1. Patients whose laboratory test results within 7 days before enrollment do not meet the relevant standards.\n2. Patients with efficacy evaluation of stable disease (SD) or progressive disease (PD) after 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, or whose EBV DNA has not been reduced to zero or below the lower limit of detection.\n3. Patients who have received any of the following for primary lesions and\u002For cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment).\n4. Patients with tumors accompanied by obvious liquefaction necrosis, which are unsuitable for radiotherapy or may lead to radioresistance.\n5. Patients with tumors invading the brain parenchyma.\n6. Patients with a history of severe allergic reactions to any components of other monoclonal antibodies or PD-1\u002FPD-L1 monoclonal antibodies.\n7. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.\n8. Patients with recurrence, distant metastasis, or concurrent other malignant tumors.\n9. Patients with severe heart disease, pulmonary dysfunction, or cardiac\u002Fpulmonary function grade 3 or lower (including grade 3).\n10. Patients with previous use of anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, or any other antibodies acting on T-cell costimulatory or checkpoint pathways.\n11. Patients with comorbidities requiring long-term treatment with immunosuppressive drugs or systemic\u002Flocal use of corticosteroids at immunosuppressive doses before enrollment.\n12. Patients with HIV positivity; HBsAg positivity with positive HBV DNA copy number (quantitative detection ≥ 1000 cps\u002Fml); positive screening for chronic hepatitis C (HCV antibody positivity).\n13. Patients with a history of allergic reactions to the drugs used in this study (gemcitabine, docetaxel, taxanes, cisplatin).\n14. Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.\n15. Patients who, within 4 weeks before enrollment: have received systemic or local glucocorticoid treatment, been vaccinated with any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.), or used traditional Chinese herbal medicines with anti-tumor effects.\n16. Women of childbearing age with positive pregnancy test results and lactating women.\n17. Other patients deemed unsuitable for inclusion by the attending physician.",{"count":386,"type":21},456,[89],"To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response \\[CR\\]\u002Fpartial response \\[PR\\] by imaging, with EBV DNA copy number reduced to zero or below the lower limit of detection), so as to provide a new treatment option for these patients.",[30],[66,391,248,392,393,394,395,396,397,398,399],"Locally Advanced","EBV DNA clearance","undetectable EBV DNA","reduced-dose radiotherapy","Randomized non-inferiority trial","Concurrent chemoradiotherapy","complete response","partial response","PD-1inhibitor","2025-12-27",{"date":402,"type":39},"2026-01-09",{"date":404,"type":39},"2025-11-18",{"date":406,"type":21},"2032-06-30",{"name":408,"class":46},"Ming-Yuan Chen",12,{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":418,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":437},"100616239","phase-3-individualized-neck-cervical-irradiation-prophylaxis-trial-of-npc-100616239","NCT07303023","Individualized Neck Cervical Irradiation Prophylaxis Trial of NPC","Individualized Versus Standard Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: A Non-inferiority, Phase III, Multicenter, Prospective, Randomized Controlled Trial","INCIPT-NPC","Inclusion Criteria:\n\n1. Age 18-70 years.\n2. Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma.\n3. Staged as T1-4N0-3 M0, Stage I-III according to the UICC\u002FAJCC 9th edition staging system.\n4. Absence of distant metastasis confirmed by systemic FDG PET\u002FCT (or whole-body bone scan plus chest CT and abdominal ultrasound).\n5. Ability to undergo MRI examination.\n6. Adequate major organ function meeting radiotherapy requirements:\n\n   1. Hematopoietic function: Hemoglobin ≥9 g\u002FL, Platelets ≥100×10⁹\u002FL, WBC ≥3.5×10⁹\u002FL, Neutrophils ≥2.0×10⁹\u002FL.\n   2. Liver function: ALT and AST \\\u003C 2.5 × ULN, Bilirubin \\\u003C 1.5 × ULN.\n   3. Renal function: Creatinine clearance ≥50 mL\u002Fmin or serum creatinine within normal range.\n   4. Patients with clinical symptoms will be evaluated based on specific manifestations.\n7. ECOG performance status 0-1; absence of severe comorbidities (e.g., severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease) that may preclude radiotherapy. Cardiac function class 1-2 (NYHA classification).\n8. Life expectancy ≥12 months.\n9. Patients must be informed of the study details and provide written informed consent.