[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-cancer-stage-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-cancer-stage-ii":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,78,107,131,159,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100577736","effect-of-meal-timing-during-cancer-treatment-in-patients-in-alaska-a-randomized-clinical-trial-100577736",false,"NCT06802172","Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Male or female\n* Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC\n* Age≥21 years\n* Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)\n* Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)\n* Histologically or cytologically confirmed solid tumor (adjuvant)\n* BMI≥18.5 kg\u002Fm2\n* Plan to receive neoadjuvant or adjuvant therapy\n* Planned duration of neoadjuvant or systemic adjuvant therapy for \\>3 months to allow sufficient time to assess impact of intervention\n* Must have capacity to give informed consent\n* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions\n* Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment\n* Score of \\\u003C 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score \\>5, have clearance from dietitian\n\nExclusion Criteria:\n\n* History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)\n* Allergic reaction to any of the treatment agents\n* Any prior pelvic radiotherapy\n* Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy\n* History of GI perforation ≤12 months prior to enrollment\n* History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)\n* Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period\n* History of uncontrolled CHF defined as NYHA Class III or greater\n* Pre-existing grade ≥3 neuropathy\n* Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment\n* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)\n* Pregnant or breastfeeding\n* Currently perform overnight shift work \\>1 day\u002Fweek\n* Strictly adhering to a \\\u003C10-hour eating window on most days\n* Severe psychiatric, cognitive, or substance misuse disorders or social conditions that would interfere with adherence to study procedures.","ALL","21 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).\n\nA promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.",[25,26,27,28,29,30,31],"Rectal Cancer Stage II","Rectal Cancer Stage III","Breast Cancer Stage I","Rectal Cancer Stage IV","Breast Cancer Stage II","Breast Cancer Stage III","Solid Tumor Cancer",[33,34,35],"Time-restricted eating","Time restricted eating","Meal timing","RECRUITING","2026-06-19",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":19},"2026-07-07",{"date":44,"type":19},"2029-08-31",{"name":46,"class":47},"Fred Hutchinson Cancer Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":20,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100606486","phase-2-clinical-trial-of-neoadjuvant-mfolfox-plus-alvenor-for-larc-patients-with-high-ywhab-expression-100606486","NCT07176182","Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression","mFOLFOX6 Combined With Citrus Flavonoid Tablets (Aimailang) as Neoadjuvant Therapy for Locally Advanced Rectal Cancer With High YWHAB Expression: A Prospective, Multi-center, Open-Label, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria\n\n1. Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded. Presence of hemorrhoids confirmed by colonoscopy or clinical physical examination.\n2. Radiographically measurable or clinically evaluable rectal tumor lesion; clinical pathologic stage T2N+ or T3-4aAnyN, M0. Clinical staging is determined by physical examination, contrast-enhanced chest and abdominopelvic CT, and pelvic MRI. For patients with MRI contraindications, staging is performed with contrast-enhanced pelvic CT plus transrectal ultrasound. Staging adheres to the 9th AJCC TNM Staging System (Appendix 1).\n3. Pelvic MRI confirms the tumor is not adherent to the mesorectal fascia (MRF-negative), defined as a tumor-MRF distance ≥ 2 mm (tumor distance \\\u003C 2 mm is defined as MRF involvement).\n4. ectal cancer tumor specimens demonstrate high YWHAB expression by immunohistochemistry.\n5. Age 18-75 years at the time of informed consent.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 3).\n7. No prior systemic anticancer therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitors, molecular targeted agents, or endocrine therapy.\n8. Adequate organ function with screening laboratory parameters meeting the following criteria:\n\n   * White blood cell count ≥ 3 × 10⁹\u002FL\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL\n   * Platelet count ≥ 75 × 10⁹\u002FL\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n   * Serum creatinine ≤ 1.5 × ULN\n9. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study treatment and agree to use a highly effective, medically acceptable contraceptive method (e.g., intrauterine device, combined oral contraceptives, barrier methods) throughout the study and for 3 months after the last study drug administration.\n10. Male patients with partners of childbearing potential must practice effective contraception during the study and for 3 months following the last study drug administration.\n11. The patient voluntarily provides written informed consent and is willing and able to comply with all scheduled study visits, treatment administration, laboratory assessments, and protocol-specified procedures.","18 Years","75 Years",{"count":59,"type":19},236,[61],"PHASE2","This study is a prospective, multicenter, open-label, randomized controlled Phase II clinical trial enrolling patients with locally advanced rectal cancer who tested positive for YWHAB (tyrosine 3-monooxygenase\u002Ftryptophan 5-monooxygenase-activating protein β) prior to surgery. The trial aims to evaluate the efficacy of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimilang) for neoadjuvant (preoperative) treatment.\n\nTreatment Regimen 4-6 cycles preoperatively, with each cycle lasting 14 days.\n\nTranslated with DeepL.com (free version)\n\nOxaliplatin: 85 mg\u002Fm² via 180-minute intravenous infusion on Day 1.\n\nLeucovorin: 400 mg\u002Fm² via 120-minute intravenous infusion on Day 1.\n\n5-Fluorouracil: 2400 mg\u002Fm² via continuous intravenous infusion over 46 hours.\n\nCitrus flavonoid tablets (Aimailang) : 500 mg orally twice times daily (Days 1-14), administered with or without the chemotherapy regimen (depending on group assignment).\n\nKey Trial Design Features Dose Adjustments: Permitted during the trial based on patient tolerance.\n\nDiscontinuation Criteria:\n\nPatients with disease progression during neoadjuvant therapy will cease study treatment and proceed to surgery or alternative therapies per local guidelines.\n\nSurgery may be initiated early if patients cannot tolerate the planned 6 cycles of neoadjuvant therapy.\n\nPatients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.\n\nPostoperative Management:\n\nPost-treatment plans (e.g., continuation of mFOLFOX + Aimailang) are determined by the investigator.\n\nControl Group Restriction: Patients in the control arm are not permitted to self-administer citrus flavonoid tablets (Aimailang) during the trial. Any requirement for this medication must be discussed with the treating physician, who will decide on alternative therapies or trial withdrawal.",[64,25,26],"Rectal Cancer Patients",[66,67,68],"Neoadjuvant Therapy","mFOLFOX6","Citrus Flavonoid Tablets (Aimailang)","2026-05-20",{"date":71,"type":40},"2026-05-26",{"date":73,"type":40},"2026-03-20",{"date":75,"type":19},"2031-03-20",{"name":77,"class":47},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":57,"enrollmentInfo":85,"targetDuration":4,"studyType":20,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":48},"100623500","phase-2-short-course-radiotherapy-combined-with-chemotherapy-and-immunotherapy-in-mid-low-locally-advanced-rectal-cancer-100623500","NCT07397442","Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer","A Prospective, Phase II, Single-Arm Study on the Efficacy and Safety of Neoadjuvant Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. ECOG performance status score 0-2.\n3. Rectal adenocarcinoma confirmed by colonoscopic pathology, with pMMR or MSS.\n4. Imaging studies confirm no distant metastasis or lateral lymph node metastasis; MRI staging is II\u002FIII (excluding T4b, N1c, N2) and any positive lymph nodes (if present) are confined within the mesorectum.\n5. MRI shows the distal margin of the tumor is ≤10 cm from the anal verge, and the mesorectal fascia (MRF) is negative.\n6. The longest diameter of the rectal cancer lesion is ≥10 mm on baseline CT or MRI (meeting the definition of a \"measurable lesion\" per RECIST 1.1 criteria).\n7. Willing and able to comply with the study procedures.\n8. Consent to the use of tissue and blood samples by the investigator for medical research purposes.\n9. No prior history of radiotherapy or immunotherapy.\n10. No history of immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, ulcerative colitis, HIV infection, etc.).\n11. No history of endocrine system diseases (e.g., hyperthyroidism, hypothyroidism, thyroid nodules, thyroiditis, type 1 diabetes, type 2 diabetes, gestational diabetes, other specific types of diabetes, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal insufficiency, pituitary adenoma, anterior pituitary hypofunction, acromegaly, gigantism, polycystic ovary syndrome, precocious puberty, hypogonadism, hyperparathyroidism, hypoparathyroidism, etc.).