[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544375":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":67,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":43,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":43,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Xi'an Jiaotong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Huaier treatment group","EXPERIMENTAL","The subjects take Huaier granules orally and start taking them within 15-30 days after surgery until the end of the study, intolerable toxicity occurs, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit.",[13],"Drug: Huaier granule",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard chemotherapy group","ACTIVE_COMPARATOR","Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment)\n\n* Gemcitabine combine with capecitabine\n* mFOLFIRINOX solution\n* Gemcitabine monotherapy\n* Tegafur，gimeracil and oteracil potassium capsules monotherapy",[19],"Drug: chemotherapy drugs",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Huaier granule","Huaier Granules: Oral administration, 10g once, 3 times a day, starting from 15-30 days after surgery until the end of the study, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that the subjects no longer benefit.",[9],[27],"Z20000109#NMPA Approval Number#",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"chemotherapy drugs","Accept treatment with Class 1A chemotherapy drugs recommended by CSCO (choose any one to receive treatment)\n\n· Gemcitabine combine with capecitabine\n\nGemcitabine 1000mg\u002Fm\\^2 intravenous infusion for more than 30 minutes, day 1, 8, 15,repeat every 4 weeks for a total of 6 cycles.\n\n· mFOLFIRINOX solution\n\nOxaliplatin 85mg\u002Fm\\^2 intravenous infusion for 2 hours, day 1 Ilitacan 150mg\u002Fm\\^2 intravenous infusion for more than 30-90 minutes, day 1 Leucovorin calcium 400mg\u002Fm\\^2 intravenous infusion for 2 hours, day 1 5-FU 2400mg\u002Fm\\^2, continuous intravenous infusion for 46 hours, repeated every 2 weeks, administered until 24 weeks.\n\n* Gemcitabine monotherapy\n\n  1000mg\u002Fm\\^2 intravenous infusion, day 1 qw x 7, rest for 1 week Afterwards, qw × 3, take a week off, and administer medication for 6 months.\n* Tegio capsules monotherapy\n\nTake tegio capsules orally, 80mg\u002Fd, day 1-28, repeated every 6 weeks, administered until 6 months.",[15],[33],"Standard chemotherapy",[35],{"name":36,"affiliation":37,"role":38},"Zheng Wang, PhD","First Affiliated Hospital Xi'an Jiaotong University","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+8615902993665",null,"zheng.wang11@mail.xjtu.edu.cn",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Liang Han, PhD","+8613379181359","hanliangxjtu@163.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Zheng Wang","RECRUITING","Xi'an","Shannxi","710065","China","CN",{"type":59,"coordinates":60},"Point",[61,62],108.92861,34.25833,{"lat":62,"lon":61},[65,66],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},{"type":38,"investigatorFullName":51,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"professor",[70,73],{"name":71,"class":72},"LinkDoc Technology (Beijing) Co. Ltd.","INDUSTRY",{"name":74,"class":6},"Huazhong University of Science and Technology","100544375","phase-4-the-study-of-huaier-granule-in-postoperative-adjuvant-therapy-of-resectable-pancreatic-cancer-100544375",false,"NCT06368063","The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer","Study on the Efficacy and Safety of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer","Inclusion Criteria:\n\n* Age range from 18 to 80 years old, regardless of gender;\n* Pancreatic cancer was diagnosed by histopathology after radical surgery within 12 weeks before enrollment;\n* Did not receive neoadjuvant therapy before surgery and did not receive any adjuvant therapy after surgery;\n* ECOG score 0-3 points;\n* Those who choose to use standard chemotherapy independently based on their own situation, or choose Huaier granules for subsequent treatment, voluntarily participate in and cooperate with various research work, including but not limited to cooperating with treatment and follow-up, cooperating with researchers for data collection, and not actively taking other treatments.\n* The subjects voluntarily signed a written informed consent form before participating in this study.\n\nExclusion Criteria:\n\n* Known to be allergic to the components of Huaier granules or to avoid or use Huai er granules with caution (Huaier group);\n* Difficulties in taking oral medication due to active gastrointestinal bleeding, perforation, gastric paralysis, etc;\n* Suffering from serious mental illness or other reasons that the researcher deems unsuitable to participate in this study.\n* History of merging with other malignant tumors;\n* Patients with concomitant myocardial infarction, cerebral infarction, and other thromboembolic diseases requiring surgical treatment;\n* Concomitant severe infection;\n* Child Pugh C-grade liver function, renal function 2-5 grades (glomerular filtration rate\\\u003C90ml\u002Fmin);\n* Pregnant or lactating women or those planning to conceive;\n* The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect, chemotherapy or physical therapy in the past 4 weeks(including but not limited to compound cantharidin capsules, cinobufotalin capsules, Kangai injection, please refer to the drug instructions for details).","ALL","18 Years","80 Years",{"count":86,"type":87},642,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer",[93],"Pancreatic Cancer Resectable",[23,95,96,97],"Postoperative adjuvant therapy","Resectable pancreatic cancer","Efficacy and safety","2024-05-07",{"date":100,"type":101},"2024-05-08","ACTUAL",{"date":103,"type":101},"2024-05-06",{"date":105,"type":87},"2028-03",{"name":5,"class":6},1]