[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-neoplasms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,45,81,141,171,197,217,246,268,293,318,342,367,392,430,455,482,505,528,554,580,602],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100299553","non-operative-management-for-locally-advanced-rectal-cancer-100299553",false,"NCT03179540","Non-operative Management for Locally Advanced Rectal Cancer","Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer","NOM","Inclusion Criteria:\n\n* Completed chemoradiotherapy (CRT) as standard of care \\[Stage II and Stage III (T3-T4N0, AnyTN1-2)\\]; \\[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\\]\n* Planned or probable APR\n* ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT\n* 18 years or older\n* Provides written consent\n\nExclusion Criteria:\n\n* Unable to undergo MRI\n* Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)\n* Pregnancy\n* Inflammatory bowel disease\n* More than one primary colorectal cancer\n* Other malignancy within 5 years of treatment for current rectal cancer\n* Unfit for surgery","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.",[27],"Rectal Neoplasms",[29,30,31],"Low Rectal Cancer","Complete Clinical Response","Non-operative Management","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2018-03-16",{"date":40,"type":21},"2028-12",{"name":42,"class":43},"Mount Sinai Hospital, Canada","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":44},"100634758","phase-2-a-prospective-multicenter-single-arm-phase-ii-exploratory-study-of-serplulimab-combined-with-oncolytic-virus-h101-short-course-radiotherapy-and-xelox-chemotherapy-as-total-neoadjuvant-treatment-for-locally-advanced-ct1-3n0m0-rectal-cancer-100634758","NCT07543848","A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer","A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)","Inclusion Criteria:\n\n\\- Participants must meet all of the following criteria:\n\n1. Age 18 to 80 years, male or female.\n2. Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge.\n3. Clinical stage T1-3N0M0 according to AJCC staging criteria.\n4. Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing.\n5. No prior anti-tumor treatment.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months.\n7. Adequate organ function, including:\n\n   * Absolute neutrophil count ≥1.5 × 10\\^9\u002FL\n   * Platelet count ≥100 × 10\\^9\u002FL\n   * Hemoglobin ≥9 g\u002FdL\n   * Serum albumin ≥3 g\u002FdL\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN)\n   * ALT and AST ≤2 × ULN\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin\n   * INR or PT ≤1.5 × ULN, and aPTT ≤1.5 × ULN\n8. Thyroid function within normal range or adequately controlled.\n9. Negative pregnancy test for women of childbearing potential.\n10. Willingness to use effective contraception during the study and for 12 months after treatment.\n11. Ability to understand and willingness to sign a written informed consent form.\n12. Willingness and ability to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Participants will be excluded if they meet any of the following criteria:\n\n  1. Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma).\n  2. Prior pelvic radiotherapy.\n  3. Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors.\n  4. Known allergy to study drugs or their components.\n  5. History of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma.\n  6. Active autoimmune disease or history of autoimmune disease requiring systemic treatment.\n  7. Immunodeficiency, including HIV infection, or history of organ transplantation.\n  8. History of interstitial lung disease or non-infectious pneumonitis.\n  9. Active tuberculosis infection or history of untreated tuberculosis.\n  10. Active hepatitis B or hepatitis C infection.\n  11. Severe cardiovascular, pulmonary, or renal disease.\n  12. Uncontrolled hypertension despite medication.\n  13. History of substance abuse (alcohol or drugs).\n  14. Active uncontrolled infection.\n  15. Use of systemic immunosuppressive therapy.\n  16. Pregnant or breastfeeding women.\n  17. Any condition that, in the investigator's opinion, may interfere with study participation or safety.","80 Years",{"count":54,"type":21},20,[56],"PHASE2","This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).\n\nIn this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.\n\nThe primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.\n\nThe results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.",[27,59],"Rectal Adenocarcinoma",[61,62,63,64,65,66,67,68,69,70],"Rectal Cancer","Total Neoadjuvant Therapy","Combination Therapy","Serplulimab","PD-1 Inhibitor","Oncolytic Virus H101","XELOX Chemotherapy","Short-course Radiotherapy","Organ Preservation","Clinical Complete Response","NOT_YET_RECRUITING","2026-04-15",{"date":74,"type":36},"2026-04-22",{"date":76,"type":21},"2026-05-01",{"date":78,"type":21},"2028-12-31",{"name":80,"class":43},"Chongqing University Cancer Hospital",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":91,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100368284","the-momentum-study-the-multiple-outcome-evaluation-of-radiation-therapy-using-the-mr-linac-study-100368284","NCT04075305","The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","MOMENTUM","Inclusion Criteria:\n\n* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;\n* Patient provides written, informed consent;\n* Patient is 18 years old or older.