[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectum-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectum-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,52,158,183,207,242,269,299,323,355,382,414,439],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100494213","adaptive-symptom-self-management-immunotherapy-study-100494213",false,"NCT05715255","Adaptive Symptom Self-Management Immunotherapy Study","Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Age 18 or older\n* Within 12 weeks after starting ICI treatment for cancer\n* Cognitively oriented to person, place and time (determined by recruiter)\n* Able to speak and understand English or Spanish\n* Access to a telephone\n* Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library\n\nExclusion Criteria:\n\n* Currently receiving regular behavioral counseling","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"NA","The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.",[26,27,28,29,30],"Breast Cancer","Colon Cancer","Lung Cancer","Skin Cancer","Rectum Cancer",[32,33,34,35,36,37,38],"Cancer","Cancer Survivors","Immunotherapy","Immune Checkpoint Inhibitors","Symptom Management","Psychosocial Oncology","Telephone Intervention","RECRUITING","2026-05-11",{"date":42,"type":43},"2026-05-14","ACTUAL",{"date":45,"type":43},"2023-05-08",{"date":47,"type":20},"2027-04-30",{"name":49,"class":50},"University of Arizona","OTHER",3,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":142,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":61,"type":20},360,[23],"Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[65,66,67,68,69,70,71,27,72,73,30,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Liver Cancer","Biliary Tract Cancer","Stomach Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[143,144,145,146,147],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":150,"type":43},"2026-02-20",{"date":152,"type":43},"2021-10-05",{"date":154,"type":20},"2027-03-16",{"name":156,"class":50},"Cedars-Sinai Medical Center",1,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":157},"100489380","machine-learning-based-surgical-guidance-system-for-robot-assisted-rectal-surgery-100489380","NCT05652361","Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery","Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study","CoBot2","Inclusion Criteria:\n\n* Patients with rectal cancer scheduled for robot-assisted rectal resection\n* Intact preoperative urogenital\u002Frectal function\n* Full capability of consent\n\nExclusion Criteria:\n\n* Previous\u002FSecond malignant disease \\\u003C5 years before diagnosis of rectal cancer\n* Previous abdominal surgery, except for laparoscopic appendectomy, laparoscopic cholecystectomy or Cesarean section\n* Pregnant or breastfeeding women\n* Addiction or illness that prevent the person concerned from assessing the nature and scope of the clinical trial and its possible consequences\n* indication that the participant is unlikely to comply with the trial protocoll (e.g. lack of compliance)\n* official or court order for involuntary hospitalization",{"count":167,"type":20},12,[23],"The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.",[30],[172,173],"Robotic Surgery","Total mesorectal excision","2026-02-02",{"date":176,"type":43},"2026-02-05",{"date":178,"type":20},"2026-02",{"date":180,"type":20},"2027-12",{"name":182,"class":50},"Technische Universität Dresden",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100432890","improving-care-for-rural-patients-with-solid-tumors-100432890","NCT04916990","Improving Care for Rural Patients With Solid Tumors","Improving the Timeliness and Quality of Care for Rural Cancer Patients With Solid Tumors","Inclusion Criteria Assessed During Screening:\n\n1. Provision to sign and date the consent form.\n2. Stated willingness to comply with all study procedures and be available for the duration of the study.\n3. Male and female adults over 18 years old\n4. English or Spanish speaking\n5. Receives cancer treatment at UCH- Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, or Parkview Medical Center.\n6. Resides in any of the rural counties served by the UCH-Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, VA, Huntsman Cancer Institute, or Parkview Medical Center with Rural-Urban Continuum Codes (RUCC) codes 4-9.\n7. Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology \\[ICD-O\\] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants\n8. Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging \\[AJCC\\] Tumor Node Metastasis \\[TNM\\] stages: I-IV)\n9. Will receive the following types of breast, bladder, cervix, colon, rectum, lung, head-and-neck cancer treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy)\n10. Diagnosed with head and neck cancer (HNC) using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants\n11. Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV\n12. Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants\n13. Diagnosed with BC using malignant neoplasm of breast ICD-O codes for connective tissue of the breast, codes: C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C50.9, and other breast cancer variants.\n14. Diagnosed with CC using malignant neoplasm of cervix uteri ICD-O codes: C53.0, C53.1, C53.8, C53.9 and other cervical cancer variants.\n15. Diagnosed with CRC using colon and rectum malignant neoplasm ICD-O codes for colon (codes: C18, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9) and rectum (code C20), and other colon and rectum cancer variants.\n16. Diagnosed with BLC using malignant neoplasm of ICD-O codes: C67.9 and other bladder cancer varients.\n\n    Inclusion Criteria Confirmed via Baseline Survey:\n17. Rural and medically underserved, defined as meeting the following criteria:\n\n    * Rural: Resides in a rural county with a RUCC code 4-9 AND,\n    * Underserved population who come from counties meeting any of the \"health professional shortage areas\" OR \"Medically Underserved Areas\u002FPopulations\" AND\u002FOR\n18. Uninsured: No health insurance (public or private insurance) AND\u002FOR\n19. Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses\n\nExclusion Criteria Assessed During Screening:\n\n1. Children under 18 years old\n2. Individuals who do not speak English or Spanish\n3. Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center.\n4. Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and\u002For head-and-neck cancer or other type of cancer not listed in the inclusion criteria.\n5. Diagnosed with a type of breast, bladder, cervix, colon, rectum, lung, and\u002For head-and-neck cancer listed under inclusion criteria but will not be treated at one of the collaborating hospital sites,\n6. Has already initiated curative treatment for the current episode of cancer.\n\n   Exclusion Criteria Assessed via Baseline Survey:\n7. Individuals from vulnerable populations (e.g., inmates or on probation, homeless\\*, and pregnant\\*)\n8. Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study.\n9. Unable to hear (not including individuals who can hear with an auditory aid).\\*\n10. Likely inability to track the individual over time (e.g. no permanent address at the time of consent) \\*Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and\u002For assigned to study condition may remain in the study until completion",{"count":191,"type":20},320,[23],"This study will assess if the CARES (Cancer Advocacy, Resources, Education and Support) intervention improves time to start of treatment after diagnosis and time to treatment completion for solid tumors (ex: lung, head, neck, thyroid, cervical, breast, bladder, colon, and rectal cancers) in rural patients.",[28,195,196,197,26,198,27,30],"Head and Neck Cancer","Thyroid Cancer","Cervical Cancer","Bladder Cancer",{"date":176,"type":43},{"date":201,"type":43},"2022-09-01",{"date":203,"type":20},"2027-06-30",{"name":205,"class":50},"University of Colorado, Denver",14,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":217,"conditions":218,"keywords":227,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":157},"100571099","target-specific-immunopet-imaging-of-digestive-system-carcinoma-100571099","NCT06715839","Target-specific immunoPET Imaging of Digestive System Carcinoma","Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma","Inclusion Criteria:\n\n1. Aged 18-75 years old and of either sex；\n2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;\n3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n1. Pregnancy；\n2. Severe hepatic and renal insufficiency;\n3. History of serious surgery in the last month;\n4. Allergic to antibody or single-domain antibody radiopharmaceuticals.","75 Years",{"count":19,"type":20},[23],"The aim of this study is to establish and optimize the target-specific PET\u002FCT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.",[219,220,221,222,223,71,73,27,30,224,125,225,69,105,226],"Malignancy","Digestive Cancer","Digestive System Neoplasm","Digestive System Carcinoma","Digestive System Cancer","Pancreatic Cancer","Gallbladder Carcinoma","Bile Duct Carcinoma",[228,229,230,231,232],"human epidermal growth factor receptor 2 (HER2)","Trophoblast cell surface antigen 2 (TROP2)","Glypican-3 (GPC3)","Glycoprotein A33 (gpA33)","Nectin cell adhesion molecule-4 (Nectin-4)","2025-12-25",{"date":235,"type":43},"2025-12-31",{"date":237,"type":43},"2024-12-04",{"date":239,"type":20},"2027-09",{"name":241,"class":50},"RenJi Hospital",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":214,"enrollmentInfo":249,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":268},"100329789","biomarkers-for-predicting-neoadjuvant-chemoradio-resistance-for-middle-low-advanced-rectal-cancer-100329789","NCT03573791","Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer","Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.","Inclusion Criteria:\n\n* Histopathology proved to be adenocarcinoma of the rectum.