[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600615":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":24,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":24,"enrollmentInfo":57,"targetDuration":24,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":24,"overallStatus":66,"whyStopped":24,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NALIRI+Lenvatinib","EXPERIMENTAL","Liposomal irinotecan+5-FU\u002FLV+Lenvatinib",[13],"Drug: Liposomal irinotecan+5-FU\u002FLV+Lenvatinib",{"label":15,"type":10,"description":16,"interventionNames":17},"NALIRI","Liposomal irinotecan+5-FU\u002FLV",[18],"Drug: NALIRI",[20,25],{"type":21,"name":11,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Liposomal irinotecan II: calculated as free base, 56.5 mg\u002Fm2, IV, d1q2w Renvastinib: ≥60kg, 12mg; \\\u003C60kg, 8mg, PO, once daily 5-FU: 1200 mg\u002F (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg\u002Fm2 intravenously, d1 q2w",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Liposomal irinotecan II: calculated as free base, 56.5 mg\u002Fm2, IV, d1q2w 5-FU: 1200 mg\u002F (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg\u002Fm2 intravenously, d1 q2w",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Wen Zhang, Doctor","CONTACT","+8618611643302","wenwen0605@163.com",[35],{"facility":36,"status":24,"city":37,"state":24,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"National Cancer Center\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","Beijing","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100600615","phase-2-a-randomized-two-cohort-prospective-phase-ii-clinical-study-of-the-second-line-treatment-of-advanced-biliary-system-tumors-with-liposomal-irinotecan-ii-combination-regimen-100600615",false,"NCT07099794","A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen","Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study","Inclusion Criteria:\n\n* The patients voluntarily joined the study and signed the informed consent;\n* Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;\n* Previous first-line combination therapy failed;\n* At least one measurable lesion meets the RECIST v1.1 criteria\n* ECOG PS：0\\~1；\n* Expected survival ≥12 weeks;\n* Essential organ and hematological function;\n* Patients need contraception;\n\nExclusion Criteria:\n\n* The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;\n* Patients had active malignancies other than BTC within 5 years or at the same time.\n* Clinical symptoms or diseases of the heart that are not well controlled;\n* Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);\n* Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea \\> grade 2;\n* A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy;\n* Use of strong CYP3A4\u002FCYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4\u002FCYP2C19 inhibitors and\u002For strong UGT1A inhibitors within 14 days prior to signing the informed consent;\n* Known allergy to the study drug;\n* An uncontrolled infection occurs during screening;\n* Patients with congenital or acquired immune deficiency (e.g., HIV);\n* Have a history of brain metastases or have developed brain metastases;","ALL","18 Years",{"count":58,"type":59},90,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU\u002FLV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.",[65],"Biliary Tract Cancer (BTC)","NOT_YET_RECRUITING","2025-07-25",{"date":69,"type":70},"2025-08-01","ACTUAL",{"date":69,"type":59},{"date":73,"type":59},"2029-08-31",{"name":5,"class":6},1]