\n\nExclusion Criteria:\n\n* MRI exclusion criteria, including\n* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.",{"count":90,"type":21},8000,"2 Years","OBSERVATIONAL","The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.",[95,96,97,98,99,100,101,102,103,104,105,106,61,107,27,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130],"Oncology","Breast Cancer","Prostate Cancer","Gynecologic Cancer","Brain Tumor","Brain Cancer","Gynecologic Tumor","Prostate Tumor","Prostate Neoplasm","Breast Tumor","Radiation Toxicity","Quality of Life","Rectal Tumor","Lung Cancer","Lung Tumor","Lung Neoplasm","Esophageal Cancer","Esophagus Cancer","Esophageal Tumor","Esophageal Neoplasm","Esophagus Tumor","Esophagus Neoplasm","Pancreatic Cancer","Pancreatic Tumor","Pancreatic Neoplasms","Head and Neck Cancer","Head and Neck Neoplasms","Head and Neck Tumor","Tumor","Neoplasms","Bladder Cancer","Bladder Neoplasm","Liver Cancer","Liver Neoplasms","Liver Metastases","Oligometastases","2026-03-03",{"date":133,"type":36},"2026-03-05",{"date":135,"type":36},"2019-02-01",{"date":137,"type":21},"2030-08-01",{"name":139,"class":43},"UMC Utrecht",18,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":151,"studyType":92,"phases":4,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":44},"100604796","comprehensive-analysis-of-gut-microbiota-signatures-in-metastatic-colorectal-cancer-100604796","NCT07154173","Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Pathologically confirmed colorectal cancer\n* Clearly defined clinical staging: including imaging or pathologically confirmed metastatic colorectal cancer (stage M1) and colorectal cancer without distant metastasis (stage M0)\n* Expected survival ≥ 3 months\n* Voluntary participation and signed informed consent\n\nExclusion Criteria:\n\n* Use of probiotics, antibiotics, or immunosuppressive agents within 1 month before surgery\n* Preoperative complete intestinal obstruction or gastrointestinal perforation\n* Intraoperative gastrointestinal perforation or tumor rupture\n* Previous history of gastrointestinal surgery (excluding colorectal cancer surgery, appendectomy, and cholecystectomy) or concurrent severe gastrointestinal diseases such as inflammatory bowel disease\n* Concurrent active systemic immune or infectious diseases, including severe allergies, rheumatoid arthritis, systemic lupus erythematosus, viral hepatitis, acquired immunodeficiency syndrome, etc.\n* Concurrent unhealed primary malignant tumors\n* Severe organ dysfunction or failure\n* Other conditions deemed unsuitable for this study by the investigator",true,"75 Years",{"count":150,"type":21},300,"1 Year","Colorectal cancer (CRC) is one of the most common and deadly cancers worldwide. About 1 in 4 people with CRC already have cancer spread (metastasis) when first diagnosed, and about half develop spread during their illness. Recent research shows that bacteria living in the gut and even within tumors might play an important role in how cancer spreads.\n\nThe goal of this study is to better understand how bacteria might influence the spread of colorectal cancer. The main questions the investigators aim to answer are:\n\nAre there differences in bacteria between people whose cancer has spread and those whose cancer has not spread? Could certain bacteria help predict which cancers might spread?\n\nTo answer these questions, the investigators will:\n\nCollect different types of samples from participants:\n\nTumor tissue Normal tissue near the tumor Tissue from where cancer has spread Stool samples before surgery Study the bacteria in these samples using advanced testing methods Compare bacterial patterns between different groups\n\nPeople can take part in this study if they:\n\nAre between 18 and 75 years old Have colorectal cancer confirmed by doctors Have not taken antibiotics recently Do not have immune system problems\n\nThis research may help us:\n\nUnderstand why some colorectal cancers spread Find new ways to predict which cancers might spread Develop better treatments for colorectal cancer",[27,154,155,156],"Colon Neoplasms","Microbiota","Metagenome",[158,159,160,161],"rectal neoplasms","colon neoplasms","microbiota","metagenomics","2025-12-26",{"date":164,"type":36},"2025-12-31",{"date":166,"type":36},"2025-01-01",{"date":168,"type":21},"2026-12-31",{"name":170,"class":43},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":44},"100511746","comparison-of-postoperative-anal-function-between-parks-and-bacon-techniques-in-low-rectal-cancer-100511746","NCT05943444","Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer","Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study","Inclusion Criteria:\n\n1. Men or women, aged between 18 and 75 years;\n2. Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;\n3. No local complications (including complete\u002F incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;\n4. Suitable for anal preservation surgery discussed by MDT;\n5. Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;\n6. R0 resection is expected technically;\n7. Provision of written informed consent.\n\nExclusion Criteria:\n\n1. Previous history of malignant colorectal tumors;\n2. Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;\n3. Unachievable R0 resection due to invasion of adjacent organs by primary tumor;\n4. Multiple primary tumors;\n5. History of other malignancy;\n6. Participation in other clinical trials within the previous 4 weeks of enrollment;\n7. ASA physical status score ≥ IV level and\u002For ECOG performance status ≥ 2;\n8. Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;\n9. History of serious mental disorders;\n10. Women in pregnancy or lactation period;\n11. Uncontrolled infection before operation;\n12. Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.",{"count":179,"type":21},256,[24],"The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life.