[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ming-Yuan Chen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":312},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,74,100,127,157,182,214,243,266,288],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100637871","phase-2-sintilimab-combined-with-anlotinib-and-taxane-based-chemotherap-for-recurrentmetastatic-nasopharyngeal-carcinoma-100637871",false,"NCT07581821","Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","A Prospective, Single-Arm Phase II Clinical Trial on the Efficacy and Safety of Sintilimab Combined With Anlotinib and Taxane-Based Chemotherapy in Previously Immunotherapy-Treated Recurrent\u002FMetastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Sign a written informed consent before implementing any trial-related procedures.\n2. Age is 18 or older and 65 or younger.\n3. Nasopharyngeal nonkeratinizing carcinoma (differentiated or undifferentiated, i.e. WHO type II or III) with histological or cytological evidence.\n4. Recurrent or metastatic nasopharyngeal carcinoma that has failed previous treatment with first-line platinum-containing standard regimens and\u002For second-line standard regimens.\n5. At least one measurable lesion according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1) is considered measurable if a lesion in a previously irradiated field is confirmed to have progressed;\n6. Participants with asymptomatic brain metastases or stable symptoms after local treatment may be enrolled, provided they meet the following criteria: 1) Measurable lesions outside the central nervous system; 2) No central nervous system symptoms or no symptom exacerbation within at least two weeks; 3) No need for glucocorticoid therapy, discontinued glucocorticoid treatment within seven days prior to initial administration, or stabilized glucocorticoid dosage within seven days prior to initial administration reduced to below 10 mg\u002Fday prednisone (or equivalent dose)\n7. Allow the subject to receive palliative radiotherapy (including cranial radiotherapy for symptomatic brain metastases), provided that the radiotherapy is completed at least 1 week prior to enrollment and that the toxicity associated with radiotherapy is restored to less than or equal to grade 1 (CTCAE 5.0, except for hair loss)\n8. ECOG score 0-1.\n9. Life expectancy\\> 3 months.\n10. If there is a risk of pregnancy, all subjects (male or female) should use contraception with an annual failure rate of less than 1% throughout the treatment period and for 120 days after the last study drug administration (or 180 days after the last study drug administration).\n\nExclusion Criteria:\n\n1. Diagnosis of a malignancy other than nasopharyngeal carcinoma within 5 years prior to the first dose (excluding cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and\u002For cured carcinoma in situ that has been resected);\n2. Participants are currently enrolled in an interventional clinical study treatment or have received another investigational drug or used an investigational device within 4 weeks prior to the first dose\n3. Within 2 weeks before the first administration, patients received systemic treatment with traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) for anti-tumor indications\n4. Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) that occurred within 2 years prior to the first treatment. Replacement therapy (e.g., thyroid hormone, insulin, or physiologically administered glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy\n5. Study participants were receiving systemic glucocorticoid therapy (not including nasal, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first study administration;\n6. The presence of clinically uncontrolled pleural\u002Fabdominal effusion (no drainage is required or the subject does not show significant increase in fluid over 3 days of discontinuation of drainage is eligible for enrollment)\n7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n8. Patients who are known to be allergic to the active ingredient or excipient of the study drug, sintilimab and anlotinib hydrochloride;\n9. Patients with multiple factors affecting oral medications (e.g., dysphagia, postgastrectomy, chronic diarrhea, intestinal obstruction, etc.);\n10. Cough, severe liver and kidney dysfunction;\n11. Not fully recovered from toxicity and\u002For complications caused by any intervention prior to starting treatment (i.e., ≤1 grade or baseline, excluding fatigue or hair loss)\n12. History of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive);\n13. Untreated active hepatitis B (defined as HBsAg-positive with HBV DNA copy count exceeding the upper limit of normal values in the laboratory department of the research center); Note: Eligible participants also include those meeting the following criteria: 1) HBV viral loa\n14. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the detection limit);\n15. Vaccinated with a live vaccine within 30 days prior to the first dose (Day 1 of Week 1); Note: Influenza vaccine injections for seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal administration of live attenuated influenza vaccine is not permitted.\n16. Pregnant or lactating women;\n17. Participants with any severe or uncontrolled systemic diseases, such as: 1) significant and symptomatically severe abnormalities in rhythm, conduction, or morphology observed on resting electrocardiogram (e.g., complete left bundle branch block, second-degree or higher cardiac block, ventricular arrhythmias, or atrial fibrillation); 2) unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Class II or higher; 3) myocardial infarction within six months prior to enrollment; 4) suboptimal blood pressure control (systolic\\>140 mmHg, diastolic\\>90 mmHg); 5) history of non-infectious pneumonia requiring glucocorticoid therapy within one year prior to first administration, or current clinical active interstitial lung disease; 6) active pulmonary tuberculosis; 7) active or uncontrolled infections requiring systemic treatment; 8) active diverticulitis, peritoneal abscess, or gastrointestinal obstruction; 9) liver disorders including cirrhosis, decompensated cirrhosis, acute\u002Fchronic active hepatitis; 10) poorly controlled diabetes (fasting blood glucose\\>10mmol\u002FL); 11) urine protein ≥++ detected in urinalysis with confirmed 24-hour protein\\>1.0 g; participants with psychiatric disorders and poor treatment compliance\n18. History or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial and prevent the subject from participating in the study, or other conditions that the investigator deems unsuitable for enrollment, or other potential risks that the investigator deems unsuitable for participation in this study.","ALL","18 Years","65 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of sintilimab combined with anlotinib and taxane-based chemotherapy in patients with recurrent (not unable to locally curative