[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642786":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":60,"collaborators":63,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shanghai 6th People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Celecoxib + Pembrolizumab + Gemcitabine\u002FCisplatin","EXPERIMENTAL","Participants receive celecoxib in combination with pembrolizumab and gemcitabine\u002Fcisplatin chemotherapy. Celecoxib is administered orally at 200 mg twice daily continuously starting from Cycle 1 Day -7. Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg\u002Fm²) and cisplatin (25 mg\u002Fm²) are administered intravenously on Day 1 and Day 8 of each cycle. Cisplatin is given for up to 8 cycles. Treatment is continued until disease progression, unacceptable toxicity, or withdrawal.",[13],"Drug: Celecoxib + Pembrolizumab + Gemcitabine\u002FCisplatin",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Pembrolizumab + Gemcitabine\u002FCisplatin","ACTIVE_COMPARATOR","Participants receive pembrolizumab in combination with gemcitabine\u002Fcisplatin chemotherapy. Pembrolizumab is administered intravenously at 200 mg on Day 1 of each 21-day cycle. Gemcitabine (1000 mg\u002Fm²) and cisplatin (25 mg\u002Fm²) are administered intravenously on Day 1 and Day 8 of each cycle. Cisplatin is given for up to 8 cycles. Treatment is continued until disease progression, unacceptable toxicity, or withdrawal.",[19],"Drug: Pembrolizumab + Gemcitabine\u002FCisplatin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Celecoxib + Pembrolizumab + Gemcitabine\u002FCisplatin","Celecoxib is administered orally at a dose of 200 mg twice daily continuously in the experimental arm. Treatment is initiated at Cycle 1 Day -7 and continued until disease progression, unacceptable toxicity, or withdrawal.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Pembrolizumab + Gemcitabine\u002FCisplatin","Participants receive pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in combination with gemcitabine 1000 mg\u002Fm² and cisplatin 25 mg\u002Fm² administered intravenously on Days 1 and 8 of each cycle. Cisplatin is administered for up to 8 cycles. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.",[15],[32],{"name":33,"affiliation":34,"role":35},"Cun Wang","State Key Laboratory of Systems Medicine for Cancer, Shanghai Cancer Institute & Department of Liver Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Chen Yang","CONTACT","86 18160747569","18160747569@163.com",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Haiyan Hu","xuri1104@163.com",[46],{"facility":47,"status":48,"city":49,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Renji Hospital","RECRUITING","Shanghai","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":35,"investigatorFullName":33,"investigatorTitle":61,"investigatorAffiliation":62,"oldNameTitle":26,"oldOrganization":26},"Principal Investigator","RenJi Hospital",[64,66,68,70],{"name":65,"class":6},"Shanghai 10th People's Hospital",{"name":67,"class":6},"Wuhan TongJi Hospital",{"name":69,"class":6},"Sun Yat-Sen University Cancer Center",{"name":62,"class":6},"100642786","phase-1-a-multicenter-prospective-randomized-open-label-phase-ibii-study-of-celecoxib-plus-pembrolizumab-and-gemcitabinecisplatin-versus-pembrolizumab-and-gemcitabinecisplatin-in-patients-with-ck56-high-unresectable-locally-advanced-or-metastatic-intrahepatic-cholangiocarcinoma-100642786",false,"NCT07632235","A Multicenter, Prospective, Randomized, Open-label Phase Ib\u002FII Study of Celecoxib Plus Pembrolizumab and Gemcitabine\u002FCisplatin Versus Pembrolizumab and Gemcitabine\u002FCisplatin in Patients With CK5\u002F6-High Unresectable Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA).\n* Unresectable locally advanced, recurrent, or metastatic disease.\n* No prior systemic therapy for advanced disease.\n* At least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0-1.\n* Availability of adequate pre-treatment tumor tissue for central pathological review.\n* CK5\u002F6 H-score ≥ 1.0 as determined by central laboratory testing.\n* Adequate organ and bone marrow function as defined by protocol-specified laboratory criteria.\n* Patients with biliary obstruction must have undergone effective drainage and achieved clinical stabilization prior to enrollment.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Other primary malignancies including extrahepatic cholangiocarcinoma, gallbladder carcinoma, or ampullary carcinoma.\n* CK5\u002F6 H-score \\\u003C 1.0.\n* Prior systemic therapy for advanced or metastatic disease.\n* Active gastrointestinal bleeding, peptic ulcer disease, or high risk of gastrointestinal perforation.\n* Recent history of significant cardiovascular events including myocardial infarction, stroke, uncontrolled hypertension, or severe heart failure.\n* Known hypersensitivity to celecoxib, sulfonamides, NSAIDs, or aspirin-exacerbated respiratory disease.\n* Active autoimmune disease or conditions contraindicating pembrolizumab therapy.\n* Severe renal impairment.\n* Child-Pugh class C hepatic impairment.\n* Active uncontrolled infection.\n* Any condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.","ALL","18 Years",{"count":80,"type":81},112,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","This study aims to evaluate whether adding celecoxib to standard therapy can improve clinical outcomes in patients with advanced intrahepatic cholangiocarcinoma. The current standard treatment typically consists of immunotherapy combined with chemotherapy; however, there are significant inter-patient differences in treatment response. Therefore, this study further introduces the biomarker CK5\u002F6 to identify patient subgroups who are more likely to benefit, thereby exploring a more precise therapeutic strategy.\n\nAll eligible participants will be randomly assigned after enrollment to either the control group or the experimental group. The control group will receive the current standard first-line regimen, which includes the immunotherapy agent pembrolizumab combined with the chemotherapy agents gemcitabine and cisplatin. The experimental group will receive the same standard treatment, with the addition of oral anti-inflammatory therapy with celecoxib taken twice daily throughout the entire treatment period.\n\nEach treatment cycle lasts 21 days. During treatment, patients will undergo regular imaging assessments, laboratory tests, and safety evaluations to monitor tumor response and treatment-related adverse events, and will be followed until disease progression or discontinuation of treatment. In addition, blood and tissue samples will be collected during the study to investigate tumor biology and potential predictive biomarkers.\n\nThe primary endpoints of this study include progression-free survival and objective response rate, along with concurrent safety evaluation. Adverse events potentially associated with chemotherapy, immunotherapy, and celecoxib may occur, such as bone marrow suppression, gastrointestinal reactions, immune-related inflammatory responses, as well as renal or cardiovascular toxicities. The study team will closely monitor and promptly manage all adverse events.\n\nThis study aims to explore a CK5\u002F6-based stratified personalized combination therapy strategy, with the goal of improving treatment benefit in patients with advanced intrahepatic cholangiocarcinoma and providing evidence for optimizing future clinical treatment strategies.",[88],"Intrahepatic Cholangiocarcinoma (Icc)","2026-06-22",{"date":91,"type":92},"2026-06-25","ACTUAL",{"date":94,"type":81},"2026-07-01",{"date":96,"type":81},"2030-12-31",{"name":5,"class":6},1]