[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-rectal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-rectal-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,44,76,109,140,168,190,216,244,271],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100638157","preoperative-adaptive-radiotherapy-concomitant-to-chemotherapy-for-rectal-adenocarcinoma-adaptive-rectal-cancer-trial-02-100638157",false,"NCT07580027","Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02)","Preoperative, Adaptive Radiotherapy Concomitant to Chemotherapy for Rectal Adenocarcinoma (Adaptive Rectal Cancer Trial 02). An Interventional Study.","Inclusion Criteria:\n\nInitial phase (standard phase). These criteria represent the conditions for which preoperative chemoradiotherapy treatment for rectal cancer is clinically indicated\n\n1. Histologically confirmed rectal adenocarcinoma\n2. Microsatellite status: stable\n3. Stage T2N0 if lower rectal lesions are candidates for subsequent intersphincteric resection or abdominoperineal amputation with permanent colostomy\n4. Stage T3-T4N0 or any T with positive lymph nodes\n5. Lower margin of lesion no more than 12 cm from anal verge Adaptive radiotherapy phase (experimental phase)\n6. ERI\\_TCP \\\u003C 32.6 calculated as follows: ERITCP=-ln\\[(1-(Vmid\u002FVpre)\\]Vpre where Vpre is the volume of the rectal tumor pre-therapy, Vmid is the volume of the residual tumor still visible in the images of the MR intermediate to RT)\n7. Lower margin of rectal lesion at least 1 cm from surgical resection line on images of the intermediate smc MRI\n8. ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2\n9. Age: 18-80 years\n10. Written informed consent\n\nExclusion Criteria:\n\n1. Distant metastases\n2. Previous cancer excluding non-melanoma skin cancer diagnosed less than 5 years before rectal cancer appearance\n3. Previous chemotherapy or radiotherapy to the pelvis\n4. Contraindications to radiotherapy: active ulcerative colitis\n5. Contraindications to chemotherapy: NE\\\u003C1.5x10\u002FL, Plt \\\u003C 100x10\u002FL), creatinine \\>1,5mg\u002Fdl, bilirubin \\> 2mg\u002Fdl, AST\u002FALT \\> 3x normal upper limit, significant cardiac disease, peripheral neuropathy.\n6. Pregnancy\n7. Breastfeeding","ALL","18 Years","80 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this clinical study is to increase the rate of pathological responses up to 70% by means of improved patient selection operated by a radiobiological index called ERI\\_TCP and by an increase in the dose of radiotherapy in the final concomitant boost of preoperative radiochemotherapy treatment for rectal adenocarcinoma.",[27],"Locally Advanced Rectal Carcinoma",[29,30],"adaptive radiotherapy","preoperative radiotherapy","NOT_YET_RECRUITING","2026-05-05",{"date":34,"type":35},"2026-05-12","ACTUAL",{"date":37,"type":21},"2026-04-30",{"date":39,"type":21},"2029-04-30",{"name":41,"class":42},"IRCCS San Raffaele","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100416471","phase-1-short-course-radiation-therapy-and-combination-chemotherapy-for-the-treatment-of-stage-ii-iii-rectal-cancer-100416471","NCT04703101","Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer","Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX","Inclusion Criteria:\n\n* Histologically confirmed rectal adenocarcinoma\n* Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI\n* No evidence of metastatic disease\n* Resectable primary lesion\n* Karnofsky performance status (KPS) \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2\n* Absolute neutrophil count (ANC) \\> 1.5 cell\u002Fmm\\^3\n* Hemoglobin (Hgb) \\> 8.0 gm\u002FdL\n* Platelets (PLT) \\> 150,000\u002Fmm\\^3\n* Total bilirubin \\\u003C or equal to 1.5 x upper limit of normal\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C or equal to three times upper limit of normal\n* If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy\n\nExclusion Criteria:\n\n* Active treatment of a separate malignancy\n* Distant metastatic disease as assessed by staging positron emission tomography (PET)\u002Fcomputed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Pregnant and\u002For breastfeeding\n* Medical\u002Fpsychological contraindication to MRI",{"count":52,"type":21},25,[54],"PHASE1","This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.",[27,57,58,59,60,61,62,63,64,65],"Rectal Adenocarcinoma","Stage II Rectal Cancer AJCC v8","Stage