[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-carcinoma-liver-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-carcinoma-liver-metastases":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100565155","phase-1-safety-of-hrx215-in-patients-after-minor-and-major-liver-resection-100565155",false,"NCT06638502","Safety of HRX215 in Patients After Minor and Major Liver Resection","Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases","Inclusion Criteria:\n\n* Participants with liver metastases originating from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases\n* Part 1 only: stable participants within 1-3 days after minor liver resection, normal non-tumor liver parenchyma\n* Part 2 and 3 only: Major liver resection.\n* Low estimated risk for post-hepatectomy liver failure PHLF\n\nFurther inclusion criteria apply\n\nExclusion Criteria:\n\n* Liver Cirrhosis\n* Preoperative presence of clinical ascites\n* Any other hepatobiliary cancer\n* BMI \\>35 kg\u002Fm2\n* ASA Score \\>4\n* Peritoneal carcinomatosis\n\nFurther exclusion criteria apply","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases.\n\nThe objectives are:\n\n1. to learn about the safety and tolerability of HRX215\n2. to learn about how the body absorbs, distributes, and gets rid of HRX215.\n3. to learn about clinical activity of HRX215\n\nResearchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.",[28,29],"Liver Resection","Colorectal Carcinoma Liver Metastases","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2025-05-06",{"date":38,"type":21},"2027-12-31",{"name":40,"class":41},"HepaRegeniX GmbH","INDUSTRY",9]