\n\nExclusion Criteria:\n\n1. Pathology not confirming WHO type I, II, or III nasopharyngeal carcinoma.\n2. Distant metastasis identified clinically or radiologically before treatment, or presence of skip metastases in cervical lymph nodes.\n3. Pregnancy (confirmed by serum or urine β-HCG test) or lactation.\n4. Unwillingness to provide informed consent.\n5. Prior radiotherapy to the head and neck region.\n6. Comorbidities or other factors that may contraindicate photon or carbon-ion therapy.\n7. Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons.\n8. Known allergy to chemotherapeutic agents (e.g., cisplatin, docetaxel, gemcitabine) or contrast media used in the study's imaging examinations.\n9. Contraindication to contrast-enhanced MRI.\n10. Major organ dysfunction, or severe uncontrolled concurrent infection or medical illness (e.g., decompensated cardiac, pulmonary, renal, or hepatic failure).\n11. History of immunodeficiency (positive HIV test), other acquired\u002Fcongenital immunodeficiency disorders, or history of organ\u002Fallogeneic bone marrow transplantation.\n12. History of other malignancies prior to enrollment (except for basal cell carcinoma of the skin).\n13. History of substance or alcohol abuse.\n14. Any other condition deemed by the investigator to potentially lead to study discontinuation, including co-morbidities (including psychiatric) requiring concomitant treatment, severely abnormal laboratory values, or familial\u002Fsocial factors compromising patient safety or data integrity.",true,{"count":420,"type":21},462,[89],"Based on the pattern of nasopharyngeal carcinoma cervical lymph node metastasis, which typically follows a sequential downward spread with rare skip metastases and a tendency for ipsilateral neck involvement, and in accordance with the latest international guidelines, we propose the following scientific hypothesis: individualized neck prophylactic irradiation for nasopharyngeal carcinoma based on the superior-to-inferior extent of metastatic lymph nodes is feasible. Specifically: if there is no lymph node metastasis, irradiation need only extend to the lower border of Level II; if there are suspected metastatic lymph nodes, a prophylactic dose of 55-60 Gy should be administered; the investigational arm will only require irradiation extending to 3 cm below the lowest level of metastatic (including suspected) lymph nodes in each neck.This study will prospectively enroll patients with N0-N3 stage nasopharyngeal carcinoma and randomize them to compare individualized neck irradiation based on the vertebral body level of metastatic lymph nodes versus selective upper neck prophylactic irradiation. The primary endpoint is neck recurrence-free survival. Secondary endpoints include overall survival, local recurrence-free survival and other survival data, incidence of acute and late neck radiation-induced injuries, and quality of life, aiming to validate the feasibility of individualized neck irradiation based on metastatic patterns.Photon IMRT and photon plus carbon-ion radiotherapy will serve as stratification factors, enabling further comparison of local control and toxicity between photon-carbon-ion therapy and photon-only (or proton) therapy. This study seeks to protect critical structures such as the thyroid, trachea, esophagus, and neck muscles while maintaining therapeutic efficacy, ultimately improving the quality of life for nasopharyngeal carcinoma patients.",[30],[425,426,427],"IMRT","carbon ion radiotherapy","Prophylactic Neck Irradiation","2025-12-18",{"date":430,"type":39},"2025-12-24",{"date":432,"type":39},"2025-09-01",{"date":434,"type":21},"2031-09",{"name":436,"class":46},"Fudan University",6,{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":47},"100607440","phase-3-phase-iii-non-inferiority-trial-reduced-target-vs-full-target-imrt-after-chemo-in-immunotherapy-treated-metastatic-nasopharyngeal-cancer-100607440","NCT07188584","Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer","A Multicenter, Phase III Non-Inferiority Clinical Trial: Locoregional Volume-Reduction Versus Conventional Definitive Target IMRT Following Full-Dose Chemotherapy for Treatment-Naïve Distant Metastatic Nasopharyngeal Carcinoma Undergoing Full-Course Immunotherapy","Inclusion Criteria:\n\n* Age: 18 years - 70 years.\n* The patient has signed the informed consent form and is willing and able to follow the visit schedule, treatment plan, laboratory tests and other research procedures as per the research plan.\n* Newly diagnosed distant metastasis patients who achieved complete response (CR) or partial response (PR) after receiving adequate first-line systematic therapy (platinum-containing doublet chemotherapy + PD-1 monoclonal antibody).