treatment) or metastatic NPC who failed at least first-line platinum-containing standard regimen and\u002For anti PD-1\u002FL1.",[27],"Recurrent or Metastatic Nasopharyngeal Carcinoma",[29,30,31,32,33],"Nasopharyngeal Carcinoma","Metastatic","Sintilimab","Anlotinib","taxane-based chemotherapy","RECRUITING","2026-05-06",{"date":37,"type":38},"2026-05-12","ACTUAL",{"date":40,"type":38},"2025-09-15",{"date":42,"type":21},"2028-12-31",{"name":44,"class":45},"Ming-Yuan Chen","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100633266","phase-3-becotatug-vedotin-mrg003-in-combination-with-pd-1-inhibitor-versus-pd-1-inhibitor-for-the-treatment-of-egfr-positive-cps1-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-100633266","NCT07524452","Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma","A Phase III Study of Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma： a Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS ≥ 1, with clinical stage (AJCC 8th edition): p16-positive oropharynx: Stage III (T4N0-2M0); p16-negative oropharynx: Stage III or IVA; larynx\u002Fhypopharynx\u002Foral cavity: Stage III or IVA;\n3. Eligible for curative-intent surgery as determined by the surgeon;\n4. Age: 18 to 75 years;\n5. ECOG performance status 0-1;\n6. Life expectancy greater than 6 months;\n7. At least one measurable lesion per RECIST 1.1;\n8. Adequate organ function, based on meeting all of the following criteria (no receipt of blood components or hematopoietic growth factors within 14 days prior to testing): hemoglobin ≥ 90 g\u002FL; absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL; serum albumin ≥ 28 g\u002FL; total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL\u002Fmin; activated partial thromboplastin time and international normalized ratio (INR) ≤ 1.5 × ULN (patients receiving a stable dose of anticoagulant therapy, such as low molecular weight heparin or warfarin, may be enrolled if INR is within the expected therapeutic range for the anticoagulant). Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be assessed, and patients with normal T3 and T4 levels may be enrolled;\n9. Baseline left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition (MUGA) scan or echocardiography (ECHO);\n10. Women of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptive pill, or condom) during the treatment period and for 3 months after the last dose;\n11. Good compliance.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. History of allergy to PD-1 inhibitors.\n3. History of other malignancies within the past 5 years or at enrollment, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary tumors.\n4. Residual toxicity from prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy, etc.) other than alopecia, fatigue, and grade 2 hypothyroidism, or clinically significant laboratory abnormalities greater than grade 1 (CTCAE v5.0).\n5. Uncontrolled cardiac conditions or diseases, such as: ① NYHA Class II or greater heart failure, ② unstable angina, ③ myocardial infarction within 1 year, and ④ patients with clinically significant ventricular arrhythmias requiring intervention.\n6. Grade ≥ 2 peripheral neuropathy (per CTCAE v5.0).\n7. Pulmonary embolism or deep vein thrombosis within 3 months prior to enrollment (excluding catheter-related thrombosis from infusion ports or PICC lines).\n8. Active bleeding, history of coagulation disorders, or patients receiving coumarin anticoagulant therapy.\n9. Known hypersensitivity to any component or excipient of vibecotamab (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80), or known grade ≥ 3 hypersensitivity reaction to other prior anti-EGFR agents (including investigational drugs) or other monoclonal antibodies.\n10. Receipt of any of the following treatments:\n\n    ① Any investigational drug prior to the first dose of the current study drug.\n\n    ② Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period.\n\n    ③ Use of systemic corticosteroids (more than 10 mg of prednisone or equivalent per day) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug, except for the use of corticosteroids for localized inflammation, prevention of allergies, or nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement doses greater than 10 mg prednisone equivalent per day are permitted.\n\n    ④ Administration of live vaccines within 4 weeks prior to the first dose of study drug.\n\n    ⑤ Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.\n11. Severe infection (greater than grade 2 per CTCAE), such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications, occurring within 4 weeks prior to the first dose of study drug; baseline chest imaging indicating active pulmonary inflammation or signs and symptoms of infection within 2 weeks prior to the first dose of study drug, or indicating the need for oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use).\n12. History of or concurrent severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc.\n13. History of active autoimmune diseases or syndromes (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo that did not require any intervention in adulthood, or childhood asthma\u002Fallergy that has resolved, are not excluded.\n14. History of immunodeficiency, including HIV-positive status or other acquired\u002Fcongenital immunodeficiency diseases, or history of organ transplantation or bone marrow transplantation.\n15. Patients with active tuberculosis infection by history or CT findings, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year prior without receiving formal treatment.\n16. Active hepatitis B (HBV DNA ≥ 2,000 IU\u002FmL or 10,000 copies\u002FmL) or hepatitis C (positive HCV antibody test with HCV RNA above the lower limit of detection).\n17. Uncontrolled pleural, peritoneal, pelvic, or pericardial effusion requiring drainage ≥ 1 time per month.\n18. Known history of substance abuse, alcoholism, or drug use.\n19. Inappropriate for inclusion based on the investigator's judgment.","75 Years",{"count":56,"type":21},430,[58],"PHASE3","This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .",[61],"Locally Advanced Head and Neck Squamous Cell Carcinoma",[63,64,65],"Resectabl locally advanced head and neck squamous cell carcinoma","Becotatug Vedotin","perioperative neoadjuvant and adjuvant therapy","2026-04-06",{"date":68,"type":38},"2026-04-13",{"date":70,"type":38},"2026-02-06",{"date":72,"type":21},"2032-02-28",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100629986","phase-3-efficacy-and-safety-of-sbrt-combined-with-becotatug-vedotin-mrg003-in-egfr-positive-metastatic-tumor-patients-with-oligometastases-100629986","NCT07481799","Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases","Phase 3 Clinical Study on the Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases","Inclusion Criteria:\n\n1. Age: 18 to 75 years (inclusive), male or female.\n2. Patients with histologically or cytologically confirmed recurrent or metastatic solid tumors who are not amenable to curative surgery.