IIA Rectal Cancer AJCC v8","Stage IIB Rectal Cancer AJCC v8","Stage IIC Rectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","Stage IIIA Rectal Cancer AJCC v8","Stage IIIB Rectal Cancer AJCC v8","Stage IIIC Rectal Cancer AJCC v8","RECRUITING","2026-03-25",{"date":69,"type":35},"2026-03-30",{"date":71,"type":35},"2021-02-11",{"date":73,"type":21},"2027-10-15",{"name":75,"class":42},"Jonsson Comprehensive Cancer Center",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":43},"100629299","phase-3-neoadjuvant-folfoxiri-and-chemoradiotherapy-versus-neoadjuvant-capoxfolfox-and-chemoradiotherapy-followed-by-surgery-or-a-watch-and-wait-approach-in-high-risk-locally-advanced-rectal-cancer-100629299","NCT07472868","Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX\u002FFOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer","MEND-IT II: Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX\u002FFOLFOX and Chemoradiotherapy, Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer.","MEND-IT II","Inclusion Criteria:\n\n* 18 years or older\n* WHO performance score 0-1.\n* Fit for (modified dose) triple chemotherapy (FOLFOXIRI)\n* Histopathological confirmed rectal cancer. (Lower border of the tumour located on or below the sigmoidal take-off as established on MRI of the pelvis.)\n* Confirmed high-risk locally advanced rectal cancer, at high risk of treatment failure, meeting one of the following imaging-based criteria:\n\n  * cT4b-tumour or evident tumour invasion of the MRF: distance to MRF 0 mm AND thickening of the MRF over a length of approximately 5 mm (MRF ≤ 1 mm is not considered sufficient).\n  * The presence of grade 4 extramural venous invasion (mrEMVI)\n  * The presence of tumour deposits (TD)\n  * The presence of bilateral extramesorectal lymph nodes with a short-axis size ≥ 7mm (LLN) or extensive LLN involving pelvic side wall structures, at high risk of an incomplete resection.\n* Resectable disease as determined on magnetic resonance imaging (MRI) or deemed resectable disease after neoadjuvant treatment. (Expected gross incomplete resection with overt tumour remaining in the patient after resection, tumour invasion in the neuroforamina, encasement of the ischiatic nerve and invasion of the cortex from S2 and upwards are considered not resectable.)\n* Written informed consent.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease at time of inclusion or within six months prior to inclusion except for patients with enlarged iliac or inguinal lymph nodes and non-specific lung noduli.\n* Homozygous DPD deficiency.\n* Any chemotherapy within the past 6 months.\n* Any contraindication for the planned systemic therapy (e.g., severe allergy, pregnancy, kidney dysfunction and thrombocytopenia), as determined by the medical oncologist.\n* Previous radiotherapy in the pelvic area precluding chemoradiotherapy with a dose of 50 - 50.4 Gy.\n* Any contraindication for the planned chemoradiotherapy (e.g., severe allergy to the chemotherapy agent or no possibility to receive radiotherapy), as determined by the medical oncologist and\u002For radiation oncologist.\n* Any contraindication to undergo surgery, as determined by the surgeon and\u002For anaesthesiologist.\n* Concurrent malignancies that interfere with the planned study treatment or the prognosis of the resected tumour.\n* Microsatellite instability (MSI).",{"count":85,"type":21},394,[87],"PHASE3","The aim of this clinical trial is to compare triplet induction therapy (FOLFOXIRI) with doublet induction therapy (CAPOX\u002FFOLFOX), followed by chemoradiotherapy and either surgery or a watch-and-wait approach, in patients with high-risk locally advanced rectal cancer. The primary questions it seeks to address are whether triplet induction therapy results in higher complete response rates, improved quality of life, and better long-term oncological outcomes compared to doublet induction therapy, despite the anticipated increased risk of toxicity.",[27],[91,92,93,94,95,96,97,98,99],"Total neoadjuvant therapy","Induction chemotherapy","Locally advanced rectal carcinoma","Complete response","Toxicity","Quality of life","Organ sparing therapies","De-escalation","Survival","2026-03-10",{"date":102,"type":35},"2026-03-16",{"date":104,"type":21},"2026-03-03",{"date":106,"type":21},"2034-03-02",{"name":108,"class":42},"J. W. A. Burger",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":43},"100495479","phase-2-serplulimab-combined-with-capeox--celecoxib-as-neoadjuvant-treatment-for-locally-advanced-rectal-cancer-100495479","NCT05731726","Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer","A Phase II Study to Explore the Neoadjuvant Treatment of Serplulimab Combined With CAPEOX + Celecoxib in the Treatment of Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Male or female subjects ≧ 18 years ≦ 75 of age.