\n* Nasopharyngeal carcinoma non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III), confirmed by histological and\u002For cytological examination, with metastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory).\n* Clinical stage: TanyNanyM1, stage IVB (AJCC 9th edition).\n* ECOG score: 0-1.\n* Female subjects with reproductive capacity must have a negative urine or serum pregnancy test within 7 days prior to enrollment, and must agree to take effective contraceptive measures during the study.\n* For male subjects, if the female partner still has reproductive capacity, the male subject must agree to take effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n* Patients with malignant pleural effusion or those with other malignant tumors\n* Patients who have received ≥2 prior lines of systemic therapy.\n* Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.\n* Patients with grade ≥ II coronary heart disease, arrhythmia (including QTc interval prolongation in males \\> 450 ms, females \\> 470 ms) and heart failure.\n* Patients who received systemic or local glucocorticoid treatment within 4 weeks prior to enrollment.\n* Patients with comorbidities requiring long-term use of immunosuppressive drugs or requiring systemic or local use of corticosteroids at immunosuppressive doses.\n* Patients with active pulmonary tuberculosis (TB), who are undergoing anti-TB treatment or have received anti-TB treatment within 1 year prior to screening.\n* HIV-positive individuals; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps\u002Fml); chronic hepatitis C blood screening positive (HCV antibody positive).\n* Patients who received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.\n* At the time of randomization, the expected lifespan of the patients was less than 6 months.\n* Other patients deemed unsuitable for inclusion by the treating physicians.",{"count":446,"type":21},166,[89],"In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with\u002Fwithout CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of \"immunotherapy combined with reduced-target radiotherapy\" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.",[30],[451,452,453,454],"Distant Metastasis Nasopharyngeal Carcinoma","Full Course Immunotherapy","Reduced-Target Radiotherapy","Full-dose Chemotherapy","2025-12-02",{"date":457,"type":39},"2025-12-09",{"date":459,"type":39},"2025-08-20",{"date":461,"type":21},"2031-07-01",{"name":408,"class":46},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":114,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":473,"briefSummary":474,"conditions":475,"keywords":477,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":47},"100614297","phase-2-induction-high-low-dose-radiotherapy-plus-anti-pd-1-followed-by-definitive-radiotherapy-in-recurrent-nasopharyngeal-carcinoma-single-arm-phase-ii-100614297","NCT07277764","Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)","Induction Therapy With High-Low Dose Radiotherapy Combined With Anti-PD-1 Monoclonal Antibody Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Single-Center Phase II Trial","REDEFINE","Inclusion Criteria：\n\nHistologically confirmed non-keratinizing NPC (WHO II\u002FIII); local (± regional) recurrence ≥1 year after prior radical therapy; surgery-ineligible;\n\nrT2-rT4 (AJCC 8th); ECOG 0-1;\n\nAdequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds);\n\nContraception requirements per protocol; signed informed consent.\n\nExclusion Criteria：\n\nDistant metastasis at recurrence; active necrosis at recurrence; active\u002Fprevious autoimmune disease; prior PD-1\u002FPD-L1 therapy; uncontrolled comorbidities; active infections (HBV\u002FHCV\u002FHIV criteria per protocol); interstitial lung disease\u002Fpneumonitis; pregnancy\u002Flactation; other protocol-specified exclusions.",{"count":472,"type":21},23,[60],"This single-arm, single-center phase II trial evaluates the safety and efficacy of a non-continuous radio-immunotherapy strategy for recurrent nasopharyngeal carcinoma (NPC) unsuitable for surgery. Induction consists of three fractions of low-dose radiotherapy (1.5 Gy ×3) plus high-dose boosts (5 Gy ×3 to tumor core with carotid\u002Fmucosal sparing) combined with anti-PD-1 (240 mg IV on Day 1 and Day 22). After a 21-28-day interval, definitive IMRT (2 Gy ×28, 5 days\u002Fweek) is delivered without concurrent immunotherapy to minimize immune damage. Anti-PD-1 maintenance (240 mg IV Q3W) starts within 2 weeks after radiotherapy for up to 12 months or until progression\u002Ftoxicity. The primary endpoint is ORR at 3 months post-radiotherapy; secondary endpoints include 3-year OS, 3-year PFS, safety (NCI-CTCAE v5.0), and quality of life (EORTC QLQ-C30). Key eligibility: histologically