[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nasopharyngeal-cancinoma-npc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nasopharyngeal-cancinoma-npc":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,48,95,123,150,174,195,217,238,263,287,315,339,360,384,409,431,451,476,507,529,558,580,602,625],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100638659","phase-1-intratumoral-injection-of-recombinant-human-endostatin-adenovirus-eds01-for-the-treatment-of-recurrent-or-metastatic-head-and-neck-tumors-100638659",false,"NCT07625423","Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors","A Phase I Clinical Trial of Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) Combined With Toripalimab for the Treatment of Recurrent or Metastatic Head and Neck Tumors","EDS01 HN","Inclusion Criteria:\n\nAdults aged 18 to 65 years. Histologically or cytologically confirmed recurrent or metastatic head and neck tumor.\n\nPreviously received at least 1 standard platinum-based systemic chemotherapy regimen for recurrent\u002Fmetastatic disease, or had platinum-insensitive or platinum-intolerant disease after prior curative-intent treatment.\n\nNot suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus injection.\n\nAt least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1.\n\nNo chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment.\n\nEstimated life expectancy of at least 12 weeks. ECOG performance status 0 to 1. Male or female participants of childbearing potential must agree to use reliable contraception during treatment and for at least 6 months after treatment.\n\nRecovery of prior treatment-related toxicities to NCI CTCAE grade 1 or baseline, with screening laboratory results within 1 week before enrollment meeting protocol requirements: ANC ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, total bilirubin ≤1.5 × ULN, ALT and AST ≤2 × ULN, and coagulation parameters ≤1.25 × ULN.\n\nWilling and able to provide written informed consent.\n\nExclusion Criteria:\n\nKnown allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection.\n\nReceiving radiotherapy to the study lesion at the same time. Prior anti-angiogenic therapy. Receiving immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes at a dose greater than prednisone 10 mg\u002Fday (or equivalent) within 2 weeks before enrollment.\n\nActive autoimmune disease or history of autoimmune disease. Congenital or acquired immunodeficiency. Risk of major nasopharyngeal hemorrhage or deep nasopharyngeal ulceration. Severe coagulation disorder or bleeding tendency. Severe uncontrolled medical disease or myocardial infarction within 3 months before enrollment.\n\nAcute infection. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","ALL","18 Years","65 Years",{"count":22,"type":23},9,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, whose disease has progressed after platinum-based systemic therapy or who are not suitable for further platinum treatment.\n\nA total of 9 participants will be enrolled in 3 planned dose groups of EDS01. EDS01 will be injected directly into an accessible tumor lesion on Days 0 and 7, and toripalimab 240 mg will be administered intravenously on Day 1 of each treatment cycle for up to 4 cycles, unless disease progression or unacceptable toxicity occurs. The study will evaluate treatment-related adverse events as well as preliminary efficacy outcomes, including tumor response, disease control, and time to progression, using clinical assessments, laboratory tests, imaging, and follow-up after treatment.",[29,30],"Head & Neck Cancer","Nasopharyngeal Cancinoma (NPC)",[32,33,34],"head and neck cancer","nasopharyngeal cancer","recombinant human endostatin adenovirus","RECRUITING","2026-06-03",{"date":38,"type":39},"2026-06-04","ACTUAL",{"date":41,"type":39},"2026-03-27",{"date":43,"type":23},"2028-03-30",{"name":45,"class":46},"West China Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100509238","phase-1-a-phase-ibii-study-of-an-anti-her3-antibody-hmbd-001-with-cetuximab---docetaxel-in-advanced-squamous-cell-cancers-100509238","NCT05910827","A Phase Ib\u002FII Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +\u002F- Docetaxel in Advanced Squamous Cell Cancers","A Phase Ib\u002FII Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Ability to understand and be willing to sign an informed consent form\n\n  * Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is \\> 18 years of age)\n  * Eastern Cooperative Oncology Group (ECOG) status of 0 to 1\n  * Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable\n  * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,\n  * Have an estimated life expectancy of at least 3 months\n  * Participants must be willing to provide a fresh tumor biopsy sample\n  * Have adequate organ function\n  * Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal\n  * Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion\n\nExclusion Criteria:\n\n* Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C\n\n  * Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and\u002For KRAS G12C mutation\n  * Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \\>2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and\u002For impact the study results e.g., alopecia\n  * Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment\n  * Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline\n  * Evidence of abnormal cardiac function\n  * History of uncontrolled allergic reactions and\u002For known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into\n  * Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n  * Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment\n  * Known Human Immunodeficiency Virus (HIV) infection\n  * Active hepatitis B or hepatitis C infection\n  * Pregnant or breast feeding\n  * COVID 19 infection within 3 months prior to the first dose of the study drug\n  * COVID 19 vaccination within 14 days prior to the first dose of the study drug\n  * Treatment with strong inhibitors or inducers of CYP3A4",{"count":56,"type":23},398,[26,58],"PHASE2","This is a Phase Ib\u002FII multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers",[61,62,63,64,65,30,66],"Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Advanced Head and Neck Squamous Cell Carcinoma","Advanced Esophageal Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Advanced Cutaneous Squamous Cell Carcinoma","Squamous Cell Carcinoma",[68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"NSCLC","Non-small Cell Lung Cancer","sqNSCLC","Lung","Squamous","HER3","ErbB3","Docetaxel","Cetuximab","cervical squamous cell carcinoma","HNSCC","CSCC","ESCC","advanced squamous cell cancer","NPC","SCC","2026-05-24",{"date":86,"type":39},"2026-05-27",{"date":88,"type":39},"2024-02-05",{"date":90,"type":23},"2027-12",{"name":92,"class":93},"Hummingbird Bioscience","INDUSTRY",20,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":103,"targetDuration":4,"studyType":24,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100617970","phase-2-ldrt-combined-with-toripalimab-and-chemotherapy-for-recurrentmetastatic-npc-100617970","NCT07325539","LDRT Combined With Toripalimab and Chemotherapy for Recurrent\u002FMetastatic NPC","Low-dose Radiotherapy (LDRT) Combined With Toripalimab and GP Chemotherapy for Recurrent\u002FMetastatic Nasopharyngeal Carcinoma (LIGHT): A Multicentre, Open-Label, Single-Arm Phase II Clinical Study","LIGHT","Inclusion Criteria:\n\n* Age: 18-65 years old.\n* Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III).\n* ECOG Performance Status score of 0-1.\n* At least one measurable lesion as per RECIST v1.1 criteria.\n* Patients with newly diagnosed metastatic NPC, or patients with locoregionally advanced NPC who developed metastasis ≥6 months or recurrence ≥12 months after completing radical radiotherapy\u002Fchemotherapy for the primary lesion.\n* No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent\u002Fmetastatic lesions.\n* Adequate organ function, meeting the following criteria within 7 days prior to treatment:\n\n  1. Hematological criteria (without transfusion or hematopoietic growth factor support within 14 days):\n\n     1. Hemoglobin (Hb) ≥90 g\u002FL.\n     2. White Blood Cell (WBC) count ≥4.0 × 10⁹\u002FL.\n     3. Platelet count (PLT) ≥100 × 10⁹\u002FL.\n  2. Biochemical criteria:\n\n     1. Total Bilirubin (TBIL) ≤1.5 × Upper Limit of Normal (ULN).\n     2. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5 × ULN.\n     3. Serum Creatinine (Cr) ≤1.5 × ULN AND Creatinine Clearance (CCr) ≥60 mL\u002Fmin.\n  3. Coagulation function: INR and APTT ≤1.5 × ULN.\n  4. Normal results for myocardial injury markers, heart failure markers, and electrocardiogram (ECG). For patients with abnormal results in any of these, the investigator will assess the need for Doppler echocardiography.\n  5. Thyroid function: TSH ≤ ULN. If abnormal, FT3 and FT4 levels should be considered; patients can be enrolled if FT3 and FT4 levels are normal.\n* Women of childbearing potential must have used reliable contraception, have a negative serum pregnancy test within 7 days before enrollment, and be willing to use adequate contraception during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterile. Men must agree to use adequate contraception or be surgically sterile during the trial and for 8 weeks after the last dose.\n* Voluntary provision of signed informed consent, with good compliance.\n\nExclusion Criteria:\n\n* Disease progression within 6 months after completing standard treatment for locoregionally advanced nasopharyngeal carcinoma.\n* Absence of identifiable tumor lesions in both the primary site and locoregional lymph nodes, precluding the development of an LDRT plan.\n* Inability to undergo MRI due to reasons such as implanted metal devices or claustrophobia.\n* Requirement for systemic use of corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose or during the study. Inhaled or topical steroids and adrenal replacement steroid doses \\>10 mg\u002Fday prednisone equivalent are permitted in the absence of active autoimmune disease. Physiological replacement doses of corticosteroids (≤10 mg\u002Fday prednisone equivalent) are allowed.\n* Recurrent target lesions suitable for curative surgery or a second course of radiotherapy.\n* History of any active autoimmune or autoimmune disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. Exceptions include type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia).\n* Active or uncontrolled severe infection (≥CTCAE Grade 3) within 4 weeks prior to enrollment.\n* History of active tuberculosis within the past year, regardless of treatment. Patients with a history of active pulmonary tuberculosis over 1 year ago who have documented evidence of adequate past anti-tuberculosis treatment may be considered; otherwise, they are excluded.\n* History of hypertension that cannot be adequately controlled with a single antihypertensive medication (systolic BP ≥150 mmHg or diastolic BP ≥90 mmHg).\n* Clinically significant bleeding symptoms or definite bleeding tendency, specifically excluding cases of local recurrence with high bleeding risk or cases within 1 year post-radiotherapy assessed to have a high risk of necrosis.\n* Urinalysis showing urine protein ≥ ++ AND confirmed 24-hour urine protein ≥1.0 g.\n* Myocardial ischemia (above Grade I), myocardial infarction, arrhythmia (including QTc ≥480 ms), or ≥ Grade 2 congestive heart failure (NYHA classification) within 6 months prior to enrollment.\n* If an echocardiogram is required per Inclusion Criterion 7(4), results showing Left Ventricular Ejection Fraction (LVEF) below the lower limit of normal (60%).\n* Diagnosis of other malignancies within 5 years prior to enrollment, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n* Presence of leptomeningeal or central nervous system metastases.