[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-rectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,42,75,95,128,154,177,204,228,250,275,304,324,345,368,412,433,453,473,494,517,540,570,591,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100641955","phase-2-brachytherapy-followed-by-nivolumab-prior-to-surgery-in-rectal-cancer-100641955",false,"NCT07645118","Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer","Pilot Evaluation of the Immunogenic Potentiation of Neo-adjuvant Brachytherapy Followed by Nivolumab Immunotherapy Without Chemotherapy in Stage II\u002FIII Locally Advanced Mismatch Repair Proficient Rectal Cancer","IMPERIA","Inclusion Criteria:\n\n1. Age ≥18 years at the time of consent.\n2. Histologically confirmed rectal adenocarcinoma arising within 5 to 15 cm of the anal verge as measured by sigmoidoscopy or MRI.\n3. Rectal cancer staging:\n\n   1. Clinical Stage cT2 or cT3 based on high resolution pelvic MRI;\n   2. No evidence of distant metastases (cM0) on contrast -enhanced CT of chest, abdomen and pelvis (or PET\u002FCT if clinically indicated);\n   3. Disease deemed technically resectable with curative intent by multidisciplinary tumor board (MDT)\\*. No radiologic evidence of unresectable local disease (e.g., tumor fixation or invasion of adjacent unresectable structures).\n4. At least one of the following adverse prognostic features observed on baseline MRI:\n\n   1. Node-positive disease (cN+);\n   2. Threatened mesorectal fascia (MRF) defined as distance from tumor to mesorectal fascia \\\u003C 1mm on pelvic MRI;\n   3. Extramural venous invasion (EMVI+).\n5. Proficient mismatch repair (pMMR) status, as determined by immunohistochemistry and\u002For microsatellite instability-low (MSI-L) status by next-generation sequencing\n6. Planned management includes neoadjuvant therapy with radiotherapy followed by curative-intent TME.\n7. Prior external beam pelvic radiation for other malignancy (prostate, gynecology, lymphoma, bladder) are acceptable, provided the colorectal surgeon deems the patient as a candidate for TME surgery.\n8. ECOG performance status of 0-2\n9. Adequate organ function, defined by:\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109\u002FL\n   2. Platelets ≥ 100 x 109\u002FL\n   3. Hemoglobin ≥ 90 g\u002FL\n   4. Estimated creatinine clearance ≥ 30 mL\u002Fmin\n   5. Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome who may only be included with total bilirubin ≤ 3.0 x ULN)\n   6. Aspartate transaminase (AST) ≤ 3.0 x ULN\n   7. Alanine transaminase (ALT) ≤ 3.0 x ULN\n   8. INR ≤ 1.5 ULN\n   9. aPTT and PT ≤ 1.5 ULN\n   10. Albumin ≥ 25 g\u002FL\n10. Ability to understand, willing to provide written informed consent, and to comply with study requirements.\n\nExclusion Criteria:\n\n1. Prior anticancer therapy for rectal cancer.\n2. Contraindication to safe MRI imaging.\n3. Evidence of bowel obstruction on MRI or clinical evaluation.\n4. Evidence of distant metastasis.\n5. Medical or surgical contraindications to major pelvic surgery\n6. Active autoimmune disease requiring systemic immunosuppressive therapy.\n7. Active\u002Funcontrolled infection. Infectious screening for HIV, Hepatitis B (HBV), Hepatitis C (HBC) and tuberculosis will be performed at screening:\n\n   1. Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks; and have undetectable HBV viral load prior to starting treatment. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.\n   2. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to start of treatment.\n   3. HIV-infected participants must have well-controlled HIV on antiretroviral treatment (ART), defined as:\n\n   i. have a CD4+ T-cell count ≥ 0.35 x109 cells\u002FL at the time of screening. ii. must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n\n   iii. must not have had any AIDS-defining opportunistic infections within the past 12 months.\n\n   iv. must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before start of treatment and agree to continue ART throughout the study.\n8. Known allergy or hypersensitivity to nivolumab or any of its excipients.\n9. Patients with other psychiatric, social or severe or uncontrolled medical conditions that in the opinion of the investigator may compromise their compliance with the protocol or may represent an unacceptable risk to their safety (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant cardiovascular disease).\n10. Requirement for prohibited concomitant medication, as outlined in section 8.4 within 14 days prior to first brachytherapy treatment.\n11. Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 28 days of first neo-adjuvant treatment.