[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590347":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":62,"collaborators":36,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":36,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":45,"whyStopped":36,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic Entecavir","EXPERIMENTAL","Entecavir is prophylactically used from the time of chemotherapy or immunotherapy initiation at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy .",[13],"Drug: Entecavir",{"label":15,"type":16,"description":17,"interventionNames":18},"Preemptive Entecavir","ACTIVE_COMPARATOR","Entecavir is preemptively used from the time that hepatitis B virus DNA copies become positive at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Entecavir","anti hepatitis B virus",[15,9],[26],"Entecavir Dispersible Tablets",[28],{"name":29,"affiliation":30,"role":31},"Xu Rui-hua, M.D. Ph.D","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+86-20-87343008",null,"xurh@sysucc.org.cn",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Wang Feng, M.D. Ph.D","+86-18620880867","fengwang@sysucc.org.cn",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58],{"name":59,"role":34,"phone":60,"phoneExt":36,"email":61},"Feng Wang","+86-20-87342479","wangfeng@sysucc.org.cn",{"type":31,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Rui-hua Xu, MD, PhD","The president of Sun Yat-sen University Cancer Center","100590347","phase-3-prophylactic-or-preemptive-entecavir-in-patients-with-gastrointestinal-cancer-who-are-inactive-hepatitis-b-carriers-100590347",false,"NCT06966232","Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers","An Open, Multicentre, Phase 3, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers","Inclusion Criteria:\n\n1. Patients with age between 18 and 75\n2. Patient with histology-proven locally advanced unresectable or metastatic gastrointestinal cancers (colorectal cancer, gastric cancer, esophageal cancer, hepatocellular carcinoma, pancreatic cancer, and cholangiocarcinoma)\n3. Planned to receive first-, second-, or third-line anti-tumor therapy (chemotherapy or PD-1\u002FPD-L1 monoclonal antibody immunotherapy)\n4. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-2\n5. Patients planned for at least 4 cycles of chemotherapy or immunotherapy\n6. Patients with at least 6 months' life expectancy from date of recruitment\n7. Patients with chronic or past HBV infection (HBsAg-positive or HBcAb-positive), and hepatitis B is inactive\n8. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), and bilirubin\n9. Patients with negative HBV-DNA\n10. Adequate major organ function (laboratory tests 14 days before randomization meeting requirements for anti-tumor therapy)\n11. Patients who sign the informed consent\n12. Patients with good compliance during chemotherapy and follow-ups.\n\nExclusion Criteria:\n\n1. History of liver cirrhosis\n2. Prior HBV reactivation\n3. Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment\n4. Active co-infection with other hepatitis viruses\n5. HIV infection\n6. Autoimmune hepatitis\n7. History of hepatic radiotherapy\n8. Scheduled hepatic radiotherapy or radioisotope therapy\n9. Pregnant or lactating women\n10. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder\n11. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history\n12. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.","ALL","18 Years","75 Years",{"count":76,"type":77},136,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","There has been no report on whether the patients with gastrointestinal cancer who are also inactive hepatitis B carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir during anti-tumor therapy. This open, multicentre, phase 3, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug entecavir on the outcomes of patients with gastrointestinal cancer who are also inactive hepatitis B carriers during chemotherapy or immunotherapy and the subsequent follow-ups, including two cohorts of chemotherapy and immunotherapy.",[83],"Gastrointestinal Cancers",[83,22,85,86,87],"Hepatitis B Carrier","Chemotherapy","Immunotherapy","2025-05-02",{"date":90,"type":91},"2025-05-11","ACTUAL",{"date":93,"type":77},"2025-05-15",{"date":95,"type":77},"2027-05-20",{"name":5,"class":6},1]