\n* HIV positive, TP positive, liver cirrhosis, decompensated liver disease, active hepatitis (uncontrolled active hepatitis despite treatment: Hepatitis B - HBsAg positive and HBV DNA ≥1 × 10⁴ copies\u002FmL; Hepatitis C - HCV RNA positive with abnormal liver function; co-infection with HBV and HCV) requiring antiviral therapy.\n* Participation in another anti-tumor drug clinical trial within 4 weeks prior to enrollment.\n* Administration of any live attenuated vaccine within 30 days prior to enrollment.\n* Contraindications to radiotherapy.\n* Known allergy to the study drug or any of its excipients, or history of severe allergic reactions to other monoclonal antibodies.\n* History of psychoactive drug abuse unable to be abstained, or presence of psychiatric disorders.\n* Any other condition assessed by the investigator as potentially endangering the patient's safety or compliance, including severe concurrent diseases (including psychiatric disorders) requiring prompt treatment, severely abnormal laboratory test results, or other psychological, familial, or sociological factors deemed high-risk.",{"count":104,"type":23},55,[58],"This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.",[30,108],"Nasopharangeal Cancer",[110,111,112],"PD-1 antibody","Low dose radiotherapy","Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","2026-05-20",{"date":115,"type":39},"2026-05-22",{"date":117,"type":39},"2026-01-12",{"date":119,"type":23},"2030-01-30",{"name":121,"class":46},"Sun Yat-sen University",2,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":24,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100616911","phase-3-prevention-and-treatment-of-radiation-induced-oral-mucositis-in-npc-with-houyanqing-oral-liquid-100616911","NCT07311772","Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid","A Randomized Controlled Study of Houyanqing Oral Liquid Combined With Conventional Treatment Versus Conventional Treatment Alone for Preventing and Treating Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Staged as Stage I-IV according to the 9th edition of the TNM Classification of Malignant Tumors formulated by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC);\n2. Age: 18 to 75 years old;\n3. Karnofsky Performance Status (KPS) score ≥ 80 before treatment;\n4. No oral diseases (such as oral mucositis or salivary gland damage) before radiotherapy;\n5. Requiring radical radiotherapy;\n6. The patient has signed the informed consent form and is willing and able to comply with the study's follow-up visits, treatment plan, laboratory tests, and other research procedures.\n\nExclusion Criteria:\n\n1. Patients with confirmed tumor recurrence, distant tumor metastasis, or who have received other anti-tumor treatments;\n2. Previous history of head and neck radiotherapy;\n3. Known allergy to the drugs used in this study (Houyanqing Oral Liquid, any conventional treatment drugs);\n4. Local use of Houyanqing Oral Liquid, Recombinant Human Epidermal Growth Factor (rhEGF) Topical Solution, Vitamin B12 Solution, or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) mouthwash in the oral cavity within one month before enrollment;\n5. Comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic\u002Flocal use of corticosteroids at immunosuppressive doses before enrollment;\n6. HIV-positive patients;\n7. Pregnant women or lactating women;\n8. Patients with severe mental illnesses;\n9. Patients with severe cardio-cerebrovascular diseases, endocrine disorders, infectious diseases, or other tumors.","75 Years",{"count":132,"type":23},386,[134],"PHASE3","To explore the efficacy of Houyanqing Oral Liquid combined with conventional treatment in preventing and treating radiation-induced oral mucositis, so as to improve the quality of life of nasopharyngeal carcinoma patients received radiotherapy.",[30,137],"Radiation-induced Oral Mucositis",[139,137,140],"Nasopharyngeal Cancinoma","Houyanqing Oral Liquid","2026-05-06",{"date":143,"type":39},"2026-05-07",{"date":145,"type":39},"2025-12-16",{"date":147,"type":23},"2027-08-15",{"name":121,"class":46},16,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":130,"enrollmentInfo":157,"targetDuration":4,"studyType":24,"phases":159,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":47},"100577787","phase-1-egfr-antibody-combined-with-pd-1-inhibitor-and-chemotherapy-in-rm-nasopharyngeal-carcinoma-100577787","NCT06802835","EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R\u002FM Nasopharyngeal Carcinoma","EGFR Antibody Combined With Programmed Death-1 Inhibitor and Chemotherapy in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma: A Prospective, Multi-center, Phase I\u002FII Clinical Trial","Inclusion Criteria:\n\n* Patients with nasopharyngeal carcinoma who have recurred\u002Fmetastasized after initial treatment or radical treatment;\n* Age 18-75, male or female;\n* Pathological diagnosis of nasopharyngeal carcinoma;\n* ECOG score 0-1;\n* Have not previously received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biotherapy for recurrence\u002Fmetastasis;\n* No contraindications of chemotherapy, immunotherapy and targeted therapy;\n* At least 1 measurable lesion that meets RECIST 1.1 criteria;\n* Blood routine examination standards should meet: WBC≥3.0×109\u002FL, ANC≥1.5×109\u002FL, PLT≥100×109\u002FL, HGB≥90g\u002FL (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct);\n* Biochemical tests should meet the following criteria: TBIL≤2.0×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance ≥60ml\u002Fmin (Cockcroft-Gault formula);\n* Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the intended range of anticoagulant drug use;\n* The myocardial enzyme spectra were in the normal range;\n* Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days of enrollment with a negative result and be willing to use an effective method of contraception during the trial and for 3 months after the last anti-PD-1 antibody administration. For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial and within 3 months after the last anti-PD-1 antibody administration;\n* The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;\n\nExclusion Criteria:\n\n* Patients with recurrence who can be treated with local resection or radiotherapy;\n* Known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies;\n* Patients have symptoms of central nervous system metastasis such as brain edema and need hormonal intervention;\n* Had an active infection or unexplained fever \\>38.5℃ during screening or prior to the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled);\n* Have any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[may be included after normal hormone replacement therapy\\]); Patients with vitiligo or complete remission of asthma in childhood without any intervention as adults could be included, but patients with asthma requiring medical intervention with bronchodilators could not be included;\n* Have congenital or acquired immunodeficiency (such as HIV), active hepatitis B (HBV-DNA≥103 copy number \u002Fml), or hepatitis C (hepatitis C antibody positive and HCR-RNA above the lower detection limit of analytical methods);\n* Previous or co-existing uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer;\n* Uncontrolled cardiovascular disease: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms); Patients with grade III-IV cardiac insufficiency according to NYHA standards, or left ventricular ejection fraction (LVEF) \\\u003C50% indicated by cardiac color ultrasound; Myocardial infarction within 1 year;\n* If the subject has undergone major surgery, the toxic effects and\u002For complications of the surgical intervention must be fully recovered before treatment is initiated;\n* Within 4 weeks prior to the first use of the investigational drug (participants in the follow-up period are counted as the last use of the investigational drug or device) or are currently participating in another clinical study;\n* Live vaccine received within 4 weeks prior to the first administration of the investigational drug is allowed to receive inactivated virus vaccine for seasonal influenza by injection, but not live attenuated influenza vaccine for nasal administration;\n* Pregnant or lactating women;\n* In the investigator's judgment, the subjects had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the safety of the subjects or the circumstances of the trial data collection.",{"count":158,"type":23},148,[26,58],"This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent\u002Fmetastatic nasopharyngeal carcinoma patients.",[30,162,163],"Recurrent Nasopharynx Carcinoma","Metastatic Nasopharyngeal Carcinoma",[165,110,166],"EGFR antibody","chemotherapy",{"date":168,"type":39},"2026-05-11",{"date":170,"type":39},"2025-07-09",{"date":172,"type":23},"2029-06",{"name":121,"class":46},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":47},"100593978","international-collaborative-study-on-ajccuicc-tnm-10-for-nasopharyngeal-cancer-100593978","NCT07013461","International Collaborative Study on AJCC\u002FUICC TNM-10 for Nasopharyngeal Cancer","International Collaborative Study to Develop the AJCC\u002FUICC TNM Version-Ten for Nasopharyngeal Cancer","Inclusion Criteria:\n\n* All histologically confirmed nasopharyngeal carcinoma treated between 1 Oct 2025 and 30 Sep 2026\n\nExclusion Criteria:\n\n* Non-epithelial tumors of nasopharynx (including lymphoma, sarcoma of soft tissue, bone\u002Fcartilagetumors. mucosal melanoma, salivary type tumors)",{"count":182,"type":23},5000,"OBSERVATIONAL","The goal of this international, multicenter, prospective observational study is to improve prognostication and prediction of failure pattern for nasopharyngeal carcinoma (NPC), in order to provide more accurate guidance for personalized treatment decision. Firstly, we aim to improve the fundamental TNM staging system \\[The American Joint Committee on Cancer(AJCC)\u002FUnion for International Cancer Control(UICC) TNM Version-Nine\\] based on universally assessable anatomical parameters. Secondly, we aim to further refine prognostication for individual patients by integrating anatomical TNM parameters with non-anatomical factors and molecular biomarkers. In addition to the core group of participating centers from China (including Hong Kong) where NPC is most prevalent, the study will enrol patients from multiple countries\u002Fregions including those from non-endemic areas to provide global data. Patients treated with contemplary treatment methods during October 2025 to September 2026 will be recruited and they will be followed up for 5 years to generate detailed records for robust evaluation.\n\nKey Questions:\n\n* To achieve optimal improvement of anatomically based AJCC\u002FUICC TNM Classification for global application\n* To achieve precise prediction of failure pattern for individual patients by integration of TNM system and non-anatomical prognostic factors\u002Fmolecular biomarkers Recruited patients with confirmed histological diagnosis of NPC will undergo standard clinical evaluations and receive treatment per institutional guidelines.\n\nThe anatomical extent of disease at presentation will be evaluated by experienced radiologists and oncologists. The patient will be followed up for 5 years and clinical outcome will be recorded for analyses on correlation with prognostic factors.