[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592086":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":43,"locations":49,"responsibleParty":69,"collaborators":24,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":24,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":24,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":24,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Patients in the treatment group would undergo FOLFOX-HAIC combining Bevacizumab or Cetuximab",[13,14,15,16,17],"Combination Product: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])","Procedure: hepatic arterial infusion chemotherapy (HAIC)","Drug: Bevacizumab","Drug: Cetuximab (Erbitux)","Procedure: liver resection",[19,25,30,35,39],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])","The procedures of FOLFOX-HAIC were as follows: 1) a 5 French sheath was inserted into the femoral artery by Seldinger technique, then a 3.5 French catheter entered the coeliac trunk and superior mesenteric artery to assess the feeding arteries of tumors and identify any extra-collateral vessels which may cause drug leakage. These vessels would be embolized with gelatin sponge particles or metallic coils if necessary. A 2.7 French microcatheter was selectively inserted into the left\u002Fright\u002Fproper hepatic artery then patients were transferred to inpatient ward to start chemotherapy drug infusion. The FOLFOX regimen involving oxaliplatin (130mg\u002Fm2, day 1, 0-2h), leucovorin (400 mg\u002Fm2, day 1, 2-3h), 5-Fu (400mg\u002Fm2, day 1, bolus at 3h, then 2400 mg\u002Fm2, day 1-3, 3-49h), was administered via the microcatheter. The microcatheter and sheath were removed after HAIC finished. We didn't implanted port catheter system and repeated percutaneous femoral artery puncture and catheterization once every 3",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"PROCEDURE","hepatic arterial infusion chemotherapy (HAIC)","The procedures of FOLFOX-HAIC were as follows: 1) a 5 French sheath was inserted into the femoral artery by Seldinger technique, then a 3.5 French catheter entered the coeliac trunk and superior mesenteric artery to assess the feeding arteries of tumors and identify any extra-collateral vessels which may cause drug leakage. These vessels would be embolized with gelatin sponge particles or metallic coils if necessary. A 2.7 French microcatheter was selectively inserted into the left\u002Fright\u002Fproper hepatic artery then patients were transferred to inpatient ward to start chemotherapy drug infusion.",[9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"DRUG","Bevacizumab","We would inject bevacizumab at the dose of 7.5mg\u002Fkg once every 3 weeks if the primary tumors located from right-side to splenic flexure colon or the genotype of RAS or RAF was mutational.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":24},"Cetuximab (Erbitux)","We would inject cetuximab at an initial dose of 400mg\u002Fm2 and maintained a dose of 250mg\u002Fm2 once every week if we didn't choose bevacizumab.",[9],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":24},"liver resection","If patients reached potential resectable state, we would perform liver resection.",[9],[44],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},"Zhang Bi Xiang","CONTACT","862783663400","bixiangzhang@hust.edu.cn",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":59,"coordinates":60},"Point",[61,62],114.26667,30.58333,{"lat":62,"lon":61},[65],{"name":66,"role":46,"phone":67,"phoneExt":24,"email":68},"Liao Wei","8615527803087","1009739952@qq.com",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Chen Xiaoping","Professor","100592086","phase-2-folfox-haic-as-conversion-treatment-for-initially-unresectable-colorectal-liver-metastasis-100592086",false,"NCT06988852","FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis","Conversion Treatment With Hepatic Arterial Infusion of Oxaliplatin, Leucovorin and Fluorouracil Plus Intravenous Bevacizumab or Cetuximab for Initially Unresectable Colorectal Liver Metastasis: A Prospective Study","Inclusion Criteria:\n\n* age 18-75 years\n* no history of other malignant diseases\n* refuse or progress in prior systemic treatment\n* diagnosed as CRLM confirmed by pathology, in spite of whether the primary tumor had been resected\n* at least one lesion in the liver could be measured\n* left ventricular ejection ≥45%, forced expiratory volume in one second\u002Fforced vital capacity≥60% and Eastern Cooperative Oncology Group (ECOG) score of 0-1\n* Child-Pugh class A\n* adequate organ function, i.e.: white blood cell (WBC) ≥3.0×109\u002FL, neutrophils ≥1.5×109\u002FL, platelet (PLT) ≥75×109\u002FL, total bilirubin ≤30μmol\u002FL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤200U\u002FL, creatinine ≤150μmol\u002FL\n\nExclusion Criteria:\n\n* extra-hepatic metastasis verified by medical imaging\n* unable to tolerate chemotherapy, anesthesia or surgery\n* allergy or previous intolerable to any agent of oxaliplatin, leucovorin, 5-Fu, bevacizumab or cetuximab\n* tumor spread in abdomen\n* cerebral infarction, cerebral hemorrhage, gastrointestinal hemorrhage\u002Fperforation within 6 months, coagulation disorders and gastrointestinal ulcer\n* primary tumor may not be completely resected\n* prior treatment of CRLM with resection, ablation or radiation\n* incomplete clinical or follow-up data","ALL","18 Years","75 Years",{"count":84,"type":85},300,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","Try FOLFOX-HAIC combining bevacizumab or cetuximab for initially unresectable colorectal liver metastasis patients to increase the conversion to resection rate to improve long-term survival outcomes",[91],"Colorectal Liver Metastasis (CRLM)","2025-05-23",{"date":94,"type":95},"2025-05-25","ACTUAL",{"date":97,"type":95},"2023-05-01",{"date":99,"type":85},"2030-12-31",{"name":5,"class":6},1]