[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554636":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":48,"centralContacts":53,"locations":58,"responsibleParty":60,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":58,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":58,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":86,"whyStopped":58,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":58},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","liposomal irinotecan+5-FU\u002FLV q2w",[13,14,15],"Drug: liposomal irinotecan","Drug: 5-FU","Drug: LV",{"label":17,"type":18,"description":19,"interventionNames":20},"Control group","ACTIVE_COMPARATOR","Irinotecan q2w or irinotecan+5-FU\u002FLV q2w",[14,15,21],"Drug: Irinotecan",[23,30,36,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","liposomal irinotecan","Liposomal irinotecan 70 mg\u002Fm²",[9],[29],"Nal-IRI",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"5-FU","5-FU 400 mg\u002Fm² bolus then 2400 mg\u002Fm2 over 46 h",[17,9],[35],"Fluorouracil",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"LV","LV 400 mg\u002Fm²",[17,9],[41],"Calcium folinate",{"type":24,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Irinotecan","Irinotecan 180 mg\u002Fm²",[17],[47],"IRI",[49],{"name":50,"affiliation":51,"role":52},"Ruihua Xu, Professor","Yat-sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Huiyan Luo, Professor","CONTACT","020-87343804",null,"luohy@sysucc.org.cn",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"SPONSOR_INVESTIGATOR","Rui-hua Xu, MD, PhD","professor","100554636","phase-3-liposomal-irinotecan-and-5-fu-as-second-line-therapy-for-patients-with-escc-100554636",false,"NCT06501664","Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC","Liposomal Irinotecan and 5-FU Versus Irinotecan \u002F Irinotecan+5-fluorouracil as Second-line Therapy for Patients With Esophageal Squamous Cell Carcinoma: A Open-label, Randomized Study","Inclusion Criteria:\n\n* Age: 18-75 years old.\n* Unresectable esophageal squamous cell carcinoma confirmed by histopathology and\u002For cytology.\n* Failure or intolerance to first-line treatment.\n* At least one measurable lesion (according to RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 \\~ 1.\n* The expected survival time ≥3 months.\n* Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count ≥100×10\\^9\u002FL, hemoglobin (Hgb) ≥90 g\u002FL.\n* Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present. Documented serum albumin ≥ 3 g\u002FdL.\n* Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL\u002Fmin.\n* Subjects agree to use contraception and are not pregnant or breastfeeding women.\n* Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.\n\nExclusion Criteria:\n\n* Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.\n* Received irinotecan\u002Firinotecan liposome based therapy in the first line.\n* Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.\n* Active HIV infection.\n* Combined with uncontrollable systemic diseases, such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; uncontrolled hypertension(Defined as systolic blood pressure≥140 mmHg and\u002For diastolic blood pressure≥90 mmHg after treatment with standardized antihypertensive drugs), or history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes, etc.\n* Presence of severe gastrointestinal disease (including active bleeding, \\> grade 1 obstruction , \\> grade 1 diarrhea or gastrointestinal perforation)\n* Allergy to or intolerance to therapeutic drugs or their excipients.\n* Presence of central nervous system metastasis.\n* Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.\n* Participated in other trial within 30 days or within 5 half-lives of the drug prior to the first dose of study treatment.\n* Patients who are not suitable to participate in this trial for any reason judged by the investigator.","ALL","18 Years","75 Years",{"count":75,"type":76},360,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan \u002F irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).",[82],"Esophageal Cancer",[25,84,85],"second-line therapy","esophageal squamous cell carcinoma","NOT_YET_RECRUITING","2024-07-09",{"date":89,"type":90},"2024-07-15","ACTUAL",{"date":92,"type":76},"2024-08-01",{"date":94,"type":76},"2027-11-30",{"name":62,"class":6}]