\n12. Patients who are pregnant or breastfeeding or WOCBP not employing an effective method of birth control.","ALL","18 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a small Phase II study testing whether targeted internal radiation treatment (HDREBT) followed by two doses of the immunotherapy drug Nivolumab is safe, practical, and potentially effective before patients undergo surgery (TME) to remove rectal cancer.",[28],"Locally Advanced Rectal Cancer","NOT_YET_RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":22},"2026-07",{"date":37,"type":22},"2030-12",{"name":39,"class":40},"Dr. Te Vuong","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":41},"100531768","phase-2-node-sparing-radiotherapy-combined-with-total-neoadjuvant-capox-and-sintilimab-for-mss-middle-and-low-rectal-cancer-100531768","NCT06204094","Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer","Total Neoadjuvant CAPOX And PD-1 Inhibitor（Sintilimab） Combined With Node-sparing Short-course Radiotherapy For MSS Locally Advanced Of Middle And Low Rectal Cancer(CASINOs): An Open Label, Single-arm, Prospective Clinical Trial","CASINOs","Inclusion Criteria:\n\n* Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.\n* Male or Female aged 18-75.\n* Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0\u002FcT3-4N0\u002F+M0, the lymph nodes are limited to the mesorectum.\n* Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.\n* Eastern Cooperative Oncology Group (ECOG) 0-1.\n* No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation).\n* Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500\u002Fmm3, neutrophils ≥1800\u002Fmm3, platelets ≥100,000\u002Fmm3, hemoglobin ≥100 g\u002FL; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g\u002FL. creatinine clearance ≥50 mL\u002Fmi, creatinine ≤1.5 × ULN;\n* Informed consent form signed.\n\nExclusion Criteria:\n\n* Patients with a previous history of malignant tumors besides rectal cancer.\n* Patients with distant metastases before enrollment.\n* Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.\n* Patients with obstruction, perforation, or bleeding that require emergency surgery.\n* Patients with severe concomitant diseases and estimated survival time ≤ 5 years.\n* Allergic to any component of the therapy.\n* Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma.\n* Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.\n* Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.\n* Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.\n* Patients with congenital or acquired immune deficiency (such as HIV infection).\n* Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.\n\nOther conditions that investigators consider not suitable for this study.","75 Years",{"count":52,"type":22},37,[25],"phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.",[28],[57,58,59,60,61,62,63,64],"rectal cancer","microsatellite stability","node-sparing","CAPOX","radiotherapy","sintilimab","immunotherapy","neoadjuvant","RECRUITING","2026-04-21",{"date":68,"type":33},"2026-04-24",{"date":70,"type":33},"2024-02-05",{"date":72,"type":22},"2028-09-01",{"name":74,"class":40},"Jinhua Central Hospital",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":41},"100633464","phase-2-a-single-arm-phase-ii-clinical-study-of-camrelizumab-combined-with-long-course-chemoradiotherapy-for-total-neoadjuvant-therapy-in-locally-advanced-low-pmmrmss-rectal-cancer-100633464","NCT07527026","A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR\u002FMSS Rectal Cancer","Inclusion Criteria:\n\n* Aged 18-75 years, male or female;\n\nHistologically confirmed T3-4 and\u002For N+ rectal adenocarcinoma (AJCC\u002FUICC TNM staging, 8th edition);\n\nLower margin of the tumor ≤10 cm from the anal verge;\n\nExpected to achieve R0 resection;\n\nEastern Cooperative Oncology Group (ECOG) performance status 0-1;\n\nAble to swallow tablets normally;\n\nNo prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;\n\nPlanned to undergo surgical treatment after neoadjuvant therapy;\n\nNo contraindications to surgery;\n\nLaboratory tests must meet the following requirements: white blood cell count (WBC) ≥4×10⁹\u002FL; absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count ≥100×10⁹\u002FL; hemoglobin ≥90 g\u002FL; serum total bilirubin ≤1.5× upper limit of normal (ULN); serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN; serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL\u002Fmin; international normalized ratio (INR) ≤1.5× ULN; activated partial thromboplastin time (APTT) ≤1.5× ULN;\n\nFertile male or female patients willing to use contraceptive measures during the trial.\n\nExclusion Criteria:\n\n* Prior or current receipt of any anti-tumor therapy for cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.\n\nKnown genetic testing showing MSI-H (microsatellite instability-high) or immunohistochemistry showing dMMR (deficient mismatch repair).\n\nMajor surgery or severe trauma within 4 weeks prior to the first dose of study drug.\n\nKnown allergy, hypersensitivity, or contraindication to any component of camrelizumab or platinum-based agents.