\n* The edge of tumor is within 12cm of anus margin.\n* According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2.\n* There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy.\n* Understand and agree to sign the informed consent for the study.\n\nExclusion Criteria:\n\n* With intestinal obstruction or impending obstruction, or perforation.\n* With other malignancies occurred within 5 years.",{"count":250,"type":20},152,"OBSERVATIONAL","Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.",[135,254,255,256,257,30,258],"Cancer of Rectum","Cancer of the Rectum","Neoplasms, Rectal","Rectal Tumors","Rectum Neoplasms","2025-03-25",{"date":261,"type":43},"2025-03-30",{"date":263,"type":43},"2018-05-21",{"date":265,"type":20},"2027-05-21",{"name":267,"class":50},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",2,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":157},"100578548","phase-2-neoadjuvant-folfirinox-and-preoperative-chemoradiotherapy-for-locally-advanced-rectal-cancer-patients-100578548","NCT06812728","Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients","Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.","Inclusion Criteria:\n\n1. Histologically proven rectal adenocarcinoma.\n2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.\n3. Resectable tumor, or considered as potentially resectable after CRT.\n4. No distant metastases.\n5. Patient eligible for surgery\n6. World Health Organization (WHO)\u002FEastern Cooperative Oncology Group (ECOG) performance status 0\u002F1.\n7. No heart failure or coronary heart disease symptoms (even controlled).\n8. No peripheral neuropathy \\> grade 1.\n9. No prior radiotherapy of the pelvis for any reason and no previous CT\n10. No major comorbidity that may preclude the delivery of treatment\n11. Adequate contraception in fertile patients.\n12. Adequate hematologic function.\n\n13 Adequate hepatic function.\n\n14\\. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Metastatic disease\n2. Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1\n3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum\n4. Medical history of angina pectoris or myocardial infarction\n5. Other concomitant cancer.\n6. Pregnant or breast-feeding woman.\n7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.","70 Years",{"count":278,"type":20},100,[280],"PHASE2","A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.",[30],[284,285,286,287,288,289],"Neoadjuvant","mFOLFIRINOX","TNT","Watch and wait approach","Complete clinical response","Sphincter sparing","2025-02-15",{"date":292,"type":43},"2025-02-19",{"date":294,"type":43},"2025-01-25",{"date":296,"type":20},"2027-02-25",{"name":298,"class":50},"Menoufia University",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":157},"100577957","image-guided-surgery-in-the-treatment-of-rectal-cancer-arcrc-100577957","NCT06805045","Image-Guided Surgery In The Treatment Of Rectal Cancer (AR_CRC)","Image-guided Surgery in the Treatment of Rectal Cancer: the Impact of Virtual and Augmented Reality in Clinical Practice","Inclusion Criteria:\n\n* Indication for radical transabdominal surgery for primary rectal cancer\n* Resection and anastomosis or abdominal-perineal amputation surgery\n* Signature of informed consent\n* Patient's age ≥18 years.\n* CT images acquired in the arterial venous and urographic phase with section thickness:1.25\u002F2.5 mm, level range:0.8\u002F0.2 mm.\n* Pelvic MRI images acquired with section thickness of 1.5 mm or images acquired with 3 tesla MRI.\n\nExclusion Criteria:\n\n* Patients who have already undergone previous rectal surgery\n* Relapse of previous rectal neoplasm\n* Neoplasm located in other pelvic organs, infiltrating the rectum\n* Indication for endoscopic or transanal treatment\n* Disease with peritoneal localisation (carcinosis)\n* Surgery for palliative purposes\n* Imaging performed elsewhere","80 Years",{"count":308,"type":20},50,[23],"The proposed study is addressed to introduce new Image-Guided Surgery (IGS) tools to assist mini-invasive surgical procedures of anterior rectal resection (TME; TA-TME, TTSS) performed with laparoscopic or robotic procedure. In details, the idea is to provide augmented reality (AR) guidance during robotic-assisted and laparoscopic surgeries, by overlaying the preoperative 3D virtual anatomical models to intraoperative surgical images (3D AR guidance).