\n3. Oligometastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory). The total number of metastatic lesions must be \\\u003C=5.\n4. The primary tumor has been treated radically and is controlled.\n5. Subjects must provide tumor tissue samples for EGFR testing of the primary tumor or metastatic lesions:\n\n   a) Sample requirements: Neutral formalin-fixed, paraffin-embedded (FFPE) tissue blocks or 10 unstained tumor tissue or cytology slides. Both fresh and archival samples are acceptable, with fresh samples preferred. Subjects unable to provide freshly obtained tissue may provide archival tumor tissue samples collected within 2 years prior to informed consent. For subjects unable to provide tumor tissue samples meeting the above requirements, enrollment is subject to confirmation after discussion with the Sponsor.\n6. All metastatic lesions are deemed amenable to SBRT (Stereotactic Body Radiation Therapy) by multidisciplinary team (MDT) consultation.\n7. For patients whose metastatic lesions have received prior local therapy (e.g., surgery, radiofrequency ablation, radiotherapy):\n\n   1. If the treated metastatic lesion is controlled on imaging, the patient is eligible, and SBRT is not required for that specific site.\n   2. If the treated metastatic lesion is not controlled on imaging:\n\n      1. If the prior therapy was surgery and the site is amenable to SBRT, the patient is eligible;\n      2. If the prior therapy was radiotherapy or RFA, the patient is ineligible.\n8. Maximum diameter of brain metastases \\\u003C= 3 cm.\n9. Maximum diameter of extra-cranial metastases \\\u003C= 5 cm.\n\n   a) For bone metastases, the criterion may be extended to a maximum diameter of 6 cm (e.g., ribs, scapula, pelvis) if the investigator deems treatment safe.\n10. ECOG performance status of 0-1.\n11. Life expectancy \\>= 6 months.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity to any component of monoclonal antibodies.\n2. The investigator's choice of systemic therapy regimen contains taxanes (or other microtubule inhibitors) .\n3. Severe infection within 4 weeks prior to the start of study treatment; or active infection of CTCAE Grade\\>=2 requiring systemic antibiotic treatment within 2 weeks prior to the first dose.\n4. Received anti-tumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first dose of study drug or investigator's choice of systemic therapy and SBRT; Exceptions:\n\n   1. The interval between the last dose of oral fluorouracil or small molecule targeted drugs and the first dose of study treatment is \\> 2 weeks or 5 half-lives (whichever is shorter);\n   2. The interval between the last dose of Traditional Chinese Medicine (TCM) with anti-tumor indications and the first dose of study treatment is \\> 2 weeks;\n   3. The interval between the completion of prior radioactive seed implantation and the first dose of study treatment is \\> 4 weeks or 5 half-lives of the seeds (whichever is shorter); the interval between the completion of Tumor Treating Fields and the first dose of study treatment is \\\u003C 7 days.\n5. Received treatment with strong CYP3A4 or CYP2D6 inhibitors or inducers, or P-gp inhibitors within 5 half-lives prior to the first dose.\n6. Prior treatment with EGFR ADCs, or prior treatment with ADCs containing microtubule inhibitors.\n7. History of interstitial lung disease, such as idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or radiation pneumonitis requiring steroid treatment; or imaging at screening suggests suspected ILD or ILD cannot be excluded (subjects with radiation pneumonitis limited solely to the radiation field may participate); or presence of respiratory failure, severe asthma, severe chronic obstructive pulmonary disease (COPD), or other pulmonary diseases severely affecting lung function; or prior pneumonectomy.\n8. Clinical or radiological evidence of spinal cord compression, or tumor distance to the spinal cord \\\u003C 3 mm.\n9. Grade \\>= 2 coronary heart disease, arrhythmia (including QTc interval prolongation \\> 450 ms for males, \\> 470 ms for females), or cardiac insufficiency.\n10. Patients with brain metastases requiring surgical decompression.\n11. Patients with malignant effusions.\n12. patients with concomitant malignancies.\n13. Dementia or seizures.\n14. Comorbidities requiring chronic use of immunosuppressive medication, or systemic or local corticosteroids at immunosuppressive doses, or receipt of high-dose corticosteroids within 4 weeks prior to enrollment.\n15. Active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received such treatment within 1 year prior to screening.\n16. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has completely resolved without need for intervention in adulthood are eligible; patients with asthma requiring bronchodilators for medical intervention are excluded.\n17. HIV positive; HBsAg positive with detectable HBV DNA \\>= 1000 copies\u002Fml); positive blood screening for chronic Hepatitis C (HCV antibody positive). Vaccination with any anti-infective vaccine (e.g., influenza, varicella) within 4 weeks prior to enrollment.\n18. Positive pregnancy test in women of childbearing potential, or breastfeeding women.\n19. Other patients considered unsuitable for inclusion by the investigator.",{"count":82,"type":21},200,[58],"The combination of local consolidative therapy for oligometastases with systemic therapy offers the potential for clinical cure and significantly prolongs survival in a subset of patients with advanced metastatic disease. However, a considerable proportion of patients still do not benefit from this approach.\n\nBecotatug vedotin (MRG003) is an antibody-drug conjugate that carries the payload monomethyl auristatin E (MMAE), a microtubule inhibitor. MMAE has been shown to effectively enhance radiosensitivity in various preclinical tumor models, including head and neck squamous cell carcinoma, liver cancer, gastric cancer, pancreatic cancer, and lung cancer. Furthermore, multiple clinical studies have demonstrated the promising therapeutic potential of vicetuximab in EGFR-positive solid tumors.\n\nBased on this background, we plan to conduct a clinical study evaluating the combination of stereotactic body radiotherapy (SBRT) for oligometastases with investigator-selected systemic therapy and Becotatug vedotin (MRG003) in patients with EGFR-positive oligometastatic tumors.",[86],"Oligo-metastatic Cancer",[88,89,90,91],"EGFR-postive oligo-metastatic cancer","SBRT","MMAE","Becotatug vedotin","2026-03-28",{"date":94,"type":38},"2026-04-02",{"date":70,"type":38},{"date":97,"type":21},"2030-02-28",{"name":44,"class":45},2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100618225","phase-3-402gy-versus-492gy-radiotherapy-in-low-risk-target-volume-for-chemosensitive-stage-ii-nasopharyngeal-carcinoma-100618225","NCT07328854","40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma","40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma Under Full-Course Immunotherapy: a Multicentre, Randomised, Phase 3 Trial","Inclusion Criteria:\n\n1. Patients are informed of the basic content of this study and sign an informed consent form;\n2. Age between 18 and 75 years;\n3. Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);\n4. Staged according to the 9th edition of the AJCC\u002FUICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);\n5. KPS ≥ 70;\n6. Normal bone marrow function: WBC ≥ 4 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, HGB ≥ 90 g\u002FL;\n7. Imaging evaluation of treatment response after three cycles of GPP\u002FTPP induction chemotherapy plus immunotherapy: CR or PR;\n8. Plasma EBV DNA level decreases to 0 copies\u002FmL or below the detection limit after induction chemotherapy;\n9. Normal liver and kidney function: total bilirubin, AST, ALT ≤ 2.0 times the upper limit of normal, creatinine clearance ≥ 60 mL\u002Fmin or creatinine ≤ 1.5 times the upper limit of normal.\n\nExclusion Criteria:\n\n1. Patients with recurrent\u002Fmetastatic nasopharyngeal carcinoma;\n2. Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment);\n3. Patients with a history of malignant tumours, excluding those who have undergone curative treatment for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ;\n4. Patients whose local\u002Fregional lesions have undergone radiotherapy or surgery (excluding diagnostic surgery), or whose lesions exhibit significant necrosis, making radiotherapy unsuitable or potentially leading to radiotherapy resistance;\n5. Patients with other severe medical conditions that may pose significant risks or impair trial compliance. Examples include unstable cardiac disease requiring treatment, renal disease, hepatic disease, uncontrolled diabetes (fasting blood glucose \\> 1.5 × ULN), severe psychiatric disorders, or other malignant tumours;\n6. Patients with a history of severe hypersensitivity reactions to any component of PD-1 monoclonal antibodies;\n7. History of allergic reactions to the chemotherapy drugs used in this study (gemcitabine, docetaxel, albumin-bound paclitaxel, paclitaxel, cisplatin);\n8. Patients with comorbidities requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects;\n9. Patients with active tuberculosis, or those currently receiving antituberculosis treatment or who have received antituberculosis treatment within the past year prior to screening;\n10. Other patients deemed ineligible for inclusion by the treating physician.",{"count":108,"type":21},346,[58],"This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.",[29],[29,113,114,115,116,117],"Reduced-dose radiotherapy","Complete response","Partial response","Epstein-Barr Virus DNA","Low-risk target volume","2025-12-27",{"date":120,"type":38},"2026-01-09",{"date":122,"type":38},"2025-11-20",{"date":124,"type":21},"2032-06-30",{"name":44,"class":45},15,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":155,"locationsCount":156},"100618224","phase-3-reduced-dose-versus-conventional-dose-intensity-modulated-radiation-therapy-for-locally-advanced-nasopharyngeal-carcinoma-with-remission-after-induction-chemotherapy-and-immunotherapy-100618224","NCT07328841","Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy","Reduced-Dose Versus Conventional-Dose Intensity-Modulated Radiation Therapy in Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy: A Multicenter, Phase III Clinical Trial","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO classification Type II or Type III).\n2. Clinical stage: AJCC 8th edition staging: T4N0-2M0, T1-4N3M0 (stage IVa); AJCC 9th edition staging: T4N0-2M0, T1-4N3M0 (stage III).\n3. After 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, the efficacy is assessed as PR or CR by nasopharyngoscopy and enhanced MRI of nasopharynx + neck, with EBV DNA reduced to zero or below the lower limit of detection.\n4. Age: 18-70 years old.\n5. PS\u002FECOG score (performance status score of 0 or 1).\n6. Adequate organ function:\n\n   1. Hematology: White blood cell count ≥ 4000\u002FμL, neutrophil count ≥ 2000\u002FμL, hemoglobin ≥ 9 g\u002FdL, platelet count ≥ 100000\u002FμL;\n   2. Liver function: Bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 × ULN are eligible), AST and ALT ≤ 1.5 × ULN, and alkaline phosphatase ≤ 1.5 × ULN; albumin ≥ 3 g\u002FdL;\n   3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin calculated by the Cockcroft-Gault formula.\n   4. Proteinuria: Urine protein\u002Fcreatinine ratio (UPC ratio) \\\u003C 1.0. For those with UPC ratio ≤ 0.5, no further examination is required; for those with UPC ratio \\> 0.5, further testing showing 24-hour urine protein \\\u003C 1000 mg is eligible.\n\n   Note: The UPC ratio of random urine is an estimate of 24-hour urine protein quantification, and the two have a good correlation. The UPC ratio can be calculated using the following formulas:\n\n   i. Urine protein\u002Furine creatinine (if both protein and creatinine are in mg\u002FdL); ii. (Urine protein) × 0.088\u002Furine creatinine (if urine creatinine is in mmol\u002FL).\n\n   e) Coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n7. Patients have signed the informed consent form and are willing and able to comply with the study's scheduled visits, treatment plans, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n1. Patients whose laboratory test results within 7 days before enrollment do not meet the relevant standards.\n2. Patients with efficacy evaluation of stable disease (SD) or progressive disease (PD) after 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, or whose EBV DNA has not been reduced to zero or below the lower limit of detection.\n3. Patients who have received any of the following for primary lesions and\u002For cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment).\n4. Patients with tumors accompanied by obvious liquefaction necrosis, which are unsuitable for radiotherapy or may lead to radioresistance.\n5. Patients with tumors invading the brain parenchyma.\n6. Patients with a history of severe allergic reactions to any components of other monoclonal antibodies or PD-1\u002FPD-L1 monoclonal antibodies.\n7. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.\n8. Patients with recurrence, distant metastasis, or concurrent other malignant tumors.\n9. Patients with severe heart disease, pulmonary dysfunction, or cardiac\u002Fpulmonary function grade 3 or lower (including grade 3).\n10. Patients with previous use of anti-PD-1\u002FPD-L1 antibodies, anti-CTLA-4 antibodies, or any other antibodies acting on T-cell costimulatory or checkpoint pathways.\n11. Patients with comorbidities requiring long-term treatment with immunosuppressive drugs or systemic\u002Flocal use of corticosteroids at immunosuppressive doses before enrollment.\n12. Patients with HIV positivity; HBsAg positivity with positive HBV DNA copy number (quantitative detection ≥ 1000 cps\u002Fml); positive screening for chronic hepatitis C (HCV antibody positivity).