\n12. No severe cardiac, pulmonary, hepatic, or renal dysfunction.\n13. No jaundice or gastrointestinal obstruction.\n14. No concurrent acute infection.\n15. Subjects must undergo all required baseline laboratory assessments, and results must be obtained within 1 week before enrollment. Laboratory values must meet the following criteria (per CTCAE 5.0):\n\n    1. White blood cell count ≥2000\u002FμL.\n    2. Neutrophil count ≥1500\u002FμL.\n    3. Platelet count ≥100×10³\u002FμL.\n    4. Hemoglobin ≥9.0 g\u002FdL.\n    5. Creatinine: serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance \\>50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n    6. Creatinine clearance for females = \\[140 - age (years)\\] × weight (kg) × 0.85 ÷ \\[72 × serum creatinine (mg\u002FdL)\\].\n    7. Creatinine clearance for males = \\[140 - age (years)\\] × weight (kg) × 1.00 ÷ \\[72 × serum creatinine (mg\u002FdL)\\].\n    8. Aspartate aminotransferase (AST) ≤3 × ULN, alanine aminotransferase (ALT) ≤3 × ULN, total bilirubin ≤1.5 × ULN.\n16. No psychiatric\u002Fpsychological disorders affecting social functioning.\n17. Women of childbearing potential must have a negative serum pregnancy test (blood HCG) within 1 week before enrollment.\n18. Women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use appropriate contraceptive methods.\n\nExclusion Criteria:\n\n1. Multifocal cancer, or concomitant other malignant tumors.\n2. Received any anti-tumor therapy for other malignant tumors within the past 5 years.\n3. Underwent major surgery recently (within 6 months).\n4. Presence of multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).\n5. Any uncontrolled, severe comorbid diseases.\n6. Allergy to any component of the study medication.\n7. Life expectancy less than 5 years for any reason.\n8. Planning to undergo or previously underwent organ\u002Fbone marrow transplantation.\n9. Received immunosuppressive agents or glucocorticoid therapy aimed at suppressing immune responses within 1 month before enrollment.\n10. For patients with a history of central nervous system diseases, the investigator will determine whether their current condition allows them to provide informed consent or comply with the study procedures, and subsequently decide whether they can be enrolled.\n11. Other diseases or conditions that may prevent completion of the study treatment (e.g., alcoholism, drug addiction, etc.).\n12. Pregnant or lactating women.",{"count":86,"type":19},19,[61],"The goal of this clinical trial is to test a new combination treatment for locally advanced rectal cancer (cancer in the lower or middle part of the rectum that has not spread to distant organs). The study aims to increase the chance of making the tumor disappear completely (called \"complete response\") and improve the quality of life by increasing the rate of anal sphincter preservation (avoiding permanent colostomy bags).\n\nThe main questions it aims to answer are:\n\nDoes the combination of short-course radiation therapy, two types of immunotherapy drugs (Qibeian and Aike), and chemotherapy (XELOX) increase the complete response rate to over 50%? Is this combination treatment safe, and what are the side effects? Can this treatment help more patients keep their anal function and avoid permanent stomas?\n\nThis is a single-arm study, meaning all participants will receive the experimental treatment (there is no placebo or control group).\n\nParticipants will:\n\nReceive short-course radiation therapy (25 Gy total, given once daily for 5 consecutive days). The radiation will target only the tumor and visible lymph nodes, intentionally avoiding unaffected lymph node areas to protect the immune system.\n\nReceive Qibei'an (a dual immunotherapy drug targeting both PD-1 and CTLA-4) once, 2 days after completing radiation.\n\nReceive Camrelizumab (a PD-1 immunotherapy drug) three times, combined with XELOX chemotherapy.\n\nReceive XELOX chemotherapy (Oxaliplatin ivgtt on Day 1, plus Capecitabine pills taken twice daily for 14 days, for each cycle) for up to 3 cycles.\n\nUndergo detailed assessments after treatment, including MRI scans, colonoscopy with biopsies, and blood tests (including ctDNA tests), to determine if the tumor has disappeared or if surgery is needed.\n\nAttend regular follow-up visits for up to 5 years after treatment (or surgery) to monitor for recurrence and assess quality of life.