\n\nPresence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure ≥ NYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention.\n\nSevere infection (CTCAE grade \\>2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicating active pulmonary inflammation; presence of signs or symptoms of infection within 14 days prior to the first dose of study drug, or requiring oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use).\n\nPresence of any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[excluding patients with stable hormone levels after treatment\\]; patients with childhood asthma that has completely resolved and requires no intervention in adulthood, or vitiligo, may be included; subjects requiring bronchodilators for medical intervention are not eligible).\n\nCongenital or acquired immunodeficiency, such as HIV infection, active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay), or co-infection with hepatitis B and C.\n\nUse of immunosuppressive drugs within 14 days prior to the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg\u002Fday prednisone or equivalent physiological dose of other corticosteroids).\n\nKnown interstitial lung disease, except for interstitial changes detected only on imaging.\n\nDiagnosis of another malignancy within 5 years prior to the first dose of study drug, except for malignancies with a low risk of metastasis or death (5-year survival rate \\>90%), such as adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ, which may be considered for enrollment.\n\nPregnant or breastfeeding women.\n\nAny other factors deemed by the investigator that may lead to premature termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, or factors that may affect subject safety or compliance.",{"count":82,"type":22},44,[25],"In pMMR\u002FMSS locally advanced rectal cancer, can the innovative \"chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation\" approach significantly improve the complete response rate and create opportunities for organ preservation?",[28],"2026-04-08",{"date":88,"type":33},"2026-04-14",{"date":90,"type":33},"2026-02-01",{"date":92,"type":22},"2029-02-01",{"name":94,"class":40},"Chinese PLA General Hospital",{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":41},"100632520","galenos-2-immunonutrition-in-head-and-neck-lung-and-rectal-cancer-patients-100632520","NCT07514754","Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients","Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study","GALENOS 2","Inclusion Criteria:\n\n* Written informed consent to study procedures\n* Male or female, age greater than 18 years\n* Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and\u002For radiotherapy according to standard clinical practice\n* ECOG Performance Status score less than 2\n* Adequate kidney, liver, and bone marrow function\n* Ability to understand, sign informed consent, and comply with study procedures\n\nExclusion Criteria:\n\n* Incomplete recovery from surgery before starting antineoplastic treatment\n* Other progressing malignancy or malignancy requiring active treatment within the last 3 years, except localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ\n* Active infection requiring systemic antibiotic therapy\n* Serious or unstable medical conditions, psychiatric disorders, or substance abuse interfering with study compliance\n* Receipt of any live vaccine within 30 days before study treatment\n* Active cardiac pacing\u002Fpacing implants\u002Fneurostimulators\u002Fhearing system not compatible with bioimpedance analysis\n* Edema and\u002For ascites not compatible with body weight evaluation and bioimpedance analysis\n* Enteral or parenteral nutritional support at baseline",{"count":104,"type":22},52,[106],"NA","GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison",[109,28,110],"Head and Neck Squamous Cell Carcinoma","Lung Cancer",[112,109,28,110,113,114,115,116,117,118],"Immunonutrition","Treatment Toxicity","Supportive Care","Body Composition","Nutritional Status","Cytokines","Quality of Life","2026-03-31",{"date":121,"type":33},"2026-04-07",{"date":123,"type":33},"2025-10-03",{"date":125,"type":22},"2027-12-30",{"name":127,"class":40},"Fondazione del Piemonte per l'Oncologia",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":153,"locationsCount":41},"100632263","galenos-1-in-head-and-neck-lung-and-rectal-cancer-patients-100632263","NCT07511413","GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients","An Observational Study on Longitudinal Nutritional Status and Body Composition Changes in Head and Neck Cancer, Lung Cancer and Rectal Cancer Patients During Antineoplastic Treatments","GALENOS 1","Inclusion Criteria:\n\n* Written informed consent provided before study procedures\n* Male or female participants aged 18 years or