[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628562":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":39,"locations":49,"responsibleParty":64,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":27,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":92,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"PULSAR Combined with FMT and the Original Regimen","EXPERIMENTAL","The experimental group patients will receive PULSAR combined with FMT and the original first-line target immunotherapy regimen (Tislelizumab+TKI) as second-line treatment until disease progression, death, or intolerable toxicity occurs.",[13,14,15],"Drug: Tislelizumab Combined With TKI","Drug: Fecal Microbiota Transplantation","Radiation: PULSAR",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard second-line treatment","ACTIVE_COMPARATOR","The control group patients will receive second-line treatment with Tislelizumab combined with regorafenib until disease progression, death, or intolerable toxicity occurs.",[13],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Tislelizumab Combined With TKI","Tislelizumab: 200mg, intravenous infusion, once every 3 weeks, D1. Targeted therapy (TKI): first-line treatment options such as lenvatinib, donafenib, apatinib, sorafenib, etc. The second-line control group was treated with Regorafenib 80mg once a day, taken for three weeks and rested for one week.\n\nCombination therapy is administered every 21 days as a cycle until disease progression, death, or intolerable toxicity occurs.",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Fecal Microbiota Transplantation","Fecal Microbiota Transplantation (FMT): 30g, orally administered, once every 3 weeks, D-3 (3 days before systemic treatment). After the preparation of the microbiota solution or capsule, store it in a -80 ℃ refrigerator. Transfer the microbiota solution or capsule to room temperature and seal it 15 minutes before use. Fasting is required 4 hours before microbiota transplantation and 1 hour after transplantation.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"RADIATION","PULSAR","PULSAR : Choose 3-5 lesions, but cannot include all newly progressing lesions (new progressing lesions must not be treated with radiotherapy to observe efficacy), once a month for 8Gy, for a total of 3-5 times.",[9],[38],"Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":27,"email":44},"Xin Wang","CONTACT","+86 28 85423609","wangxin213@sina.com",{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},"Feng Wen","+86 28 85422589","172571964@qq.com",[50],{"facility":5,"status":27,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Chengdu","Sichuan","610041","China","CN",{"type":57,"coordinates":58},"Point",[59,60],104.06667,30.66667,{"lat":60,"lon":59},[63],{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Wang Xin","Clinical Professor","100628562","phase-2-pulsar-combined-with-fecal-microbiota-transplantation-for-advanced-hepatocellular-carcinoma-progressing-after-first-line-targeted-immunotherapy-100628562",false,"NCT07463248","PULSAR Combined With Fecal Microbiota Transplantation for Advanced Hepatocellular Carcinoma Progressing After First-Line Targeted-Immunotherapy","Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Fecal Microbiota Transplantation (FMT) for Reversing Resistance to First-Line Targeted-Immunotherapy in Advanced HCC: A Clinical Application Study","Key Inclusion Criteria:\n\n1. Clinically or pathologically confirmed unresectable primary hepatocellular carcinoma;\n2. Liver cancer patients with BCLC stage B or C;\n3. Not receiving systematic treatment before enrollment;\n4. Patients with acquired resistance who achieved disease control (DCR: CR, PR, or SD) following first-line targeted-immunotherapy but later experienced disease progression (PD);\n5. Child Pugh score ≤ 7 points;\n6. Subject must have at least 1 measurable target lesion examined by CT or MRI according to RECIST1.1 criteria;\n7. The Eastern Oncology Consortium (ECOG) Behavioral status score was 0 or 1.\n\nKey Exclusion Criteria:\n\n1. Failure to recover to NCI-CTC AE Grade ≤1 (excluding alopecia and fatigue) or to baseline level from toxicities and\u002For complications of prior interventions before PD-1 monoclonal antibody re-challenge;\n2. Subjects requiring systemic therapy with corticosteroids (\\>10 mg prednisone equivalent daily) or other immunosuppressive agents within 14 days prior to PD-1 monoclonal antibody re-challenge；\n3. Received abdominal radiotherapy or administered radioactive substances within 28 days prior to PD-1 monoclonal antibody re-challenge;\n4. History of gastrointestinal perforation and\u002For fistula within 6 months prior to PD-1 monoclonal antibody re-challenge;\n5. Active gastrointestinal bleeding within 1 week before the first fecal microbiota transplantation.\n6. Occurrence of infection within 28 days prior to PD-1 monoclonal antibody re-challenge;\n7. Active infection requiring systemic antimicrobial therapy before PD-1 monoclonal antibody re-challenge and intestinal microbiota transplantation, excluding local infections requiring only topical antibiotics (e.g., skin infections);\n8. Received live or attenuated vaccines within 30 days prior to PD-1 monoclonal antibody re-challenge, or planned vaccination during the study period;\n9. Known history of primary immunodeficiency or HIV infection;\n10. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea), except patients with chronic diarrhea who had no recurrence within 2 years before enrollment;\n11. Known history of active tuberculosis (TB)；\n12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n13. Suffering from active, known or suspected autoimmune disease, or with a history of autoimmune disease;\n14. History of cardiovascular or cerebrovascular events or accidents within 6 months;\n15. Other conditions deemed by the investigator to be inappropriate for enrollment, including patients with hyperprogressive disease.","ALL","18 Years","75 Years",{"count":79,"type":80},64,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","This is an open-label, multicenter, randomized controlled Phase II trial. Patients with advanced hepatocellular carcinoma (HCC) who developed secondary resistance to first-line targeted-immunotherapy were randomly assigned to receive either the original first-line targeted-immunotherapy combined with FMT and PULSAR (experimental group), or second-line targeted-immunotherapy (control group). The first-line targeted-immunotherapy regimens consisted of tislelizumab combined with one of the first-line evidence-based tyrosine kinase inhibitors (TKIs), including lenvatinib, donafenib, apatinib, and sorafenib. Given that this study enrolled patients who progressed after an initial response to first-line targeted-immunotherapy, the second-line regimen in the control group continued tislelizumab immunotherapy while switching the TKI to regorafenib, an agent with second-line evidence.",[86],"Hepatocellular Carcinoma (HCC)",[88,89,34,90,91],"Advanced Hepatocellular Carcinoma","Fecal Microbiota Transplantation (FMT)","targeted-immunotherapy","reverse drug resistance","NOT_YET_RECRUITING","2026-03-10",{"date":95,"type":96},"2026-03-11","ACTUAL",{"date":98,"type":80},"2026-03-05",{"date":100,"type":80},"2029-01-31",{"name":66,"class":6},1]