\n\nTo optimize the intraoperative view during the 3D AR guidance, AI-based algorithms will be developed to allow the real time detection and segmentation of surgical instruments, needed to provide instrument de-occlusion during AR robotic surgery.\n\nWe use 3D modelling technology in surgical planning (7 case) and intra-operative navigation ( 2 cases). The pilot study focused to 3D virtual reconstruction of the pelvis, rectum and neurovascular structure to the test the feasibility of virtual reality to this type of anatomy. Implementation of reconstruction using 3D nerve sequence (3 Tesla MRI) was used for the last 3 cases.\n\nAfter the creation of a complete virtual model of pelvis and its structures the last two models were applied in the operating-room during a laparoscopic rectal resection with the ausilium of AI. The test has showed good results: a good overlap of the 3D structures to the real organs of the pelvis. The focus of this research was on developing support tools aimed at enhancing surgical safety. AR can assist surgeons in identifying vascular and nerve structures that are not always clearly visible during minimally invasive procedures, compensating for the lack of tactile perception and thereby improving overall surgical safety.\n\nThe next step of the study is to evaluate its benefits and limitations in clinical practice to reduce the post-operative complications and oncological recurrence.",[30],[313],"augmented reality rectal cancer","2025-01-28",{"date":316,"type":43},"2025-02-03",{"date":318,"type":43},"2024-05-29",{"date":320,"type":20},"2027-12-31",{"name":322,"class":50},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":331,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":21,"phases":335,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":157},"100556837","phase-1-biological-tumor-infiltrating-lymphocytes-therapy-with-immunotherapy-for-colon-and-rectum-cancer-100556837","NCT06530303","Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Immunotherapy in Patients With Advanced or Metastatic Refractory Colon and Rectal Cancer (Colorectum)","BAH248","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Cancer\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.","16 Years","90 Years",{"count":334,"type":20},85,[336,280],"PHASE1","This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response, while Aldesleukin will be used to further stimulate the TILs. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.",[339,27,30],"Colorectal Cancer",[341,342,343,344,34,345],"Tumor Infiltrating Lymphocytes","CAR-T CELL","Biological Therapy","Advanced or Metastatic Refractory","TIL","2024-11-04",{"date":348,"type":43},"2024-11-05",{"date":350,"type":43},"2024-09-29",{"date":352,"type":20},"2026-12-28",{"name":354,"class":50},"Essen Biotech",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":214,"enrollmentInfo":362,"targetDuration":4,"studyType":21,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":372,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":4},"100559716","conformal-sphincter-preservation-operation-versus-intersphincteric-resection-on-anal-function-in-low-rectal-cancer-100559716","NCT06567756","Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer","A Multicenter, Prospective, Randomized Controlled Clinical Trial of the Effect of Conformal Sphincter-preservation Operation Versus Intersphincteric Resection on Postoperative Anal Function in Patients With Low Rectal Cancer","Inclusion Criteria:\n\n1. Age: 18-75 years;\n2. Pathologically confirmed: moderately \\& well-differentiated rectal cancer;\n3. Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;\n4. Tumor diameter: ≤3cm or \\\u003C1\u002F3 bowel circumference;\n5. Tumor infiltration depth: cT1-2, Bordeaux\u002FRullier classification: type II-III;\n6. Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;\n7. ASA score: I-III and ECOG score: 0-1;\n8. Undergo elective TME for colorectal or colorectal-anal canal anastomosis;\n9. Normal preoperative anal function: Wexner score \\\u003C10, LARS score \\\u003C20;\n10. Agree to participate in the clinical trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Combination of synchronous or metachronous (within 5 years) malignant tumors;\n2. Combined distant metastasis of the tumor;\n3. Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;\n4. Combined psychiatric disorders that do not allow them to understand and participate in the study;\n5. Combined systemic diseases that cannot tolerate surgery;\n6. Women who are pregnant or breastfeeding;\n7. Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.",{"count":363,"type":20},84,[23],"In this clinical trial, the investigators compared anal function, genitourinary function, quality of life, perioperative safety, and oncological prognosis after CSPO for patients with low rectal cancer, using ISR as a control, to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical approaches for patients with low rectal cancer.",[30],[368,369,370,371],"low rectum cancer","CSPO","ISR","anal function","NOT_YET_RECRUITING","2024-08-20",{"date":375,"type":43},"2024-08-23",{"date":377,"type":20},"2024-09",{"date":379,"type":20},"2030-09",{"name":381,"class":50},"Changhai Hospital",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":251,"phases":4,"briefSummary":392,"conditions":393,"keywords":400,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":157},"100524998","online-adaptive-radiotherapy-using-a-novel-linear-accelerator-ethos-100524998","NCT06116019","Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)","A Prospective Study on Online Adaptive Radiotherapy (ART) Using the ETHOS Linear Accelerator for Various Tumor Entities and the Feasibility of Integrating Multi-Parametric Patient Data Into the Adaptive Workflow","ART-02","Inclusion Criteria:\n\n* Adult patients (\\>18 years)\n* All tumor entities with an indication for radiotherapy and\u002For chemoradiotherapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients who are not capable of giving consent",{"count":391,"type":20},649,"The study focuses on the scientific and clinical evaluation of online adaptive radiotherapy (ART) using the Varian\u002FSHS ETHOS treatment system. In this study, radiation treatment plans are dynamically adjusted on a daily basis over several weeks of therapy to account for anatomical shifts in either the tumour or adjacent normal tissue - a capability that has been difficult to achieve due to technical limitations. With the ETHOS accelerator, such real-time adjustments can be made based on cone beam computed tomography (CBCT). This is a prospective observational study with the primary objective of investigating the feasibility and acceptability of performing ART with ETHOS for different tumour entities. The study will also evaluate the feasibility of integrating multi-parametric data sets into the ART workflow, such as standardised electronic feedback on treatment toxicity from both patients (ePROMS) and physicians (ePRT).",[394,195,395,396,397,198,30,398,399],"Prostate Cancer","NSCLC","SCLC","Esophageal Cancer","Cervix Cancer","Other Carcinoma",[401,402,403,404],"online adaptive radiation therapy","ART","cone beam CT","ePROMS","2023-10-30",{"date":407,"type":43},"2023-11-03",{"date":409,"type":43},"2023-10-11",{"date":411,"type":20},"2027-10-09",{"name":413,"class":50},"Charite University, Berlin, Germany",{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":21,"phases":423,"briefSummary":424,"conditions":425,"keywords":426,"overallStatus":372,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":4},"100521233","reconstruction-of-the-pelvic-floor-and-perineal-wound-after-rectal-elape-100521233","NCT06066931","Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE","Reconstruction of the Pelvic Floor and Perineal Wound After Extralevatory Abdominal-perineal Extirpation of the Rectum","Inclusion Criteria:\n\n1. Patients over 18 years old suffering from cancer of the lower ampullary rectum cT1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition).\n2. Patients with planned extralevatory abdominal-perineal extirpation of the rectum.\n3. Physical status of patients according to ASA classification I-II.\n4. Signed informed consent to participate in the study.\n\nNon-inclusion criteria:\n\n1. Verification of the squamous cell carcinoma diagnosis.\n2. The presence of acute purulent processes in the area of surgical intervention.\n\nExclusion Criteria:\n\n1. Refusal to participate at any stage of the study.\n2. Death in the early postoperative period (up to 30 days after surgery) caused by somatic complications not associated with surgery (PATE, myocardial infarction, stroke).",{"count":422,"type":20},150,[23],"A multicenter, cohort, randomized, controlled study is being conducted since the 1of September, 2023 whereby the immediate and long-term results of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation of the rectum will be compared. The study is conducted on the basis of the Federal State Budgetary Educational Institution of the Ministry of Health Care of the Russian Federation, the Department of General Surgery at the clinical base of the State Budgetary Healthcare Institution \" Krasnodar Regional Hospital No. 1 named after Professor S.V. Ochapovsky\" of the Ministry of Health Care of the Krasnodar Territory, State Budgetary Healthcare Institution \" Krasnodar Oncological Dispensary No. 1\" of the Ministry of Health Care of the Krasnodar Territory The study included patients over 18 years old suffering from cancer of the lower ampullary rectum with T1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition), who are scheduled for extralevatory abdominal-perineal extirpation of the rectum. Patients are randomized into 3 groups: the first group includes patients with plastic surgery in a simple way (Plastic surgery with local tissues), the second group includes patients with plastic surgery with a mesh endoprosthesis and the third one includes patients with plastic surgery in a new way.