[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-nasopharyngeal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-nasopharyngeal-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,73,93,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100518340","phase-2-testing-the-addition-of-bms-986016-relatlimab-to-the-usual-immunotherapy-after-initial-treatment-for-recurrent-or-metastatic-nasopharyngeal-cancer-100518340",false,"NCT06029270","Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer","A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent\u002FMetastatic Nasopharyngeal Carcinoma (REMAIN)","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* Pathologically (histologically or cytologically) proven diagnosis of nasopharyngeal carcinoma (NPC) that has recurred locoregionally and\u002For is present at distant sites. Patients who present with metastatic disease (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. Eligible patient must have the following characteristics:\n\n  * Tumor showing (histological\u002Fcytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or\n  * A known history of detectable plasma EBV DNA (via a polymerase chain reaction \\[PCR\\]-based assay) at any time point since the initial diagnosis of NPC.\n* Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated.\n\n  * Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable.\n  * CT the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated).\n  * Patients with known locoregional disease must have contrast enhanced MRI or CT of the nasopharynx and neck as this disease site(s) may be assessed as target lesions. For patients without known locoregional disease, imaging of the nasopharynx and neck is optional.\n  * Symptomatic and active brain metastases and\u002For leptomeningeal metastasis on CT and\u002For MRI imaging: Patients who have prior therapies for brain and leptomeningeal metastasis or cord\u002Fcauda compression who are clinically stable for \\>= 2 months prior to registration and have discontinued systemic steroids therapy (\\> 10 mg\u002Fday prednisone or equivalent) \\> 4 weeks prior to registration are eligible.\n  * Patients with base of skull involvement by NPC are allowed unless their disease is directly invading the brain parenchyma, associated with clinical symptoms and\u002For significant vasogenic edema on radiological imaging.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n* Absolute neutrophil count (ANC) \\>= 1500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin (Hgb) \\>= 8.0 g\u002FdL (Transfusion is accepted. Erythropoietin dependency not accepted.).\n* Total bilirubin =\\\u003C 1.5 × institutional upper limit of normal (ULN) or direct bilirubin =\\\u003C ULN for patients with total bilirubin levels \\> 1.5 × ULN. Patients with known Gilbert's disease who have serum bilirubin level =\\\u003C 3 × ULN may be enrolled.\n* Alanine transaminase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 × ULN (=\\\u003C 5 × ULN for patients with liver metastases).\n* Serum creatinine =\\\u003C 1.5 × ULN or calculated creatinine clearance (CrCl) based on Cockcroft-Gault equation \\>= 30 mL\u002Fmin for patients with serum creatinine levels \\> 1.5 × ULN. Cisplatin or carboplatin may be used at the discretion of the investigator - except for patients with CrCl between 30-50 mL\u002Fmin, for whom carboplatin should be used instead of cisplatin. CrCl must be \\> 50 mL\u002Fmin for cisplatin to be used.\n* Albumin-adjusted calcium level based on corrected calcium equation =\\\u003C 1.5 × ULN (patients are allowed to have treatment for hypercalcemia prior to starting treatment).\n* No prior systemic treatment of palliative intent for recurrent\u002Fmetastatic (R\u002FM) NPC including cytotoxic chemotherapy. Prior treatment for non-recurrent and non-metastatic NPC is allowed. Systemic therapy given prior to curative intent re-irradiation or surgery is allowed for potentially curable locoregional recurrence.\n* No prior treatment with a PD-1 inhibitor (except if given as adjuvant or neoadjuvant therapy for NPC), PD-L1 inhibitor, anti-PD-L2 inhibitor, LAG-3 inhibitor, CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n* The interval between the last dose of curative-intent treatment for non-recurrent, non-metastatic NPC, including definitive radiotherapy (RT) and\u002For induction, concurrent, or adjuvant chemotherapy and recurrence must be ˃ 6 months.\n* Clinically significant toxicities from any prior systemic therapy or radiotherapy must have resolved to grade 0 or 1 as per National Cancer Institute (NCI) CTCAE v 5.0 - except alopecia, dry mouth, dysgeusia, dysphagia, and fatigue. Patients with a history of grade 3-4 cisplatin related neuropathy must have recovered to grade 0-2 prior to registration. Patients with a history of hearing impairment, or ototoxicity from prior cisplatin, of any grade are allowed.\n* No prior palliative RT within 30 days prior to registration unless the irradiated site(s) are not the target lesions. The irradiated site(s) also must not be the only sites of measurable recurrent disease.\n* No major surgical procedures within 30 days prior to registration.\n* No history of unstable angina requiring hospitalization within the last 6 months.\n* No history of myocardial infarction within the last 6 months.\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III\u002FIV are not eligible). Patients with symptomatic coronary artery disease, congestive heart failure or a known history of having a left ventricular ejection fraction \\\u003C 50% must be stably controlled with medication in the opinion of the treating physician, in consultation with a cardiologist if appropriate.