\n\nThe main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.",[27,183,184,106],"Low Anterior Resection Syndrome","Anastomotic Leak",[186,187,188],"anal function","Parks technique","Bacon technique","2025-12-11",{"date":191,"type":36},"2025-12-18",{"date":193,"type":36},"2023-08-08",{"date":195,"type":21},"2027-08-08",{"name":170,"class":43},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":215,"locationsCount":4},"100613693","application-of-multimodal-mri-in-histological-grading-and-prognostic-assessment-of-rectal-cancer-100613693","NCT07269912","Application of Multimodal MRI in Histological Grading and Prognostic Assessment of Rectal Cancer","Sub-region Analysis Based on Intravoxel Incoherent Motion MRI for Preoperative Prediction of Lymphovascular Invasion and Prognosis in Rectal Cancer","Inclusion Criteria:\n\n* (1) patients underwent preoperative abdominal pelvic IVIM-MRI examination; (2) patients underwent surgical resection within 2 weeks after IVIM-MRI examination; (3) complete postoperative pathological data, including LVI status.\n\nExclusion Criteria:\n\n* (1) radiotherapy or chemotherapy before surgery; (2) preoperative metastatic disease; (3) poor image quality; (4) incomplete clinical data.",{"count":205,"type":21},400,"Rectal cancer (RC) is among the most prevalent gastrointestinal cancers \\[1\\], characterized by significant tumor heterogeneity \\[2\\]. Neoadjuvant chemoradiotherapy followed by total mesorectal excision is a standard treatment for locally advanced rectal cancer \\[3\\]. Although the locoregional recurrence rate has decreased due to this treatment, distant metachronous metastases still occur in over 20-30% of cases \\[4,5\\]. The varying biological characteristics of rectal cancer may result in different treatment responses and prognoses \\[6\\]. Patients who are diagnosed with the same tumor-node-metastasis (TNM) stage of RC frequently exhibit vastly different clinical outcomes, despite receiving the same therapeutic interventions \\[7\\]. While the TNM staging system remains the predominantly used framework for directing treatment choices and forecasting prognosis, it is crucial to take into account additional pathological elements, such as tumor budding, lymphovascular invasion (LVI), perineural invasion, and extramural venous invasion \\[8-10\\]. A recent investigation has highlighted that LVI, rather than the traditionally prioritized extent of tumor invasion, serves as a significant risk factor for metastasis in early-stage RC \\[11\\]. Patients exhibiting LVI+ demonstrate a considerably worse prognosis and overall survival when compared to those with LVI -. Identifying LVI before surgery is crucial for informing treatment strategies in RC \\[12\\]. LVI offers important information regarding the tumor's biological behavior and its likelihood of metastasizing, thus improving the precision of disease staging. This information enables clinicians to tailor treatment approaches, which helps prevent overtreatment in patients with LVI -. In cases where LVI is present, it may be essential to adopt more aggressive treatment methods, such as postoperative chemotherapy, radiotherapy, or more extensive surgical resections, to reduce the chances of recurrence and metastasis. In summary, LVI serves as a crucial prognostic factor, providing essential insights into the tumor's potential for metastasis and recurrence, which has significant clinical implications for predicting postoperative outcomes, including recurrence, metastasis, and disease-free survival. Therefore, a preoperative non-invasive assessment of LVI, particularly in patients with LVI +, may be instrumental in guiding clinical practice.\n\nConventional magnetic resonance imaging (MRI) is particularly effective in observing large blood vessels and has moderate sensitivity and high specificity to distinguish LVI \\[13\\]. However, it can noninvasively and accurately assess extramural vascular invasion with a diameter greater than 3 mm. In contrast, it is challenging to evaluate vascular invasion with a diameter less than 3 mm, as well as intramural vascular and lymphatic infiltration, due to the limitations in resolution \\[14,15\\]. In addition, pathological biopsy is the gold standard for preoperative diagnosis. However, this invasive approach may not reflect the LVI status of the entire tumor due to possible sample errors \\[16\\]. Therefore, effectively assessing LVI in RC via preoperative imaging remains a significant challenge.\n\nIntravoxel incoherent motion (IVIM) is a functional imaging method that can display the diffuse movement of water molecules and blood flow, microcirculation perfusion, thereby improving the diagnostic accuracy of RC \\[17,18\\]. The IVIM model has the potential to identify perfusion effects using multiple b-value samples and biexponential curve fit analysis \\[19\\], which can lead to three parameters, namely the true diffusion coefficient (D), the pseudo-diffusion coefficient (D\\*), and the perfusion fraction (f). Li et al \\[20\\]. discovered that the D value obtained from IVIM of LVI+ patients was significantly higher than that of LVI- patients with RC, but only 42 patients were included in this study, making it more difficult to accurately assess the feasibility of IVIM. In another study, Kan et al \\[21\\]. revealed that the D value was helpful to assess the prognostic factor related to RC, while the AUC of the D value for evaluating LVI was only 0.646. Currently, studies utilizing conventional IVIM quantitative parameters have demonstrated a relatively low diagnostic efficiency in detecting LVI, with AUC values ranging from 0.629 to 0.646 \\[22,23\\].