\n\nThis study will be another important milestone for NPC staging because firstly, this is the first time that the data are based on prospective data to ensure comprehensive coverage of all essential evidence; and secondly, this is the first time that centers from non-endemic countries\u002Fregions will also participate to ensure that the final recommendations are globally applicable. The findings will provide valuable evidence for the development of the AJCC\u002FUICC TNM Version-Ten staging system and prognostic system to improve risk stratification for designing personalized treatment strategy, ultimately leading to improvement of patient outcome and patient selection for future research worldwide.",[30],"2026-04-28",{"date":188,"type":39},"2026-05-04",{"date":190,"type":39},"2026-01-09",{"date":192,"type":23},"2031-12-31",{"name":194,"class":46},"The University of Hong Kong-Shenzhen Hospital",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":4},"100633553","phase-2-pd-1-monoclonal-antibody-combined-with-gemcitabine-and-cisplatin-followed-by-selective-radiotherapy-for-unresectable-locally-recurrent-npc-100633553","NCT07528183","PD-1 Monoclonal Antibody Combined With Gemcitabine and Cisplatin Followed by Selective Radiotherapy for Unresectable Locally Recurrent NPC","PD-1 Monoclonal Antibody Combined With Gemcitabine and Cisplatin Followed by Selective Radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma: A Multicenter, Prospective, Single-Arm Phase II Trial","Inclusion Criteria:\n\n1. Age 18-70 years, any gender.\n2. Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery.\n3. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).\n4. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.\n5. ECOG performance status 0-1.\n6. Expected survival ≥ 3 months.\n7. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma\n8. No contraindications to immunotherapy, chemotherapy, or re-irradiation.\n9. Adequate organ function within 14 days before first dose, defined as:\n\n   Hematology：Hemoglobin ≥ 90 g\u002FL，ANC ≥ 1.5 × 10⁹\u002FL，Platelet count ≥ 100 × 10⁹\u002FL Renal Function：Creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) \u002F eGFR ≥ 60 mL\u002Fmin Liver Function：Total bilirubin ≤ 1.5 × ULN，AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN in the presence of liver metastases\n10. INR or PT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range，APTT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range.\n\nExclusion Criteria:\n\n1. Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence\n2. Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.\n3. Prior treatment with PD-1\u002FPD-L1 or CTLA-4 inhibitors.\n4. History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.\n5. Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma\u002Fatopy.\n6. Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms.\n7. Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies\u002FmL\n8. Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative\n9. HIV infection\n10. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia).\n11. Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis.\n12. Major surgery within 4 weeks before enrollment, or unhealed surgical wound.\n13. Pregnant or breastfeeding women, or those planning pregnancy during the study period.\n14. Known allergy or hypersensitivity to study drugs or their excipients.\n15. Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.","70 Years",{"count":204,"type":23},86,[58],"The investigators plan to conduct a multicenter, prospective, single-arm phase II clinical trial of PD-1 monoclonal antibody combined with gemcitabine and cisplatin followed by selective radiotherapy for unresectable locally recurrent nasopharyngeal carcinoma to evaluate the efficacy and safety of PD-1 antibody plus GP chemotherapy followed by sequential selective radiotherapy in patients with unresectable locally recurrent disease who achieve tumor regression after immunochemotherapy, thereby providing evidence-based medical evidence for the treatment of unresectable locally recurrent NPC and improving treatment outcomes for these patients.",[30],"NOT_YET_RECRUITING","2026-04-07",{"date":211,"type":39},"2026-04-14",{"date":213,"type":23},"2026-04-10",{"date":215,"type":23},"2035-04-10",{"name":121,"class":46},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":224,"targetDuration":4,"studyType":24,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":47},"100631093","phase-2-becotatug-vedotin-for-la-npc-with-a-suboptimal-response-to-induction-chemotherapy-combined-with-immunotherapy-100631093","NCT07496190","Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy","Becotatug Vedotin for Locoregionally Advanced Nasopharyngeal Carcinoma With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy: A Prospective, Single-Arm, Phase II Trial","Inclusion Criteria:\n\n* Voluntary participation and written informed consent must be signed.\n* Age between 18 and 70 years, male or non-pregnant female.\n* Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).\n* Stage Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.\n* Efficacy after 3 cycles of induction immunochemotherapy assessed as stable disease (SD) or progressive disease (PD) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.\n* ECOG performance status score of 0 or 1.\n* Adequate hematological function: Hemoglobin (HGB)≥90g\u002FL, White Blood Cell (WBC) ≥ 4.010\\^9\u002FL, and Platele (PLT) ≥10010\\^9\u002FL.\n* Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g\u002FL.\n* Adequate renal function: Serum creatinine ≤ 1.5\\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (using the Cockcroft-Gault formula).\n* International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \\*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT\u002FINR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).\n\nExclusion Criteria:\n\n* Patients with recurrent or distant metastatic nasopharyngeal carcinoma.\n* Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).\n* Patients who have previously received radiotherapy or systemic chemotherapy.\n* Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.\n* HIV positive.\n* History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).\n* Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).",{"count":225,"type":23},59,[58],"Based on the short-term efficacy and plasma EBV DNA levels following immuno-induction chemotherapy, patients with locally advanced nasopharyngeal carcinoma who derive different benefits from this treatment can be identified. For high-risk patients who do not respond to immuno-induction chemotherapy (defined as EBV DNA \\>0 copies\u002FmL or imaging response evaluation showing SD\u002FPD after immuno-induction chemotherapy), the addition of becotatug vedotin, which has a different mechanism of action, during concurrent radiotherapy and the adjuvant phase may improve patient survival. Based on the above research and background, the investigators plan to conduct the first prospective, single-arm, phase II clinical study of becotatug vedotin in patients with locally advanced nasopharyngeal carcinoma who are suboptimal responsive to immuno-induction chemotherapy, aiming to obtain sufficient evidence-based medical data to provide an additional treatment option for the concurrent and adjuvant phases of nasopharyngeal carcinoma.",[30],[230],"high-risk locally advanced nasopharyngeal carcinoma",{"date":232,"type":39},"2026-04-13",{"date":234,"type":39},"2026-02-10",{"date":236,"type":23},"2034-02-10",{"name":121,"class":46},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":24,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":4},"100633263","phase-3-becotatug-vedotin-mrg003-with-pd-1-blockade-and-chemoradiotherapy-in-high-risk-locoregionally-advanced-nasopharyngeal-carcinoma-100633263","NCT07524413","Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma","A Randomized, Controlled, Multicenter, Phase III Trial of Becotatug Vedotin in Combination With PD-1 Blockade Plus Chemoradiotherapy Versus PD-1 Blockade Plus Chemoradiotherapy in Patients With High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years at the time of diagnosis, regardless of sex\n\n  2\\. Histologically confirmed newly diagnosed nasopharyngeal carcinoma (NPC) of non-keratinizing carcinoma histology (WHO classification)\n\n  3\\. Locoregionally advanced NPC staged as T4N2 or T1-4N3 according to the American Joint Committee on Cancer\u002FUnion for International Cancer Control (AJCC\u002FUICC) 9th edition staging system. All patients must undergo the following evaluations prior to initiation of any treatment to confirm clinical staging: complete medical history and physical examination, complete blood count (CBC) and biochemistry panel, plasma Epstein-Barr virus (EBV) DNA titer and serology, nasopharyngoscopy, magnetic resonance imaging (MRI) of the head and neck, chest X-ray or computed tomography (CT) of the chest, abdominal ultrasound, and bone scintigraphy. 18F-fluorodeoxyglucose positron emission tomography\u002FCT (¹⁸F-FDG PET\u002FCT) may be used as a substitute for the latter three imaging modalities.\n\n  4\\. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n\n  5\\. Willing to provide archived tumor tissue (primary or metastatic lesion, obtained within 2 years prior to enrollment) or fresh biopsy specimen. Patients unable to provide tumor tissue may still be enrolled at the investigator's discretion, provided all other eligibility criteria are met.\n\n  6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to first dose\n\n  7\\. Adequate organ function, as defined by the following laboratory parameters, obtained within 4 weeks prior to screening, with no blood transfusions, hematopoietic growth factors, or thrombopoietic agents administered during this period: a) Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; white blood cell count \\> 4 × 10⁹\u002FL; hemoglobin \\> 90 g\u002FL; platelet count \\> 100 × 10⁹\u002FL; b) Hepatic and renal function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL\u002Fmin; urinary protein ≤ 2+ or ≤ 1000 mg\u002F24 hours; c) Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients receiving stable low-dose anticoagulation therapy, such as aspirin 100 mg\u002Fday, are permitted)\n\n  8\\. Normal findings on thyroid function tests, serum amylase and lipase, pituitary function tests, inflammatory and infectious markers, cardiac enzyme panel, and electrocardiogram (ECG): a) Patients aged \\> 50 years with a smoking history must have normal pulmonary function test results; b) Patients with ECG abnormalities or a prior cardiovascular history (not meeting exclusion criteria) must additionally undergo myocardial function testing and echocardiography, with normal results required for enrollment\n\n  9\\. Willing and able to provide written informed consent and to comply with all protocol-specified requirements, including scheduled visits, treatment administration, laboratory assessments, and other study procedures\n\n  10\\. Patients of reproductive potential must agree to use effective contraception from the time of informed consent through 6 months after the last dose of study treatment. Women of childbearing potential (WOCBP), defined as premenopausal women and women within 2 years of menopause, must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.