[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579013":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":29,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":11,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":11},{"fullName":5,"class":6},"Eastern Hepatobiliary Surgery Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"inetetamab+ Gemcitabine + Cisplatin ± PD-1\u002FPD-L1 Inhibitor","EXPERIMENTAL",null,[13],"Drug: Inetetamab + Gemcitabine + Cisplatin ± PD-1\u002FPD-L1 inhibitor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Inetetamab + Gemcitabine + Cisplatin ± PD-1\u002FPD-L1 inhibitor","A 21-day cycle is used, with the initial dose of inetuximab at 8 mg\u002Fkg (IV), followed by 6 mg\u002Fkg (IV) on Day 1 of each subsequent cycle. Gemcitabine (1000 mg\u002Fm²) + cisplatin (25 mg\u002Fm²) are administered in combination on Day 1 and Day 8 of each cycle. The appropriate PD-1\u002FPD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Shen Feng, MD.; PhD","CONTACT","8616628552926","shenfengdfgd@163.com",{"name":27,"role":23,"phone":11,"phoneExt":11,"email":28},"Feng Xie, MD","13386272885@189.cn",{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Shen Feng","Dean of the Clinical Research Institute, Director of the Department","100579013","phase-4-inetetamab-plus-chemotherapy--pd-1pd-l1-in-her2-advanced-biliary-cancer-100579013",false,"NCT06818773","Inetetamab Plus Chemotherapy ± PD-1\u002FPD-L1 in HER2+ Advanced Biliary Cancer","Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1\u002FPD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n* Males or females aged ≥18 years;\n* Histologically confirmed HER2-positive metastatic biliary tract cancer;\n* ECOG performance status of 0 to 1;\n* No prior treatment with anti-HER2 therapies;\n* Patients have not received any systemic anticancer treatment in the recurrent\u002Fmetastatic setting;\n* Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and\u002For radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;\n* Presence of at least one measurable lesion;\n* Adequate function of major organs as defined by the following criteria;\n* Estimated survival of ≥3 months;\n* Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to any component of the study drugs;\n* Previous treatment with anti-HER2 therapies;\n* Prior use of immunotherapy;\n* Use of immunosuppressive agents within 14 days before the first dose, except:\n\nIntranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg\u002Fday prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)\n\n* Known active central nervous system metastases or carcinomatous meningitis;\n* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;\n* Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;\n* Severe cardiac disease;\n* Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;\n* Neuropathy ≥ Grade I per NCI criteria;\n* Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;\n* History of immunodeficiency;\n* Participation in another drug trial within 4 weeks before screening;\n* Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;\n* Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.","ALL","18 Years",{"count":43,"type":44},35,"ESTIMATED","INTERVENTIONAL",[47],"PHASE4","To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.",[50,51],"Metastatic Biliary Tract Cancer","HER2 Positive","NOT_YET_RECRUITING","2025-02-07",{"date":55,"type":56},"2025-02-10","ACTUAL",{"date":58,"type":44},"2025-02",{"date":60,"type":44},"2027-12-31",{"name":5,"class":6}]