confirmed non-keratinizing NPC (WHO II\u002FIII), rT2-rT4, ECOG 0-1, adequate organ function.",[30,476],"Recurrent Nasopharyngeal Neoplasms",[217,478,479,480,481],"re-irradiation","high-low dose radiotherapy","induction radio-immunotherapy","PD-1 inhibitor","2025-11-30",{"date":484,"type":39},"2025-12-11",{"date":486,"type":39},"2025-10-10",{"date":488,"type":21},"2029-12-31",{"name":228,"class":46},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":114,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":507,"leadSponsor":509,"locationsCount":4},"100612345","phase-2-a-clinical-study-of-hetrombopag-for-prevention-of-thrombocytopenia-induced-by-gemcitabine-plus-cisplatin-in-the-treatment-of-nasopharyngeal-carcinoma-100612345","NCT07252375","A Clinical Study of Hetrombopag for Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma","A Single-Arm, Exploratory, Self-Controlled Clinical Study of Hetrombopag for Secondary Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* 1\\. Aged 18 to 75 years old, regardless of gender;\n* 2\\. Patients with nasopharyngeal carcinoma confirmed by pathological or cytological examination;\n* 3\\. Currently receiving treatment with the Gemcitabine + Cisplatin (GP) regimen at a 21-day cycle, with the lowest platelet count \\\u003C 75×10⁹\u002FL in the previous chemotherapy cycle, and expected to maintain the same chemotherapy regimen for at least 2 more cycles;\n* 4\\. Estimated survival time ≥ 12 weeks;\n* 5\\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;\n* 6\\. Laboratory test indicators meeting the following requirements:\n\n  1. Absolute Neutrophil Count (ANC) \\> 1.0×10⁹\u002FL, Hemoglobin (Hb) \\> 80 g\u002FL;\n  2. Renal function: Creatinine (Cr) ≤ 1.5 × Upper Limit of Normal (ULN) or estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml\u002Fmin (calculated by the Cockcroft-Gault formula);\n  3. Liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; (If the patient has intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN);\n  4. Coagulation function: International Normalized Ratio (INR) of Prothrombin Time (PT) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) within the normal range;\n* 7\\. Females of childbearing potential must agree to use contraception during the study and for 6 months after the study ends; non-lactating females are eligible. Males must agree to use contraception during the study and for 6 months after the study ends;\n* 8\\. No participation in other clinical trials of drugs within 4 weeks prior to enrollment;\n* 9\\. Subjects must understand the study details and voluntarily sign the Informed Consent Form (ICF);\n* 10\\. No severe complications such as active massive gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or non-cancerous fever \\> 38℃;\n* 11\\. Expected to have good compliance and be able to complete follow-up for efficacy and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* 1\\. Thrombocytopenia not caused by cancer therapy occurring within 6 months prior to screening, including but not limited to hepatic cirrhosis with hypersplenism, infection, and bleeding;\n* 2\\. Having other hematopoietic system diseases besides chemotherapy-induced thrombocytopenia, including leukemia, primary immune thrombocytopenia (ITP), myeloproliferative diseases (MPDs), multiple myeloma (MM), myelodysplastic syndromes (MDS), etc.;\n* 3\\. Complicated with bone marrow involvement or bone marrow metastasis;\n* 4\\. Having received pelvic, spinal radiotherapy or large-field bone irradiation within 3 months prior to screening;\n* 5\\. History of any arterial or venous thrombosis occurring within 6 months prior to screening;\n* 6\\. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within 2 weeks prior to screening;\n* 7\\. Severe cardiovascular diseases (e.g., NYHA Cardiac Function Classification Grade III-IV) within 6 months prior to screening, or patients with arrhythmias known to increase thromboembolic risk (such as atrial fibrillation \\[AF\\]), history of coronary artery stenting, angioplasty, or coronary artery bypass grafting (CABG);\n* 8\\. Brain tumor or brain metastasis;\n* 9\\. Having received platelet transfusion within 2 days prior to enrollment;\n* 10\\. Having received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonist drugs (such as eltrombopag, avatrombopag) within 5 days prior to screening;\n* 11\\. Patients with known or anticipated allergy or intolerance to the active ingredient or excipients of Hetrombopag Ethanolamine Tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose \\[L-HPC\\], magnesium stearate, film-coating premix);\n* 12\\. Pregnant or lactating women;\n* 13\\. Patients deemed ineligible for enrollment by the