[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617972":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Advanced unresectable HCC cohort",null,"Cohort 1: Impact of ED on first-line therapy for advanced, unresectable HCC (n=243)",[13],"Other: Scale score",{"label":15,"type":10,"description":16,"interventionNames":17},"Advanced unresectable ICC cohort","Cohort 2: Impact of ED on first-line therapy for advanced, unresectable intrahepatic cholangiocarcinoma (ICC) (n=175)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Resectable high-risk HCC cohort","Cohort 3: Impact of ED on postoperative recurrence in resectable high-risk HCC (n=233)",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Scale score","* The PHQ-9 rating scale and GAD-7 rating scale were used to screen for depression and anxiety symptoms in cancer patients;\n\n  * The PSQI was used to assess the sleep quality index of cancer patients; ③ The PHQ-9 rating scale and GAD-7 rating scale were used to evaluate the depression and anxiety status of patient caregivers; ④ The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) was used to assess the quality of life of cancer patients.",[9,15,19],[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Wanguang Zhang","CONTACT","13886195965","wgzhang@tjh.tjmu.edu.cn",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","430000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],114.26667,30.58333,{"lat":46,"lon":45},[49],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Wan-Guang Zhang","Professor","100617972","impact-of-emotional-disorders-on-response-to-immune-checkpoint-inhibitor-therapy-in-liver-cancer-100617972",false,"NCT07325565","Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer","Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer: A Multicenter, Prospective, Multi-Cohort Study","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive, regardless of gender.\n* Presence of at least one radiologically measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (defined as a lesion with a longest diameter of ≥10 mm on CT scan).\n* Newly diagnosed, treatment-naïve patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).\n* Child-Pugh liver function score ≤ 7.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Absence of severe organic diseases affecting the heart, lungs, brain, or other major organs.\n\nExclusion Criteria:\n\n* History of other malignancies.\n* Recurrent HCC.\n* Prior systemic therapy for HCC.\n* Hepatic decompensation.\n* History of severe psychiatric disorders.\n* Current use of antidepressant or anxiolytic medication.\n* Inability to comprehend or complete the assessment questionnaires.","ALL","18 Years","75 Years",{"count":65,"type":66},651,"ESTIMATED","OBSERVATIONAL","Hepatocellular carcinoma (HCC) carries a poor prognosis, with limited efficacy from current therapies including immune checkpoint inhibitors (ICIs). Concurrently, emotional distress (ED) is highly prevalent in cancer patients and is implicated in tumor progression via neuroendocrine-immune axis dysregulation (e.g., HPA axis activation, immunosuppressive TME). Emerging evidence, particularly from lung cancer, suggests ED may adversely impact ICI efficacy. However, its specific role and clinical significance in HCC, especially regarding ICI response, remain poorly understood.\n\nTo address this gap, we propose a large-scale, prospective, multicenter, multi-cohort study to systematically evaluate the impact of ED on treatment outcomes in HCC patients receiving immunotherapy.",[70,71],"Liver Cancer","Emotional Disorder","2025-12-24",{"date":74,"type":75},"2026-01-08","ACTUAL",{"date":77,"type":75},"2025-12-20",{"date":79,"type":66},"2028-12-31",{"name":5,"class":6},1]