\n\nTumor heterogeneity has emerged as a significant biomarker for tumor staging and prognosis \\[24\\]. Sub-region analysis, an innovative imaging post-processing technique, has demonstrated its potential in exploring intratumor heterogeneity in recent years. Prior research has underscored the importance of sub-region analysis derived from either single-modality or multiparametric MRI in the investigation of intratumor heterogeneity in RC \\[25-27\\]. However, to our knowledge, the application of sub-region analysis based on IVIM-MRI to evaluate LVI status and prognosis in patients with RC has not been reported. Thus, this study aimed to assess the fe",[27,208],"Prognosis","2025-11-26",{"date":211,"type":36},"2025-12-08",{"date":213,"type":21},"2027-11-01",{"date":213,"type":21},{"name":216,"class":43},"Sichuan Cancer Hospital and Research Institute",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":147,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":44},"100435395","intraoperative-neuromonitoring-of-pelvic-autonomous-nerve-plexus-during-total-mesorectal-excision-100435395","NCT04949646","Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision","Inclusion Criteria:\n\n* Histologically confirmed rectal cancer\n* Surgical resection with TME\n* \\\u003C90 years old\n* Signed informed consent\n\nExclusion Criteria:\n\n* Emergency operation\n* Presence of pacemaker\n* Partial mesorectal excision\n* Sepsis or systematic infection\n* Physical or mental impairment\n* Pregnancy or nursing\n* Insufficient preoperative data for the urogenital\u002F anorectal function\n* Lack of compliance with the research process","90 Years",{"count":225,"type":21},44,[24],"The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.",[27],[230,231,232,233,234,235,236],"intraoperative","neuromonitoring","pelvic","autonomous","total","mesorectal","excision","2025-09-03",{"date":239,"type":36},"2025-09-04",{"date":241,"type":36},"2021-09-19",{"date":243,"type":21},"2028-09-19",{"name":245,"class":43},"Larissa University Hospital",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":44},"100499913","effects-of-aerobic-exercise-on-skeletal-muscle-remodeling-in-colorectal-cancer-100499913","NCT05789433","Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer","RESTORE","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed stage I, II, or III colon or rectal cancer\n* Completed surgical resection with curative intent\n* Completed other cancer-directed treatments\n* Engage in \\\u003C150 minutes per week of moderate- to vigorous-intensity structured endurance exercise\n* No planned major surgery during the study period\n* Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire\n* Ability to provide written informed consent\n* Provide written approval by a qualified healthcare professional\n* Willing to be randomized\n\nExclusion Criteria:\n\n* Evidence of metastatic or recurrent colorectal cancer\n* Concurrently actively treated other (non-colorectal) cancer\n* Scheduled to receive other postoperative cancer-directed treatment(s)\n* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks\n* Currently participating in another study with competing outcomes\n* Contraindications to magnetic resonance imaging\n* Any dietary condition or restriction that would limit tolerance of a mixed meal challenge\n* Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol\n* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol",{"count":254,"type":21},70,[24],"The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors.",[258,27],"Colonic Neoplasms","2025-07-01",{"date":261,"type":36},"2025-07-03",{"date":263,"type":36},"2023-05-01",{"date":265,"type":21},"2027-03-01",{"name":267,"class":43},"AdventHealth Translational Research Institute",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":151,"studyType":92,"phases":4,"briefSummary":278,"conditions":279,"keywords":280,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100585464","endoscopic-submucosal-dissection-vs-transanal-endoscopic-surgery-for-rectal-neoplasia-100585464","NCT06902701","Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia","Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study","ESTER","Inclusion Criteria:\n\n* Adult patients (\\>18 years)\n* Non-pedunculated (sessile) lesions larger than 2 cm.\n* Lesions located within 15 cm from the anal verge confirmed by sigmoidoscopy or magnetic resonance imaging (MRI)\n\nExclusion Criteria:\n\n* Evidence of lymph node involvement, T2 rectal tumors, or distant metastasis on preoperative imaging modalities (MRI, ERUS, CT)\n* Previous attempt at endoscopic resection\n* Previous rectal surgery\n* Previous pelvic radiation therapy\n* Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)",{"count":277,"type":21},156,"This prospective observational cohort study aims to compare the clinical and procedural outcomes of Endoscopic Submucosal Dissection (ESD) and Transanal Minimally Invasive Surgery (TAMIS) for the treatment of early-stage rectal neoplasia. The study will evaluate recurrence rates, en bloc resection rates, R0 resection rates, procedure time, complication rates, and length of hospital stay over a 1-year follow-up period. Data will be collected from patients treated at multiple centers with expertise in ESD and TAMIS.",[27],[281,282,283],"endoscopic submucosal dissection","transanal endoscopic surgery","early rectal neoplasms","2025-06-18",{"date":286,"type":36},"2025-06-24",{"date":259,"type":21},{"date":289,"type":21},"2028-07-01",{"name":291,"class":43},"Turkish Society of Colon and Rectal Surgery",5,{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":301,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":44},"100535462","study-for-wait-and-watch-suitable-in-rectal-cancer-100535462","NCT06252142","Study for Wait and Watch Suitable in Rectal Cancer","Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch (ARROW)","ARROW","Inclusion Criteria:\n\n* Age more than 18 years.\n* Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines \\[3,1\\]\n* Biopsy-proven adenocarcinoma (non-signet or non-mucinous) T1-4a or N0-2, plus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ)\n* Non-circumferential disease with CCL less than 7 cm\n* Lower - mid rectum starting upto 7 cm from Anal verge\n* Previously treated with the intent of wait-and-watch with TNT or LCRT with or without brachytherapy and completed TNT part of treatment till March 2024(for retrospective cohort).