[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395751":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":32,"centralContacts":37,"locations":44,"responsibleParty":63,"collaborators":32,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":32,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":32,"overallStatus":84,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","ATRA 20 mg, three times a day (tid), for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles; combined with the treatment regimen chosen by the investigator since Day 6 of cycle 1.",[13],"Drug: All-trans Retinoic Acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).",[19,20],"Drug: VEGFR inhibitor","Drug: Chemotherapy",[22,29,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","All-trans Retinoic Acid","ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles",[9],[28],"Ailike",{"type":23,"name":30,"description":30,"armGroupLabels":31,"otherNames":32},"VEGFR inhibitor",[15],null,{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Chemotherapy","chemotherapy",[15],[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Guopei Zhu, M.D","CONTACT","021-23271699","5665","antica@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Shanghai Ninth People's Hospital","RECRUITING","Shanghai","Shanghai Municipality","200011","China","CN",{"type":54,"coordinates":55},"Point",[56,57],121.45806,31.22222,{"lat":57,"lon":56},[60],{"name":61,"role":40,"phone":41,"phoneExt":42,"email":62},"Lulu Ye, Master","yee166@163.com",{"type":64,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100395751","phase-2-all-trans-retinoic-acid-atra-in-the-treatment-of-recurrentmetastatic-adenoid-cystic-carcinoma-of-the-head-and-neck-100395751",false,"NCT04433169","All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent\u002FMetastatic Adenoid Cystic Carcinoma of the Head and Neck","A Prospective, Open-label, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of All-trans Retinoic Acid (ATRA) in the Treatment of Patients With Recurrent\u002FMetastatic Adenoid Cystic Carcinoma of the Head and Neck","Aplus","Inclusion Criteria:\n\n1\\. Age ≥ 18 years, male or female; 2. ECOG PS (performance status) score: 0-1; 3. Pathologically or histologically confirmed advanced, recurrent\u002Fmetastatic ACC, with measurable disease (≥10 mm by spiral CT scan, meeting RECIST 1.1 criteria); 4. Patients with therapeutic indications; 5. Main organ functions normal, i.e., meeting the criteria below:\n\n1. Criteria for routine blood test: (no blood transfusion within 14 days)\n\n   1. HB ≥ 90 g\u002FL;\n   2. WBC ≥ 3.5 × 109\u002FL and \\\u003C 10 × 109\u002FL;\n   3. ANC ≥ 1.5 × 109\u002FL;\n   4. PLT ≥ 80 × 109\u002FL\n2. Criteria for biochemical tests:\n\n   1. BIL \\\u003C 1.25 × upper limit of normal (ULN)\n   2. ALT and AST \\\u003C 2.5 × ULN; in the presence of metastases to liver, ALT and AST \\\u003C 5 × ULN;\n   3. Serum Cr ≤ 1 × ULN, endogenous creatinine clearance \\> 50 mL\u002Fmin (Cockcroft-Gault equation); 5. Subjects who volunteer to participate in this study, sign the informed consent, have good compliance and cooperate in follow-up; 6. Patients who, in the doctor's opinion, can benefit from the treatment.\n\nExclusion Criteria:\n\n1. Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;\n2. Coagulation abnormal (INR\\>1.5, APTT\\>1.5×ULN), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency \\[e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and\u002For hematemesis, hemoptysis in the past 3 months\\];\n3. Confirmed hypersensitivity to ATRA;\n4. Grade I and above coronary artery diseases, arrhythmias \\[including QTc prolongation (males: \\> 450 ms, females: \\> 470 ms)\\] and cardiac dysfunction;\n5. Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);\n6. Pregnant or lactating women;\n7. History of psychotropic abuse with abstinence failure, or existing mental disorder;\n8. Participation in other drug clinical trials within 4 weeks;\n9. Other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator.","ALL","18 Years",{"count":76,"type":77},30,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This is a prospective, open-label, randomized controlled clinical intervention study to evaluate the efficacy and safety of all-trans retinoic acid (ATRA) in treating patients with recurrent metastatic adenoid cystic carcinoma of the head and neck.",[83],"Adenoid Cystic Carcinoma of the Head and Neck","UNKNOWN","2021-01-31",{"date":87,"type":88},"2021-02-02","ACTUAL",{"date":90,"type":88},"2020-06-03",{"date":92,"type":77},"2023-06",{"name":5,"class":6},1]