[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603674":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Hebei General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Iparomlimab and Tuvonralimab combined with albumin-paclitaxel","EXPERIMENTAL","Iparomlimab and Tuvonralimab: 5.0mg\u002Fkg, D1, Q3w; Albumin-paclitaxel: 260mg\u002Fm², D1, Q3w",[13],"Drug: Iparomlimab\u002FTuvonralimab (anti PD-1\u002FCTLA-4) combined with albumin-bound paclitaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Iparomlimab\u002FTuvonralimab (anti PD-1\u002FCTLA-4) combined with albumin-bound paclitaxel","Iparomlimab\u002FTuvonralimab : 5.0mg\u002Fkg, D1, Q3W Albumin-bound paclitaxel: 260mg\u002Fm², D1, Q3W",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Qingxia Li, Professor","CONTACT","+8613613110158","lqx73@163.com",[28],{"facility":5,"status":20,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Shijiazhuang","Hebei","050000","China","CN",{"type":35,"coordinates":36},"Point",[37,38],114.47861,38.04139,{"lat":38,"lon":37},[41,45],{"name":42,"role":24,"phone":43,"phoneExt":20,"email":44},"Jia Chen","（+86）0311-85988973","utm5012@163.com",{"name":23,"role":46,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Qingxia Li","Professor","100603674","the-efficacy-and-safety-of-iparomlimabtuvonralimab-anti-pd-1ctla-4-combined-with-albumin-bound-paclitaxel-in-second-line-treatment-of-patients-with-advanced-gastricgastroesophageal-junction-adenocarcinoma-100603674",false,"NCT07139587","The Efficacy and Safety of Iparomlimab\u002FTuvonralimab (Anti PD-1\u002FCTLA-4) Combined With Albumin-bound Paclitaxel in Second-line Treatment of Patients With Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Aged 18-75;\n* ECOG PS 0-2;\n* Histologically confirmed advanced of the gastric cancer\u002Fgastroesophageal junction adenocarcinoma;\n* Failure of first-line treatment: Progression or intolerance after receiving platinum-based (oxaliplatin\u002Fcisplatin) + fluorouracil (5-FU\u002F capecitabine \u002FS-1) regimens;\n* The first-line use of PD-1 inhibitors is permitted;\n* At least one measurable lesion (RECIST v1.1);\n* Good organ function (ANC≥1.5×109\u002FL, PLT≥100×109\u002FL, with normal liver and kidney functions）.\n\nExclusion Criteria:\n\n* Her2-positive gastric cancer\u002Fgastroesophageal junction adenocarcinoma;\n* Active autoimmune disease;\n* Previously received PD-1\u002FCTLA-4 bispecific antibody or taxanes at first-line treatment.","ALL","18 Years","75 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (anti PD-1\u002FCTLA-4) combined with albumin-paclitaxel in the second-line treatment of patients with advanced gastric\u002Fgastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1. Can the combination of Iparomlimab\u002FTuvonralimab and albumin-paclitaxel for advanced gastric cancer\u002Fgastroesophageal junction cancer who has progressed or is intolerant to first-line SOC prolong the PFS and OS, improve ORR, DCR, and prolong DoR; 2. Whether Iparomlimab\u002FTuvonralimab ( anti PD-1\u002FCTLA-4) combined with albumin-paclitaxel for second-line treatment remains effective for patients who have progressed from first-line PD-1±chemotherapy; 3. The safety and tolerability of Iparomlimab\u002FTuvonralimab in combination with albumin-paclitaxel for second-line treatment.Participants will:1. Use Iparomlimab\u002FTuvonralimab 5.0mg\u002Fkg, D1, Q3W; At least 30 minutes later, administer the chemotherapy albumin-paclitaxel: 260mg\u002Fm², D1, Q3W, and complete the infusion within 30 minutes. The combined regimen was administered every 3 weeks, with efficacy evaluated every 2 cycles (RECIST 1.1) until disease progression, intolerable toxicity or patient withdrawal.",[68,69],"Gastric Cancer","Gastroesophageal Junction Adenocarcinoma",[71,72,73,74],"Immunotherapy","gastric cancer","gastroesophageal junction adenocarcinoma","PD-1\u002FCTLA-4","NOT_YET_RECRUITING","2025-09-08",{"date":78,"type":79},"2025-09-10","ACTUAL",{"date":81,"type":62},"2025-09",{"date":83,"type":62},"2028-12",{"name":49,"class":6},1]