investigator.",{"count":498,"type":21},35,[60],"This study is a single-arm, exploratory, self-controlled clinical trial for the prevention of thrombocytopenia induced by gemcitabine plus cisplatin in the treatment of nasopharyngeal carcinoma. It aims to investigate the efficacy and safety of hetrombopag for the secondary prevention of thrombocytopenia caused by gemcitabine plus cisplatin in patients with nasopharyngeal carcinoma. The study protocol has been reviewed and approved by the Institutional Ethics Committee of Fujian Cancer Hospital, allowing the conduct of this clinical study.",[30,502],"CTIT-Chemotherapy Induced Thrombocytopenia","2025-11-19",{"date":505,"type":39},"2025-11-26",{"date":482,"type":21},{"date":508,"type":21},"2028-11-30",{"name":510,"class":511},"Fujian Cancer Hospital","OTHER_GOV",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":536},"100580574","phase-2-a-phase-ii-study-to-evaluate-hlx43-in-subjects-with-recurrentmetastatic-nasopharyngeal-carcinoma-failed-or-intolerance-to-second-line-therapy-100580574","NCT06839066","A Phase II Study to Evaluate HLX43 in Subjects With Recurrent\u002FMetastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent\u002FMetastatic Nasopharyngeal Carcinoma (NPC) Failed or Intolerance to Second-line Therapy","Inclusion Criteria:\n\n1. Fully understand the study content, procedures, and potential adverse reactions before the trial, sign the informed consent form (ICF), voluntarily participate in the trial, and be able to complete the study per the protocol requirements;\n2. Age ≥ 18 years at the time of signing the ICF, regardless of gender;\n3. Histologically or cytologically confirmed recurrent\u002Fmetastatic nasopharyngeal carcinoma;\n4. Recurrent\u002Fmetastatic nasopharyngeal carcinoma patients who have failed or are intolerant to at least two prior lines of chemotherapy (including at least one platinum-based regimen) and PD-1\u002FPD-L1 inhibitor therapy. Intolerance is defined as experiencing CTCAE ≥ grade 3 adverse events;\n5. At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization;\n6. Willing to provide archived (preferably within 2 years) or fresh tumor tissue specimens for the detection of PD-L1 expression.\n7. At least 4 weeks (or 5 half-lives, whichever is shorter) since last major surgery, medical device treatment, radiotherapy (except palliative bone radiotherapy), cytotoxic chemotherapy, immunotherapy, or biological therapy; ≥2 weeks since last hormonal therapy or small molecule targeted therapy; ≥1 week since last traditional Chinese medicine treatment with anti-tumor indications or minor surgery; with treatment-related adverse events recovered to CTCAE v5.0 ≤ grade 1 (except grade 2 peripheral neuropathy and alopecia);\n8. ECOG performance status 0-1 within 1 week before randomization;\n9. Expected survival ≥ 3 months；\n10. Adequate organ function within 1 week before randomization (no blood transfusion or colony-stimulating factors within 14 days prior to first dose)\n11. Fertile participants must use ≥1 highly effective contraceptive method during the trial and for ≥6 months after last dose; females of childbearing potential must have negative pregnancy test within 7 days before enrollment.\n\nExclusion Criteria:\n\n1. Recurrent nasopharyngeal carcinoma candidates eligible for curative local therapy (surgery or radiotherapy).\n2. Imaging showing tumor invasion\u002Fencasement of major thoracic\u002Fcervical\u002Fpharyngeal blood vessels (may be exempted if investigators confirm no impact on trial participation).\n3. History of other malignancies within 2 years prior to randomization (except radically treated early-stage malignancies).\n4. Previous ≥Grade 3 immune-related adverse events during immunotherapy.\n5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n6. Symptomatic\u002Funtreated\u002Fprogressing CNS or leptomeningeal metastases.\n7. History of ≥Grade 3 radiation pneumonitis; steroid-requiring (non-infectious) interstitial lung disease (ILD), current ILD, or ILD unexcludable by imaging; or severe respiratory impairment from pulmonary disease.\n8. Poorly controlled cardiovascular\u002Fcerebrovascular conditions including.\n9. Candidates for organ\u002Fmarrow transplantation or previous transplant recipients.\n10. Active systemic infections requiring IV antibiotics within 2 weeks pre-randomization.\n11. Use of strong CYP2D6\u002FCYP3A inhibitors\u002Finducers within 2 weeks pre-randomization.\n12. Systemic corticosteroid use (\\>10mg prednisone\u002Fday equivalent) or immunosuppressants within 2 weeks pre-randomization. Exceptions: Topical\u002Focular\u002Fintra-articular\u002Fnasal\u002Finhaled steroids; short-term prophylactic use for contrast agents.