[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476472":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":34,"collaborators":38,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":20,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":20},{"fullName":5,"class":6},"Affiliated Cancer Hospital & Institute of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Capecitabine plus toripalimab maintenance therapy","EXPERIMENTAL","capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.",[13],"Drug: Capecitabine plus toripalimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Capecitabine plus toripalimab","Capecitabine tablet: 650mg\u002Fm2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Yin Wen-Jing","STUDY_DIRECTOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","0086-13929503157","wenjing1342@163.com",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Liu Jin-Quan","0086-137-1086-6485","609149209@qq.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Wenjing Yin","attending physician",[39,41],{"name":40,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":42,"class":6},"Hunan Cancer Hospital","100476472","phase-2-capecitabine-plus-toripalimab-maintenance-therapy-in-metastatic-nasopharyngeal-carcinoma-after-first-line-treatment-100476472",false,"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","ALL","18 Years","65 Years",{"count":54,"type":55},40,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","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.",[61],"Metastatic Nasopharyngeal Carcinoma",[63,64,65,66],"nasopharyngeal carcinoma","capecitabine","toripalimab","maintenance therapy","NOT_YET_RECRUITING","2022-07-30",{"date":70,"type":71},"2022-08-02","ACTUAL",{"date":73,"type":55},"2022-09",{"date":75,"type":55},"2029-09",{"name":5,"class":6}]