\n13. Patients with a history of allergic reactions to the drugs used in this study (gemcitabine, docetaxel, taxanes, cisplatin).\n14. Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.\n15. Patients who, within 4 weeks before enrollment: have received systemic or local glucocorticoid treatment, been vaccinated with any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.), or used traditional Chinese herbal medicines with anti-tumor effects.\n16. Women of childbearing age with positive pregnancy test results and lactating women.\n17. Other patients deemed unsuitable for inclusion by the attending physician.","70 Years",{"count":136,"type":21},456,[58],"To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response \\[CR\\]\u002Fpartial response \\[PR\\] by imaging, with EBV DNA copy number reduced to zero or below the lower limit of detection), so as to provide a new treatment option for these patients.",[140],"Nasopharyngeal Carcinoma (NPC)",[29,142,116,143,144,145,146,147,148,149,150],"Locally Advanced","EBV DNA clearance","undetectable EBV DNA","reduced-dose radiotherapy","Randomized non-inferiority trial","Concurrent chemoradiotherapy","complete response","partial response","PD-1inhibitor",{"date":120,"type":38},{"date":153,"type":38},"2025-11-18",{"date":124,"type":21},{"name":44,"class":45},12,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":46},"100607440","phase-3-phase-iii-non-inferiority-trial-reduced-target-vs-full-target-imrt-after-chemo-in-immunotherapy-treated-metastatic-nasopharyngeal-cancer-100607440","NCT07188584","Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer","A Multicenter, Phase III Non-Inferiority Clinical Trial: Locoregional Volume-Reduction Versus Conventional Definitive Target IMRT Following Full-Dose Chemotherapy for Treatment-Naïve Distant Metastatic Nasopharyngeal Carcinoma Undergoing Full-Course Immunotherapy","Inclusion Criteria:\n\n* Age: 18 years - 70 years.\n* The patient has signed the informed consent form and is willing and able to follow the visit schedule, treatment plan, laboratory tests and other research procedures as per the research plan.\n* Newly diagnosed distant metastasis patients who achieved complete response (CR) or partial response (PR) after receiving adequate first-line systematic therapy (platinum-containing doublet chemotherapy + PD-1 monoclonal antibody).\n* Nasopharyngeal carcinoma non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III), confirmed by histological and\u002For cytological examination, with metastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory).\n* Clinical stage: TanyNanyM1, stage IVB (AJCC 9th edition).\n* ECOG score: 0-1.\n* Female subjects with reproductive capacity must have a negative urine or serum pregnancy test within 7 days prior to enrollment, and must agree to take effective contraceptive measures during the study.\n* For male subjects, if the female partner still has reproductive capacity, the male subject must agree to take effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n* Patients with malignant pleural effusion or those with other malignant tumors\n* Patients who have received ≥2 prior lines of systemic therapy.\n* Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.\n* Patients with grade ≥ II coronary heart disease, arrhythmia (including QTc interval prolongation in males \\> 450 ms, females \\> 470 ms) and heart failure.\n* Patients who received systemic or local glucocorticoid treatment within 4 weeks prior to enrollment.\n* Patients with comorbidities requiring long-term use of immunosuppressive drugs or requiring systemic or local use of corticosteroids at immunosuppressive doses.\n* Patients with active pulmonary tuberculosis (TB), who are undergoing anti-TB treatment or have received anti-TB treatment within 1 year prior to screening.\n* HIV-positive individuals; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps\u002Fml); chronic hepatitis C blood screening positive (HCV antibody positive).\n* Patients who received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.\n* At the time of randomization, the expected lifespan of the patients was less than 6 months.\n* Other patients deemed unsuitable for inclusion by the treating physicians.",{"count":165,"type":21},166,[58],"In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with\u002Fwithout CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of \"immunotherapy combined with reduced-target radiotherapy\" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.",[140],[170,171,172,173],"Distant Metastasis Nasopharyngeal Carcinoma","Full Course Immunotherapy","Reduced-Target Radiotherapy","Full-dose Chemotherapy","2025-12-02",{"date":176,"type":38},"2025-12-09",{"date":178,"type":38},"2025-08-20",{"date":180,"type":21},"2031-07-01",{"name":44,"class":45},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100598360","phase-2-combination-therapy-for-pd-1-resistant-recurrent-or-metastatic-nasopharyngeal-carcinoma-a-bayesian-adaptive-phase-ii-trial-100598360","NCT07070479","Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial","A Bayesian Adaptive Phase II Randomized Trial Comparing Ivonescimab, Ivonescimab Plus Nimotuzumab, Liposomal Mitoxantrone Plus Anti-PD-1 Antibody, and Liposomal Irinotecan Plus S-1 in Patients With PD-1-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undifferentiated subtype, corresponding to WHO type II or III).\n2. Age between 18 and 70 years.\n3. Performance Status (PS) score of 0 or 1.\n4. Disease progression after prior platinum-based doublet chemotherapy.\n5. Received at least one line of systemic therapy previously. (Progression occurring during or within 6 months after definitive concurrent chemoradiotherapy, neoadjuvant\u002Fadjuvant therapy, or treatment completion may be counted as first-line treatment.)\n6. Resistance to anti-PD-1 antibody therapy (either combination or sequential), including primary or secondary resistance（PD-1 exposure must be at least 6 weeks.）\n7. At least one measurable lesion according to RECIST 1.1 criteria.\n8. All acute toxicities from prior anti-tumor therapies have resolved to grade ≤1 (per NCI-CTCAE v5.0) or meet the specified inclusion\u002Fexclusion thresholds. (Certain toxicities such as alopecia, hair color changes, nail changes, fatigue, etc., which do not pose safety risks, are exempt.)\n9. Adequate organ function:\n\n   Hematology: WBC ≥ 4000\u002FμL, absolute neutrophil count ≥ 2000\u002FμL, hemoglobin ≥ 9 g\u002FdL, platelets ≥ 100,000\u002FμL.\n\n   Liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with Gilbert's syndrome and bilirubin ≤ 3 × ULN are eligible); AST and ALT ≤ 3 × ULN; alkaline phosphatase ≤ 3 × ULN; albumin ≥ 3 g\u002FdL.\n\n   Coagulation: INR, prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n\n   Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin calculated by Cockcroft-Gault formula. Proteinuria: Urine protein\u002Fcreatinine ratio (UPC) \\\u003C 1.0. For UPC ≤ 0.5, no further testing is required; for UPC \\> 0.5, 24-hour urine protein must be \\\u003C 1000 mg for eligibility.