\n\nExclusion Criteria:\n\n* 1\\. History of any other malignancy within the past 5 years, with the exception of curatively treated cervical carcinoma in situ, papillary thyroid carcinoma, or basal cell carcinoma of the skin\n\n  2\\. Prior receipt of any anti-tumor therapy for nasopharyngeal carcinoma, or any of the following: a) Any ADC drug with a monomethyl auristatin E (MMAE) payload within 3 months prior to first dose; b) Any investigational drug from another clinical trial within 28 days prior to first dose; c) Major surgery within 28 days prior to first dose without full recovery, or planned major surgery within the first 12 weeks after initiation of study treatment\n\n  3\\. Positive human immunodeficiency virus antibody (HIV-Ab); active tuberculosis; active hepatitis B virus infection (HBV-DNA \\> 1 × 10³ copies\u002FmL); or active hepatitis C virus infection (HCV antibody positive and HCV-RNA above the lower limit of detection)\n\n  4\\. History of primary immunodeficiency, or active autoimmune disease requiring immunosuppressive therapy or systemic corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment. The following conditions are exempt: type 1 diabetes mellitus; hypothyroidism (including autoimmune thyroid disease) stable on hormone replacement therapy; psoriasis, vitiligo, or alopecia not requiring systemic treatment; and use of topical or inhaled corticosteroids, or short-term (≤ 7 days) systemic corticosteroids for prophylaxis or treatment of non-autoimmune, non-recurrent allergic conditions\n\n  5\\. Uncontrolled cardiac disease, including any of the following: (1) heart failure of New York Heart Association (NYHA) Class ≥ 2; (2) unstable angina; (3) myocardial infarction within the past 1 year; (4) prolonged QT interval (QTc \\> 450 ms in males or QTc \\> 470 ms in females), complete left bundle branch block, third-degree atrioventricular block, or supraventricular or ventricular arrhythmia requiring treatment or intervention\n\n  6\\. Hypertension inadequately controlled with two antihypertensive agents (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg)\n\n  7\\. Poorly controlled blood glucose, defined as: (a) fasting blood glucose \\> 10 mmol\u002FL on two occasions, or (b) glycated hemoglobin (HbA1c) \\> 8%; or concurrent diabetic gangrene\n\n  8\\. History of interstitial lung disease (ILD) or pulmonary inflammation requiring steroid treatment (including pulmonary fibrosis and radiation pneumonitis), current ILD or pulmonary inflammation, or imaging findings at screening that cannot exclude suspected ILD or pulmonary inflammation\n\n  9\\. Concurrent pulmonary disease causing clinically severe respiratory impairment, including but not limited to: (a) any underlying pulmonary condition (e.g., pulmonary embolism, severe asthma, or severe chronic obstructive pulmonary disease \\[COPD\\] within 3 months prior to screening); (b) restrictive lung disease; (c) history of or concurrent interstitial pneumonitis, radiation pneumonitis, severe COPD, severe pulmonary insufficiency, or symptomatic bronchospasm\n\n  10\\. Unstable thromboembolic events requiring therapeutic intervention within 6 months prior to screening, including deep vein thrombosis, arterial thrombosis, or pulmonary embolism; catheter-related thrombosis is exempt\n\n  11\\. Pregnant or breastfeeding women (pregnancy testing should be considered for sexually active women of childbearing potential)\n\n  12\\. Known hypersensitivity to any component of Pucotenlimab or Becotatug Vedotin (MRG003) (including histidine, histidine hydrochloride, sucrose, mannitol, and polysorbate 80), or a history of Grade ≥ 3 hypersensitivity reaction to any macromolecular protein preparation or monoclonal antibody\n\n  13\\. Serious infection (CTCAE Grade \\> 2) within 4 weeks prior to first dose, including but not limited to severe pneumonia, bacteremia, sepsis, or active tuberculosis\n\n  14\\. Pre-existing peripheral neuropathy of Grade \\> 1\n\n  15\\. Receipt of a live vaccine within 30 days prior to first dose of Becotatug Vedotin (MRG003)\n\n  16\\. Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT)\n\n  17\\. Any other condition judged by the investigator to potentially compromise patient safety or compliance, including but not limited to serious medical conditions requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory findings, or other psychological, familial, or social high-risk factors",{"count":246,"type":23},514,[134],"This randomized controlled trial aims to evaluate the efficacy and safety of Becotatug Vedotin (MRG003), an antibody-drug conjugate (ADC), combined with the PD-1 inhibitor Pucotenlimab as induction therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), compared to the standard gemcitabine and cisplatin (GP) regimen combined with Pucotenlimab, followed by concurrent chemoradiotherapy (CCRT) and adjuvant immunotherapy.",[30,250],"Nasopharyngeal Cancer",[110,252,253,254,255],"Antibody-Drug Conjugate","MRG003","Becotatug Vedotin","Pucotenlimab","2026-04-06",{"date":232,"type":39},{"date":259,"type":23},"2026-04",{"date":261,"type":23},"2032-04",{"name":121,"class":46},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":270,"targetDuration":4,"studyType":24,"phases":272,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100608421","phase-3-reduced-dose-vs-standard-dose-irradiation-for-low-risk-clinical-target-volume-in-nasopharyngeal-carcinoma-100608421","NCT07201337","Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.","A Randomized, Open-Label, Non-Inferiority Phase III Multicenter Clinical Trial Comparing Reduced-Dose to Standard-Dose Prophylactic Irradiation for Low-Risk Clinical Target Volume (CTV) in the Treatment of Nasopharyngeal Carcinoma.","Inclusion Criteria:\n\nNewly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; aged between 18 and 70 years; Eastern Cooperative Oncology Group performance score of 0-1; adequate hematologic function (neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥100×109\u002FL, and hemoglobin≥ 90 g\u002FL); adequate renal function (creatinine ≤ 1.5 upper limit of normal \\[ULN\\]) or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); and adequate hepatic function (serum bilirubin ≤ 2.0×ULN, and alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN).\n\nExclusion Criteria:\n\nPrevious chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy (except for cured basal cell carcinoma or carcinoma in situ of the cervix); lactation or pregnancy; or severe coexisting illness.\n\n\\-",{"count":271,"type":23},700,[134],"To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).",[30],[276,277,278],"Nasopharyngeal Carcinoma","De-escalation","Radiotherapy","2026-03-31",{"date":256,"type":39},{"date":282,"type":39},"2025-11-17",{"date":284,"type":23},"2031-11-17",{"name":121,"class":46},6,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":295,"targetDuration":4,"studyType":24,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100576646","phase-2-ldrt-and-chemoimmunotherapy-in-npc-with-liver-metastasis-100576646","NCT06788002","LDRT and Chemoimmunotherapy in NPC With Liver Metastasis","Low-dose Radiotherapy and Chemoimmunotherapy in Nasopharyngeal Carcinoma With Liver Metastasis","Light","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.\n2. Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III)\n3. Stage IVB (AJCC 8th edition staging)\n4. De novo nasopharyngeal carcinoma with liver metastasis, or patients who had received curative treatment (radical radiotherapy or radical radiotherapy combined with chemotherapy) and developed liver metastasis more than 6 months after treatment completion.\n5. ECOG performance status: 0 or 1\n6. Must have at least one measurable lesion (assessed according to RECIST v1.1)\n7. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; platelets ≥ 100 × 10\\^9\u002FL; hemoglobin ≥ 90 g\u002FL.\n8. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n9. Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin.\n10. Serum total bilirubin ≤ 1.5 × ULN (patients with Gilbert's syndrome may be included if total bilirubin \\\u003C 3 × ULN); AST and ALT ≤ 5 × ULN （because of liver metastasis）\n\nExclusion Criteria:\n\n1. Patients with tumor recurrence at the primary site who have previously received radical radiotherapy.\n2. Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator.\n3. Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment.\n4. Previous treatment with immune checkpoint inhibitors (e.g., PD-1\u002FPD-L1, CTLA-4).\n5. Patients with active autoimmune diseases or a history of autoimmune diseases with a risk of recurrence.\n6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).\n7. Conditions requiring systemic corticosteroid therapy (equivalent to \\>10 mg\u002Fday of prednisone or similar medications) or other immunosuppressive therapy within ≤14 days prior to treatment.\n8. Uncontrolled diabetes or laboratory abnormalities ≥Grade 1 in potassium, sodium, or corrected calcium levels despite standard treatment, or ≥Grade 3 hypoalbuminemia within ≤14 days before treatment.\n9. History of the following diseases: interstitial lung disease, non-infectious pneumonitis, or uncontrolled diseases, including pulmonary fibrosis or acute lung disease.\n10. Severe chronic or active infections requiring systemic antibiotics, antifungals, or antivirals within ≤14 days before the first dose of the investigational drug (including tuberculosis infection).\n11. Known history of HIV infection.\n12. Untreated chronic hepatitis B patients or hepatitis B virus (HBV) carriers with HBV DNA ≥500 IU\u002FmL, or active hepatitis C virus (HCV) carriers.\n13. Any major surgery requiring general anesthesia within ≤28 days prior to treatment.\n14. Previous allogeneic stem cell transplantation or organ transplantation.\n15. Any cardiovascular risk factors, including: cardiac chest pain that restricts daily instrumental activities ≤28 days before treatment. Symptomatic pulmonary embolism within ≤3 months before treatment. Acute myocardial infarction within ≤6 months before treatment. History of heart failure meeting New York Heart Association (NYHA) Class III or IV within ≤6 months before treatment. Grade ≥2 ventricular arrhythmias within ≤6 months before treatment. History of cerebrovascular accident within ≤6 months before the first dose of the investigational drug.\n16. Evident bleeding tendencies or clinically significant bleeding symptoms ≤28 days prior to randomization, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis or retrograde blood-stained nasal discharge), and persistent bleeding disorders or coagulopathy.\n17. Known allergy to any component of the investigational drug or a history of severe hypersensitivity to other monoclonal antibodies.\n18. Peripheral neuropathy of Grade ≥2 as defined by NCI CTCAE v5.0.\n19. Administration of live vaccines within ≤4 weeks prior to treatment.\n20. Underlying medical conditions (including laboratory abnormalities) or alcohol\u002Fdrug abuse or dependency that could impair drug administration, interpretation of drug toxicity, or adverse events (AEs), or could compromise study compliance or execution.\n21. Pregnant or breastfeeding women.\n22. Other factors deemed by the investigator that could lead to the premature termination of the study, such as other severe illnesses, significant laboratory abnormalities, or family\u002Fsocial factors that could affect participant safety or the collection of study data.",{"count":296,"type":23},26,[58],"This study aims to evaluate the efficacy and toxicity of adding low-dose radiotherapy to chemoimmunotherapy as a first-line treatment for nasopharyngeal carcinoma patients with liver metastasis.",[30],[301,302,303,166,304],"nasopharyngeal carcinoma","liver metastasis","low-dose radiotherapy","immunotherapy","2026-03-28",{"date":307,"type":39},"2026-04-02",{"date":309,"type":39},"2025-01-14",{"date":311,"type":23},"2027-06-30",{"name":313,"class":46},"Hunan Cancer Hospital",7,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":322,"targetDuration":4,"studyType":24,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},"100620850","phase-2-toripalimab-combined-with-different-platinum-based-induction-chemotherapy-regimens-for-locally-advanced-nasopharyngeal-carcinoma-100620850","NCT07362979","Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma","Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma: A Randomized, Open-label, Controlled, Multicenter Phase II Trial","Inclusion Criteria:\n\n1. Age between 18 and 70 years, male or non-pregnant female.\n2. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).\n3. Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).\n4. ECOG performance status score of 0 or 1.\n5. Adequate hematological function: Hemoglobin (HGB)≥90g\u002FL, Absolute Neutrophil Count (ANC) ≥ 1.5\\*10\\^9\u002FL, and Platele (PLT) ≥100\\*10\\^9\u002FL.\n6. Adequate hepatic function: ALT and AST≤2.5\\*Upper Limit of Normal (ULN), total bilirubin ≤2.0\\*ULN, and serum albumin≥30g\u002FL.\n7. Adequate renal function: Serum creatinine ≤ 1.5\\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (using the Cockcroft-Gault formula).