\n\nThe study will enroll approximately 19 patients at Beijing Friendship Hospital, Capital Medical University. An independent safety monitoring board will regularly review the data to ensure participant safety.",[90,25,26],"Rectal Cancer, Adenocarcinoma",[92,93,94,95,96],"locally advanced rectal cancer","short-course radiotherapy","anti-PD1","anti-CTLA4","complete response","NOT_YET_RECRUITING","2026-02-09",{"date":100,"type":40},"2026-02-11",{"date":102,"type":19},"2026-03-01",{"date":104,"type":19},"2033-02-28",{"name":106,"class":47},"Beijing Friendship Hospital",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":20,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100559509","the-impact-of-preoperative-exercise-and-nutritional-optimization-on-perioperative-outcomes-for-patients-undergoing-treatment-for-rectal-cancer-the-propel-trial-100559509","NCT06565052","The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial","Inclusion Criteria:\n\n* Age greater than or equal to 18 years at time of enrollment.\n* English-Speaking.\n* Diagnosis of clinical stage II-III rectal cancer.\n* Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.\n* Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n* Distant metastatic disease known at the time of diagnosis.\n* Functional incapacity (i.e., incapable of performing exercise testing).\n* Comorbid conditions or cognitive\u002Fphysical impairments that contraindicate exercise.\n* Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.\n* Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.\n* Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.",{"count":114,"type":19},40,[22],"The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and\u002For radiation, followed by surgical resection.\n\nThe names of the groups in this research study are:\n\n* Group A: Prehabilitation program\n* Group B: Usual Care",[118,119,25,26],"Rectal Cancer","Colorectal Cancer",[118,119,25,26],"2025-11-19",{"date":123,"type":40},"2025-11-24",{"date":125,"type":40},"2024-12-15",{"date":127,"type":19},"2027-08-07",{"name":129,"class":47},"Dana-Farber Cancer Institute",2,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":139,"targetDuration":141,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100579361","can-neoadjuvant-chemoradiotherapy-be-ommited-in-mid-rectal-cancer-100579361","NCT06823297","Can Neoadjuvant Chemoradiotherapy be Ommited in Mid-rectal Cancer","Can Neoadjuvant Chemoradiotherapy be Omitted in cT2N+ and cT3 Mid-rectal Cancer: A Prospective, Observational Cohort Study","CANO","Inclusion Criteria:\n\n* Pathologically confirmed rectal cancer\n* Rectal cancer within 6-12 cm from anal verge confirmed by sigmoidoscopy or located between the anorectal junction and peritoneal reflection identified by MRI\n* Clinical local staging performed by MRI\n* cT2N+, cT3N0 and cT3N+ tumors\n* Patients without mesorectal fascia involvement assessed by MRI (≤1 mm)\n* Patients without pathological (short axis ≥7 mm) lateral (extramesorectal) lymph nodes on MRI\n* Patients without EMVI on MRI\n\nExclusion Criteria:\n\n* cT4 tumors\n* Stage IV disease\n* Patients with MSI (+) in TME pathology\n* PAtients who received neoadjuvant immunotherapy\n* Emergency surgery\n* Clinical obstruction\n* Previous pelvic radiotherapy\n* Patients treated without a multidisciplinary council decision\n* Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)\n* Familial adenomatous polyposis (FAP), attenuated FAP, and other polyposis syndromes\n* Hereditary non-polyposis colorectal cancer (Lynch syndrome)\n* Synchronous colon tumors",{"count":140,"type":19},436,"5 Years","OBSERVATIONAL","This project aims to compare the oncological and functional outcomes of patients with mid-rectal cancer who have a low risk of local recurrence (without MRF involvement) and who either receive or do not receive neoadjuvant chemoradiotherapy (nCRT).\n\nMain Question:\n\nH0: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), there is no difference in 3-year disease-free survival between direct TME and TME after nCRT.\n\nH1: In mid-rectal cancer patients without MRF involvement (cT2N+ and cT3Nx), direct TME is associated with worse 3-year disease-free survival compared to TME after nCRT.