\n3. Histological or cytological documentation of adenocarcinoma of the rectum.\n4. No previous any systemic anticancer therapy for rectal cancer disease.\n5. The lower margin of the tumor is less than 10cm from the anus verge.\n6. cT2N1-2M0, cT3N0-2M0, cT4N0-2M0 MSS with MRF(-) assessed by MRI.\n7. Primary tumor can be detected by CT or MRI.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. Eligible tumor tissues were identified for MSI\u002FMMR assays.\n10. Hepatitis B Surface Antigen (HBsAg) (-).\n11. If HBsAg (+) , HBV-DNA must be less than 2500 copies\u002FmL or 500 IU\u002FmL to be enrolled.\n12. Patients with HCV antibody (-) or HCV-RNA negative can be enrolled. Aspartate aminotransferase (AST) must be ≤ 3 x ULN for the lab. If HCV-RNA is positive, patients with both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) performed ≤3×ULN could be enrolled. Patients infected with both hepatitis B virus and hepatitis C virus should be excluded (positive for HBsAg or HBcAb and positive for HCV antibodies).\n\nExclusion Criteria:\n\n1. Patients with recurrent rectal cancer or a history of pelvic radiotherapy.\n2. Patients with a history of inflammatory bowel disease.\n3. Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2 antibody, HTLV1 antibody positive) should be excluded.\n4. Patients who are preparing for or have previously received an organ or bone marrow transplant.\n5. History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc interval calculated by Fridericia formula).\n6. According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular ejection fraction (LVEF) \\\u003C50%.Poor hypertension control (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.\n7. Poor hypertension control (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.\n8. Patients had undergone major surgery within 28 days prior to enrollment. Patients with tumor biopsy or lymph node dissection biopsy were admitted. Patients undergoing enterostomy due to intestinal obstruction were admitted.\n9. The patients had previously been treated with other antibodies\u002Fdrugs that target immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte-associated Antigen 4 (CTLA-4).\n10. Patients are participating in other clinical studies, or plan to start this study treatment less than 14 days from the end of the previous clinical study.\n11. Uncontrolled tumor-related pain.\n12. A known history of severe allergy to any monoclonal antibody.\n13. Known to be allergic or intolerance to any oxaliplatin and capecitabine ingredients.\n14. Pregnant or lactating women.\n15. The investigators determined that the patient had other factors that might have led to the early termination of the study.","75 Years",{"count":118,"type":21},50,[120],"PHASE2","Colorectal cancer of Mismatch Repair-proficient (pMMR)\u002F Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy, such as CAPEOX regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Celecoxib, a COX-2 inhibitor, can improve the immune microenvironment and have a potential to synergy with immunotherapy. Chemotherapy can improve the immunogenicity of cancer cells that might enhance the efficacy of immunotherapy. The aim of this study is to explore whether chemotherapy and cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could improve efficacy for resectable colorectal cancer patient with the pMMR\u002FMSS phenotype.",[123,124,125,27],"pMMR","MSS","MSI-L",[127,128,129,130,131],"Rectal cancer","Serplulimab","Celecoxib","CAPEOX","neoadjuvant therapy",{"date":133,"type":35},"2026-03-05",{"date":135,"type":35},"2023-02-22",{"date":137,"type":21},"2026-12-30",{"name":139,"class":42},"Zhejiang University",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":43},"100621567","phase-3-modulated-electro-hyperthermia-in-combination-with-multimodal-therapy-for-locally-advanced-rectal-cancer-100621567","NCT07372300","Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer","The Efficacy of Combination of Modulated Electro-Hyperthermia(mEHT) in