\n* Patients not consenting to ongoing interventional studies, such as the SCOTCH study or any future studies, will be considered and offered\n* Consent to be on standard regular follow-up and answer quality of life questionnaires\n* Patients on lost to follow up will be included if they have completed treatment and taking follow up locally, accepting telephonically to participate.\n\nExclusion Criteria:\n\n* Not eligible as per the above inclusion criteria",{"count":302,"type":21},260,"One of the standard treatment options offered to patients of locally advanced rectal cancer is neoadjuvant (treatment given before surgery) radiotherapy \\& chemotherapy followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the wait and watch strategy is also an option. This is another standard treatment option for patients of locally advanced rectal cancers. In this, the patient is monitored after treatment completion. In this study, investigators are only going to observe the patient's response to treatment, monitor their side-effects due to treatment and assess their quality of life using standardized quality of life questionnaires. No additional tests or hospital visits will be required as a part of this study. The patient will be followed up, as per standard follow-up protocol, for at least 2 years after the completion of their treatment.",[27],[61,306,307,308],"Wait and Watch","SCRT","LCRT","2025-04-07",{"date":311,"type":36},"2025-04-10",{"date":313,"type":36},"2024-04-01",{"date":315,"type":21},"2026-06",{"name":317,"class":43},"Tata Memorial Centre",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":44},"100524167","ratme-vs-latme-in-middle-and-low-rectal-cancer-100524167","NCT06105203","RATME Vs LATME in Middle and Low Rectal Cancer","A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.","Inclusion Criteria:\n\n1. male patients diagnosed with rectal cancer by pathological biopsy;\n2. abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;\n3. Preoperative rectal magnetic resistance (MR) evaluation showed that the tumor was located at or below the peritoneal reflux plane, and at least 1cm above the anal sphincter groove, and did not invade the external anal sphincter;\n4. Tumors located above the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-3, cN0-1, M0, and MRF (-); The tumors located below the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-2, cN0-1, M0, and MRF (-). After neoadjuvant treatment, the tumor above the hiatus of levator ani muscle is ycT3NxM0 or below; The tumor below the hiatus of levator ani muscle is ycT2NxM0;\n5. The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.\n\nExclusion Criteria:\n\n1. multiple primary cancers;\n2. history of open surgery;\n3. no preoperative MR evaluation and inadequate evaluation of tumor stage;\n4. Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;\n5. Pregnant or patients with concomitant inflammatory bowel disease;\n6. Patients with preoperative complete bowel obstruction or requiring emergency surgery;\n7. Preoperative evaluation indicates that patient may require combined organ resection;\n8. Recently receiving treatment for other malignant tumors;\n9. Bordeaux type IV low rectal cancer;\n10. The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.\n\nExit Criteria\n\n1. Refuse surgical treatment after randomization;\n2. Open surgery was performed for treatment after randomization;\n3. Patients request to withdraw from the study at any time during the entire study process after randomization",{"count":326,"type":21},1026,[24],"This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.",[330,27,331,332],"Total Mesorectal Excision","Robotic Surgical Procedures","Laparoscopy","2025-02-16",{"date":335,"type":36},"2025-02-19",{"date":337,"type":21},"2025-11-01",{"date":339,"type":21},"2031-01",{"name":341,"class":43},"The First Hospital of Jilin University",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":44},"100363033","development-of-a-clinical-and-biological-database-in-rectum-cancer-100363033","NCT04006951","Development of a Clinical and Biological Database in Rectum Cancer","Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer","BCBRectum","Inclusion Criteria:\n\n* Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)\n* Age \\> 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient not affiliated to Social Protection system\n* Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons\n* Patient under guardianship",{"count":150,"type":21},[24],"A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.",[27],[355,356,357],"Cancer","Colorectal cancer","Biological Specimen Banks","2025-02-11",{"date":360,"type":36},"2025-02-13",{"date":362,"type":36},"2014-10-08",{"date":364,"type":21},"2026-12",{"name":366,"class":43},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":44},"100477401","neoadjuvant-chemoradiotherapy-and-consolidation-chemotherapy-for-rectal-cancer-a-randomized-controlled-trial-100477401","NCT05496491","Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Histologically confirmed rectal adenocarcinoma\n* cT3, cT4, threatened CRM \u002F MRF, EMVI (+), ≥N1\n* Multidisciplinary tumor board decision for neoadjuvant treatment\n* Tumor distance from the anal verge \\\u003C15 cm based on endoscopy or magnetic resonance imaging\n* Patient 18 to 80 years old\n* General health condition status WHO 0-1\n* Absence of co-morbidities that may affect treatment\n* Neutrophils \\>1,500 \u002F mm3, platelets \\>100,000 \u002F mm3, hemoglobin\\> 10 g \u002F dL, normal creatinine, and creatinine clearance\\> 50 mL \u002F min\n* Signed informed consent of the patient\n\nExclusion Criteria:\n\n* Distant metastases\n* Non-resectable cancer\n* Contraindications for the administration of chemotherapy\n* Previous pelvic radiotherapy or chemotherapy\n* History of inflammatory bowel disorders\n* History of angina, acute myocardial infarction or heart failure\n* Active sepsis or systemic infection\n* Untreated