\n* No prior history of myocarditis.\n* No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments at the time of study registration.\n* No history of (non-infectious) pneumonitis that required steroids or current pneumonitis requiring steroids and\u002For immunosuppressive therapy, idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans), or idiopathic pneumonitis.\n* No history of multi-drug resistant mycobacterium tuberculosis (TB) or active TB, as defined by systemic treatment received =\\\u003C 2 years prior to registration. Note: Patients who had a history of treated TB ˃ 2 years prior to registration are allowed.\n* No prior solid organ transplant or bone marrow transplant.\n* No conditions requiring systemic treatment with either immunosuppressive doses of corticosteroids (\\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid premedication for the prophylaxis of CT contrast-related allergies is allowed. The use of dexamethasone as an anti-emetic premedication prior to chemotherapy is also allowed.\n* No active autoimmune disease requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These may include (but not limited to) patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, autoimmune hepatitis, glomerulonephritis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome.\n\n  * Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; alopecia; and\u002For psoriasis not requiring systemic treatment. Conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* No prior live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines that are approved by the local drug regulatory authority of the participating region are allowed.\n* No known history of grade 3-4 allergic reaction or hypersensitivity reaction to cisplatin, carboplatin, or gemcitabine.\n* No known history of grade 4 hypersensitivity (or infusion) reaction to any monoclonal antibody. Patients who had prior grade 3 hypersensitivity (or infusion) reaction but could tolerate resumption of the antibody treatment after appropriate pre-medication are eligible.\n* PRIOR TO STEP 2 REGISTRATION:\n* Collection of plasma EBV DNA at baseline is mandatory for all patients prior to Step 2 registration and induction treatment.\n\n  * Note: Submission of the baseline sample will be batch shipped.\n* PRIOR TO STEP 3 REGISTRATION\u002FRANDOMIZATION: PATIENTS WITHOUT PROGRESSIVE DISEASE (PD) ONLY:\n* All patients must have received minimum of 3 cycles, and up to a maximum of 6 cycles of induction treatment within 20 weeks from cycle 1, day 1 of induction treatment (i.e., patients must have completed all induction treatment within 20 weeks from cycle 1 day 1, including the treatment breaks). Patients must have completed 6 cycles of induction treatment, except in the following circumstances:\n\n  * Significant dose delays as a result of treatment-related toxicities.\n  * Intercurrent illness(s), that rendered the patient unable to continue induction treatment.\n  * Note: If a patient received \\\u003C 6 cycles of induction treatment for reasons other than the above circumstances, they will not be eligible for randomization.\n* A CT scan within 30 days prior to Step 3 registration\u002Frandomization is required. If the most recent scan performed is not within this time frame, a repeat scan is required to assess response.\n* Did not meet any criteria that result in permanent discontinuation of study treatment during induction treatment phase.\n* Must meet the criteria for starting\u002Fresuming a new cycle of maintenance treatment.\n* Did not experience any nivolumab-related autoimmune toxicities that would result in permanent discontinuation of nivolumab during the induction treatment phase.\n* Collection of the plasma EBV DNA post-induction treatment is mandatory.\n\n  * Note: Submission of the post-induction sample will be batch shipped.","ALL","18 Years",{"count":19,"type":20},156,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.",[26,27,28],"Metastatic Nasopharyngeal Carcinoma","Recurrent Nasopharyngeal Carcinoma","Stage IV Nasopharyngeal Carcinoma AJCC v8","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2024-07-15",{"date":37,"type":20},"2029-04-30",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",88,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"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.","75 Years",{"count":51,"type":20},148,[53,23],"PHASE1","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.",[56,57,26],"Nasopharyngeal Cancinoma (NPC)","Recurrent Nasopharynx Carcinoma",[59,60,61],"EGFR antibody","PD-1 antibody","chemotherapy","2026-05-06",{"date":64,"type":33},"2026-05-11",{"date":66,"type":33},"2025-07-09",{"date":68,"type":20},"2029-06",{"name":70,"class":71},"Sun Yat-sen University","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":26,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":72},"100584208","phase-1-metastatic-nasopharyngeal-carcinoma-100584208","NCT06886347","Penpulimab Plus Gemcitabine and Anlotinib in the Treatment of Metastatic Nasopharyngeal Cancer, A Single Arm, Open-label, Phase Ib Clinical Trial","Inclusion Criteria:\n\n1. The participants voluntarily signed an informed consent form.\n2. Age of ≥ 18 years and ≤ 75 years at the time of enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. xpected survival of ≥ 3 months.\n5. Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th).\n6. Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.\n7. At least one measurable tumor lesion per RECIST 1.1 criteria.\n8. Adequate organ function.\n9. Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study.\n10. The subjects are willing and able to comply with the visit schedule, treatment plan, laboratory examination, and other requirements of the study.