[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617495":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":12,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":12,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":12,"enrollmentInfo":63,"targetDuration":12,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":37,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","NO_INTERVENTION","Patients in the control group continued their original chemotherapy\u002Ftargeted therapy regimen, with each treatment cycle lasting 3 weeks, for a total of 5 cycles. Treatment efficacy was assessed after every 2 cycles.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental Group","EXPERIMENTAL","Patients in the FMT group received treatment starting from the fourth cycle on top of their existing regimen. They underwent one FMT treatment within 3 days prior to chemotherapy\u002Ftargeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor gut microbiota encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g\u002Fcapsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.",[18],"Biological: Fecal microbiota transplantation (FMT)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Fecal microbiota transplantation (FMT)","Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered within 3 days prior to chemotherapy\u002Ftargeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor intestinal bacteria encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g\u002Fcapsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.",[14],[26,27],"Chemotherapy","Targeted Therapy",[29],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Da Wang","CONTACT","86-0571-87784720","wangda0618@zju.edu.cn",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Second Affiliated Hospital Zhejiang University School of Medicine","RECRUITING","Zhejiang","Hangzhou","310009","China","CN",{"type":44,"coordinates":45},"Point",[46,47],105.583,25.3238,{"lat":47,"lon":46},[50],{"name":30,"role":31,"phone":51,"phoneExt":12,"email":33},"8613819108162",{"type":53,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100617495","phase-1-a-real-world-study-of-fecal-transplants-for-cancer-therapy-side-effects-100617495",false,"NCT07319364","A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects","An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention\u002FReduction of Chemotherapy\u002FTargeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.","Inclusion Criteria:\n\n1. Age ≥ 18 years, gender not restricted;\n2. Estimated survival time ≥ 3 months;\n3. Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;\n4. TNM staging of cancer in patients is Stage IV;\n5. Having undergone PD-1 or PD-L1 testing;\n6. Planned to receive the 4th cycle of chemotherapy\u002Ftargeted therapy;\n7. Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy\u002Ftargeted therapy;\n8. Patients are able and willing to sign the informed consent form and complete follow-up;\n9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;\n10. Use of oral\u002Fintravenous broad-spectrum antibiotics with caution within 3 days;\n11. Patients are able to swallow capsules without chewing;\n12. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;\n13. Laboratory test results during the screening period indicate that the subjects have sufficient organ function.\n\nExclusion Criteria:\n\n1. Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency\u002Fhepatic failure;\n2. Uncontrolled or severe infections;\n3. Known history of psychotropic substance abuse, alcoholism, and drug abuse;\n4. Patients with severe infections complicated with septicemia or sepsis;\n5. Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;\n6. Patients with active viral infections;\n7. Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);\n8. Patients with gastrointestinal perforation and\u002For fistula;\n9. Other conditions deemed unsuitable for enrollment by the investigator.","ALL","18 Years",{"count":64,"type":65},90,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy \u002F targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.",[71,72,73,74],"Fecal Microbiota Transplantation (FMT)","Gastrointestinal Neoplasms","Antineoplastic Agents","Drug-related Side Effects and Adverse Reactions",[76,72,73,77],"Fecal Microbiota Transplantation","Drug-Related Side Effects and Adverse Reactions","2025-12-21",{"date":80,"type":81},"2026-01-06","ACTUAL",{"date":83,"type":81},"2025-09-01",{"date":85,"type":65},"2026-09-01",{"name":5,"class":6},1]