[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525573":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1811","EXPERIMENTAL",null,[13],"Drug: SHR-A1811",{"label":15,"type":16,"description":11,"interventionNames":17},"The investigators' choice","ACTIVE_COMPARATOR",[18],"Drug: Ramucirumab \u002F Paclitaxel\u002F Docetaxel\u002F Irinotecan",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","SHR-A1811 6.4 mg\u002Fkg IV infusion every 3 weeks on Day 1 of each 21-day cycle",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Ramucirumab \u002F Paclitaxel\u002F Docetaxel\u002F Irinotecan","Ramucirumab 8mg\u002Fkg，D 1,15 + Paclitaxel 80mg\u002Fm2，D1,8,15，Q4W; Paclitaxel 80mg\u002Fm2，D1,8,15，Q4W; Docetaxel 75mg\u002Fm2，D1，Q3W; Irinotecan 150mg\u002Fm2，D1，Q2W.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Yang Wu","CONTACT","0518-82342973","yang.wu.yw96@hengrui.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Shanghai East Hospital","RECRUITING","Shanghai","Shanghai Municipality","200433","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":11,"email":53},"Jin Li","+86-21-38804518","lijin@csco.org.cn",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100525573","phase-3-shr-a1811-for-subjects-with-her2-positive-gastric-cancer-and-gastroesophageal-junction-adenocarcinoma-after-progression-on-or-after-first-line-anti-her2-therapy-containing-regimen-100525573",false,"NCT06123494","SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen","A Phase 3, Multicenter, Randomized, Open-label Study of SHR-A1811 (HER2-ADC) Compared With the Chemotherapy Treatment Chosen by the Investigators for Subjects With HER2-positive Metastatic and\u002For Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma Who Have Progressed on or After First-line Anti-HER2 Therapy-containing Regimen","Inclusion Criteria:\n\n1. Age 18-75 years old, male and female;\n2. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma, and unresectable locally advanced or metastatic disease\n3. Prior anti-HER-2 containing treatment\n4. Progression on or after first-line standard treatment (Prior neoadjuvant or adjuvant therapy can be counted as a line of therapy if the subject progressed on or within 6 months of completing neoadjuvant or adjuvant therapy);\n5. Centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH) as classified by ASCO-CAP on a tumor biopsy\n6. At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n7. ECOG: 0-1;\n8. Expected survival ≥12 weeks;\n9. Good blood reserve and liver, kidney and coagulation function;\n10. Willing to provide informed consent for study participation.\n\nExclusion Criteria:\n\n1. Receive the last dose of anti-cancer therapy(including chemotherapy, radiotherapy, biological therapy, targeted therapy or immunotherapy) within 4 weeks, prior to the first dose;\n2. Known allergies to monoclonal antibodies and inactive ingredients of this product, and allergies to paclitaxel, docetaxel, and irinotecan concurrently;\n3. The toxicity of prior anti-tumor therapy did not recover to the level specified by CTCAE v5.0 grade evaluation ≤ Grade 1 or inclusion\u002Fexclusion criteria;\n4. Clinically active central nervous system metastases;\n5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n6. Clinically significant gastrointestinal disorder by the opinion of Investigator;\n7. Has a history of immunodeficiency, including a positive HIV test;\n8. During the screening visits and before the first dose, unexplained fever \\> 38.5℃, severe infection (CTC-AE \\> Grade 2), and active pulmonary inflammation were indicated by screening imaging;\n9. Subjects with interstitial pneumonia or with ≥ grade 3 interstitial pneumonia during prior treatment with immune checkpoint inhibitors;\n10. Active hepatitis B(HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA above the lower limit of detection of the analytical method);\n11. Clinically significant cardiovascular disease ,such as severe\u002Funstable angina, symptomatic congestive heart failure (NYHA ≥ Class II.), clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, myocardial infarction within 6 months before the first dose, cerebrovascular accident (including transient ischemic attack); QTcF of 12-lead ECG was ≥470 ms; Left ventricular ejection fraction \\\u003C50%; Clinically uncontrolled hypertension;\n12. Had other malignancies with 5 years;\n13. Pregnant or lactating women;\n14. Other factors that might have led to drop out the study by the investigator opinion.","ALL","18 Years","75 Years",{"count":67,"type":68},360,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","This study will assess the efficacy and safety of SHR-A1811 compared with treatment chosen by the investigator in participants with HER2-positive (defined as immunohistochemistry \\[IHC\\] 3+ or IHC 2+\u002Fin situ hybridization \\[ISH\\]+) gastric or GEJ adenocarcinoma (based on \\[American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a first-line anti-HER2 therapy-containing regimen.",[74],"HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","2024-01-11",{"date":77,"type":78},"2024-01-16","ACTUAL",{"date":80,"type":78},"2024-01-09",{"date":82,"type":68},"2027-06-30",{"name":5,"class":6},1]