\n\nExclusion Criteria:\n\n1. ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.\n2. Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.\n3. Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.\n4. Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance).\n5. Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease.\n6. Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy.\n7. Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.\n8. Previously received anti angiogenic therapy.\n9. According to the judgment of the investigator, there are subjects with concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who believe that there are other reasons that are not suitable for enrollment.",{"count":80,"type":20},47,[53],"To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.",[26],"2025-03-14",{"date":86,"type":33},"2025-03-20",{"date":88,"type":33},"2023-07-07",{"date":90,"type":20},"2026-04-01",{"name":92,"class":71},"Chen Xiaozhong",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100541590","phase-2-stop-and-go-strategy-as-first-line-treatment-for-widely-metastatic-nasopharyngeal-carcinoma-100541590","NCT06331845","Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma","Stop and go Strategy as First-line Treatment in Patients With Objective Response After Systematic Chemotherapy for Widely de Novo Metastatic Nasopharyngeal Carcinoma: A Phase II Trial","Inclusion Criteria:\n\n1. Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases were defined as more than 5 lesions and\u002For more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥ 6 months as judged by the Investigator;\n3. The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Adequate organ function;\n4. Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;\n5. Able and willing to provide a signed informed consent form, and able to comply with all procedures.\n6. The time from the last chemotherapy and\u002For radiotherapy to randomization must be ≥6 months.\n\nExclusion Criteria:\n\n1. Patients with a hypersensitivity to any of the drugs used in our study;\n2. With any active autoimmune disease or history of autoimmune disease;\n3. Clinically significant cardiovascular and cerebrovascular diseases;\n4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);\n5. Active systemic infection;\n6. Drug or alcohol abuse;\n7. No or limited capacity for civil conduct;\n8. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;\n9. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy；\n10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and the subject requiring hormone therapy during trials.\n11. Pregnancy or breastfeeding.","70 Years",{"count":102,"type":20},39,[23],"This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC).",[26,106],"Intermittent Systematic Chemotherapy",[108,109,110],"metastatic nasopharyngeal carcinoma","systematic chemotherapy","intermittent systematic chemotherapy","NOT_YET_RECRUITING","2024-03-20",{"date":114,"type":33},"2024-03-26",{"date":116,"type":20},"2024-05-01",{"date":118,"type":20},"2028-05-01",{"name":120,"class":121},"Fujian Cancer Hospital","OTHER_GOV",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100476472","phase-2-capecitabine-plus-toripalimab-maintenance-therapy-in-metastatic-nasopharyngeal-carcinoma-after-first-line-treatment-100476472","NCT05484375","Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment","Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Gemcitabine\u002FCisplatin Plus Toripalimab Treatment: a Single Arm, Open Label, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n1. Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC\u002FUICC 8th，any T，any N，M1）\n2. Patients receiving gemcitabine\u002Fcisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies\n3. Age ≥18 years and ≤65 years\n4. WBC≥4×10\\^9\u002FL, platelet ≥ 100×10\\^9\u002FL, hemoglobin ≥ 90g\u002FL and Albumin≥28 g\u002FL\n5. With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)\n6. With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml\u002Fmin)\n7. ECOG score is 0-1\n8. At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine\u002Fcisplatin plus toripalimab)\n9. Life expectancy is at least 12 weeks\n10. Patients sign informed consent forms\n\nExclusion Criteria:\n\n1. History of severe anaphylaxis to any component of capecitabine or toripalimab\n2. Active or untreated central nervous system metastases\n3. Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding\n4. Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.\n5. Patients with poorly controlled or symptomatic hypercalcemia\n6. Pregnancy or lactation\n7. Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.\n8. Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.\n9. History of autoimmune diseases\n10. Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.\n11. Receive any active vaccine within 4 weeks prior to enrollment\n12. Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study\n13. Active pneumonia\n14. Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.\n15. Presence of severe neurological or psychiatric disorders, including dementia and seizures.\n16. Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE\n17. Major cardiovascular diseases","65 Years",{"count":131,"type":20},40,[23],"to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine\u002Fcisplatin combined with toripalimab.",[26],[136,137,138,139],"nasopharyngeal carcinoma","capecitabine","toripalimab","maintenance therapy","2022-07-30",{"date":142,"type":33},"2022-08-02",{"date":144,"type":20},"2022-09",{"date":146,"type":20},"2029-09",{"name":148,"class":71},"Affiliated Cancer Hospital & Institute of Guangzhou Medical University"]