[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jinbo Yue\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":25,"conditions":26,"keywords":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100595260","phase-2-phase-ii-study-of-neoadjuvant-tislelizumab-plus-radiotherapy-and-gp-chemotherapy-for-borderlineunresectable-hilar-cholangiocarcinoma-100595260",false,"NCT07030140","Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline\u002FUnresectable Hilar Cholangiocarcinoma","A Phase II, Single-arm, Prospective Clinical Study of Neoadjuvant Therapy With Tislelizumab Combined With Radiotherapy and Gemcitabine-Platinum Chemotherapy for Borderline Resectable or Unresectable Hilar Cholangiocarcinoma","Inclusion Criteria:\n\n* Age 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma\n* Borderline resectable or unresectable disease based on imaging and MDT evaluation\n* ECOG performance status 0-1\n* Adequate hematologic, hepatic, and renal function\n* No prior anti-tumor therapy for current diagnosis\n* Expected survival ≥ 3 months\n* Signed informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis\n* Prior treatment with immune checkpoint inhibitors\n* Uncontrolled infection or serious medical comorbidities\n* Active autoimmune disease requiring systemic therapy\n* History of organ transplantation or immunodeficiency\n* Pregnancy or lactation","ALL","18 Years","75 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase II, single-arm, prospective clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy combining stereotactic body radiotherapy (SBRT), GP chemotherapy (gemcitabine and cisplatin\u002Foxaliplatin), and tislelizumab in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Eligible patients will receive SBRT followed by three cycles of tislelizumab plus GP chemotherapy. Patients with resectable disease after evaluation may undergo surgery and receive postoperative treatment as recommended by the multidisciplinary team. Those who remain unresectable will receive three additional cycles of systemic therapy. The primary endpoint is overall survival (OS); secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, progression-free survival (PFS), local control rate, and treatment-related safety.",[27,28,29],"Cholangiocarcinoma","Hilar Cholangiocarcinoma","Bile Duct Cancer",[31,32,33,34,35,36,37,38,39,40,41,42],"Borderline Resectable","Unresectable","SBRT","Tislelizumab","Gemcitabine","Cisplatin","Oxaliplatin","Neoadjuvant Therapy","Immunotherapy","Radiation Therapy","PD-1 Inhibitor","Biliary Tract Cancer","RECRUITING","2026-04-27",{"date":46,"type":47},"2026-05-01","ACTUAL",{"date":49,"type":47},"2025-07-01",{"date":51,"type":21},"2028-01-01",{"name":53,"class":54},"Jinbo Yue","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":55},"100593495","phase-2-conversion-therapy-plus-surgery-and-radiotherapy-for-retroperitoneal-nodal-metastases-in-gastric-cancer-100593495","NCT07007182","Conversion Therapy Plus Surgery and Radiotherapy for Retroperitoneal Nodal Metastases in Gastric Cancer","A Randomized, Controlled, Multicenter Phase II Study of Conversion Therapy Combined With Surgery and Radiotherapy for Retroperitoneal Lymph Node Metastases in Gastric Cancer","Inclusion:\n\nHistologically confirmed gastric adenocarcinoma with isolated para-aortic (station 16) lymph node metastasis; pMMR or MSS subtype; ECOG performance status 0-2; Life expectancy ≥ 3 months; Adequate organ function (hematologic, hepatic, renal); Ability to provide tumor tissue for biomarker analysis; Ability to understand and willingness to sign written informed consent; Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during study and for 12 months after treatment; men with partners of childbearing potential must also agree to contraception.\n\nExclusion Criteria:\n\nEvidence of visceral or peritoneal metastasis; MSI-H or dMMR subtype; HER2-positive disease (IHC 3+ or IHC 2+ with FISH positive); Prior systemic anti-tumor therapy; Prior malignancy within 3 years (except adequately treated basal cell\u002Fsquamous cell carcinoma of the skin or in situ carcinoma); Prior PD-1\u002FPD-L1\u002FCTLA-4 therapy; Participation in another interventional trial within 4 weeks; Active autoimmune disease requiring systemic therapy within past 2 years; Uncontrolled infection, hepatitis B, C, or HIV; CNS metastases or carcinomatous meningitis; Uncontrolled cardiovascular disease (unstable angina, recent MI, NYHA III-IV heart failure, QTc ≥480 ms); Interstitial lung disease or uncontrolled pulmonary disease; Uncontrolled diabetes mellitus (FBG \\>10 mmol\u002FL); Pregnancy or breastfeeding; Major surgery within 4 weeks prior to randomization; Any other condition that may interfere with protocol compliance or increase risk as judged by the investigator.",{"count":64,"type":21},54,[24],"This is a randomized, controlled, multicenter phase II clinical trial evaluating the efficacy and safety of conversion therapy combined with radical gastrectomy and adjuvant radiotherapy targeting para-aortic (station 16) lymph nodes in patients with gastric adenocarcinoma and isolated station 16 nodal metastases. Eligible participants must have no evidence of peritoneal dissemination, visceral metastases, or non-regional lymphatic spread. Based on PD-L1 combined positive score (CPS), patients in the experimental arm will receive systemic therapy with SOX (S-1 plus oxaliplatin) with or without a PD-1 inhibitor, followed by D2 gastrectomy and postoperative adjuvant SOX chemotherapy, then intensity-modulated radiotherapy (IMRT) to the para-aortic region. The control arm will receive standard chemotherapy with CAPEOX or SOX, with or without immunotherapy, according to CPS status. The primary endpoint is progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. This study aims to explore whether the addition of locoregional treatment to systemic therapy improves long-term outcomes in this select patient population.",[68,69],"Gastric Adenocarcinoma","Stomach Neoplasms",[71,72,73,74,75,39],"Conversion therapy","Para-aortic lymph nodes","D2 gastrectomy","Radiotherapy","SOX regimen",{"date":46,"type":47},{"date":78,"type":47},"2025-10-01",{"date":80,"type":21},"2030-10-01",{"name":53,"class":54},""]