[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622866":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":22,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":22,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":22,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":22,"overallStatus":78,"whyStopped":22,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LC-K76 + Tislelizumab + ADT","EXPERIMENTAL","Participants receive oral LC-K76 combined with intravenous Anti-PD-1 monoclonal antibody (Tislelizumab) and standard androgen deprivation therapy (ADT). Treatment continues for 24 weeks.",[13,14,15],"Dietary Supplement: LC-K76","Drug: Tislelizumab","Drug: Standard Androgen Deprivation Therapy (ADT)",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIETARY_SUPPLEMENT","LC-K76","Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","Tislelizumab","Intravenous infusion, 200 mg every 3 weeks (Q3W).",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Standard Androgen Deprivation Therapy (ADT)","Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix).",[9],[33],{"name":34,"role":35,"phone":36,"phoneExt":22,"email":37},"Ren, MD,PhD","CONTACT","86021-81886999","renshancheng@gmail.com",[39],{"facility":40,"status":22,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Changzheng hospital","Shanghai","Shanghai Municipality","201109","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":36,"phoneExt":22,"email":37},"Shancheng Ren, PhD\u002FMD",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Ren Shancheng","Professor, Chief of Urology","100622866","early-phase-1-safety-and-preliminary-efficacy-evaluation-of-lc-k76-plus-anti-pd-1-therapy-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100622866",false,"NCT07389187","Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","An Open-Label, Single-Arm, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n1. Male, aged 18 to 85 years.\n2. Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components.\n3. Metastatic Castration-Resistant Prostate Cancer (mCRPC) with disease progression after at least one novel endocrine therapy (e.g., abiraterone or enzalutamide) and\u002For docetaxel chemotherapy.\n4. Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT).\n5. Serum testosterone at castration levels (\\\u003C 50 ng\u002FdL or 1.75 nmol\u002FL).\n6. ECOG performance status ≤ 2.\n7. Life expectancy \\> 6 months.\n8. Adequate bone marrow, hepatic, and renal function.\n9. Willing to undergo biopsies before and during treatment\n\nExclusion Criteria:\n\n1. Lack of pathological evidence for prostate cancer.\n2. Other primary malignant tumors active or requiring treatment within the past 3 years.\n3. Has visceral metastases.\n4. Poorly controlled diabetes after continuous insulin therapy.\n5. Significant abnormalities in laboratory values at randomization (Hb \\\u003C 90 g\u002FL; Neutrophils \\\u003C 1.5x10\\^9\u002FL; Platelets \\\u003C 75x10\\^9\u002FL; ALT\u002FAST \\> 2.5xULN; Bilirubin \\> 1.5xULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2) .\n6. Severe cardiopulmonary disease or high-risk conditions.\n7. Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1).\n8. Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts.\n9. History of severe drug allergies.\n10. Factors affecting drug intake\u002Fabsorption (e.g., swallowing difficulty, chronic diarrhea).\n11. Concurrent psychiatric or neurological conditions","MALE","18 Years","85 Years",{"count":70,"type":71},10,"ESTIMATED","INTERVENTIONAL",[74],"EARLY_PHASE1","This open-label, single-arm study evaluates the safety and preliminary efficacy of LC-K76 combined with Tislelizumab and ADT in 10 patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who progressed on prior therapies. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.",[77],"mCRPC","NOT_YET_RECRUITING","2026-02-03",{"date":81,"type":82},"2026-02-05","ACTUAL",{"date":84,"type":71},"2026-02",{"date":86,"type":71},"2028-06",{"name":5,"class":6},1]