The Multimodality Management in Locally Advanced Rectal Cancer: A Multicenter Phase 3 Randomized Control Trial.","mEHT","Inclusion Criteria:\n\n1. Age: 20 years and above\n2. Gender: Not restricted\n3. Initial pathological diagnosis of adenocarcinoma of the rectum\n4. Expected survival ≥ six months\n5. Clinical staging of cT3N0 with high recurrence risk or cT3N1-2 or cT4N0-2 rectal cancer, requiring neoadjuvant therapy, without distant metastasis; must meet the following tumor definitions \\[staging system according to the 8th edition of the AJCC staging manual\\]:\n\n   1. cT3: Tumor invades through the muscularis propria into pericolorectal tissues\n   2. cT4a: Tumor invades through the visceral peritoneum (including gross perforation of the bowel through tumor and continuous invasion of tumor through areas of inflammation to the surface of the visceral peritoneum)\n   3. cT4b: Tumor directly invades or adheres to adjacent organs or structures \\*High recurrence risk factors: cT3 tumor ≤ 5 cm from the anal verge or MRI showing circumferential resection margin (CRM) \\\u003C 0.2 cm; cT4 tumor or cN2, presence of MRI showing extramural vascular invasion.\n\n7\\. ECOG performance status: 0 - 2 8. Healthy condition suitable for standard treatment, including 25 to 30 fractions of long-course radiotherapy and concurrent chemotherapy (capecitabine or fluorouracil) and subsequent 4- to 6-month chemotherapy, including modified FOLFOX-6 or CAPEOX 9. Willingness to participate in the clinical trial and signed the informed consent form for the protocol.\n\nExclusion Criteria:\n\n* (e) Active infection or severe underlying disease making the patient unsuitable for the trial treatments\n* Known HIV infection\n* Untreated thyroid disease\n* Active Crohn's disease or ulcerative colitis\n* Other systemic autoimmune diseases 9. History of any physical or mental disorder resulting the patient unable to understand or comply with trial requirements, or diminished social communication ability, or unable to provide informed consent 10. Known allergic reaction to trial medications 11. Pregnant or breastfeeding women 12. Substance or alcohol dependence within six months before screening 13. Inability to comply with treatment, assessments, or follow-up","20 Years",{"count":150,"type":21},126,[87],"The goal of this clinical trial is to investigate if the addition of modulated electro-hyperthermia (mEHT) improves tumor down-staging and pathological response in adult patients (20 years and above) with locally advanced rectal adenocarcinoma (cT3N0M0 with high risk of recurrence, cT3N1-2M0, or cT4N0-2M0). The main questions it aims to answer are:\n\n* Does the addition of mEHT to the Total Neoadjuvant Therapy (TNT) regimen significantly increase the rate of tumor down-staging (ypT and ypN) compared to TNT alone?\n* Does the combination therapy improve the pathological complete response (pCR) rate and long-term outcomes (such as disease-free survival) compared to standard TNT?\n\nResearchers will compare participants randomized to receive Total Neoadjuvant Therapy (TNT) plus mEHT using the Oncotherm EHY-2030 device to participants receiving TNT alone to see if the adjunctive mEHT therapy enhances tumor regression and improves patient prognosis. Participants will be randomized (1:1) into one of the two groups and will undergo the following regimen:\n\n* Receive standard TNT, which includes 5-6 weeks of chemoradiotherapy (CRT) followed by 4-6 months of neoadjuvant chemotherapy.\n* Patients in the experimental group will receive mEHT twice a week during the CRT period.",[27],[127,155,156,157,158],"Hyperthermia","Neoadjuvant","Radiotherapy","Downstaging","2026-01-19",{"date":161,"type":35},"2026-01-28",{"date":163,"type":35},"2025-09-23",{"date":165,"type":21},"2027-12-31",{"name":167,"class":42},"Shih-Kai Hung",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100540141","phase-2-a-series-of-neoadjuvant-chemoradiotherapy-combined-with-immunotherapy-for-locally-advanced-rectal-cancer-100540141","NCT06312982","A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer","A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study","Inclusion Criteria:\n\n1. Signed a written informed consent form and volunteered to join the study;\n2. .Age: 18-75 years old, male or female;\n3. Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical results of pMMR or genetic test results of MSS;\n4. The baseline clinical stage assessed by MRI was T1-2N1-2M0 or T3N0-2M0, MRF (-), lateral lymph nodes (-);\n5. The lower tumor margin is 10cm away from the anal margin;\n6. Surgical resection;\n7. Ability to swallow tablets normally;\n8. ECOG PS 0-1；\n9. Have not received any anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;\n10. Plan to undergo surgery after the completion of the neoadjuvant therapy;\n11. No contraindications to surgery;\n12. Main organ function is normal.\n\nExclusion Criteria:\n\n1. Previous history of allergy to monoclonal antibodies, any component of tislelizumab,and capecitabine;\n2. Previously has received or is receiving any of the following treatments:\n\n   A)Any tumor-specific surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; B)Treatment with immunosuppressive drugs or systemic hormones within 2 weeks of first use (dose\\> 10mg \u002F day prednisone or equivalent dose); inhaled or topical steroids and dose\\> 10mg \u002F day prednisone or equivalent dose of adrenocorticoid replacement in the absence of active autoimmune disease; C)Having received a live attenuated vaccine within 4 weeks before the first use of the study drug; D)Major surgery or severe trauma within 4 weeks before the first use of study drug;\n3. History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after hormone replacement therapy); patients with psoriasis or asthma \u002F allergy in childhood and adults without any intervention, but patients requiring medical intervention with bronchodilators should not be included;\n4. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;\n5. Not well controlled cardiac clinical symptoms or disease, including but not limited to: such as (1) grade NYHA II above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinical meaningful supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention still poor control;\n6. Severe infection (Grade CTCAE\\> 2) within 4 weeks prior to the first use of study drug, Such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging indicated the presence of active lung inflammation, presence of symptoms and signs and signs of infection within 14 days prior to the first administration of study drug or need for oral or intravenous antibiotics, Except for the preventive use of antibiotics; Found active tuberculosis infection by history or CT, Or those with a history of active tuberculosis infection within 1 year prior to enrollment, Or those with a history of active tuberculosis infection more than 1 year ago but without formal treatment;\n7. Presence of active hepatitis B (HBV DNA 2000 IU \u002F mL or 104copies \u002F mL), hepatitis C (positive for hepatitis C antibody, and HCV RNA above the lower limit of detection of the analytical method);\n8. A diagnosis of other malignancies within 5 years prior to the first use of study drug, unless a malignancy with low risk of metastasis or death (5-year survival\\> 90%), such as adequately treated skin basal cell carcinoma or squamous cell carcinoma in situ, are considered;\n9. Women in pregnancy or lactation;\n10. Other factors, as judged by the investigator, may lead to forced termination of the study, such as other serious illness (including mental illness), alcohol, substance abuse, family or social factors, which may affect the safety or compliance of the subject.",{"count":176,"type":21},375,[120,87],"The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer.\n\nThe main questions it aims to answer are:\n\nTo evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy \u002F 25f, capecitabine 850-1000 mg \u002F m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg\u002Fm2,iv.gtt; D1-D14, capecitabine, 850-1000mg \u002F m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart.",[27],"2026-01-12",{"date":182,"type":35},"2026-01-13",{"date":184,"type":35},"2024-03-16",{"date":186,"type":21},"2026-12-01",{"name":188,"class":42},"Beijing Friendship Hospital",2,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":199,"phases":4,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":43},"100580926","radiological-markers-in-locally-advanced-rectal-cancer-100580926","NCT06843655","Radiological Markers in Locally Advanced Rectal Cancer","LARC","Inclusion Criteria:\n\n* Risonanza Magnetica informed consent signed\n* All patients that received total neoadjuvant therapy (TNT) (chemo\u002Fradiotherapy followed by surgery), between 2009 and 