[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disitamab-vedotin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disitamab-vedotin":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100605184","phase-2-disitamab-vedotin-plus-lenvatinib-and-pd-1-inhibitors-for-treating-her2-positive-advanced-biliary-tract-cancer-100605184",false,"NCT07159217","Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer","A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer","Inclusion criteria:\n\n1. Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.\n2. Age ≥ 18 years and any gender.\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).\n4. At least one measurable lesion (according to RECIST 1.1).\n5. ECOG performance status score of 0-1.\n6. Child-Pugh score ≤ 7 .\n7. HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2\u002FCEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.\n8. No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.\n9. Expected survival \\> 12 weeks.\n10. Adequate hematological and major organ function.\n\nExclusion criteria：\n\n1. Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.\n2. Pregnant women (positive pregnancy test before medication) or lactating women.\n3. Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.\n4. History of other active malignancies within 5 years prior to screening.\n5. Presence of central nervous system metastasis and\u002For leptomeningeal metastasis.\n6. Unhealed severe wounds, active ulcers, or untreated fractures.\n7. Administration of live vaccines within 30 days prior to randomization.\n8. Active autoimmune disease or history of autoimmune disease.\n9. Presence of clinically significant gastrointestinal disorders.\n10. Presence of clinically significant cardiovascular or cerebrovascular diseases.","ALL","18 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This trial is a single-arm exploratory phase II clinical study initiated by the investigator.\n\nSubjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.",[26,27,28,29],"Biliary Tract Cancer","Disitamab Vedotin","Lenvatinib","Immune Checkpoint Inhibitors",[31,32,28,33],"Biliary tract cancer","Disitamab vedotin","Immune checkpoint inhibitors","NOT_YET_RECRUITING","2025-08-28",{"date":37,"type":38},"2025-09-08","ACTUAL",{"date":40,"type":20},"2025-08-30",{"date":42,"type":20},"2028-05-31",{"name":44,"class":45},"Peking Union Medical College Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100530332","phase-2-rc48-combined-with-egfr-or-her2-tki-for-locally-advanced-or-metastatic-nsclc-patients-with-her2-alterations-100530332","NCT06185400","RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations","Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations","Inclusion Criteria:\n\n1. Age: 18 (inclusive) or above, regardless of gender.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).\".\n3. HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression;\n4. Number of treatment lines:\n\n   * Arm1: patients who have not previously received systemic treatment for advanced diseases;\n   * Arm2: Previously received first line of third-generation EGFR-TKIs treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation EGFR-TKIs treatment;\n   * Arm3: Previously received first line of third-generation EGFR-TKIs treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation EGFR-TKIs treatment;\n5. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.\n6. ECOG fitness status score: 0 or 1 point.\n\nExclusion Criteria:\n\n1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.\n2. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.\n3. Have a history of severe cardiovascular disease.\n4. Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia.\n5. Have a history of neurological disorders or mental illnesses, including epilepsy or dementia.\n6. Pregnant or lactating women.\n7. The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.",{"count":55,"type":20},108,[23],"Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.",[59,60,61,27],"Non Small Cell Lung Cancer","ERBB2 Mutation-Related Tumors","ERBB2 Gene Duplication","2023-12-28",{"date":64,"type":38},"2023-12-29",{"date":66,"type":20},"2024-02-01",{"date":68,"type":20},"2026-12-01",{"name":70,"class":45},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"]