[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534072":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":57,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Astragalus + Gemcitabine","EXPERIMENTAL","Participants will receive Astragalus in combination with Gemcitabine by intravenous infusion (IV).\n\nParticipants will receive IV infusion of 20ml of Astragalus injection (the content of Astragalus crude drug is 2g\u002Fml plus 250ml of normal saline 1 day before chemotherapy, once a day for 21 consecutive days constitute a course of treatment a total of 4 courses of treatment.\n\nGemcitabine is one of the main chemotherapy drugs used to treat pancreatic cancer.",[13],"Drug: Astragalus + Gemcitabine",{"label":15,"type":16,"description":17,"interventionNames":18},"Gemcitabine alone","ACTIVE_COMPARATOR","Participants will receive Neoadjuvant Chemotherapy of Gemcitabine 1000 mg\u002Fm2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).",[19],"Drug: Gemcitabine alone",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will receive Astragalus combined with Gemcitabine. Astragalus, a traditional Chinese medicine, exhibits promising potential in cancer treatment. Studies suggest its role in regulating immune responses, suppressing tumors, and improving overall treatment outcomes in cancer patients. Astragalus combined with chemotherapeutic drug such as Gemcitabine is a popular complementary and alternative therapy used for cancer patients because it can increase therapeutic effects and decrease side effects. This synergistic approach holds potential for more effective and targeted therapeutic outcomes in pancreatic cancer patients.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Gemcitabine is a potent chemotherapy drug widely employed in treating various cancers, including pancreatic cancer. As a nucleoside analog, it disrupts DNA synthesis, impeding cancer cell proliferation. Gemcitabine is administered intravenously and has shown efficacy in alleviating symptoms, improving survival rates, and enhancing the quality of life for patients undergoing cancer treatment.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Wei Zhang, PhD","CONTACT","+8618616835965","zhangwei9501@szu.edu.cn",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Mikiyas Amare Getu, PhD","+8613028815957","makmiky86@gmail.com",[40],{"facility":5,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Shenzhen","Guangdong","518055","China","CN",{"type":47,"coordinates":48},"Point",[49,50],114.0683,22.54554,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":55,"phoneExt":25,"email":56},"Xianbin Zhang, PhD","+8613530765815","xianbin.zhang@szu.edu.cn",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Xianbin Zhang","Principal Investigator","100534072","phase-2-comparing-astragalus-plus-gemcitabine-to-gemcitabine-alone-as-neoadjuvant-treatment-for-pancreatic-cancer-patients-100534072",false,"NCT06234072","Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients","Comparison of Neoadjuvant Treatment for Pancreatic Cancer: Astragalus Combined With Gemcitabine Versus Gemcitabine Alone - A Single-Center, Randomized, Double-Blind Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;\n* Is 18 years of age or older;\n* ECOG performance status 0 to 2;\n\nPatient organ function tests must meet the following laboratory parameters:\n\n* Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.\n* Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN),\n* Neutrophils 1,500\u002FUl,\n* hemoglobin \\> 8.0 gm\u002FdL,\n* Platelet count ≥ 100,000\u002Fmm3 (IU: ≥ 100 x 109\u002FL),\n* serum creatinine \\\u003C 2.0 mg\u002FdL,\n* Expected postoperative survival ≥ 3 months;\n* Ability to comply with the study visit plan and other protocol requirements;\n* Voluntary participation and signing of informed consent.\n* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* CNS damage or soft meningeal disease;\n* Metastasis to distant sites;\n* Other serious diseases or conditions, including congestive heart failure (New York Heart Association class III or IV), unstable angina pectoris, infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, and substance abuse;\n* Known hypersensitivity to Astragalus or gemcitabine;\n* Pregnant or lactating women. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of study drug. Sexually active, fertile men who are not using effective contraception themselves if their partner is a woman of childbearing potential;\n* Known neuroendocrine tumor of the pancreas;\n* Receiving a concomitant treatment with drugs interacting with gemcitabine;\n* Past or concurrent cancers with primary foci or histology completely different from pancreatic cancer, except for cervical cancer in situ, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis \\& T1). Any cancer cured \\>5 years prior to enrollment is allowed;\n* Inability to swallow herbal medicines or untreated malabsorption syndrome and unwillingness to take herbal medicines.\n* Patients with poor compliance","ALL","18 Years",{"count":71,"type":72},120,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.",[78],"Pancreatic Cancer","NOT_YET_RECRUITING","2024-01-31",{"date":82,"type":83},"2024-02-02","ACTUAL",{"date":85,"type":72},"2024-02",{"date":87,"type":72},"2027-01",{"name":5,"class":6},1]