older\n* Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer\n* Candidate for standard antineoplastic treatment according to clinical practice\n* ECOG Performance Status score less than 2\n* Adequate kidney, liver, and bone marrow function\n* Ability to adhere to study visits and protocol requirements\n\nExclusion Criteria:\n\n* Incomplete recovery from surgery before start of antineoplastic treatment\n* Other additional malignancies progressing or requiring active treatment within the previous 3 years, except localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ\n* Active infection requiring systemic antibiotic therapy Serious or unstable medical conditions, psychiatric disorders, or substance abuse that would interfere with study compliance\n* Receipt of any live vaccine within 30 days before planned start of study therapy\n* Active cardiac pacing\u002Fpacing implants\u002Fneurostimulators\u002Fhearing systems not compatible with bioimpedance analysis\n* Edema and\u002For ascites interfering with body weight evaluation or bioimpedance analysis\n* Enteral or parenteral nutritional support at baseline",{"count":137,"type":22},110,"OBSERVATIONAL","GALENOS 1 is a prospective observational study designed to explore longitudinal changes in nutritional status and body composition in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer undergoing standard antineoplastic treatments. The study is the preparatory observational component of the FOR-GALE PREVENTION project, which aims to support the future development of a galenic immunonutrition dietary supplement intended to reduce adverse events and improve treatment compliance",[109,28,110],[109,110,28,116,115,142,143,144,145,117,118,113,146,112,114],"Skeletal Muscle Mass","Sarcopenia","Bioimpedance Analysis","Handgrip Strength","Treatment Tolerance","2026-03-30",{"date":149,"type":33},"2026-04-06",{"date":151,"type":33},"2024-09-23",{"date":125,"type":22},{"name":127,"class":40},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":41},"100537713","phase-2-capox-and-pd-1-antibody-combined-with-or-without-radiotherapy-for-mss-locally-advanced-rectal-cancer-100537713","NCT06281405","CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer","A Prospective Randomized Phase II Trial of CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for Microsatellite Stable Locally Advanced Rectal Cancer (TORCH-iTNT)","TORCH-iTNT","Inclusion Criteria\n\n1. Age 18-70 years old, female and male;\n2. Pathological confirmed adenocarcinoma;\n3. The distance from anal verge ≤ 10 cm;\n4. MSI\u002FMMR status: MSS\u002FpMMR;\n5. Clinical stage T3-4 and\u002For N+, without distance metastases;\n6. At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;\n7. KPS ≥ 70;\n8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;\n9. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\\^9\u002FL, Hb ≥ 90 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL, ALT\u002F AST ≤ 2.5 ULN, Cr ≤ 1 ULN;\n10. With good compliance and signed the consent form.\n\nExclusion Criteria\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n6. Uncontrolled infection which needs systemic therapy;\n7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;\n9. Allergic to any component of the therapy.","70 Years",{"count":164,"type":22},192,[25],"TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4\u002FN+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy\u002F5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, organ or anal preservation rate, 3-year DFS rate, etc.",[28,168],"Neoadjuvant Therapy",{"date":170,"type":33},"2026-04-03",{"date":172,"type":33},"2024-03-28",{"date":174,"type":22},"2028-12-31",{"name":176,"class":40},"Fudan University",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":203},"100629027","phase-2-short-course-rt-plus-capox-and-tislelizumab-vs-long-course-crt-plus-tislelizumab-for-locally-advanced-rectal-cancer-100629027","NCT07469306","Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer","Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Age 18-75 years, any gender.\n* Pathologically confirmed rectal adenocarcinoma.\n* Baseline MR stage T3-4\u002FN+.\n* Distance from anal verge ≤12cm.\n* No distant metastasis.\n* Karnofsky Performance Status ≥70.\n* Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.\n* Microsatellite\u002Fmismatch repair status MSS\u002FpMMR.\n* No prior chemotherapy or any other anti-tumor treatment before inclusion.\n* No prior immunotherapy.\n* Ability to comply with the study protocol during the study period.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Pathological diagnosis of signet ring cell carcinoma.\n* History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.\n* Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.\n* Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.\n* Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.