[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427398":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":23,"responsibleParty":47,"collaborators":23,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":23,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":73,"overallStatus":79,"whyStopped":23,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":23},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug group 1","EXPERIMENTAL","hyperthermic intraperitoneal chemotherapy (HIPEC) (with Mitomycin): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation.\n\nChoice of perfusate: Normal saline. Drug selection and dose: Mitomycin 30 mg\u002Fm2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).",[13],"Drug: Mitomycin",{"label":15,"type":10,"description":16,"interventionNames":17},"Drug group 2","hyperthermic intraperitoneal chemotherapy (HIPEC) (with lobaplatin): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation.\n\nChoice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg\u002Fm2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).",[18],"Drug: Lobaplatin",{"label":20,"type":21,"description":22,"interventionNames":23},"Control group","NO_INTERVENTION","hyperthermic intraperitoneal therapy (HIPET) (no drug) : Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation.\n\nChoice of perfusate: Normal saline. Drug selection and dose: no drug. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DRUG","Mitomycin","Mitomycin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Mitomycin 30mg\u002Fm2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"Lobaplatin","Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Lobaplatin 50mg\u002Fm2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).",[15],[35],{"name":36,"affiliation":5,"role":37},"Kaixiong Tao, Professor","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":23,"email":42},"CONTACT","+86- 027-85351662","kaixiongtao@hust.edu.cn",{"name":44,"role":40,"phone":45,"phoneExt":23,"email":46},"Cuanqing Wu, Doctor","+86-13995598966","linyaomt@163.com",{"type":48,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100427398","phase-2-comparative-study-of-mitomycin-and-lobaplatin-in-advanced-colorectal-cancer-patients-with-radical-surgery-combined-with-hyperthermic-intraperitoneal-chemotherapy-100427398",false,"NCT04845490","Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy","Comparative Study on the Efficacy of Mitomycin and Lobaplatin in the Treatment of Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy","WUHIPEC02","Inclusion Criteria:\n\n1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;\n2. Aged 18-75 years;\n3. Male or non-pregnant or lactating women;\n4. Pathological diagnosis of colorectal adenocarcinoma;\n5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given radical surgery (AJCC Version 8, 2018);\n6. Normal function of major organs;\n7. Routine blood examinations meeting the following criteria:\n\n   A. HB ≥ 90 g\u002FL; B. ANC ≥ 1.5 x 10 9 \u002FL; C. PLT ≥ 125 × 10 9 \u002FL;\n8. Chemistry indexs meeting the following criteria:\n\n   A. TBIL \\\u003C 1.5ULN; B. ALT and AST \\\u003C 2.5ULN; ALB \\> 30 g\u002FL C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n9. ECOG score 0-1;\n\nExclusion Criteria:\n\n1. A history of other malignant tumors within 5 years;\n2. Distant metastasis found during surgery;\n3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;\n4. Suffering from epilepsy or other mental illness, unable to control behavior;\n5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;\n6. Pregnant or lactating women.\n7. Receiving anti-cancer drug therapy from other clinical trials.","ALL","18 Years","75 Years",{"count":61,"type":62},201,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy",[68,69,70,71,72],"Colorectal Cancer","Chemotherapy Effect","Surgery","Metastasis","Survival",[74,75,76,77,78],"advanced colorectal cancer","hyperthermic intraperitoneal chemotherapy","mitomycin","lobaplatin","prognosis","NOT_YET_RECRUITING","2022-02-18",{"date":82,"type":83},"2022-02-21","ACTUAL",{"date":85,"type":62},"2022-09-01",{"date":87,"type":62},"2026-09-01",{"name":5,"class":6}]