\n13. Active\u002Fsuspected autoimmune diseases. Exceptions: Hypothyroid patients on thyroid replacement; controlled type 1 diabetes with insulin.\n14. Live\u002Fattenuated vaccines within 4 weeks pre-randomization (inactivated influenza vaccines permitted).\n15. History of severe hypersensitivity to biologics\u002Fmonoclonal antibodies or trial drug components.\n16. Active tuberculosis.\n17. Immunodeficiency disorders (HIV-positive or congenital\u002Facquired immune deficiencies).\n18. Active HBV\u002FHCV infection or co-infection:\n19. Pregnant\u002Flactating women.\n20. Investigators' judgment of clinical\u002Flab abnormalities or other factors making participation inappropriate.",{"count":520,"type":21},70,[60],"The study is to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent\u002Fmetastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line herapy.",[30],[525,66,526],"HLX43","anti-PD-L1 ADC",{"date":528,"type":39},"2025-11-24",{"date":530,"type":39},"2025-04-02",{"date":532,"type":21},"2027-11-22",{"name":534,"class":535},"Shanghai Henlius Biotech","INDUSTRY",15,{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":22,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":47},"100591582","phase-1-sstr2-imaging-with-68gaga-dota-toc-petct-in-npc-100591582","NCT06982300","SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET\u002FCT in NPC","Towards Improved Therapy Selection and Targeted Treatment for Nasopharyngeal Carcinoma: a Proof-of-concept Pilot Study for Somatostatin Receptor 2 Imaging With [68Ga]Ga-DOTA-TOC PET\u002FCT.","NACASOR","Inclusion Criteria:\n\n* Stage IB-IVA NPC (AJCC 9th edition), EBV positive determined by Epstein-Barr virus-encoded RNA (EBER).\n* Planned treatment with induction chemotherapy or CRT without induction chemotherapy.\n* Age ≥ 18 years.\n* Signed informed consent.\n* Willingness and ability to comply with all protocol required procedures.\n* Negative serum pregnancy test at screening in women of childbearing potential.\n* Archival tumor tissue available or consent to undergo a tumor biopsy procedure.\n\nExclusion Criteria:\n\n* Previous treatment with chemotherapy or radiotherapy for NPC.\n* Treatment with any investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to \\[68Ga\\]Ga-DOTA-TOC injection.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or that may affect the interpretation of the results or render the patient at high risk from complications.\n* Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n* Inability to lie in supine position for 25 minutes.\n* Patients who are pregnant or breastfeeding.",{"count":546,"type":21},10,[240,60],"This is an investigator-initiated, single-center clinical trial designed to evaluate the feasibility of \\[68Ga\\]Ga-DOTA-TOC positron emission tomography (PET) scan in patients with Epstein-Barr virus (EBV) related nasopharyngeal carcinome (NPC) prior to and three weeks after the start of induction chemotherapy or concurrent chemoradiotherapy (CRT). Archival tumor tissue from the diagnostic biopsy will be used to perform somatostatin receptor 2 (SSTR2) immunohistochemistry (IHC). Blood samples will be drawn at baseline, after three weeks, after completion of induction chemotherapy if applicable, and after CRT.",[30],"2025-09-29",{"date":552,"type":39},"2025-10-03",{"date":554,"type":39},"2025-09-25",{"date":556,"type":21},"2026-12",{"name":558,"class":46},"University Medical Center Groningen",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":566,"maxAge":114,"enrollmentInfo":567,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":4},"100608226","molecular-research-on-predictive-efficacy-and-new-therapeutic-targets-for-nasopharyngeal-carcinoma-100608226","NCT07198802","Molecular Research on Predictive Efficacy and New Therapeutic Targets for Nasopharyngeal Carcinoma","Molecular Research on Predictive Efficacy and New Therapeutic Targets for Nasopharyngeal Carcinoma Based on Tumor Immune Microenvironment","Inclusion Criteria Before the trial, the participants must meet all of the following requirements to be eligible for inclusion.\n\n1. Clearly diagnosed with nasopharyngeal carcinoma by pathology;\n2. Patients who have received combined radiotherapy, chemotherapy and immunotherapy in our hospital;\n3. Patients diagnosed in our hospital from January 2025 to December 2028;\n4. Have relatively complete clinical data;\n5. Age between 15 and 75 years old;\n\nExclusion Criteria Before the trial, the participants who meet any of the following requirements cannot be included.