\n* Patients with autoimmune diseases.\n* Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.\n* Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g\u002FL; absolute neutrophil count (ANC) .≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP\n\n  ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C1 times the upper limit of normal; serum albumin ≥30g\u002FL.\n* Known deficiency of dihydropyrimidine dehydrogenase (DPD).\n* Allergy to any investigational drug components.",{"count":185,"type":22},130,[25],"To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.",[28],[190,191,60,192],"Modified Short-course radiotherapy (mSCRT)","Long-course radiotherapy (LCRT)","PD-1 monoclonal antibody","2026-03-10",{"date":195,"type":33},"2026-03-13",{"date":197,"type":22},"2026-08-10",{"date":199,"type":22},"2027-09-01",{"name":201,"class":202},"Fujian Cancer Hospital","OTHER_GOV",3,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":41},"100627787","onco-ret-supervised-resistance-training-during-total-neoadjuvant-therapy-for-locally-advanced-rectal-cancer-100627787","NCT07453173","ONCO-RET: Supervised Resistance Training During Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","A Pilot, Single-Arm, Prospective Study Assessing Feasibility and Safety of a Supervised Progressive Resistance Training Program During Total NeoadjuvantTherapy (RAPIDO) Until Surgery in Locally Advanced Rectal Cancer","ONCO-RET","Inclusion Criteria:\n\n* Locally advanced rectal adenocarcinoma planned for RAPIDO total neoadjuvant therapy (short-course RT + chemotherapy + surgery), meeting protocol staging criteria (e.g., cT3N1\u002FcT4\u002FcN2\u002FEMVI+\u002Fthreatened mesorectal fascia\u002Flateral pelvic disease).\n\nExclusion Criteria:\n\n* Metastatic disease at diagnosis.\n* Severe\u002Funcontrolled cardiovascular disease (ejection fraction \\<50%).",{"count":213,"type":22},15,[106],"Colorectal cancer is a major cause of cancer death in Chile. Many people with rectal cancer that has grown into nearby tissues receive chemotherapy and radiation before surgery. These treatments can cause tiredness and loss of muscle, which may make it harder for patients to complete treatment.\n\nThis study will look at whether a supervised strength-training exercise program is practical and safe during treatment before surgery. Participants will do a personalized strength-training program two times per week. The program will start when cancer treatment begins and will continue until surgery (about 24 weeks).\n\nThe study will measure how practical the program is by looking at how many people join the study, stay in the study, and attend the exercise sessions, and whether the study team can collect all planned information. The study will also track any problems or side effects related to exercise.\n\nThe study will also explore whether the exercise program may help maintain muscle, improve strength and physical function, improve quality of life, reduce fatigue, and affect how the tumor responds to treatment. These results will be compared with information from similar patients previously treated at the same hospital.",[28],[218],"prehabilitation; resistance training; total neoadjuvant therapy; RAPIDO; feasibility; safety","2026-03-03",{"date":221,"type":33},"2026-03-05",{"date":223,"type":22},"2026-03-09",{"date":225,"type":22},"2027-03-31",{"name":227,"class":40},"Fundacion Arturo Lopez Perez",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":41},"100470916","phase-1-smart-tnt-for-the-conservative-management-of-locally-advanced-rectal-cancer-100470916","NCT05412082","SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer","Selective Treatment With Magnetic Resonance Image Guided Pelvic Adaptive Radiation Therapy Combined With Total Neoadjuvant ChemoTherapy for the Conservative Management of Locally Advanced Rectal Cancer","SMART TNT","Inclusion Criteria:\n\n1. Patients with newly diagnosed, biopsy proven, rectal adenocarcinoma.\n2. Primary tumor located ≤18 cm from margin verge.\n3. Primary tumor either a T3N0 or T1-4 N positive (as defined per pelvic MRI; nodes ≤ 15 mm).\n4. ≥ 18 years of age.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n6. Serum liver function tests values within the range of 1.5 x Upper Limit of Normal (within 6 weeks of enrollment).\n7. Negative pregnancy test for women of child-bearing potential (within 4 weeks of enrollment).\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. Patient is assessed by a surgeon, medical oncologist and a radiation oncologist and deemed fit for Total Neoadjuvant ChemoTherapy (TNT) and surgery.\n\nExclusion Criteria:\n\n1. Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan).\n2. Synchronous cancer found on colonoscopy.\n3. Previous history of pelvic radiotherapy.\n4. History of concurrent, active malignancy other than non-metastatic skin cancer within the last 2 years.