\n\nThe purpose of the study is to evaluate the effectiveness of the developed method of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation of the rectum. It is easily reproducible and provides high-quality closure of the deep and skin defect of the perineal wound. In addition, the new method will reduce the frequency of postoperative complications when compared with the use of conventional methods of closing the defect of the perineum, the method improves the quality of life and provides early rehabilitation of patients.\n\nStudy status- patients are being recruited. Number of patients selected is 150 patients. The primary endpoint of the study is the assessment of the early postoperative period and the frequency of postoperative complications (Flap necrosis; Suppuration; Hematoma; Bleeding; Seroma) within 30 days from the date of surgery. The study was approved by the Independent Ethics Committee Protocol No. 112 of 12th November, 2022.\n\nIt is planned to recruit patients within 2 years and monitor each of them for 30 days after surgery to assess the primary endpoint and to monitor patients within 1 year to assess the secondary endpoint. The secondary endpoint means an assessment of the frequency of late postoperative complications (perineal fistula, abscess, hernia) and an assessment of the quality of life within 1 year after surgery. It is planned to complete the study in 2025.\n\nEventually it is planned to publish the protocol of the study, the results obtained after the recruitment of the required number of patients as well as the results of evaluation of the primary endpoint.",[30],[427,428,429],"Cancer of the lower ampullary rectum","Extralevatory abdominal-perineal extirpation","Plastic surgery of the pelvic floor and perineal wound","2023-10-07",{"date":432,"type":43},"2023-10-10",{"date":434,"type":20},"2023-10-01",{"date":436,"type":20},"2026-10-01",{"name":438,"class":50},"Kuban State Medical University",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":21,"phases":449,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":157},"100370930","phase-2-neo-adjuvant-pembrolizumab-and-radiotherapy-in-localised-mss-rectal-cancer-100370930","NCT04109755","Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer","A Phase II Study to Evaluate Safety and Efficacy of Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer","PEMREC","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of rectal adenocarcinoma will be enrolled in this study.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation.\n* Patients with previously untreated localized T3-T4 N0 or T any or N1-2, M0 rectal adenocarcinoma.\n* Tumour must be microsatellite stable (MSS).\n* A multi-disciplinary tumour board should recommend neo-adjuvant short course radiotherapy and surgery.\n* Have provided archival tumour tissue sample or newly obtained core or excisional biopsy of a tumour lesion not previously irradiated. Formalin-fixed paraffin embedded (FFPE) tissue blocks are preferred.\n* Have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n* Has a microsatellite instable tumour (MSI-High).\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Has received for the same disease prior systemic anti-cancer therapy including investigational agents prior to starting pembrolizumab. Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Has received prior radiotherapy for the same disease. If treated with radiotherapy for another disease, participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a known history of Human Immunodeficiency Virus (HIV).\n* Has a known history of Hepatitis B virus (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\> 1.5E1 is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",{"count":448,"type":20},25,[280],"This project investigates the clinical and biological impact of combining immunotherapy (pembrolizumab) with short course radiotherapy (5Gy, five times) in the neo-adjuvant treatment of localised microsatellite stable (MSS) rectal cancer.",[30,135],[453,34,454,455,456,457],"Rectal cancer","Short course radiotherapy","5x5Gy","Pembrolizumab","Localised rectal cancer","2021-09-29",{"date":460,"type":43},"2021-09-30",{"date":462,"type":43},"2020-06-02",{"date":464,"type":20},"2028-03",{"name":466,"class":50},"University Hospital, Geneva"]