\n8. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \\*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT\u002FINR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).\n\nExclusion Criteria:\n\n1. Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.\n2. Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).\n3. Prior history of radiotherapy or systemic chemotherapy.\n4. Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.\n5. HIV-positive status.\n6. History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix).\n7. Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).\n8. Patients with immunodeficiency diseases or a history of organ transplantation.\n9. Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior.\n10. Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.\n11. Concurrent use of other investigational drugs or current participation in another clinical trial.\n12. Patients who refuse or are unable to provide signed informed consent for trial participation.\n13. Patients with personality or psychiatric disorders, or those lacking legal capacity or with limited legal capacity.\n14. Hepatitis B surface antigen (HBsAg) positive with peripheral blood Hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 copies\u002Fml.\n15. Patients with positive Hepatitis C virus (HCV) antibody test results are eligible only if the HCV ribonucleic acid (RNA) polymerase chain reaction test result is negative.\n16. Arterial or venous thrombotic events within 6 months prior to screening initiation, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n17. Known history of active tuberculosis (TB). Subjects suspected of having active TB must be evaluated and ruled out via chest X-ray, sputum examination, and clinical signs and symptoms.\n\n21.Any other severe, uncontrolled medical condition, infection, or treatment contraindication, or any other condition that, in the investigator's judgment, may pose a risk for receiving the investigational drug, or may interfere with the assessment of the investigational drug, subject safety, or interpretation of the study results.",{"count":323,"type":23},243,[58],"This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.",[30],[301,328,329],"Toripalimab","different platinum-based induction chemotherapy","2026-03-16",{"date":332,"type":39},"2026-03-17",{"date":334,"type":39},"2026-03-12",{"date":336,"type":23},"2031-03-12",{"name":121,"class":46},4,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":130,"enrollmentInfo":346,"targetDuration":4,"studyType":24,"phases":348,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100622290","phase-2-mrg003-combined-with-immunotherapy-in-recurrentmetastatic-nasopharyngeal-carcinoma-a-phase-ii-clinical-trial-100622290","NCT07381699","MRG003 Combined With Immunotherapy in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial","Becotatug Vedotin Plus Pucotenlimab as First-line Therapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial","Inclusion Criteria:\n\n1. Aged 18 to 75 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Life expectancy ≥ 3 months.\n4. Histologically or cytologically confirmed nasopharyngeal carcinoma (NPC).\n5. Metastatic NPC (Stage IVB, AJCC 8th) or locally recurrent NPC unfit for curative local therapy (e.g., surgery, TACE, radiotherapy).\n6. Must be treatment-naive for recurrent or metastatic NPC.\n7. Must have ≥ 1 measurable lesions as defined per RECIST v1.1.\n8. Adequate organ function.\n9. For women of childbearing potential: negative pregnancy test within 7 days prior to treatment initiation. All participants of childbearing potential must agree to use effective contraception during the study and for 1 year after treatment discontinuation.\n10. Willing and able to provide written informed consent and comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n1. Peripheral neuropathy of Grade 2 or higher.\n2. Anticipated need for any other local or systemic anti-tumor therapy during the study period.\n3. Diagnosed and\u002For treated additional malignancy within 5 years of enrollment, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and\u002For curatively-resected in situ cervical and\u002For breast carcinoma.\n4. Active central nervous system (CNS) metastases or carcinomatous meningitis.\n5. Laboratory values within 7 days prior to enrollment falling outside specified eligibility ranges (e.g., Child-Pugh C; creatinine clearance \\\u003C30 mL\u002Fmin; serum sodium \\\u003C135 mmol\u002FL; serum potassium \\\u003C3.5 mmol\u002FL).\n6. Severe or uncontrolled cardiovascular disease.\n7. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, or symptomatic bronchospasm.\n8. Active infection requiring systemic therapy.\n9. Severe, or uncontrolled systematic diseases (e.g., uncontrolled hypertension, or uncontrolled diabetes).\n10. Known history of testing positive for human immunodeficiency virus (HIV).\n11. Known history of allogeneic hematopoietic stem cell, bone marrow, or solid organ transplantation.\n12. Known active hepatitis B or C infection, or other severe liver disease.\n13. Live vaccine within 30 days prior to the first dose.\n14. Residual toxicity from prior anti-tumor therapy higher than grade 1 (except alopecia, fatigue, and grade 2 hypothyroidism).\n15. Active autoimmune disease or a history of autoimmune disease requiring systemic steroid or immunosuppressive therapy. The following conditions are not exclusionary: mild asthma controlled with intermittent bronchodilators; stable hypothyroidism on hormone replacement; vitiligo; Graves' disease; or Hashimoto's disease.\n16. Known history of Grade 3 or higher hypersensitivity to any component of MRG003 or to other monoclonal antibodies.\n17. Uncontrolled pleural effusion, ascites, or pericardial effusion.\n18. Pregnancy, breastfeeding, or unwillingness to use a highly effective method of contraception during the treatment period and for at least 180 days after the last dose.\n19. Any other condition that, in the opinion of the investigator, may compromise the safety and integrity of the study participant.",{"count":347,"type":23},30,[58],"This study was designed to compare the efficacy and safety of Becotatug Vedotin (MRG003) combined with Pucotenlimab as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.",[30],[139],"2026-02-11",{"date":354,"type":39},"2026-02-13",{"date":356,"type":23},"2026-02-01",{"date":358,"type":23},"2030-02-01",{"name":45,"class":46},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":367,"targetDuration":4,"studyType":24,"phases":369,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":4},"100622550","phase-3-anlotinib-plus-immunotherapy-and-chemoradiotherapy-for-high-risk-nasopharyngeal-carcinoma-100622550","NCT07385079","Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma","A Randomized, Multicenter, Phase 3 Trial of Anlotinib Plus Immunochemoradiotherapy vs Immunochemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria\n\n1. Age ≥18 and ≤65 years\n2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.\n3. Tumor staged as T4N2 and T1-4N3 (AJCC 9th)\n4. Eastern Cooperative Oncology Group performance score of 0-11.\n5. Adequate marrow function: white blood cell count \\> 4 × 10⁹\u002FL hemoglobin \\>90g\u002FL and platelet count \\>100×10⁹\u002FL\n6. Adequate hepatic and renal function：\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN\n   * Alkaline phosphatase ≤ 2.5 × ULN\n   * clearance rate ≥ 60 ml\u002Fmin\n7. Other laboratory and clinical criteria\n\n   * Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)\n   * For patients aged \\>50 years with a history of smoking, normal pulmonary function test (PFT) results are required\n   * For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits\n8. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.\n9. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).\n\nExclusion Criteria\n\n1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1×103 copies\u002FmL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody\n2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).\n3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.\n4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.\n5. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.\n6. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \\>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.\n7. Uncontrolled cardiac conditions, such as:\n\n   * Heart failure with New York Heart Association (NYHA) classification ≥ Class II;\n   * Unstable angina;\n   * History of myocardial infarction within the past year;\n   * Supraventricular or ventricular arrhythmias requiring treatment or intervention\n8. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)\n9. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n10. Known hypersensitivity to macromolecule protein products or any component of benmelstobart.\n11. Active infections requiring systemic treatment within 1 week prior to enrollment.\n12. Administration of live vaccines within 30 days prior to the first dose of anlotinib hydrochloride.\n13. History of organ transplantation or hematopoietic stem cell transplantation.\n14. Presence of clinically significant bleeding symptoms or a definite hemorrhagic tendency; specifically, cases with a high risk of bleeding from local recurrence, or those within one year post-radiotherapy assessed to have a high risk of necrosis, must be excluded.\n15. History of hypertension that remains poorly controlled with medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).\n16. Urinalysis showing urine protein ≥ ++, confirmed by 24-hour urine protein quantification ≥1.0 g.\n17. Factors significantly affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea, or intestinal obstruction.\n18. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.",{"count":368,"type":23},412,[134],"This trial aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC).",[30,250],[373,374,375],"anlotinib hydrochloride","PD-L1 antibody","chemoradiotherapy","2026-01-29",{"date":378,"type":39},"2026-02-03",{"date":380,"type":23},"2026-03-01",{"date":382,"type":23},"2030-01-01",{"name":121,"class":46},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":391,"targetDuration":393,"studyType":183,"phases":4,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":404,"leadSponsor":406,"locationsCount":47},"100621898","imrt-alone-for-stage-ib-nasopharyngeal-carcinoma-without-high-risk-features-100621898","NCT07376603","IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features","Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features","Inclusion Criteria:\n\n1\\. Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma 3. Age 18-70 years 4. Stage IB disease (T1-2N1M0) per the 9th edition AJCC\u002FUICC staging system 5. Upper-neck nodal metastasis only: inferior border of every positive node at or above the inferior border of the hyoid bone 6. ECOG performance status 0-2 7. Adequate bone-marrow function\n\nExclusion Criteria:\n\n1. Age \\> 70 years or \\\u003C 18 years\n2. Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and\u002For extracapsular extension forming a confluent mass\n3. Largest metastatic lymph-node ≥ 3 cm in the longest dimension\n4. Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone\n5. Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix\n6. Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)\n7. Previous radiotherapy to the head-and-neck region\n8. Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)\n9. Any severe comorbidity that would confer unacceptable risk or compromise protocol adherence, including but not limited to unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder\n10. History of severe hypersensitivity reactions",{"count":392,"type":23},169,"3 Years","This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach",[30,396,397],"Intensity-modulated Radiotherapy","Stage IB",[399,397,400],"Nasopharyngeal Cancinomar","RT along","2026-01-26",{"date":376,"type":39},{"date":117,"type":39},{"date":405,"type":23},"2030-12-31",{"name":407,"class":408},"Qiaojuan Guo","OTHER_GOV",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":416,"targetDuration":4,"studyType":24,"phases":418,"briefSummary":419,"conditions":420,"keywords":421,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":430,"locationsCount":4},"100621697","phase-3-short-course-tislelizumab-combined-with-chemoradiotherapy-for-nasopharyngeal-carcinoma-100621697","NCT07373990","Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma","Short-course Tislelizumab Combined With Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized, Controlled, Multicenter, Phase 3 Non-inferiority Clinical Trial","Inclusion Criteria:\n\n1. Age ≥18 and ≤65 years\n2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.\n3. Eastern Cooperative Oncology Group performance score of 0-1.\n4. Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition).\n5. Adequate marrow function:\n\n   white blood cell count \\> 4 × 10⁹\u002FL hemoglobin \\>90g\u002FL and platelet count \\>100×10⁹\u002FL\n6. Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN, Alkaline phosphatase ≤ 2.5 ×ULN, clearance rate ≥ 60 ml\u002Fmin 7. Other laboratory and clinical criteria Normal: thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG); For patients aged \\>50 years with a history of smoking, normal pulmonary function test (PFT) results are required; For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits.\n\n8\\. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.\n\n9\\. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1×10 copies\u002FmL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody\n2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).\n3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment.\n4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.\n5. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.\n6. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \\>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.\n7. Uncontrolled cardiac conditions, such as: Heart failure with New York Heart Association (NYHA) classi dication ≥ Class II; or Unstable angina; or History of myocardial infarction within the past year; or Supraventricular or ventricular arrhythmias requiring treatment or intervention\n8. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)\n9. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n10. Known hypersensitivity to macromolecule protein products.\n11. Active infections requiring systemic treatment within 1 week prior to enrollment.\n12. Administration of live vaccines within 30 days prior to the first dose of tile.\n13. History of organ transplantation or hematopoietic stem cell transplantation.\n14. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.\n15. Patients who have previously received immune checkpoint (CTLA-4, PD-1, PD-L1, etc.) inhibitor therapy.",{"count":417,"type":23},418,[134],"This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.",[30,250],[422,110,423],"tislelizumab","short-course","2026-01-20",{"date":426,"type":39},"2026-01-28",{"date":428,"type":23},"2026-01-15",{"date":405,"type":23},{"name":121,"class":46},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":438,"targetDuration":4,"studyType":24,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":47},"100604788","phase-3-adaptive-immunotherapy-for-nasopharyngeal-carcinoma-100604788","NCT07154069","Adaptive Immunotherapy for Nasopharyngeal Carcinoma","Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial","Inclusion Criteria:\n\n* 18-65 years;\n* Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);\n* Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;\n* ECOG performance status: 0-1;\n* Adequate bone marrow function: white blood cell count \\> 4 × 10⁹\u002FL, hemoglobin \\> 90 g\u002FL, platelet count \\> 100 × 10⁹\u002FL;\n* Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL\u002Fmin;\n* Normal thyroid function, amylase, lipase, pituitary function;\n* Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy;\n* Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;\n* Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment.\n\nExclusion Criteria:\n\n* T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;\n* Disease progression after induction therapy;\n* Hepatitis B surface antigen (HBsAg) positive with HBV DNA \\>1×10³ copies\u002FmL, or anti-hepatitis C virus (HCV) antibody positive;\n* Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);\n* Active tuberculosis;\n* Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);\n* History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year;\n* Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible;\n* Uncontrolled cardiac disease;\n* Pregnant or lactating women;\n* History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma;\n* Known allergy to macromolecular protein preparations or any component of toripalimab;\n* Active infection requiring systemic treatment within one week prior to enrollment;\n* Administration of a live vaccine within 30 days before the first dose of toripalimab;\n* History of organ transplantation;\n* Contraindications to MRI examination, which would prevent the completion of required imaging;\n* Any other condition deemed by the investigators to potentially compromise patient safety or compliance.",{"count":439,"type":23},802,[134],"1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy.\n2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.",[30],"2025-11-24",{"date":445,"type":39},"2025-11-25",{"date":447,"type":39},"2025-11-13",{"date":449,"type":23},"2033-09",{"name":121,"class":46},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":457,"targetDuration":4,"studyType":24,"phases":459,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":47},"100581141","phase-3-phase-3-trial-comparing-imrt-or-impt-plus-cirt-for-patients-with-npc-100581141","NCT06846450","Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC","Inclusion criteria:\n\n* Willingness to sign the written informed consent.\n* Pathologically confirmed Nasopharyngeal carcinoma.\n* Patients with any stage of disease except distant metastasis.\n* Age: ≥ 18 and ≤ 70 years old.\n* Eastern Cooperative Oncology Group score: 0-1.\n* Adequate laboratory test results.\n* Willingness to accept adequate contraception.\n\nExclusion criteria:\n\n* Presence of distant metastasis.\n* Previous radiotherapy to head and neck region.\n* Previous surgery (except for biopsy) for the primary lesion or cervical lymph nodes.\n* History of malignant tumor within the past 5 years.\n* Presence of multiple primary tumors.\n* Presence of diseases that may interfere with the evaluation of study endpoints.\n* Presence of severe major organ dysfunction.\n* Mental illness that may affect the understanding of informed consent.",{"count":458,"type":23},470,[134],"The goal of this phase 3 non-inferiority trial is to compare the efficacy and toxicity of proton or photon radiation therapy plus carbon ion radiation therapy for newly diagnosed nasopharyngeal carcinoma. The main question it aims to answer is that if proton radiation therapy plus carbon ion radiation therapy is non-inferior to photon radiation therapy plus carbon ion radiation therapy in terms of therapeutic efficacy. Participants will be randomized to receive either proton radiation therapy (arm 1) or photon radiation therapy (arm 2), in addition to carbon ion radiation therapy (for both arms).",[30],[463,464,465,466,467],"Proton","Photon","Carbon ion","Phase 3 Trial","Locally Advanced NPC",{"date":469,"type":39},"2025-12-02",{"date":471,"type":39},"2025-04-01",{"date":473,"type":23},"2031-01-31",{"name":475,"class":46},"Lin Kong, MD",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":486,"conditions":487,"keywords":489,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":47},"100610830","prospective-immuno-radiomic-profiling-in-nasopharyngeal-carcinoma-treated-with-proton-or-photon-chemoradiotherapy-100610830","NCT07232680","Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy","Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy","IMPRINT","Inclusion Criteria:\n\n1. Willingness to provide written informed consent.\n2. Pathologically confirmed diagnosis of nasopharyngeal carcinoma\n3. Age ≥18 years\n4. ECOG performance status 0-1\n5. Patients with AJCC v.9 stage I-III disease who undergo chemoradiotherapy\n6. Adequate bone marrow, liver, and renal function within 4 weeks before study registration\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n   * Platelet count ≥ 50,000\u002FμL\n   * Total bilirubin \\\u003C 2.5 mg\u002FdL\n   * Serum albumin \\>2.8 g\u002FdL\n   * Serum creatinine ≤ 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n1. Presence of distant metastasis\n2. Patients with AJCC v.9 cT1N0M0 disease who undergo radiotherapy alone.\n3. Synchronous or prior invasive malignancy, unless disease-free for at least 2 years.\n4. Prior radiotherapy to the head and neck region\n5. Presence of severe major organ dysfunction\n6. Pregnant women or women of childbearing potential who are unwilling to use medically acceptable contraception.",{"count":485,"type":23},500,"To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes.",[488,30],"NPC Patients",[82,490,491,492,493,494,495,496,497,498],"proton radiotherapy","photon radiotherapy","proton beam therapy","IMPT","IMRT","IMAT","chemoradiation","Immune response","Radiomics","2025-11-19",{"date":443,"type":39},{"date":502,"type":39},"2025-11-20",{"date":504,"type":23},"2034-08-15",{"name":506,"class":46},"Cheng-En Hsieh",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":514,"targetDuration":4,"studyType":24,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":4},"100611283","phase-3-phase-iii-trial-of-ebv-dna-guided-adaptive-immunotherapy-for-advanced-nasopharyngeal-carcinoma-100611283","NCT07238569","Phase III Trial of EBV-DNA-Guided Adaptive Immunotherapy for Advanced Nasopharyngeal Carcinoma","Multicenter, Prospective Phase III Clinical Trial of EBV-DNA-Guided Adaptive Immunotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Age ≥18 and ≤65 years\n2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.\n3. Eastern Cooperative Oncology Group performance score of 0-1.\n4. Tumor staged as II-III disease (AJCC 9th edition), excluding T3N0-1.\n5. Adequate marrow function: white blood cell count \\> 4 × 10⁹\u002FL hemoglobin \\>90g\u002FL and platelet count \\>100×10⁹\u002FL\n6. Adequate hepatic and renal function：\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN\n   * Alkaline phosphatase ≤ 2.5 × ULN\n   * clearance rate ≥ 60 ml\u002Fmin\n7. Other laboratory and clinical criteria\n\n   * Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)\n   * For patients aged \\>50 years with a history of smoking, normal pulmonary function test (PFT) results are required\n   * For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits\n8. Patients with persistent EBV DNA positivity or stable disease following 3 cycles of induction chemotherapy (gemcitabine, cisplatin, and adebrelimab).\n9. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.\n10. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).\n\nExclusion Criteria:\n\n1. Disease progression after induction chemotherapy\n2. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1×103 copies\u002FmL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody\n3. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).\n4. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.\n5. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.\n6. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.\n7. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \\>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.