[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613190":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":29,"responsibleParty":45,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":18,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib","EXPERIMENTAL",[12],"Drug: Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","Iparomlimab and Tuvonralimab Injection:5 mg\u002Fkg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 4 to 6 cycles.\n\nLenvatinib: 8-12 mg, orally once daily (qd). The dose is determined by body weight:8 mg po qd for body weight \\\u003C 60 kg;12 mg po qd for body weight ≥ 60 kg\n\nGemOX Regimen:\n\nOxaliplatin: 85 mg\u002Fm², intravenous infusion on Day 1 of each 3-week cycle (q3w); for a maximum of 6 cycles.\n\nGemcitabine: 1000 mg\u002Fm², intravenous infusion on Day 1 and Day 8 of each 3-week cycle (q3w); for a maximum of 6 cycles.\n\nPostoperative Treatment for Patients with Successful Conversion:\n\nIparomlimab and Tuvonralimab Injection: 5 mg\u002Fkg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 8 cycles.\n\nFor Patients without Successful Conversion:\n\nSubsequent treatment regimens will be determined by the investigator.",[9],null,[20,25],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Wei Zhang","CONTACT","+86 18622025401","zhangweitjch@163.com",{"name":26,"role":22,"phone":27,"phoneExt":18,"email":28},"Wen X Liu","18515456035","liuwenxiao2016@outlook.com",[30],{"facility":5,"status":18,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Tianjin","Tianjin Municipality","300000","China","CN",{"type":37,"coordinates":38},"Point",[39,40],117.17667,39.14222,{"lat":40,"lon":39},[43],{"name":21,"role":22,"phone":44,"phoneExt":18,"email":24},"18526812877",{"type":46,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100613190","phase-2-iparomlimab-and-tuvonralimab-injection-combined-with-gemox-and-lenvatinib-as-conversion-therapy-for-initially-potentially-resectable-intrahepatic-cholangiocarcinoma-and-gallbladder-cancer-100613190",false,"NCT07263360","Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","A Single-arm, Single-center Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Histologically or cytologically confirmed diagnosis of locally advanced or potentially resectable intrahepatic cholangiocarcinoma or gallbladder cancer, defined as T2b-T4 or N1 M0 according to the AJCC 8th edition.\n* Expected life expectancy ≥ 12 weeks.\n* No prior systemic treatment for biliary tract cancer before the first dose of study medication.\n* At least one measurable lesion as defined by RECIST 1.1 criteria.\n* ECOG Performance Status of 0 or 1.\n* Adequate organ function, without severe dysfunction of the hematologic, cardiac, pulmonary, hepatic, renal, bone marrow, or immune systems.\n* Laboratory tests meeting the following requirements: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. For men, they must be surgically sterile or agree to use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug.\n* Patient voluntarily participates and provides written informed consent.\n* Good compliance is anticipated, allowing for efficacy and adverse event follow-up per the protocol.\n\nExclusion Criteria:\n\n* The subject has received any prior antitumor therapy or any investigational anticancer agents.\n* Presence of any active autoimmune disease or a history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[may be enrolled if stable on hormone replacement therapy\\]). Patients with childhood asthma that has completely resolved in adulthood without any intervention, or vitiligo, may be enrolled. Patients requiring medical intervention with bronchodilators are not eligible.\n* Known congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection.\n* Uncontrolled cardiac clinical symptoms or diseases, e.g., NYHA Class II or above heart failure, unstable angina, myocardial infarction within 1 year, or patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n* Severe concurrent infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever \\>38.5°C during screening\u002Fprior to the first dose.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period.\n* History of or concurrent other malignant tumors within the past 5 years (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ovarian cancer).\n* Gastrointestinal bleeding event or active hemoptysis within 28 days prior to the first dose.\n* Gastric or esophageal varices requiring treatment.\n* Active malignant tumors within 36 months prior to enrollment.\n* Known allergy to any of the investigational drug components.\n* Poorly controlled psychiatric disorder.\n* Presence of superior mesenteric vein tumor thrombus, metastasis to group 16 lymph nodes, or distant metastasis to other organs \u002F biological factors: peritoneal metastasis, direct invasion to adjacent organs, etc. \u002F involvement of organs (pancreas, stomach, duodenum, colon) that cannot be resected en bloc.\n* Any other condition deemed by the investigator as unsuitable for enrollment. This includes, but is not limited to, pre-existing central nervous system metastases, severe laboratory abnormalities, or familial\u002Fsocial factors that could compromise the subject's safety, or data\u002Fsample collection.\n* Patients with extensive liver metastases involving the entire liver.","ALL","18 Years",{"count":57,"type":58},29,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","The primary objective is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1\u002FCTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer.",[64],"BTC",[66,67,68],"lparomlimab and Tuvonralimab injection","GemOX","Lenvatinib","NOT_YET_RECRUITING","2025-11-23",{"date":72,"type":73},"2025-12-04","ACTUAL",{"date":75,"type":58},"2026-02-01",{"date":77,"type":58},"2029-12-31",{"name":5,"class":6},1]