[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"local-advanced-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:local-advanced-rectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100646505","phase-3-short-course-radiotherapy-followed-by-capox-with-or-without-iparomlimab-and-tuvonralimab-in-pmmrmss-locally-advanced-rectal-cancer-100646505",false,"NCT07686640","Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR\u002FMSS Locally Advanced Rectal Cancer","Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR\u002FMSS Locally Advanced Rectal Cancer (SCRIT): A Multicenter Phase III Randomized Controlled Trial","SCRIT","Inclusion Criteria:\n\n* Patients aged 18-75 years with histologically confirmed pMMR\u002FMSS rectal adenocarcinoma are eligible if they have MRI-defined clinical stage II or III disease according to AJCC 8th edition, tumor located within 12 cm from the anal verge, and at least one high-risk feature, including cT4b, cN2, EMVI positivity, MRF positivity, lateral lymph node positivity, tumor deposits, or tumor located ≤5 cm from the anal verge. Patients must have no distant metastasis, ECOG performance status 0-1, life expectancy greater than 6 months, and adequate hematologic, hepatic, and renal function\n\nExclusion Criteria:\n\n* active or prior autoimmune disease requiring systemic treatment, use of immunosuppressive therapy or systemic corticosteroids at immunosuppressive doses, severe hypersensitivity to monoclonal antibodies, uncontrolled cardiac disease, significant coagulopathy or bleeding tendency, active infection, interstitial lung disease or severe pulmonary dysfunction, HIV infection or active hepatitis, prior or concurrent malignancy except specified cured cancers, recent investigational drug use, planned use of other systemic antitumor therapy during the study, pregnancy or breastfeeding, and any other condition judged by the investigator to make participation unsuitable.","ALL","18 Years","75 Years",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This multicenter, randomized, controlled, phase III trial evaluates whether adding iparomlimab and tuvonralimab injection to CAPOX consolidation chemotherapy after short-course radiotherapy improves tumor response in patients with treatment-naive, proficient mismatch repair\u002Fmicrosatellite-stable (pMMR\u002FMSS) locally advanced rectal adenocarcinoma. Eligible patients will be randomly assigned in a 1:1 ratio to receive short-course radiotherapy followed by CAPOX plus iparomlimab and tuvonralimab, or short-course radiotherapy followed by CAPOX alone.\n\nAfter total neoadjuvant therapy, patients with a clinical complete response may undergo a Watch-and-Wait strategy, whereas other patients will undergo total mesorectal excision according to standard clinical practice. The primary endpoint is complete response rate, defined as pathologic complete response after surgery or clinical complete response sustained for more than 1 year. Secondary endpoints include 3-year relapse-free survival, 3-year overall survival, sphincter preservation rate, and grade 3-4 acute adverse events. Exploratory analyses will assess tissue and blood biomarkers associated with treatment response.",[28,29,30],"Local Advanced Rectal Cancer","Radiotherapy","Immunotherapy",[32,33,34],"local advanced rectal cancer","radiotherapy","immunotherapy","RECRUITING","2026-08-17",{"date":38,"type":39},"2026-08-18","ACTUAL",{"date":41,"type":39},"2026-08-15",{"date":43,"type":22},"2030-07-15",{"name":45,"class":46},"Shandong Cancer Hospital and Institute","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100646636","phase-3-anti-pcsk9-antibody-tafolecimab-and-anti-pd-1-antibody-sintilimab-combined-with-neoadjuvant-chemoradiotherapy-for-pmmr-mss-locally-advanced-rectal-cancer--a-prospective-multicenter-randomized-open-label-parallel-controlled-trial-100646636","NCT07686796","Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR\u002F MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial","Inclusion Criteria:\n\n1. Age 18 to 75 years, any sex.\n2. Histologically confirmed rectal adenocarcinoma, determined to be pMMR (proficient mismatch repair) or MSS (microsatellite stable) by immunohistochemistry and\u002For genetic testing; clinical stage cT3\u002FT4 or cN+; distal tumor margin ≤ 12 cm from the anal verge; and eligible for surgical resection.\n3. No evidence of distant metastases.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. Adequate hematologic and biochemical function: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 × 10⁹\u002FL, ALT\u002FAST ≤ 2.5 times the upper limit of normal (ULN), creatinine ≤ 3.0 × ULN.\n6. Anticipated good compliance and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy or severe adverse reaction to any study drug, including tafolecimab, PD-1 inhibitor (sintilimab), capecitabine, oxaliplatin, or any excipients.\n2. Rectal cancer confirmed as dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high).\n3. Pregnant or breastfeeding women, or patients of childbearing potential who refuse to use effective contraception during the study.\n4. Other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, or other malignancies considered cured after adequate treatment.\n5. Prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, or local surgical excision.