physical and mental disability\n* Synchronous malignancy\n* Pregnancy or breast-feeding\n* Lack of compliance with the protocol process\n* Non-granting of signed informed consent",{"count":374,"type":21},84,[24],"The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.",[27],[379,380,381,382,383,235,236],"rectal","cancer","neoadjuvant","radiotherapy","chemotherapy","2024-10-07",{"date":386,"type":36},"2024-10-08",{"date":388,"type":36},"2022-08-30",{"date":390,"type":21},"2026-08-30",{"name":245,"class":43},{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":409,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":44},"100556381","effect-of-pelvic-rehabilitation-after-low-anterior-resection-for-cancer-rectum---a-randomised-controlled-trial-100556381","NCT06524362","Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial","Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial (PERECARE TRIAL)","PERECARE","Inclusion Criteria:\n\n* Age: Adults aged 18 years or older.\n* Surgical Procedure: Have undergone Low Anterior Resection (LAR) for rectal cancer.\n* Cognitive Ability: Capable of understanding and completing the questionnaires effectively\n\nExclusion Criteria:\n\n* Medical History: History of proctitis, ulcerative colitis, or Crohn's disease.\n* Surgical Extent: Extensive resection (beyond Total Mesorectal Excision - TME) for\n* locally advanced (T4) tumors, patients undergoing APR.\n* Surgical Complications: History of anastomotic leakage.\n* Recent Physiotherapy: History of invasive physiotherapy within the past 6 months.\n* Mental or Physical Inabilities: Inability to undergo Pelvic Floor Rehabilitation due to mental or physical limitations","85 Years",{"count":402,"type":21},77,[24],"Study Purpose:\n\nThis study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care.\n\nBackground:\n\nRectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2)\n\nCurrent Knowledge:\n\nAdvances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery.\n\nPast studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5)\n\nNeed for the Study:\n\nThere is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most.\n\nStudy Design:\n\nThis study is a randomized controlled trial that will:\n\n* Compare PFR to usual care in patients after LAR surgery.\n* Focus on bowel control and quality of life.\n* Provide detailed insights to improve aftercare for rectal cancer patients.",[61,406,27,59,183,407,408],"Rectum Neoplasm","Fecal Incontinence","Bowel Dysfunction",[410,411,412,413,414,415,416,417,418,419,420],"Pelvic Floor Rehabilitation","Low Anterior Resection","Ultra Low Anterior Resection","Rectal Cancer Surgery","Post operative care","Bowel function","Quality of life","Randomized controlled trial","Fecal Urgency","Pelvic Floor Muscle Training","Oncological outcomes","2024-07-23",{"date":423,"type":36},"2024-07-29",{"date":425,"type":21},"2024-08",{"date":427,"type":21},"2026-03",{"name":429,"class":43},"GEM Hospital & Research Center",{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":440,"conditions":441,"keywords":442,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":44},"100550065","selection-of-surgical-technique-in-rectal-cancer-100550065","NCT06442215","Selection of Surgical Technique in Rectal Cancer","Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes","TECARE","Inclusion Criteria:\n\n* Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.\n* Age ≥ 18 years.\n* Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.\n* Initial stage T1-T4a. Any N. Any M.\n* Intention for R0 resection.\n\nExclusion Criteria:\n\n* Colorectal tumor with histology different from adenocarcinoma.\n* Synchronous colon tumor.\n* Benign pathology or adenoma.\n* Tis.\n* T4b or oncological multivisceral resections.\n* History of neoplastic colorectal surgery or local excision or TAMIS.\n* Perforated or obstructive rectal neoplasm.",{"count":439,"type":21},333,"Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.\n\nTherefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.",[27],[443,444,445,420],"Rectal cancer","Surgery","Minimal invasive surgery","2024-06-04",{"date":448,"type":36},"2024-06-05",{"date":450,"type":36},"2024-04-03",{"date":452,"type":21},"2026-04-03",{"name":454,"class":43},"Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":4},"100546134","phase-2-organ-preservation-with-tislelizumab-and-total-neoadjuvant-therapy-in-patients-with-low-rectal-cancer-relieve--01-study-100546134","NCT06390982","Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study","A Single-arm, Multicenter, Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancer：the RELIEVE-01 Study","Inclusion Criteria:\n\n1. Able to provide written informed consent, understand and comply with the requirements and evaluation schedule\n2. ≥18, ≤75 years old\n3. Histologically confirmed rectal adenocarcinoma\n4. immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR \u002FNGS confirmed MSI-L or MSS\n5. The distance from the lower edge of the tumor to the anal verge is ≤5 cm through colonoscopy, digital anal examination or MRI\n6. clinical stage cT1-3N1M0 or cT2-3N0M0 (the 8th UICC\u002FAJCC; T and N is evaluated by MRI)\n7. Resectable primary tumor assessed by the Investigator\n8. Have not received any anti-tumor treatment for rectal cancer\n9. ECOG PS ≤ 1\n10. Adequate organ function\n11. Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.\n\nExclusion Criteria:\n\n1. Histologically confirmed poorly differentiated\u002Fundifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma\n2. Have received any treatments for rectal cancer, or evidence of distant metastasis\n3. Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d\n4. Presence or in high risk of obstruction, perforation or bleeding;\n5. Not suitable for long-course radiotherapy\n6. Cannot tolerate surgery\n7. ≥2 colorectal cancer lesions at the same time\n8. Contraindications for MRI examination\n9. Other malignant tumors in the past or at the same time\n10. Have an active autoimmune disease requiring systemic therapy within the past 2 years\n11. HIV infection\n12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \\> 500 IU\u002FmL) or active HCV carriers with detectable HCV RNA;\n13. Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container\n14. Other conditions judged by the researcher that do not meet the enrollment requirements",{"count":463,"type":21},46,[56],"This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).",[467,61],"RECTAL NEOPLASMS",[469,470,471,472,473],"tislelizumab","low rectal cancer","organ preservation","watch and wait","TNT","2024-04-26",{"date":476,"type":36},"2024-04-30",{"date":478,"type":21},"2024-05",{"date":40,"type":21},{"name":481,"class":43},"Fudan University",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":147,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":503,"locationsCount":4},"100533422","no-stoma-vs-ghost-stoma-in-patients-undergoing-total-mesorectal-excision-for-rectal-cancer-100533422","NCT06225609","No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer","Ghost Ileostomy Group Versus no Stoma Group in Patients Undergoing Total Mesorectal Excision for Rectal Cancer: A Randomized Controlled Study","Inclusion Criteria:\n\n* Pathologically confirmed rectal cancer.\n* age ≥18 years and ≤80 years.\n* intraoperative ghost ileostomy or no stoma was performed.\n\nExclusion Criteria:\n\n* ASA score \\>3.\n* Patients with coexisting complete intestinal obstruction.\n* History of long-term use of immunosuppressive drugs or glucocorticoids.\n* Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2.\n* Patients with a history of myocardial infarction or coronary artery surgery within 6 months before the procedure.\n* chronic renal failure (requiring dialysis or glomerular filtration rate \\\u003C30 mL\u002Fmin).\n\nIntraoperative combined multi-organ resection.\n\n* Combined cirrhosis of the liver.\n* Intraoperative findings of incomplete anastomosis and positive insufflation test.",{"count":490,"type":21},500,[24],"This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the number of hospitalizations with ghost ileostomy group versus no ileostomy group after total mesorectal excision for rectal cancer.",[27],[495,496,443],"Ghost ileostomy","No ileostomy","2024-01-17",{"date":499,"type":36},"2024-01-26",{"date":501,"type":21},"2024-03-01",{"date":265,"type":21},{"name":504,"class":43},"fan li",{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":517,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":525,"locationsCount":527},"100295393","watch-and-wait-as-treatment-for-patients-with-rectal-cancer-100295393","NCT03125343","Watch and Wait as Treatment for Patients With Rectal Cancer","A Multicenter Prospective National Cohort Study for Patients With Advanced Rectal Cancer - is it Possible to Induce Remission and Avoid Surgery - Watch and Wait?","WoW","Inclusion Criteria:\n\nAll patients in Sweden with a palpable rectal cancer staged as cT4bNX\u002FanycTanycN and cMRF+\u002FanycTanycN and lateral lymph nodes on MRI considered appropriate for 5x5 Gy and 6-8 weeks of wait prior to surgery according to Stockholm III (28) or a palpable rectal cancer staged as cT4bNX\u002FanycTanycN and cMRF+\u002FanycTanycN and lateral lymph nodes on MRI a planned schedule for CRT according to the Swedish National Program for rectal cancer scheduled for neoadjuvant therapy are possible to include.\n\nThe study includes two parts, where part one is optional in including hospitals. The aim of the biopsy substudy to identify tumour and plasma markers for complete response, thus all patients that will receive (chemo)radiotherapy in the neoadjuvant setting are included to provide a control for the biopsies.\n\nFor the WoW part of the study all patients that achieve complete response after neoadjuvant treatment according to the specified criteria above can be included in the Watch and Wait protocol. In detail this includes patients with:\n\nMidrectal or low rectal cancers that are palpable and considered with an indication of 5x5 Gy and long wait (6-8 weeks) (the indication for waiting may be logistics, co-morbidity, advanced age):\n\n* cT4bNX\n* anycTanycN and cMRF+ anycTanycN and lateral lymph nodes on MRI\n\nExclusion Criteria:\n\n* No informed consent received for participation.\n* Patients with rectal cancer that is scheduled for (chemo) radiotherapy but is not palpable during rectal examination (10-15 cm) as this cannot be examined by digital examination and followed as scheduled.\n* Contraindication for MRI such as presence of non compatible metallic implants or claustrophobia.",{"count":205,"type":21},[24],"A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX\u002FanycTanycN and cMRF+\u002FanycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included.",[27],[382,383,518],"complete response","2023-11-03",{"date":521,"type":36},"2023-11-07",{"date":523,"type":36},"2017-01",{"date":40,"type":21},{"name":526,"class":43},"Sahlgrenska University Hospital",2,{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":44},"100517441","phase-3-neoadjuvant-chemotherapy-with-pd-1-inhibitors-combined-with-sib-imrt-in-the-treatment-of-locally-advanced-rectal-cancer-100517441","NCT06017583","Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer","Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Aged 18 to 70 years.\n2. The pathological type of rectal cancer diagnosed by histopathology is adenocarcinoma.\n3. Patients with T3-4 in the eighth AJCC stage or positive regional lymph node and no distant metastasis.\n4. Having at least one measurable lesion according to RECIST 1.1.\n5. ECOG score 0-1.\n6. Expected survival time ≥6 months.