\n10. Estimated life expectancy of at least 3 months.\n11. Signed informed consent and willingness and ability to comply with study visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Locoregional recurrent lesions that are amenable to definitive (curative) treatment, such as surgery.\n2. Prior treatment with any regimen included in the study protocol.\n3. Prior use of agents targeting the VEGF or VEGFR pathway.\n4. Diagnosis and\u002For treatment of another malignancy within the past 5 years, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ.\n5. Receipt of surgery, chemotherapy, radiotherapy, immunotherapy, any investigational agent, or other anti-cancer therapy within 4 weeks prior to enrollment (or within 2 weeks for palliative radiotherapy).\n6. Tumor encasement of the internal carotid artery or evidence of nasopharyngeal necrosis observed on endoscopy prior to enrollment.\n7. Any significant bleeding event (≥ Grade 2, CTCAE v5.0) within 4 weeks prior to enrollment, or visible hemoptysis defined as ≥ 1\u002F2 teaspoon of fresh red blood or blood clots with little or no sputum. Recurrent positive fecal occult blood test (++ or more) during screening also leads to exclusion. (Patients with occasional blood-tinged sputum may be eligible.)\n8. Active peptic ulcers or gastrointestinal surgery within 1 month prior to enrollment; history within 6 months of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal hemorrhage, esophageal varices, or pathological fracture.\n9. Uncontrolled hypertension (systolic \\>140 mmHg or diastolic \\>90 mmHg) despite antihypertensive therapy; coronary artery disease ≥ Grade II; or any of the following within 6 months prior to enrollment: myocardial infarction, severe or unstable angina, NYHA class II or higher heart failure, sustained arrhythmia ≥ Grade 2 (including QTc \\>450 ms in males or \\>470 ms in females), atrial fibrillation of any grade, coronary or peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular events (e.g., TIA or symptomatic pulmonary embolism). History of arterial thromboembolism or venous thromboembolism \\> Grade 3. (ST elevation ≥2 mm on ECG without clinical evidence of myocardial infarction or ischemia is not exclusionary.)\n10. History of bleeding diathesis, hemorrhagic disorders, or coagulopathy; current use of anticoagulants or antiplatelet agents including warfarin, heparin, aspirin \\>325 mg\u002Fday, ticlopidine, clopidogrel, or cilostazol, unless discontinued ≥10 days prior to first dose and coagulation parameters meet inclusion criteria.\n11. Severe infection requiring intravenous antibiotics, antifungals, or antivirals within 4 weeks prior to the first dose, or unexplained fever \\>38.5°C within 7 days prior to the first dose; baseline WBC \\>15 × 10⁹\u002FL.\n12. Known hypersensitivity to study drugs or excipients, or a history of severe hypersensitivity reactions such as generalized rash\u002Ferythema, hypotension, bronchospasm, angioedema, or anaphylaxis.\n13. Conditions that may affect oral drug absorption, including dysphagia, nausea\u002Fvomiting, chronic diarrhea, or bowel obstruction.\n14. Ongoing treatment with immunosuppressants or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to the first dose.\n15. Presence of any active autoimmune disease or a history of autoimmune diseases likely to recur (including but not limited to interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions include vitiligo and childhood asthma now in complete remission. Patients with asthma requiring bronchodilator therapy are excluded.\n16. History of acute exacerbation of chronic obstructive pulmonary disease or other respiratory disease requiring hospitalization within 1 month prior to enrollment; patients with active tuberculosis or those who received anti-TB therapy within 1 year prior to screening.\n17. HIV positive; or positive HBsAg with quantifiable HBV DNA ≥1000 cps\u002FmL; or positive anti-HCV antibody.\n18. Receipt of live vaccines within 4 weeks prior to first dose or anticipated during the study period.\n19. Positive pregnancy test or currently breastfeeding.\n20. Women of childbearing potential or sexually active men who are unwilling or unable to use medically accepted methods of contraception during the study period.\n21. Any condition, as determined by the investigator, that may interfere with the study results or patient safety, such as substance abuse, serious physical or mental illness requiring concurrent treatment, significant laboratory abnormalities, or adverse social\u002Ffamily circumstances.",{"count":190,"type":21},208,[24],"This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1\u002FPD-L1 therapy.\n\nThe four treatment arms include:\n\n1. Ivonescimab monotherapy,\n2. Ivonescimab combined with nimotuzumab,\n3. Liposomal mitoxantrone plus anti-PD-1 antibody, and\n4. Liposomal irinotecan plus S-1.",[27],[195,196,197,198,199,200,201,202,203,204],"nasopharyngeal carcinoma","Recurrent","metastatic","PD-1 resistance","Bayesian adaptive design","Ivonescimab","Nimotuzumab","Liposomal mitoxantrone","Liposomal irinotecan","S-1","2025-09-12",{"date":207,"type":38},"2025-09-18",{"date":209,"type":38},"2025-06-24",{"date":211,"type":21},"2028-01-30",{"name":44,"class":45},6,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":221,"sex":16,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":46},"100582985","comparison-and-strategy-optimization-of-plasma-ebv-dna-and-p85-ab-with-vcaebna1-iga-for-screening-nasopharyngeal-carcinoma-in-high-risk-areas-100582985","NCT06870435","Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA\u002FEBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas","Comparison and Strategy Optimization of Plasma Epstein-Barr Virus (EBV) DNA and BNLF2b Total Antibodies (P85-Ab) with VCA-IgA and EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas","Inclusion Criteria:\n\n* Voluntarily signed informed consent.\n* Age between 30 and 69 years at the time of screening.\n* Residents of Guangdong Province or Guangxi Province.\n* Able to cooperate with long-term follow-up.\n\nExclusion Criteria:\n\n* Severe medical comorbidities, significant organ (heart, lung, liver, kidney) dysfunction, or psychiatric disorders.\n* Severe autoimmune diseases or immunodeficiency.\n* History of or current malignant tumors.\n* Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.",true,"30 Years","69 Years",{"count":225,"type":21},68649,[227],"NA","This study is a prospective, self-controlled, multicenter clinical trial. All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored.\n\nFirst, it aims to investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening, thereby identifying the optimal initial NPC screening strategy. Based on the determined optimal initial screening strategy, the study will validate the proposed two-step method (subjects first undergo two-antibody method testing and P85-Ab testing; those positive for either one biomarker above proceed to plasma EBV DNA testing; subjects positive in both steps are defined as high-risk and receive endoscopic examinations with or without biopsy) compared with the single-step method (subjects simultaneously undergo two-antibody method testing, P85-Ab testing, and plasma EBV DNA testing; subjects with any positive biomarker undergo endoscopic examinations with or without biopsy) and each single screening testing. The aim is to determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity, thereby enhancing screening efficiency, reducing the rate of invasive procedures (such as endoscopic biopsies), and lowering medical costs and insurance burdens.",[140,230,231],"Screening","Epstein Barr Virus",[140,230,231,233,234],"EBV DNA","EBV antibody","2025-03-06",{"date":237,"type":38},"2025-03-11",{"date":239,"type":38},"2025-01-24",{"date":241,"type":21},"2035-12-31",{"name":44,"class":45},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":46},"100552409","phase-2-clinical-study-of-mitoxantrone-hydrochloride-liposome-combined-with-pd-1-blockade-in-recurrent-or-metastatic-npc-100552409","NCT06472713","Clinical Study of Mitoxantrone Hydrochloride Liposome Combined with PD-1 Blockade in Recurrent or Metastatic NPC","A Prospective, Single-arm Phase 2 Study Evaluating the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection Combined with PD-1 Blockade in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Willing to participate in the study, sign the informed consent form (ICF), and comply with study plan visits, treatment plans, laboratory tests, and other study procedures.\n2. Nasopharyngeal carcinoma confirmed by histopathology (differentiated or undifferentiated non-keratinous carcinoma).\n3. Age ≥ 18 \\& ≤ 70 years.\n4. PS (Performance Status) score 0-1.\n5. Recurrent or metastatic nasopharyngeal carcinoma that has failed first-line platinum-containing standard regimen and\u002For second-line standard regimen failure.\n6. Previously received at least one line of systemic therapy. (Progression after radical concurrent chemoradiotherapy, during neoadjuvant or adjuvant therapy, or within 6 months after the end of treatment can be recorded as 1-line therapy).\n7. Recurrent or metastatic nasopharyngeal carcinoma that has failed anti PD-1\u002FL1: anti PD-1\u002FL1 exposure at least 6 weeks, and the protocol used at the time of enrollment in this study meets one of the following two points: (1) Relapse during adjuvant therapy after radiotherapy, or relapse within 6 months after the end of treatment; (2) First-line treatment phase, progression during anti PD-1\u002FL1 treatment, or progression within 3 months after the end of anti PD-1\u002FL1 (whether combined with chemotherapy\u002Ftargeting drugs);\n8. At least one measurable lesion according to RECIST 1.1 criteria (the spiral CT scan diameter of the measurable lesion is ≥ 10 mm or the short diameter of the enlarged lymph node is ≥15mm ); lesions that have undergone local treatment can be selected as target lesions if there is clear evidence of significant progress compared to the end of treatment.\n9. All acute toxicities of previous antitumor therapy have returned to ≤ grade 1 (according to NCI-CTCAE v5.0) or reached the level specified in the inclusion\u002Fexclusion criteria. (Except for partial toxicity, such as alopecia, hair color change, nail change, fatigue, etc., which do not pose safety risks to subjects).\n10. Adequate main organ function. a. Hematology: neutrophil absolute value (ANC) ≥1.5×10\\^9\u002FL, hemoglobin (Hb) ≥ 9.0 g\u002FdL, platelets ≥ 100×10\\^9\u002FL; b. Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN could be enrolled; patients with liver metastasis, ≤ 5 times ULN), AST and ALT ≤ 3 times ULN, and alkaline phosphatase ≤ 3 times ULN; Albumin ≥ 3 g\u002FdL; c. International Normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times; d. Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL\u002Fmin according to Cockcroft-Gault formula; e. Proteinuria: urinary protein\u002Fcreatinine ratio (UPC ratio) \\\u003C 1.0. If the UPC ratio is less than or equal to 0.5, no further check is required. Patients with UPC ratio \\> 0.5 and those with 24-hour urinary protein \\\u003C 1000 mg could be enrolled; f. Note: The UPC ratio of random urine is a quantitative estimate of 24-hour urinary protein, and the two have a good correlation. UPC ratio can be calculated using the following formula: (a) Urinary protein\u002Furinary creatinine (if both protein and creatinine are mg\u002FdL); (b) (urinary protein)\\*0.088\u002F urinary creatinine (if urinary creatinine is mmol\u002FL).\n11. Survival is expected to be ≥ 3 months.\n12. Female subjects with negative blood human chorionic gonadotropin (HCG) (except for menopause and hysterectomy), female subjects of reproductive age and their partners using effective contraception during the trial period and within 6 months after the end of the last dose (e.g. Combined hormones \\[containing estrogen and progesterone combined to inhibit ovulation, progesterone contraception combined to inhibit ovulation, IUD, intrauterine hormone release system, bilateral tubal ligation, vasectomy, abstinence from sex, etc.).\n13. Male patients and their partners agree to use one of the contraceptive measures described in Article 9.\n\nExclusion Criteria:\n\n1. Recurrent lesions in local areas suitable for radical method (surgery) treatment.\n2. Severe allergy to mitoxantrone or liposome (such as systemic rash\u002Ferythema hypotension, bronchospasm, angioedema, or anaphylaxis).\n3. Prior treatment with doxorubicin or other anthracyclines and the cumulative doxorubicin doses greater than 350 mg\u002Fm\\^2 (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mg mitoxantrone).\n4. Estimated survival \\\u003C 3 months.\n5. Diagnosed and\u002For treated with other malignancies within 5 years prior to initial administration. (except for cervical cancer, skin basal cell or squamous cell carcinoma, localized prostate cancer, and ductal carcinoma in situ after radical treatment).\n6. Received surgery, chemotherapy, radiotherapy, immunotherapy, or any investigational drug or other antitumor therapy within the 4 weeks prior to initial administration (less than 2 weeks after palliative radiotherapy).\n7. Patients with hypertension who cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure \\> 140 mmHg\u002F diastolic blood pressure \\> 90 mmHg); Have ≥ grade II coronary heart disease; Any of the following conditions occurred during the first 6 months of enrollment: Myocardial infarction, severe\u002Funstable angina pectoris, NYHAII grade or higher cardiac insufficiency, grade 2 or higher persistent arrhythmias (including prolonged QTc interval \\> 450ms in men), Women \\> 470ms), any grade of atrial fibrillation, coronary\u002Fperipheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); The ejection fraction of the heart is below 50% or below the lower limit of the range of laboratory tests at the study center. Patients with a history of arterial thromboembolism events and venous thromboembolism \\> grade 3. (Patients with S-T elevation ≥ 2mm on the ECG may be enrolled if they do not show signs of recent myocardial infarction or ischemia) (according to NCI-CTCAE v5.0).