[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426996":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":39,"centralContacts":44,"locations":49,"responsibleParty":69,"collaborators":28,"id":73,"slug":28,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":52,"whyStopped":28,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,16,19],{"label":9,"type":10,"description":11,"interventionNames":12},"A (First-Line Therapy)","EXPERIMENTAL","Docetaxel 25 mg\u002Fsquare metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg\u002Fsquare metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg\u002Fsquare metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.",[13,14,15],"Drug: Docetaxel","Drug: Oxaliplatin","Drug: Fluorouracil",{"label":17,"type":10,"description":11,"interventionNames":18},"B (Second-Line Therapy)",[13,14,15],{"label":20,"type":10,"description":11,"interventionNames":21},"C (Third- or Later-Line Therapy)",[13,14,15],[23,29,33],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Docetaxel","25 mg\u002Fsquare metre, D1, D8, D15, repeat every 4 weeks.",[9,17,20],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Oxaliplatin","85 mg\u002Fmsquare metre, D1, D15, repeat every 4 weeks.",[9,17,20],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Fluorouracil","1200 mg\u002Fsquare metre, D1, D8, D15, repeat every 4 weeks.",[9,17,20],[38],"5-FU",[40],{"name":41,"affiliation":42,"role":43},"Jian Xiao, MD","The Sixth Affiliated Hospital, Sun Yat-sen University","STUDY_CHAIR",[45],{"name":41,"role":46,"phone":47,"phoneExt":28,"email":48},"CONTACT","86-20-38250745","xiao_jian@139.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"The Sixth Affiliated hosipital, Sun Yat-Sen University","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65],{"name":66,"role":46,"phone":67,"phoneExt":28,"email":68},"Jian Xiao, PhD","13711114566","Xiaoj26@mail.sysu.edu.cn",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Jian Xiao","Doctor of Medicine","100426996",false,"NCT04840264","Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction","A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction","Inclusion Criteria:\n\n* 18-75 years of age;\n* ECOG PS ≤3;\n* pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;\n* peritoneal carcinomatosis established by imaging data or pathological evidence;\n* MBO below the Treitz ligament based on clinical grounds or radiological findings;\n* considered as inoperable MBO by two independent surgical consultants;\n* Hb≥60g\u002FL, WBC ≥4×10E9\u002FL, ANC≥2×10E9\u002FL，PLT≥100×10E9\u002FL;\n* Cr≤ Upper Normal Limit(UNL);\n* Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;\n* Written informed consent form paticipants.\n\nExclusion Criteria:\n\n* treated by a combination regimen containing all the study drugs;\n* allergy to any of the study drugs;\n* HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);\n* strangulated intestinal obstruction;\n* active gastrointestinal bleeding;\n* uncontrolled active infection;\n* unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);\n* severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);\n* mental disorders that affect clinical treatment or central nervous system diseases;\n* concomitant cerebral parenchymal or meningeal metastasis;\n* HIV infection or untreated active hepatitis;\n* bowel surgery or stenting required due to obstruction;\n* pregnant or lactating women;\n* other conditions that are not suitable for participation in the study.","ALL","18 Years","75 Years",{"count":83,"type":84},79,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.",[90,91,92],"Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Peritoneal Carcinomatosis",[94,25,30,34],"Malignant Bowel Obstruction","2024-03-14",{"date":97,"type":98},"2024-03-18","ACTUAL",{"date":100,"type":98},"2022-01-07",{"date":102,"type":84},"2027-06-30",{"name":5,"class":6},1]