\n7. Major organ function is normal, that is, meeting the following criteria: blood routine: HB≥90g\u002FL, ANC≥1.5×109\u002FL, PLT≥80×109\u002FL; Biochemical examination of ALB≥30g\u002FL, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml\u002Fmin.\n8. Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Patients have had or currently have other malignant tumors within 5 years.\n2. Patients allergic or sensitive to any drug in the study protocol.\n3. Patients innate or acquired immune deficiency (e.g. HIV infection).\n4. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); The subject had vitiligo. Subjects with asthma require bronchodilators for medical intervention.\n5. The presence of active infections requiring systemic treatment.\n6. The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.\n7. Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment, excluding alopecia.\n8. Patients with a history of myocardial infarction or stroke, unstable angina pectoris, decompensated heart failure or deep vein thrombosis.\n9. Patients with long-term untreated wounds or fractures, major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks.\n10. Pregnant or lactating women.\n11. Patients with liver and kidney dysfunction.\n12. Patients with a history of abuse of psychotropic drugs and unable to abstain or patients with mental disorders.\n13. Patients who have participated in clinical trials of other drugs within 4 weeks.\n14. Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study.\n15. The investigator judged that participation in this study was not conducive to the maximum benefit of the subjects.","70 Years",{"count":537,"type":21},48,[539],"PHASE3","This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.",[27],[443,543,544],"Tislelizumab","SIB IMRT","2023-10-10",{"date":547,"type":36},"2023-10-11",{"date":549,"type":36},"2023-09-01",{"date":551,"type":21},"2026-08-31",{"name":553,"class":43},"Yong Zhang,MD",{"id":555,"slug":556,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":147,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":44},"100522440","study-of-brain-gut-function-reconstruction-after-intersphincteric-resection-for-ultra-low-rectal-tumors-100522440","NCT06082648","Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors","Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors","Inclusion Criteria:\n\n* Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.\n* Patient who is willing to participate in the study, and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Anastomotic leakage or other serious complications occur after surgery.\n* Advanced tumor, tumor recurrence or metastasis.\n* Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.\n* Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.\n* Combined with organic brain disease and drug abuse history.\n* Combined with other mental diseases.\n* Pregnant or lactating women.",{"count":562,"type":21},57,[24],"To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the \"new\" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.",[27],[567,568,569,570],"Ultra-low rectal tumors","Intersphincteric Resection","transcranial magnetic stimulation","fMRI","2023-10-07",{"date":573,"type":36},"2023-10-13",{"date":575,"type":36},"2023-06-01",{"date":577,"type":21},"2026-10-30",{"name":579,"class":43},"Huashan Hospital",{"id":581,"slug":582,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":588,"targetDuration":590,"studyType":92,"phases":4,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":44},"100506236","choice-of-the-optimal-treatment-strategies-for-mid-low-rectal-cancer-100506236","NCT05871762","Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer","Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study","COMREC","Inclusion Criteria:\n\n* pathologically confirmed rectal adenocarcinoma\n* located within 12cm below the anal verge\n\nExclusion Criteria:\n\n* diagnosed with distant metastasis\n* multiple primary colorectal cancers\n* history of previous malignant tumors\n* Pregnant or lactating women",{"count":589,"type":21},3705,"3 Years","The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.",[27],"2023-08-24",{"date":595,"type":36},"2023-08-28",{"date":597,"type":36},"2023-06-04",{"date":599,"type":21},"2027-05-17",{"name":601,"class":43},"Peking Union Medical College Hospital",{"id":603,"slug":604,"hasResults":11,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":151,"studyType":92,"phases":4,"briefSummary":610,"conditions":611,"keywords":618,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":628,"locationsCount":44},"100492256","reconstruction-after-abdominoperineal-resection-with-robot-assisted-harvest-of-vram-flap-100492256","NCT05689775","Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap","Inclusion Criteria:\n\n* patients with rectal or anal cancer\n* scheduled for robot-assisted abdominoperineal resection\n* reconstruction of pelvic floor and\u002For vagina with rectus abdominis muscle flap\n\nExclusion Criteria:\n\n* patients not eligible for robot-assisted procedure\n* rectus abdominis muscle not available for harvest\n* the expected wound defect is not suitable for reconstruction with rectus abdominis muscle flap",{"count":609,"type":21},40,"Non-randomized study of robot-assisted perineal reconstruction with rectus abdominis muscle flap in patients operated with abdominoperineal resection for irradiated locally advanced rectal or anal cancer. Operative time, complications, wound healing, pre- and postoperatively abdominal wall strength and patient related outcomes including sexual health will be registered.",[612,613,27,614,615,616,617],"Perineum; Wound","Postoperative Complications","Rectus Abdominis Hernia","Prospective Studies","Wound Heal","Sexual Health",[619,620,621],"Rectus abdominis muscle flap","Reconstruction","Perineum","2023-01-10",{"date":624,"type":36},"2023-01-19",{"date":626,"type":36},"2022-09-01",{"date":168,"type":21},{"name":629,"class":43},"Oslo University Hospital"]