[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"npc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:npc":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100613495","phase-2-pembrolizumab--mrgoo3-as-neoadjuvant-in-npc-100613495",false,"NCT07267338","Pembrolizumab + MRGOO3 as Neoadjuvant in NPC","Pembrolizumab Combined With MRG-003 as Neoadjuvant Treatment of EBV- Associated Locoregionally Advanced Nasopharyngeal Carcinoma: A Single-arm, Single-center, Prospective Phase II Trial","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 stage III-IVa (Exclude T3N0) nasopharyngeal carcinoma (NPC) will be enrolled in this study.\n2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n3. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n4. Archival tumor tissue sample or newly obtained \\[core or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slide. Newly obtained biopsies are preferred to archived tissue.\n5. 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.\n6. Epsitein-Barr virus-encoded RNA(EBER) positive.\n7. Epidermal Growth Factor Receptor (EGFR) positive.\n8. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Have adequate organ function. Specimens must be collected within 10 days prior to the start of study intervention.\n\nExclusion Criteria:\n\n1. Presence of any distant metastasis.\n2. Has received prior therapy with EGFR target therapy, or an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to \\[allocation\\].\n4. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Known additional malignancy that is progressing or has required active treatment within the past 3 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. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n9. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, MRG003 and\u002For any of its excipients.\n11. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n12. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n13. Has an active infection requiring systemic therapy.\n14. History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]) infection.\n\n    Note: Testing for Hepatitis B or C is not required unless mandated by local health authority.\n15. Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n\n    Note: Hepatitis B and C screening tests are not required unless:\n    * Known history of HBV and HCV infection\n    * As mandated by local health authority\n16. Has not adequately recovered from major surgery or has ongoing surgical complications.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.\n21. History of HIV infection. HIV testing is not required unless mandated by local health authority.","ALL",{"count":18,"type":19},35,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The goal of this clinical trial is to evaluate efficacy and safety of neoadjuvant of the anti PD1 agent Pembrolizumab combined with MRG003 and adjuvant treatment of Pembrolizumab in patients with Epstein-Barr virus (EBV) - associated locoregionally advanced nasopharyngeal carcinoma.\n\nThe expected sample size is 35 patients.\n\nParticipants will receive 3 cycles of neoadjuvant pembrolizumab 200mg Q3W plus MRG003 2.3mg\u002Fkg Q3W followed by the standard concurrent chemoradiotherapy. Then participants will receive 14 cycles of adjuvant Pembrolizumab 200 mg Q3W after the standard concurrent chemoradiotherapy.\n\nThe estimated average length of treatment per patients is 1 year.",[25,26],"NPC","Locoregionally Advanced Nasopharyngeal Carcinoma","NOT_YET_RECRUITING","2025-11-24",{"date":30,"type":31},"2025-12-05","ACTUAL",{"date":33,"type":19},"2026-06",{"date":35,"type":19},"2029-06",{"name":37,"class":38},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100571378","phase-2-a-clinical-trial-to-evaluate-effect-of-iae0972-combined-with-chemotherapy-for-rm-hnscc-or-npcnote-it-is-currently-phase-ii-100571378","NCT06719479","A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R\u002FM HNSCC or NPC(Note: It is Currently Phase II.).","A Phase II\u002FIII Clinical Trial to Evaluate the Effect of IAE0972 Combined with Chemotherapy Selected by Doctors for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma\u002FNasopharyngeal Carcinoma.","Inclusion Criteria:\n\n1. The age is 18\\~75 years old (including the critical value), regardless of gender.\n2. Phase II cohort 1, cohort 2: locally advanced squamous cell carcinoma of the head and neck which only occurred in the oral cavity, oropharynx, hypopharynx and larynx after histological diagnosis or had no indication of radical local treatment; In the past, I only received ≤2 line therapy for recurrent and metastatic head and neck squamous cell carcinoma.