2022 at our institution\n* Staging and re-staging MRI available\n\nExclusion Criteria:\n\n* Staging and re-staging MRI not available",{"count":198,"type":21},179,"OBSERVATIONAL","The goal of this observational study is to evaluate the prognostic significance of radiological markers, including the Likert Score derived from diffusion-weighted MRI (DWI), in patients with locally advanced rectal cancer (LARC) treated with total neoadjuvant therapy (TNT). Specifically, the study investigates the association between the Likert Score on restaging MRI and key clinical outcomes, such as overall survival (OS) and time to progression (TTP). Furthermore, it examines the impact of other MRI-derived markers-extramural venous invasion (EMVI), tumor deposits (TDs), and mesorectal fascia invasion (MFI)-on disease progression and patient prognosis. This study retrospectively analyzes 179 patients who underwent TNT followed by surgery between 2009 and 2022. Participants were required to have pre- and post-treatment MRI scans. MRI imaging data and patient outcomes, including overall survival (OS) and time to progression (TTP), will be analyzed over a follow-up period extending until July 31, 2024. Findings from this study may help refine MRI-based prognostic tools for personalized treatment strategies in rectal cancer.",[27],[203,204,205,206,207],"Locally Advanced Rectal Cancer (LARC)","Total Neoadjuvant Therapy (TNT)","Diffusion-Weighted MRI (DWI)","Likert Score","Radiological Prognostic Markers","2025-02-21",{"date":210,"type":35},"2025-02-25",{"date":212,"type":21},"2025-03-01",{"date":214,"type":21},"2025-08-15",{"name":41,"class":42},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":43},"100537350","early-phase-1-exercise-for-improving-long-course-chemoradiotherapy-efficacy-in-people-with-locally-advanced-rectal-cancer-100537350","NCT06276686","Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer","A Single Arm Feasibility Study of Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* 18 years or older\n* Have been diagnosed with locally advanced rectal cancer using MRI (Magnetic Resonance Imaging) and histological finding\n* Have been offered long-course neoadjuvant chemoradiotherapy in the Queens Centre, Castle Hill Hospital\n* Willing and able to comply with all study requirements\n* Able and willing to voluntarily give informed consent to take part.\n\nExclusion Criteria:\n\n* Inability to understand basic written and spoken English, as research materials will all be written in English.\n* Any movement deficiencies limiting ability to engage in exercise.\n* Impaired cognition and\u002For capacity limiting ability to provide informed consent.\n* Cardiovascular and\u002For cardiopulmonary conditions that will impede ability to safely perform exercise.\n* Severe psychiatric disorders.\n* With any other health condition which oncologists and research team agrees will impede ability to safely perform exercises.\n* Presence of metastatic cancer.",{"count":224,"type":21},30,[226],"EARLY_PHASE1","This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods.",[27],[230,231,232,233,234],"Exercise","chemoradiotherapy","Treatment efficacy","Locally advanced rectal cancer","Vigorous intensity aerobic interval exercise","2025-01-30",{"date":237,"type":35},"2025-02-04",{"date":239,"type":35},"2024-12-10",{"date":241,"type":21},"2026-02-28",{"name":243,"class":42},"University of Hull",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":43},"100485471","phase-2-circulating-tumor-dna-guided-neoadjuvant-treatment-strategy-for-locally-advanced-rectal-cancer-100485471","NCT05601505","Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer","Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer --- a Multicenter Randomized Controlled Trial (CINTS-R)","CINTS-R","Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. ECOG score 0-2;\n3. Rectal adenocarcinoma confirmed by pathology;\n4. The lower margin of the tumor was less than 12cm from the anal margin;\n5. Patients with clinical stage cT3-4N0M0 or cTanyN+M0;\n6. Newly treated patients who have not received treatment including radiotherapy, chemotherapy and surgery;\n7. Liver, kidney and other organs have good function and can tolerate radiotherapy, chemotherapy and surgery;\n8. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.\n\nExclusion Criteria:\n\n1. ECOG score \\> 2;\n2. Patients with multiple primary colorectal cancers;\n3. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;\n4. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery;\n5. pregnant or lactating women;\n6. Patients with a history of severe mental illness, immune disease, hormone medication;\n7. Patients contraindicated by MRI examination, chemoradiotherapy, immunotherapy or surgery;\n8. Participated in other clinical researchers in the past 3 months;\n9. Any other circumstances that the investigator considers inappropriate for inclusion.",{"count":253,"type":21},470,[120],"Rectal cancer still remains one of the most popular tumors, however, distance metastasis still remains as high as 30% and the long-term survival outcomes are still unsatisfying. The recent conception of total neoadjuvant therapy and immune therapy is becoming popular and the oncologic effects are encouraging, especially in terms of circulating tumor DNA (ctDNA), the prognostic value of ctDNA has been demonstrated by our prior study. This study will carry out accurate ctDNA-guided neoadjuvant therapy on the basis of previous studies of the research group, and give appropriate treatment plans and treatment intensity to patients with different disease degrees. At the same time, combined with the latest progress in clinical diagnosis and treatment, the potential beneficiaries of immunotherapy were screened scientifically, and the combined immunotherapy was implemented accordingly.",[27,257],"Circulating Tumor DNA",[233,259,260,91,261],"circulating tumor DNA","Neoadjuvant chemoradiotherapy","Randomized Controlled Trial","2024-12-19",{"date":264,"type":35},"2024-12-24",{"date":266,"type":35},"2023-02-03",{"date":268,"type":21},"2026-11-01",{"name":270,"class":42},"Peking Union Medical College Hospital",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":287,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100498643","organ-preservation-in-rectal-cancer-contact-x-ray-brachytherapy-vs-extending-the-waiting-interval-and-local-excision-100498643","NCT05772923","Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision","Organ Preservation in Patients With a Good Clinical Response After (Chemo)Radiation for Rectal Cancer: Defining the Role of Additional Contact X-ray Brachytherapy Versus Extending the Waiting Interval and Local Excision","OPAXX","Inclusion Criteria:\n\n* histologically verified adenocarcinoma above the dentate line and within 10cm of the anal verge;\n* neoadjuvant short-course radiotherapy for patients with 1) IRC and delayed response evaluation according to the Dutch national guidelines (cT1-3, cN1-2 lymph nodal status, no involved MRF or cT3c-d, N0-1 lymph nodal status without pres-ence of significant distant metastases) without full dose chemotherapy in the inter-val (e.g. Rapido-scheme) or 2) LARC due to comorbidity or frailty; OR\n* neoadjuvant long-course radiotherapy (chemoradiation) for patients with 1) LARC according to the Dutch national guidelines (cT4 tumour, cN2 lymph nodal status, lateral lymph node involvement, and\u002For involved MRF, without the presence of significant distant metastases) or 2) early rectal cancer or IRC and a strong wish for organ preservation;\n* clinically near-complete response or a small residual tumour mass \\\u003C3 cm;\n* technically feasible to perform both treatment options (contact x-ray brachytherapy or local excision);\n* age \\>18 years;\n* written informed consent.\n\nExclusion Criteria:\n\n* neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation, e.g. patients with a Rapido or M1-scheme are not eligible;\n* radiation dose \\>50.4 Gy or boost dose on the primary tumour;\n* presence of suspicious lymph nodes (yN1\u002FN2) at first response evaluation;\n* residual tumour ≥ 3cm or over half of the circumference of the rectal lumen;\n* patients who are unable to undergo contact x-ray brachytherapy or local excision;\n* patients who cannot tolerate a completion- or salvage-TME because of comorbidity or frailty;",{"count":280,"type":21},168,[24],"The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.",[284,285,286,27],"Organ Preservation","Rectal Cancer","Quality of Life",[288,127,289,290,291,292],"Organ preservation","(Chemo)radiation","Local excision","Contact x-ray brachytherapy","TAMIS","2023-03-14",{"date":295,"type":35},"2023-03-17",{"date":297,"type":35},"2021-04-16",{"date":299,"type":21},"2029-03",{"name":301,"class":42},"The Netherlands Cancer Institute",7]