\n8. Severe infection (such as intravenous antibiotics, antifungals, or antivirals as required by clinical practice) during the 4 weeks prior to the first dose, or any unexplained fever \\>38.5 ° C during the screening period \u002F 7 days prior to the first dose, or white blood cell count \\>15×109\u002FL at baseline.\n9. Immunosuppressants, or systemic hormone therapy (dose \\>10mg\u002F day of prednisone or other therapeutic hormone) are being used for the purpose and continue to be used within 2 weeks before the first dose.\n10. The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention as adults were included; Patients with asthma requiring medical intervention with bronchodilators were not included).\n11. Exacerbations of COPD or other respiratory diseases requiring hospitalization within 1 month prior to registration.Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening.\n12. HIV-positive people; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥1000 cps\u002Fml); Chronic hepatitis C blood screening positive (HCV antibody positive).\n13. Live vaccine was administered within 4 weeks before the first dose or possibly during the study period.\n14. Pregnant or lactating women.\n15. Women with reproductive potential and sexually active men who are unwilling\u002Funable to use medically acceptable forms of contraception.\n16. Have any serious and\u002For uncontrollable medical conditions that, as determined by the investigator, may affect the patient's participation in the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, and family or social factors that affect the safety of the patient.\n17. Other situations that the investigator determines to be inappropriate for participation.",{"count":251,"type":21},32,[24],"This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with PD-1 blockade in patients with recurrent (not unable to locally curative treatment) or metastatic NPC who failed at least first-line platinum-containing standard regimen and\u002For anti PD-1\u002FL1.",[27],[29,196,30,256,257],"Mitoxantrone Hydrochloride Liposome","PD-1 Blockade","2025-01-09",{"date":260,"type":38},"2025-01-13",{"date":262,"type":38},"2024-07-20",{"date":264,"type":21},"2027-09-30",{"name":44,"class":45},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":99},"100569016","surgery-alone-verus-sugery-combined-with-dose-reduced-radiotherapy-for-newly-diagnosed-stage-i-nasopharyngeal-carcinoma-100569016","NCT06688760","Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma","Endoscopic Nasopharyngectomy Combined with Retropharyngeal Lymph Node Dissection Plus Low-dose Radiotherapy Versus Bilateral Upper Neck Dissection for Newly Diagnosed Stage I Nasopharyngeal Carcinoma: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\nInclusion Criteria:\n\n* Performance Status Score 0-1 points.\n* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and\u002For cytologically.\n* According to the UICC\u002FAJCC eighth edition staging, the patient is defined as T1N0M0 stage I.\n* Adequate organ function: WBC ≥ 4×10\\^9 \u002FL, NEUT ≥ 2×10\\^6 \u002FL, HGB ≥ 9 g\u002FdL, PLT count ≥ 100×10\\^9\u002FL, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g\u002FdL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL\u002Fmin.\n* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.\n\nExclusion Criteria:\n\n* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.\n* Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.\n* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.\n* During pregnancy or lactation.\n* Other patients that the chief physician considered as illegal for this trial.",{"count":274,"type":21},86,[227],"The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma.",[29,278,279],"Surgery","Radiotherapy","2024-11-12",{"date":282,"type":38},"2024-11-14",{"date":284,"type":38},"2023-11-01",{"date":286,"type":21},"2028-11-01",{"name":44,"class":45},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":46},"100556780","surgery-plus-reduced-target-chemoradiotherapy-vs-surgery-plus-reduced-dose-chemoradiotherapy-for-newly-diagnosed-operable-nasopharyngeal-carcinoma-100556780","NCT06529562","Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.","Surgery Plus Reduced Target Chemoradiotherapy Versus Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma : a Prospective, Multicenter, Radomized Control Trial","Inclusion Criteria:\n\n* Performance Status Score 0-1 points.\n* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and\u002For cytologically.\n* Patients with primary nasopharyngeal lesions evaluated as surgically resectable, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus) and tumor diameter ≤1.5cm. Resectable retropharyngeal lymph nodes were defined as; The diameter was ≤ 1.5cm, the tissue space was intact, and there was no obvious extranodal invasion; The resectable cervical lymph nodes were defined as ≤ 3cm in diameter, located above the lower edge of the cricoid cartilage, with moderate mobility and no obvious extranodal invasion. Clinical stage: T1-3N1-2M0, T2-3N0M0 (Stage II-III) according to AJCC 8th staging edition.\n* Adequate organ function: WBC ≥ 4×10\\^9 \u002FL, NEUT ≥ 2×10\\^6 \u002FL, HGB ≥ 9 g\u002FdL, PLT count ≥ 100×10\\^9\u002FL, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g\u002FdL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL\u002Fmin.\n* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.\n\nExclusion Criteria:\n\n* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.\n* Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy or chemotherapy.\n* Retropharyngeal lymph node diameter\\>1.5cm, or extranodal invasion, such as invasion of internal carotid artery, muscle, or extensive extracapsular dissemination.\n* Cervical lymph node diameter\\>3cm, or in the area below the lower margin of the cricoid cartilage, or with extranodal invasion, such as invasion of the internal carotid artery, skin, muscle, mediastinal structure, prevertebral fascia or cervical spine, or extensive extra-capsular spread, subcutaneous metastasis, etc.\n* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.\n* During pregnancy or lactation.\n* Other patients that the chief physician considered as illegal for this trial.",{"count":296,"type":21},384,[227],"The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .",[29],[278,301,302,303],"Target-Reduction Chemoradiotherapy","Dose-Reduction Chemoradiotherapy","Locally Resectable Nasopharyngeal Carcinoma","2024-07-30",{"date":306,"type":38},"2024-07-31",{"date":308,"type":38},"2022-11-01",{"date":310,"type":21},"2032-11-01",{"name":44,"class":45},""]