\n\n1. The final diagnosis of the participants is other diseases, including lymphoma, or oropharyngeal cancer, etc.;\n2. The participants failed to obtain pathological and imaging data for various reasons;\n3. Due to physical conditions, they did not undergo relevant examinations, refused to accept examinations, or interrupted treatment for other reasons, and were unable to complete clinical assessment.","15 Years",{"count":568,"type":21},600,"To analyze the spatiotemporal dynamic evolution of nasopharyngeal carcinoma before and after immunotherapy and during tumor progression, 2\\~3 key cell subsets or node molecules were screened to predict the curative effect. Spatial metabolome and organoids were used to elucidate the mechanism of key factors leading to immunotherapy tolerance in NPC and identify new targets for intervention.",[30],"2025-09-22",{"date":573,"type":39},"2025-09-30",{"date":575,"type":21},"2025-10",{"date":577,"type":21},"2028-12",{"name":579,"class":46},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":135,"enrollmentInfo":587,"targetDuration":117,"studyType":118,"phases":4,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":596,"leadSponsor":598,"locationsCount":4},"100603479","precise-guidance-of-adaptive-radiotherapy-for-nasopharyngeal-carcinomar-100603479","NCT07137052","Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinomar","A Prospective Multi-center Clinical Study on Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinomar by Multi-dimensional Molecular Imaging","Inclusion Criteria:\n\n1. Any sex; age 18-70 years.\n2. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (World Health Organization (WHO) type II or III).\n3. Clinical stage I-IVA (American Joint Committee on Cancer (AJCC)\u002FUnion for International Cancer Control (UICC) 8th edition) with no evidence of distant metastasis.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n5. No prior anti-tumor treatment for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, immunotherapy, or biologic therapy.\n6. No contraindications to radiotherapy or chemotherapy.\n7. Adequate major organ function as defined below:\n\n   7.1 Hematology: white blood cell (WBC) ≥ 4.0 × 10\\^9\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL (no blood transfusion or blood products within 14 days and no use of granulocyte colony-stimulating factor (G-CSF) or other hematopoietic growth factors to correct counts);\n\n   7.2 Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); blood urea nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin calculated by the Cockcroft-Gault formula.\n8. Participant voluntarily agrees to join the study, signs informed consent, has good compliance, and is able to attend follow-up.\n\nExclusion Criteria:\n\n1. Pathological type of keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.\n2. History of or concurrent other active (unresolved) malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial bladder cancer.\n3. Currently participating in another clinical trial.\n4. Pregnant or breastfeeding women.\n5. Uncontrolled cardiovascular disease, including ≥ Grade II myocardial ischemia or myocardial infarction, uncontrolled cardiac arrhythmias (including corrected QT (QTc) interval ≥ 470 ms); heart failure New York Heart Association (NYHA) class III-IV, or left ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography; or myocardial infarction within the past year.\n6. Other severe comorbidities such as uncontrolled hypertension, severe cerebrovascular disease, severe renal disease, uncontrolled diabetes mellitus, or other chronic wasting diseases.\n7. History of substance or alcohol abuse, psychiatric illness, or lack of full or having limited civil capacity.\n8. In the investigator's judgment, other familial or social factors that could force premature withdrawal from the study, or other conditions likely to affect participant safety or the collection of trial data.",{"count":588,"type":21},732,"This is an observational cohort study designed to (1) evaluate whether Gallium-68 (68Ga)-labeled fibroblast activation protein inhibitor ligand LM3 (68Ga-FAPI-LM3) positron emission tomography\u002Fcomputed tomography (PET\u002FCT) improves the accuracy of nasopharyngeal carcinoma (NPC) staging, and (2) determine whether Gallium-68-labeled programmed death-ligand 1 (68Ga-PD-L1) PET\u002FCT imaging parameters can provide early prediction of response to neoadjuvant immunotherapy. The study will assess the sensitivity and specificity of each tracer for staging and for predicting therapeutic response, analyze changes in tumor uptake parameters on 68Ga-FAPI-LM3 and 68Ga-PD-L1 PET\u002FCT before and after treatment, and compare treatment efficacy and survival outcomes between patients with different degrees of residual PET uptake and between those who did and did not receive neoadjuvant immunotherapy. The primary question it aims to answer is:\n\nDoes 68Ga-FAPI-LM3 PET\u002FCT improve the accuracy of NPC staging, and can 68Ga-PD-L1 PET\u002FCT imaging parameters provide an early prediction of response to neoadjuvant immunotherapy?