\n3. Phase II cohort 3, cohort 4, cohort 5: Histologically confirmed nasopharyngeal carcinoma, stage IVb or recurrent nasopharyngeal carcinoma that is not suitable for local treatment according to the TNM of AJCC nasopharyngeal carcinoma in the 8th edition of 2017; In the past, they only received ≤2 line therapy for recurrent and metastatic nasopharyngeal carcinoma.\n4. According to the researcher's judgment, the chemotherapy in this experiment is applicable.\n5. According to the RECIST 1.1 standard, there is at least one measurable lesion (tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not regarded as measurable lesions, unless the lesions make clear progress or persist after radiotherapy for three months).\n6. The score of physical condition of the ECOG is 0\\~1.\n7. The estimated survival time is ≥3 months.\n8. Have sufficient organ functions:\n\n   * Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): ANC≥1.5×109\u002FL, PLT≥90×109\u002FL, HGB≥ 90 g\u002FL; ② Liver function: TBIL≤1.5 times the ULN, except Gilbert syndrome; AST and ALT are ≤3.0 times ULN, while subjects with liver metastasis or liver cancer need AST and ALT≤3.0 times ULN and total bilirubin ≤ 3.0 times ULN;\n\n     * Renal function: Cr≤1.5 times ULN; If the creatinine is more than 1.5 times ULN, the CCR should be ≥ 50 ml\u002Fmin (calculated according to Cockcroft-Gault formula);\n\n       * Coagulation function: INR≤1.5 times ULN, APTT≤1.5 times ULN, and INR and APTT≤2.5 times ULN for patients with liver metastasis or liver cancer.\n9. Qualified fertile subjects (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners during the trial and at least 6 months after the last medication; The blood pregnancy test of female subjects of childbearing age must be negative within 7 days before the first use of the study drug.\n10. Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Having received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the investigating drug, the following drugs should be excluded according to the following criteria:\n\n   ① Nitrosourea or mitomycin C was used within 6 weeks before the first use of the study drug;\n\n   ② Oral administration of fluorouracil and small molecule targeted drugs 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer);\n\n   ③ Chinese patent drugs with anti-tumor indications were used within 2 weeks before the first use of the study drugs.\n2. Received other unlisted clinical research drugs or treatments within 4 weeks before using the research drugs.\n3. The adverse reactions of previous anti-tumor treatments have not recovered to NCI CTCAE 5.0 grade evaluation ≤1 grade or the relevant provisions of the selection criteria (except for the toxicity that the researchers judged to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.).\n4. It is known that it has hypersensitivity to any antibody drugs (NCI CTCAE 5.0 rating is ≥3), or it has hypersensitivity to research drugs, active ingredients or inactive excipients of chemotherapy schemes.\n5. Have received major surgery (excluding puncture biopsy), major trauma or need to undergo elective surgery during the trial within 4 weeks before the first use of the study drug.\n6. Having received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or similar drugs with the same dose) within 14 days before the first use of the study drug, except for the following cases: using topical, ophthalmic, intra-articular and intranasal corticosteroids; Short-term use of glucocorticoids for preventive treatment (for example, prevention of contrast agent allergy).\n7. Treatment with other immunosuppressants within 28 days or 5 half-lives (whichever is longer) before the first use of the study drug.\n8. Have used immunomodulatory drugs within 14 days before the first use of the study drug (Appendix 5).\n9. Have been vaccinated with any live vaccine within 4 weeks before the first use of the study drug.\n10. Received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past.\n11. Brain parenchymal metastasis or meningeal metastasis with clinical symptoms.\n12. It has active infection and needs intravenous anti-infection treatment at present.\n13. Have a history of immunodeficiency disease, including positive detection of HIV antibody.\n14. Active hepatitis B (HBsAg positive and HBV-DNA positive or above the upper limit of normal value) and active hepatitis C (HCV antibody positive and HCV RNA positive or above the upper limit of normal value).