\n6. Previous treatment with a PCSK9 inhibitor for any indication.\n7. Severe or uncontrolled neurological disease, psychiatric disorder, or cognitive impairment that, in the investigator's judgment, would affect informed consent or protocol adherence.\n8. Severe cardiovascular or cerebrovascular disease, including but not limited to: unstable angina, myocardial infarction, coronary revascularization, or stroke within 6 months before enrollment; clinically significant arrhythmia requiring treatment or left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) class III or IV heart failure.\n9. Active infection requiring long-term systemic therapy (e.g., antibiotics, antivirals, or antifungals).\n10. Active autoimmune disease, or requirement for long-term systemic immunosuppressive therapy or corticosteroids (at a dose equivalent to prednisone \\> 10 mg\u002Fday).\n11. Known history of human immunodeficiency virus (HIV) infection, or active syphilis, or active pulmonary tuberculosis.\n12. Active hepatitis B (HBsAg positive and HBV DNA \\> 200 IU\u002FmL or \\> 1000 copies\u002FmL) or active hepatitis C (HCV RNA positive).\n13. Any other clinical condition that, in the investigator's opinion, could interfere with study assessments, increase treatment risk, or lead to premature study discontinuation (including but not limited to severe alcohol or drug abuse).",{"count":55,"type":22},148,[25],"This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab (an anti-PD-1 inhibitor) versus neoadjuvant chemoradiotherapy combined with sintilimab alone in patients with pMMR\u002FMSS locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, including the pathological complete response (pCR) rate in patients who undergo surgery after neoadjuvant therapy, and the clinical complete response (cCR) rate in patients managed with a watch-and-wait strategy. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), downstaging rate, R0 resection rate, tumor regression grade, sphincter preservation rate, disease-free survival (DFS), overall survival (OS), and safety.",[28,59,60,61,29,62,63],"PD-1 Inhibitor","PCSK9 Inhibitor","RCT","Capecitabine","Oxaliplatin","NOT_YET_RECRUITING","2026-07-06",{"date":67,"type":39},"2026-07-07",{"date":69,"type":22},"2027-01-01",{"date":71,"type":22},"2035-01-01",{"name":73,"class":46},"Guangdong Provincial People's Hospital",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100628563","results-of-low-anterior-resections-with-or-without-preventive-stoma-in-nonemergency-department-100628563","NCT07463261","REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department","Results of Anastomotic Leak After Low Anterior Resection With or Without Preventive Stoma for Rectal Cancer in Low-risk Patients in Nonemergency Departments (RELOAD): Protocol of Multicenter Randomized Controlled Non-inferiority Trial","RELOAD","Inclusion Criteria:\n\n* Age \\>18 years;\n* Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);\n* Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;\n* Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and\u002For pelvic MRI);\n* Planned radical minimally invasive (laparoscopic\u002Frobot-assisted) intervention with TME and formation of primary colorectal\u002Fcolonanal anastomosis;\n* Adequate hematologic function: hemoglobin ≥100 g\u002FL, leukocytes \\>4 × 10\\^9\u002FL, platelets \\>100 × 10\\^9\u002FL;\n* Adequate renal function: serum creatinine \\\u003C150 µmol\u002FL;\n* Adequate hepatic function: AST\u002FALT \\\u003C100 U\u002FL;\n* Predicted risk of anastomotic leakage ≤10% (AFOR 0-1).\n\nExclusion Criteria:\n\n* Age ≥80 years;\n* Presence of a pre-existing diverting ileostomy or colostomy;\n* Peritumoral abscess or tumor perforation;\n* Distant metastases (M1) identified preoperatively and\u002For intraoperatively;\n* Synchronous or metachronous malignancy;\n* Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);\n* Evidence of malnutrition (serum albumin \\\u003C34 g\u002FL);\n* Severe uncontrolled comorbid conditions (e.g., acute myocardial infarction, uncontrolled hypertension, decompensated heart failure, immunosuppression, systemic corticosteroid therapy, severe chronic obstructive pulmonary disease, chronic kidney disease stage 4-5), type 1 or type 2 diabetes mellitus, or psychiatric\u002Fneurological disorders impairing the ability to provide informed consent;\n* Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and\u002For intraoperatively;\n* Predicted risk of anastomotic leakage \\>10% (AFOR 2-6).","70 Years",{"count":84,"type":22},442,[86],"NA","The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage.\n\nThe primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferior to that in the diverting stoma group.\n\nThe secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year.\n\nParticipants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage \\\u003C10% according to the study risk model.",[89,90,91,92,28],"TME","Rectal Cancer Surgery","Low Rectal Cancer","Middle Rectal Cancer",[94,95,96,97,98],"rectal cancer","preventive stoma","randomized trial","low-risk patients","anastomotic leak","2026-05-11",{"date":101,"type":39},"2026-05-13",{"date":103,"type":39},"2026-05-05",{"date":105,"type":22},"2027-06-10",{"name":107,"class":46},"ANO Scientific and Practical Club for the Development of Modern Medical Technologies",7]