\n\nParticipants will be patients with biopsy-proven nasopharyngeal carcinoma who undergo 68Ga-FAPI-LM3 and\u002For 68Ga-PD-L1 PET\u002FCT as part of clinical care or a research protocol. Tumor uptake metrics (e.g., maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), metabolic\u002Fvolumetric indices) will be measured pre- and post-treatment; diagnostic performance (sensitivity, specificity) and associations between uptake changes and clinical outcomes (response rates, progression-free and overall survival) will be calculated.",[30,591],"PET \u002F CT","2025-09-16",{"date":594,"type":39},"2025-09-17",{"date":573,"type":21},{"date":597,"type":21},"2029-01-30",{"name":599,"class":46},"The First Affiliated Hospital of Xiamen University",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":610,"conditions":611,"keywords":612,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":618,"leadSponsor":619,"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.",{"count":608,"type":21},30,[60],"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.",[30],[613,614],"Toripalimab","Omega-3",{"date":616,"type":39},"2025-08-22",{"date":616,"type":21},{"date":488,"type":21},{"name":309,"class":46},{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":22,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":47},"100599553","phase-2-effect-of-nutritional-management-on-patients-with-concurrent-chemoradiotherapy-for-nasopharyngeal-carcinoma-100599553","NCT07085988","Effect of Nutritional Management on Patients With Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma","Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Has an Impact on Immunonutritional Status and Therapeutic Phase Toxicity and Prognostic Effects","Inclusion Criteria:\n\n* 1.Patients with nasopharyngeal carcinoma confirmed by histopathology;2.Clinical stage stage II-IVa,Concurrent chemoradiotherapy is included in the definitive treatment regimen;3.Age ≥ 18 years, male or female;4.PG-SGA score of 0-8 before radiotherapy;5.KPS score ≥ 60 or ECOG score ≤3;6.Nutritional supplementation can be given by mouth or enterally;7.Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies;8.Serum hemoglobin ≥ 90 g\u002FL, platelet ≥ 100×109\u002FL, absolute neutrophil count ≥ 1.5×109\u002FL;9.serum creatinine ≤1.25 times ULN or creatinine clearance ≥60 mL\u002Fmin;10.Serum bilirubin ≤ 1.5-fold ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5-fold ULN, and alkaline phosphatase ≤ 5-fold ULN.\n\nExclusion Criteria:\n\n* 1.Have a second primary tumor;2.Those who do not receive concurrent chemoradiotherapy;3.Comorbid diabetes mellitus, or history of severe endocrine and metabolic diseases;4.Those who are allergic to oral nutritional meal replacements.",{"count":628,"type":21},109,[60],"Nasopharyngeal carcinoma (NPC) is a malignant tumor that develops in the nasopharyngeal mucosal epithelium. Due to the disease itself and the impact of anti-tumor therapy, malnutrition has become a common clinical complication in patients with NPC, among which NPC patients receiving concurrent chemoradiotherapy are one of the groups with the highest incidence of malnutrition, and malnutrition seriously affects the prognosis of NPC patients. Nutritional management throughout the course has a positive impact on the prognosis and life management of NPC patients. As an immune-enhancing oral nutritional preparation, it is helpful to maintain the weight and immune function of patients with nasopharyngeal carcinoma during concurrent chemoradiotherapy, reduce the degree of treatment-related side effects during concurrent chemoradiotherapy for nasopharyngeal carcinoma, and delay the occurrence of acute side effects. The purpose of this study was to investigate the effect of rapid rapid rapid improvement of patients' immune status during concurrent chemoradiotherapy, and to further evaluate its impact on patients' weight, prognosis, treatment-related toxic side effects, and quality of life. In this study, 109 patients with nasopharyngeal carcinoma who received concurrent chemoradiotherapy in our hospital are planned to be included, and all patients in this group will be given oral tachyphin at a standard dose from the first day of radiotherapy. The nutritional immune status of the patient was assessed at different points during the treatment period.",[30],[66,396,633],"Immunonutrition Lymphocyte count","2025-07-24",{"date":636,"type":39},"2025-07-25",{"date":638,"type":39},"2025-01-01",{"date":640,"type":21},"2028-12-31",{"name":228,"class":46}]