[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478218":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":40,"responsibleParty":50,"collaborators":40,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":40,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":77,"whyStopped":40,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant chemoradiotherapy plus PD-1 inhibitor","EXPERIMENTAL","Capecitabine 1650mg\u002Fm2 is given 5 days a week in parallel with radiotherapy 45 to 50 Gy during 5 consecutive weeks.\n\nTislelizumab is given on day 1 of week 2, 5 and 8 at 200 mg i.v. 8-12 weeks after completion of radiation therapy, patients undergo total mesorectal excision (TME).",[13,14,15],"Drug: PD-1 inhibitor","Drug: Capecitabine","Radiation: Long-course radiation therapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Neoadjuvant chemoradiotherapy","ACTIVE_COMPARATOR","Capecitabine 1650mg\u002Fm2 is given 5 days a week in parallel with radiotherapy 45 to 50 Gy during 5 consecutive weeks.\n\n8-12 weeks after completion of radiation therapy, patients undergo total mesorectal excision (TME).",[14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","PD-1 inhibitor","Tislelizumab (3 cycles): 200mg i.v. q3w on day 1 of each cycle, and starting from the second week after the start of radiotherapy",[9],[28],"Tislelizumab",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Capecitabine","Capecitabine 1650mg\u002Fm2\u002Fd orally twice-daily, 5 days a week for a total of 5 weeks.",[17,9],[34],"Xeloda",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"RADIATION","Long-course radiation therapy","45-50 Gy\u002Fday, 5 days a week for a total of 5 weeks.",[17,9],null,[42],{"name":43,"affiliation":5,"role":44},"Jiaolin Zhou, Ph.D","STUDY_CHAIR",[46],{"name":43,"role":47,"phone":48,"phoneExt":40,"email":49},"CONTACT","+86-13910136704","conniezhjl@163.com",{"type":51,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100478218","phase-2-time-in-immunotherapy-combined-with-ncrt-for-rectal-cancer-100478218",false,"NCT05507112","TIME in Immunotherapy Combined With nCRT for Rectal Cancer","The Therapeutic and Prognostic Implications of Tumor Immune Microenvironment in The Neoadjuvant Immunotherapy Combined With Chemoradiotherapy for Rectal Cancer","TIMENT-R","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤75 years on the day of signing informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n3. Histologically proven rectal adenocarcinoma.\n4. \\\u003C12 cm from anal verge.\n5. Clinical stage of T3\u002FT4 or N positive and M0\n6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment\n7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease, dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC), autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection.\n8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery.\n9. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Allergic to any component of chemotherapy or immunotherapy;\n2. Patients with multiple primary colorectal cancer;\n3. Other malignant tumors within 5 years, except for adequately treated cervical carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled localized prostate cancer or surgically excised ductal carcinoma in situ of breast;\n4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection;\n5. Prior or planed organ\u002Fbone marrow transplant\n6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study;\n7. Pregnant or lactating women\n8. Patients with a history of severe mental illness or being unable to comply with the research protocols.\n9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery.\n10. Patients who have any other conditions that investigator judges unsuitable to participate.","ALL","18 Years","75 Years",{"count":64,"type":65},100,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.",[71],"Locally Advanced Rectal Cancer",[73,74,75,76],"Rectal Cancer","Immunotherapy","neoadjuvant therapy","Tumor Immune Microenvironment","NOT_YET_RECRUITING","2022-09-16",{"date":80,"type":81},"2022-09-21","ACTUAL",{"date":83,"type":65},"2022-09-20",{"date":85,"type":65},"2029-12-01",{"name":5,"class":6}]