\n\nParticipants already taking both interventions as part of their regular medical care for rectal cancer will be recruited in a prospective database for 5 years.",[145,25,26],"Mid-Rectal Cancer",[145,147,148],"Radiotherapy","Mesorectal fascia","2025-06-23",{"date":151,"type":40},"2025-06-27",{"date":153,"type":19},"2025-08-01",{"date":155,"type":19},"2035-08-01",{"name":157,"class":47},"Turkish Society of Colon and Rectal Surgery",5,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":48},"100561378","ctdna-monitoring-to-predict-the-efficacy-of-tnt-for-rectal-cancer-100561378","NCT06589388","ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer","ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer","Inclusion Criteria:\n\n* 18 years and older, both genders\n* Patients are diagnosed with stage II-III rectal cancer and indicated for total neoadjuvant therapy\n* Biopsy FFPE sample is available at the time of diagnosis\n* Patients consented to participate in the study\n\nExclusion Criteria:\n\n* Stage I rectal cancer, recurrent or metastatic cancer\n* Other cancer metastasis to the rectum\n* Patients are indicated for chemoradiation therapy only\n* Have been or are being treated for cancer\n* Patients do not agree to participate in the studies.","80 Years",{"count":18,"type":19},"This is a prospective observational study with three primary objectives:\n\nObjective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before, during, and after total neoadjuvant therapy (TNT).\n\nDetermine the detection rate and change of CtDNA in blood samples of cancer patients before, during, and after TNT then assess changes in ctDNA expression within the study population during treatment.\n\n* Determine the ctDNA positivity rate before treatment.\n* Determine the ctDNA positivity rate during TNT.\n* Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment.\n\nObjective 2: Investigate the relationship between ctDNA expression and MRI\u002FCT scan imaging with the pathological complete response (pCR) to neoadjuvant therapy :\n\n* Correlation between ctDNA detection and pCR\u002FTRG\u002FNAR score. Calculate the Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,\n* Correlation between MRI\u002FCT scan imaging and pCR. Calculate the PPV and NPV of MRI\u002FCT scan\n* Combination of ctDNA detection and MRI\u002FCT scan imaging to predict pCR. Calculate the PPV and NPV of the combined markers.\n\nObjective 3: Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients.",[118,25,26],[171,172,173,174],"liquid biopsy","circulating tumor DNA","Vietnam","total neoadjuvant therapy","2024-09-05",{"date":177,"type":40},"2024-09-19",{"date":179,"type":40},"2024-05-21",{"date":181,"type":19},"2027-12",{"name":183,"class":184},"Gene Solutions","INDUSTRY",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":20,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":48},"100535645","phase-2-the-effects-of-neoadjuvant-tislelizumab-combined-with-chemotherapy-in-locally-advanced-mss-rectal-cancer-100535645","NCT06254521","The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer","Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study","Inclusion Criteria:\n\n* Age ≥18 years old and ≤70 years old.\n* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.\n* The lower edge of the tumor is less than 12cm from the anus as measured by colonoscopy and MRI,or TRUS.\n* It was confirmed by magnetic resonance imaging (MRI) or intracavitary ultrasound of the rectum as T3-4 or N+, and M0 by enhanced CT.\n* The ECOG physical status score is 0-1.\n* Life expectancy is expected to be more than 1 year.\n* First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.\n* Appropriate organ function is defined as follows: Hemoglobin level ≥ 90g\u002FL, Neutrophil count ≥ 1.5×10\\^9\u002FL, Platelet count ≥ 75×10\\^9\u002FL, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL.\n* Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.\n\nExclusion Criteria:\n\n* Early rectal cancer (T1-2N0M0); The lower margin of the tumor was less than 5cm from the anus and T4. APR(combined abdominal perineal resection) is required;\n* Multifocal colorectal cancer.\n* Tumor obstruction or high risk of obstruction, bleeding, and\u002For perforation requiring emergency surgery or stent placement.\n* Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.\n* History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.\n* Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and\u002For severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score \\> 3 points.\n* Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.\n* Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.\n* Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy.\n* Unable to undergo enhanced CT examination\n* Pregnancy or lactation.\n* Refused to participate in this study.\n* Other situations in which the researcher deems unsuitable for this study.",{"count":193,"type":19},60,[61],"This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.",[118,25,26],[92,198,199],"neoadjuvant","PD-1","2024-02-03",{"date":202,"type":40},"2024-02-12",{"date":204,"type":19},"2024-02-22",{"date":206,"type":19},"2027-12-30",{"name":208,"class":47},"First Affiliated Hospital of Guangxi Medical University"]