\n15. Having serious and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease, etc.).\n16. Have a serious history of cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    ① Severe cardiac rhythm or conduction abnormality, such as ventricular arrhythmia requiring clinical intervention and II-III degree atrioventricular block;\n\n    ② The mean QT interval (QTcF) corrected by Fridericia method was≥470 ms；\n\n    ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration; (4) There is heart failure or LVEF less than 50% with the NYHA cardiac function classification ≥II or structural heart disease with high risk judged by other researchers;\n\n    ⑤ Clinically uncontrollable hypertension.\n17. Suffering from active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), with the exception of clinically stable autoimmune thyroiditis, type I diabetes, vitiligo, cured atopic dermatitis in children, psoriasis that does not require systemic treatment (within the past 2 years), etc.\n18. Suffering from other malignant tumors within 5 years before the start of study administration, except for the following cases: malignant tumors that can be expected to be cured after treatment (including but not limited to thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer or breast ductal carcinoma in situ treated by radical surgery).\n19. There is clinically uncontrollable effusion in the third space, which is judged by the researcher to be unsuitable for the group.\n20. Known alcohol or drug dependence.\n21. Have mental disorder or poor compliance.\n22. Pregnant or lactating women.\n23. The researcher thinks that the subject has other serious history of systemic diseases, or is not suitable to participate in this clinical study for other reasons.","18 Years","75 Years",{"count":50,"type":19},60,[22,52],"PHASE3","Phase II: To evaluate the safety and tolerability of IAE0972 combined with chemotherapy selected by doctors for R\u002FM HNSCC\u002FNPC after failure or progress of ≤2-line system therapy, and to determine the MTD of combined therapy.\n\nPhase III: According to the RECIST 1.1, the effectiveness of IAE0972 combined with chemotherapy regimen chosen by doctors compared with placebo plus chemotherapy regimen chosen by doctors was evaluated through OS in patients with R\u002FM NPC who failed or progressed after treatment with ≤2-line system.",[25,55,56,57],"HNSCC","Recurrence","Metastasis",[25,55,56,57],"2024-12-02",{"date":61,"type":31},"2024-12-05",{"date":63,"type":19},"2025-01-01",{"date":65,"type":19},"2028-01-01",{"name":67,"class":68},"SUNHO（China）BioPharmaceutical CO., Ltd.","INDUSTRY",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":39},"100356327","phase-3-cisplatin-based-and-carboplatin-based-chemoradiation-in-locoregionally-advanced-nasopharyngeal-carcinoma-100356327","NCT03919552","Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma","Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：: A Phase 3 Trial","Inclusion Criteria:\n\n* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).\n* Tumor staged as T3-4Nx\u002FTxN2-3 (according to the 8th American Joint Commission on Cancer edition).\n* No evidence of distant metastasis (M0).\n* Satisfactory performance status: Karnofsky scale (KPS) \\> 70.\n* Adequate marrow: leucocyte count ≥4000\u002FμL, hemoglobin ≥90g\u002FL and platelet count ≥100000\u002FμL.\n* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \\\u003C1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.\n* Adequate renal function: creatinine clearance ≥60 ml\u002Fmin.\n* Patients must be informed of the investigational nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.\n* Age ≥65 years or \\\u003C18 years.\n* Treatment with palliative intent.\n* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.\n* Pregnancy or lactation.\n* History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).\n* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.\n* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \\>1.5×ULN), and emotional disturbance.","64 Years",{"count":78,"type":19},482,[52],"The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.",[82,83,25],"Cisplatin","Carboplatin",[85,86,87],"Nasopharyngeal Carcinoma","cisplatin","carboplatin","RECRUITING","2023-06-14",{"date":91,"type":31},"2023-06-18",{"date":93,"type":31},"2018-01-31",{"date":95,"type":19},"2026-12-31",{"name":97,"class":38},"Nanfang Hospital, Southern Medical University"]