\n8. Uncontrolled cardiac conditions, such as:\n\n   * Heart failure with New York Heart Association (NYHA) classification ≥ Class II;\n   * Unstable angina;\n   * History of myocardial infarction within the past year;\n   * Supraventricular or ventricular arrhythmias requiring treatment or intervention\n9. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)\n10. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n11. Known hypersensitivity to macromolecule protein products or any component of adebrelimab.\n12. Active infections requiring systemic treatment within 1 week prior to enrollment.\n13. Administration of live vaccines within 30 days prior to the first dose of adebrelimab.\n14. Factors significantly affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea, or intestinal obstruction.\n15. History of organ transplantation or hematopoietic stem cell transplantation.\n16. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.",{"count":515,"type":23},516,[134],"This trial evaluated the efficacy of two adjuvant regimens following identical induction and concurrent chemoradiotherapy (IC+CCRT) in locoregionally advanced nasopharyngeal carcinoma (LANPC) patients with persistent EBV DNA positivity or stable disease after three IC cycles. The control arm received adjuvant adebrelimab, while the experimental arm received adebrelimab plus capecitabine.",[30,108],[520,374,375,521],"adebrelimab","capecitabine","2025-11-16",{"date":502,"type":39},{"date":525,"type":23},"2025-12-01",{"date":527,"type":23},"2031-05-23",{"name":121,"class":46},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":24,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":47},"100602919","phase-2-perioperative-chemotherapy-and-immunotherapy-for-locally-recurrent-nasopharyngeal-carcinoma-100602919","NCT07129772","Perioperative Chemotherapy and Immunotherapy for Locally Recurrent Nasopharyngeal Carcinoma","A Multicenter, Single Arm Phase II Study on Pembrolizumab and Chemotherapy as Perioperative Treatment Followed by Nasopharyngectomy and Maintenance Pembrolizumab for Locally Recurrent Nasopharyngeal Carcinoma (PINNACLE)","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of histologically confirmed locally recurrent (rT2-T4, N0-N1, M0) NPC (undifferentiated carcinoma with Epstein-Barr virus (EBV) infection by either presence of Epstein-Barr virus encoded RNA (EBER) in in-situ hybridization of the recently obtained tumor specimen before study entry) or an elevation of plasma EBV DNA in the subject's peripheral blood), staged according to the 8th edition of American Joint Committee on Cancer\u002FUnion for International Cancer Control (AJCC\u002FUICC) staging classification (TNM-8). All patients should NOT have received any form of anti-tumor treatment for their locally recurrent NPC before joining the study. However, prior radical treatment for their NPC at diagnosis is allowed if there is at least a 6-month interval between prior radical treatment and the start of study intervention of this study.\n2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n3. Aged ≥18 years old\n4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n5. All eligible patients must be magnetic resonance imaging of T1, T2 and T1-contrast enhanced sequences of the head and neck region and PET-CT scan within 30 days of study entry.\n6. Modified Charlson Comorbidity Score \\\u003C2\n7. Adult Comorbidity Evaluation (ACE)-27 Index \\\u003C2\n8. Pre-existing peripheral neuropathy \\\u003C=1\n9. Have adequate organ function as defined in the following table (Table 5.1.1).\n10. Body Weight \\>30kg\n11. For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to the start of treatment for their NPC. Women will be considered postmenopausal if they are amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: - Women 1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n13. Must have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment or 5 half-lives, whichever is shorter.\n2. Has a diagnosis of severe active scleroderma, lupus, other rheumatologic or autoimmune disease within the past 3 months before study recruitment. Patients with a documented history of clinically severe autoimmune disease or a syndrome requiring systemic steroids or immunosuppressive agents will not be allowed on this study. Subjects with vitiligo or resolved childhood asthma\u002Fatopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement are not excluded from this study.\n3. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n4. Has had any prior monoclonal antibody before study entry, including but not limited to anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another costimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137 etc).\n5. Has had prior chemotherapy or targeted small molecule therapy (including sorafenib or other anti-vascular endothelial growth factor inhibitor) before study entry. Patients who received radical radiation therapy and chemotherapy (but not immune checkpoint inhibitors or any form of immunotherapy) for their previously untreated nasopharyngeal carcinoma at diagnosis was allowed to join this study, provided that such radical treatment was completed \\>6 months before study entry.\n6. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Other exceptions may be considered with Sponsor consultation.\n\n   Note: Participants with low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or T2a with a Gleason score ≤6 and a prostate-specific antigen (≤10 ng\u002Fml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation.\n7. Has known carcinomatous meningitis (also known as leptomeningeal carcinomatosis).\n8. Has an active infection requiring intravenous systemic therapy or hospital admission.\n9. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n10. Has a history or current evidence of any condition, therapy, or laboratory abnormality, including psychiatric or substance abuse disorder, 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.\n11. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 31 weeks after the last dose of trial treatment.\n12. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Routine checking for Anti-HIV1 or Anti-HIV2 is not mandatory.\n13. Has a known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA \\[qualitative\\] is detected) infection.\n14. Has received a live vaccine 30 days prior to the first dose of trial treatment.\n15. Has experienced Grade 4 toxicity on treatment with prior radiation.\n16. Has experienced Grade 3-4 intracranial toxicity (hypophysitis or central nervous system toxicity) with either prior intracranial radiation and\u002For chemotherapy.\n17. Is taking \\> 4mg\u002Fday of dexamethasone or its equivalent at the start of immunotherapy or has required \\> 4mg\u002Fday of dexamethasone or its equivalent for 3 consecutive days within 1 week of starting treatment.\n18. Allergies and adverse drug reaction to the following: History of allergy to study drug components; History of severe hypersensitivity reaction to any monoclonal antibody.\n19. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade \\>=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. (a) Patients with Grade \\>=2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. (b) Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with pembrolizumab may be included only after consultation with the Study Physician.\n20. Major surgical procedure (as defined by the Investigator within 28 days prior to the first dose of IP. Local surgery of isolated lesions for palliative intent is acceptable.\n21. History of allogenic organ transplantation.\n22. History of leptomeningeal carcinomatosis.\n23. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>=470ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n24. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>=470ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n25. Current or prior use of immunosuppressive medication within 14 days before the first dose of pembrolizumab. The following are exceptions to this criterion: (a) Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) (b) Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\> of prednisone or its equivalent (c) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)",{"count":537,"type":23},53,[58],"Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China and southeast Asia. Despite intensive radical therapy, between 15% and 30% of NPC patients develop relapse. Recent phase III randomized-controlled trials conducted in China demonstrated an improvement of progression-free survival with combinational therapy immune checkpoint inhibitors (ICI) (camrelizumab, toripalimab, and tislelizumab, respective) and chemotherapy gemcitabine (G) and cisplatin (P) compared with chemotherapy GP alone for recurrent or metastatic NPC. However, none of these studies have described in details the treatment outcomes of those subjects with locally recurrent NPC only, and whether any of these patients would undergo radical surgery to remove the residual locally recurrent NPC after ICI and chemotherapy. Continuation of the same ICI as maintenance therapy may only be the treatment option for these patients who were recruited into these phase III trials, unless if they withdrew from the study and opted for radical resection. While continuing the same ICI may still lead to persistent objective response and disease control, there is a possibility of tumor recurrence leading to unresectable disease and a worse survival outcome, or unexpected, rare but recognized immune-related emergent adverse events with ICI. Radical resection after maximal response to ICI and chemotherapy for patients with locally recurrent NPC only may provide a chance of cure of the disease and these patients may be obviated from continuous exposure to ICI therapy.\n\nIn view of the above, we are now proposing a phase II single-arm study on perioperative pembrolizumab and chemotherapy followed by radical surgery for locally recurrent NPC. As a collateral study, we will also perform single-cell DNA and RNA sequencing and proteomics study to observe the tumor and immune microenvironment which certainly helps us decipher the mechanisms of tumor response at genomic, transcriptomic and proteomic levels.",[541,30],"Nasopharyngeal Cancer Recurrent",[543,544,545,546,547,548],"Nasopharyngeal carcinoma","Locally recurrent","Perioperative treatment","Immune checkpoint inhibitor","Chemotherapy","Minimally invasive surgery","2025-08-27",{"date":551,"type":39},"2025-09-04",{"date":553,"type":23},"2025-11-01",{"date":555,"type":23},"2028-06-30",{"name":557,"class":46},"The University of Hong Kong",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":130,"enrollmentInfo":565,"targetDuration":4,"studyType":24,"phases":567,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":47},"100603628","phase-2-ebv-lytic-reactivation-therapy-combined-with-pd-1-antibody-in-recurrentmetastatic-nasopharyngeal-carcinoma-100603628","NCT07138989","EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","Efficacy and Safety of EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent\u002FMetastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm Phase II Trial","Inclusion Criteria:\n\n* Patients must voluntarily participate and provide written informed consent.\n* Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) at enrollment, with positive EBERs by pathological immunohistochemistry.\n* Metastatic NPC includes both newly diagnosed metastatic disease and metastatic disease after failure of first-line therapy, as well as recurrent NPC not amenable to local regional treatment, with confirmed metastatic or recurrent disease and no prior treatment after diagnosis.\n* Age ≥ 18 years and ≤ 75 years, of any sex.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival time ≥ 3 months.\n* Baseline plasma EBV DNA \\> 0 copies\u002FmL.\n* Adequate organ function confirmed by the following criteria (no blood component transfusions or use of hematopoietic growth factors within 2 weeks prior to study treatment initiation):\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 100 × 10\\^9\u002FL; hemoglobin ≥ 90 g\u002FL. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin . Total bilirubin (TBil) ≤ 1.5 × ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (for patients with liver metastases, TBil ≤ 3 × ULN; AST and ALT ≤ 5 × ULN). Serum albumin ≥ 28 g\u002FL.\n\nExclusion Criteria:\n\n* History of severe hypersensitivity reactions to other monoclonal antibodies or to any component of PD-1 inhibitors.\n* Receipt of radiotherapy, biological therapy (e.g., tumor vaccines, cytokines, or growth factors), or other immunotherapy (excluding PD-1 and PD-L1 inhibitors), or any other anti-tumor treatment within 28 days or 5 half-lives prior to the first dose of study drug, whichever is shorter.\n* Prior treatment targeting Epstein-Barr virus (EBV) specifically.\n* History of any Grade ≥3 bleeding event, as defined by CTCAE v5.0, within 4 weeks prior to screening, or patients deemed at high risk of bleeding by the investigator.\n* Presence of necrotic lesions within 4 weeks prior to screening, with high risk of major hemorrhage as judged by the investigator.\n* Known congenital or acquired immunodeficiency (e.g., HIV-positive individuals).\n* Requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within 14 days prior to initiation of study treatment.\n* History of active tuberculosis (TB). Suspected active TB must be excluded through chest X-ray, sputum examination, and clinical assessment of signs and symptoms.\n* Patients with HBV DNA ≥1000 copies\u002FmL. Patients with positive hepatitis C antibody results may only be enrolled if polymerase chain reaction (PCR) testing confirms HCV RNA negativity.\n* Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.\n* History of other malignancies, except for adequately treated basal cell carcinoma or carcinoma in situ of the cervix.\n* Uncontrolled cardiovascular conditions, including but not limited to: Heart failure with NYHA classification ≥2; Unstable angina; Myocardial infarction within the past year; Supraventricular or ventricular arrhythmias requiring treatment or intervention.\n* Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function.\n* Severe and uncontrolled medical illnesses or infections.\n* Concurrent participation in another clinical trial or use of another investigational agent.\n* Refusal or inability to sign informed consent.\n* Any other contraindications to study treatment as determined by the investigator.\n* Individuals with personality disorders or psychiatric conditions, and those lacking or having limited legal capacity to provide consent.",{"count":566,"type":23},10,[58],"Nearly all undifferentiated nasopharyngeal carcinoma (NPC) are associated with the Epstein-Barr Virus (EBV), which typically remains in a latent, non-immunogenic state within tumor cells. By combining EBV lytic induction strategy with standard chemo-immunotherapy, this study aims to create a synergistic anti-tumor effect and improve clinical outcomes for patients with recurrent\u002Fmetastatic NPC (r\u002Fm NPC). This is a phase II, single-center, single-arm clinical trial designed to evaluate the efficacy and safety of a novel combination therapy in patients with r\u002Fm EBV-positive NPC.",[30],[301,571,304],"Epstein-Barr virus","2025-08-16",{"date":574,"type":39},"2025-08-24",{"date":576,"type":23},"2025-08-19",{"date":578,"type":23},"2031-08-18",{"name":121,"class":46},{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":588,"targetDuration":4,"studyType":24,"phases":589,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":47},"100601443","phase-2-radiotherapy-omitting-prophylactic-neck-irradiation-with-neoadjuvant-and-adjuvant-toripalimab-in-nasopharyngeal-carcinoma-100601443","NCT07110558","Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma","A Single-arm, Phase II Trial of Radiotherapy Without Prophylactic Neck Irradiation in Combination With Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab for Nasopharyngeal Carcinoma","PUPA","Inclusion Criteria:\n\n1. Age: 18 Years to 70 Years;\n2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III\n3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1\n4. TNM stage based on AJCC 9th edition with N0-1 (retroperitoneal lymph nodes only), and either one following criteria:\n\n   1. T2 and primary gross tumor volume (GTV) greater than 30.0 cm3;\n   2. T3-4;\n5. Patients' lymph node without adverse features (no central necrosis, no muscle\u002Fskin invasion, no lymph node fusion).\n6. Male and no pregnant female\n7. Normal bone marrow function: white blood cell count \\> 4×10\\^9\u002FL, hemoglobin \\> 90g\u002FL, platelet count \\> 100×10\\^9\u002FL;\n8. Normal liver function: total bilirubin (TBIL) \\\u003C upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) \\\u003C 1.5 × ULN;\n9. Normal kidney function: creatinine clearance rate ≥ 60 ml\u002Fmin;\n10. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;\n\nExclusion Criteria:\n\n1. Patients have evidence of relapse or distant metastasis\n2. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)\n3. Patients with positive cervical lymph nodes\n4. Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.).\n5. Receiving radiotherapy or chemotherapy previously\n6. Patients with active immunodeficiency disease and history of immunodeficiency disease\n7. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS)\n8. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible.\n9. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved.\n10. HBV DNA \\>2000 cps\u002Fml (or HBV DNA \\> 2000 IU\u002Fml); or HCV RNA \\>1000 cps\u002Fml; Hepatitis B surface antigen (HBsAg) positive and HCV antibody positive.\n11. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n12. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.\n13. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2), 2) unstable angina, 3) myocardial infarction in past 1 year, 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.\n14. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.\n15. Severe, uncontrolled medical conditions and infections.\n16. At the same time using other test drugs or in other clinical trials.\n17. Refusal or inability to sign informed consent to participate in the trial.\n18. Other treatment contraindications.\n19. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.",{"count":225,"type":23},[58],"This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.",[30],[301,593,304],"radiotherapy","2025-07-31",{"date":596,"type":39},"2025-08-07",{"date":598,"type":23},"2025-08-15",{"date":600,"type":23},"2032-08-14",{"name":121,"class":46},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":609,"targetDuration":4,"studyType":24,"phases":611,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"100598477","phase-3-shrinking-the-anterior-border-of-ctv2-for-nasopharyngeal-carcinoma-to-reduce-the-radiation-of-nasal-cavity-100598477","NCT07072000","Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity","Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity : an Open-label, Non-inferiority, Multicenter, Randomized Phase III Trial","Inclusion Criteria:\n\n1. Newly diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification).\n2. Stage I-III disease (AJCC 9th edition).\n3. Tumor extends to nasal cavity (including nasal septum).\n4. No distant metastasis (M0).\n5. Age 18-70 years.\n6. Male or non-pregnant female.\n7. Scheduled for radiotherapy.\n8. ECOG performance status 0-1 .\n9. Adequate bone marrow function: white blood cells \\>4×10⁹\u002FL, hemoglobin \\>90 g\u002FL, platelets \\>100×10⁹\u002FL.\n10. Normal hepatic\u002Frenal function: total bilirubin ≤1.5×ULN, AST\u002FALT ≤2.5×ULN, alkaline phosphatase ≤2.5×ULN, creatinine clearance ≥60 mL\u002Fmin.\n11. Written informed consent obtained.\n\nExclusion Criteria:\n\n1. Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma.\n2. Age \\\u003C18 or \\>70 years.\n3. Recurrent disease or distant metastasis.\n4. No tumor extension into the nasal cavity (including the nasal septum).\n5. Prior malignancy (except adequately treated basal\u002Fsquamous cell skin cancer or cervical carcinoma in situ).\n6. Pregnancy\u002Flactation (premenopausal women require pregnancy test; effective contraception mandated).\n7. Prior radiotherapy (except non-melanoma skin cancer with lesions outside current portals).\n8. Preoperative chemotherapy or surgical resection of primary\u002Fneck lesions (excluding diagnostic procedures).\n9. Severe coexisting illness.",{"count":610,"type":23},550,[134],"This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.",[30],[301,593],"2025-07-16",{"date":617,"type":39},"2025-07-18",{"date":619,"type":23},"2025-08-01",{"date":621,"type":23},"2032-07-31",{"name":623,"class":46},"Hai-Qiang Mai,MD,PhD",5,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":24,"phases":634,"briefSummary":635,"conditions":636,"keywords":637,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":47},"100598113","phase-2-tislelizumab-combined-with-capecitabine-for-nasopharyngeal-carcinoma-with-residual-ebv-dna-after-radiotherapy-100598113","NCT07067268","Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy","A Multicenter, Randomized Controlled, Phase II Trail of Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA After Radiotherapy","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically confirmed nasopharyngeal carcinoma;\n3. Expected survival time ≥12 weeks;\n4. ECOG performance status: 0-1;\n5. Received definitive radiotherapy (± induction and\u002For concurrent chemotherapy);\n6. Plasma EBV DNA \\>0 copies\u002FmL within the period from 1 week before to 4 weeks after completion of radiotherapy ;\n7. Adequate organ function meeting the following criteria: Hematological: a. Hemoglobin (HB) ≥90 g\u002FL; b. Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL; c. Platelet count (PLT) ≥80×10⁹\u002FL; Biochemical: a. Total bilirubin (BIL) \\\u003C1.5× upper limit of normal (ULN); b. ALT and AST \\\u003C2.5×ULN; c. Serum creatinine (Cr) ≤ULN, and creatinine clearance rate ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula); d. Normal myocardial enzymes and thyroid function; e. Normal cardiac function assessed by echocardiography.\n8. Signed informed consent with willingness to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)；\n2. Distant metastasis detected by pre-treatment clinical or imaging examinations;\n3. History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;\n4. History of autoimmune diseases, except for the following conditions (eligible after evaluation):\n\n   1. Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;\n   2. Type I diabetes mellitus under stable insulin therapy with controlled blood glucose;\n5. Previous or concurrent malignancies (except those cured and disease-free for \\>5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);\n6. Positive pregnancy test in women of childbearing potential;\n7. Concurrent medical conditions that may compromise patient enrollment or safety during the study;\n8. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases;\n9. Active psychiatric disorders or other mental conditions affecting informed consent comprehension;\n10. Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+);\n11. Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular\u002Fventricular arrhythmias requiring clinical intervention;\n12. Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric\u002Fneurological disorders, chronic diarrhea, ascites, pleural effusion);\n13. Unwillingness to sign informed consent.",{"count":633,"type":23},76,[58],"This study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy.",[30],[276,638,639,521,640],"EBV DNA","Tislelizumab","Adjuvant therapy","2025-07-05",{"date":615,"type":39},{"date":644,"type":39},"2024-09-14",{"date":646,"type":23},"2029-12",{"name":648,"class":46},"Fudan University"]