\n5. Symptomatic congestive heart failure of New York Heart Association Class III or IV, unstable angina pectoris or uncontrolled severe cardiac arrhythmia, myocardial infarction within the last 6 months.\n6. Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Active (acute or chronic) or uncontrolled severe infections requiring intravenous antibiotics or active tuberculosis (TB).\n8. Patients with poorly controlled acquired immune deficiency syndrome (AIDS) who are not deemed candidates for FOLFOX, mFOLFIRINOX or CAPOX chemotherapy. Active connective tissue disorders, such as lupus or scleroderma, that, in the opinion of the treating physician may put the patient at high risk for radiation toxicity.\n9. Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity\n10. Sensory or motor neuropathy ≥ grade 2.\n11. Women who are breast feeding.\n12. Exclusions due to MRI use in study: ferromagnetic metal in body\u002Feye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted).",{"count":7,"type":22},[238],"PHASE1","The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is usually delivered and see if patients could have complete response and be spared from surgery.",[28],"2026-02-04",{"date":243,"type":33},"2026-02-06",{"date":245,"type":33},"2022-10-05",{"date":247,"type":22},"2028-10-31",{"name":249,"class":40},"University of Miami",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":18,"minAge":162,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100520112","efficacy-and-safety-of-conventional-neoadjuvant-therapy-versus-total-neoadjuvant-therapy-in-older-patients-with-locally-advanced-rectal-cancer-100520112","NCT06052332","Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer","Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial","SHAPERS","Inclusion Criteria:\n\n1. Age ≥ 70 years old\n2. ECOG performance status (PS):\n\n   * ≤1 if age \\> 75 years old\n   * ≤2 if age ≤ 75 years old\n3. Histologically or cytologically confirmed adenocarcinoma of the rectum\n4. Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge\n5. Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement\u002Fthreatening \\[i.e.,tumour within 1 mm of the MRF\\], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible.\n6. Adequate bone marrow function as defined below:\n\n   * Absolute neutrophil count ≥1,500\u002FµL\n   * Haemoglobin ≥9 g\u002FdL\n   * Platelets ≥100,000\u002FµL\n7. Adequate liver function as defined below:\n\n   * Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert's syndrome \\\u003C3xUNL is allowed\n   * AST (SGOT) and ALT (SGPT) ≤2.5 x ULN\n   * Alkaline phosphatase ≤2.5 x ULN\n8. Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73m² (according to the CKD-EPI 2021 equation).\n9. Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and\u002For surgery.\n10. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n11. Male subjects with partners of childbearing potential must agree to use condom during the course of this study and for at least 6 months after the last administration of study drugs.\n\nExclusion Criteria:\n\n1. Extensive growth into cranial part of the sacrum (above S2\u002F3 junction) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is achieved.\n2. Presence of metastatic disease or recurrent rectal tumour.\n3. Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0.\n4. Significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n5. Any contraindication to pelvic irradiation as evaluated by the investigator.\n6. Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications.\n7. Any investigational anti-cancer therapy other than the protocol specified therapies (participation in other prospective studies which do not imply any specific intervention may be allowed after discussion with the Study Chair).\n8. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment.\n9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke, myocardial infarction, unstable angina, congestive heart failure (grade III or IV as classified by the New York Heart Association), or serious cardiac arrhythmia requiring medication within the past 6 months.\n10. Complete dihydropyrimidine dehydrogenase (DPD) deficiency.\n11. Any previous treatment for rectal cancer.\n12. Use of brivudine, sorivudine or their chemically related analogues.",{"count":259,"type":22},230,[106],"The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.",[28,263],"Older People",[57],"2025-11-28",{"date":267,"type":33},"2025-12-05",{"date":269,"type":33},"2024-02-07",{"date":271,"type":22},"2033-12",{"name":273,"class":40},"Jules Bordet Institute",19,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":282,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":292,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":41},"100612010","phase-2-a-phase-ii-single-arm-study-of-high-bioavailability-curcumin-as-neoadjuvant-chemoradiotherapy-in-mid-to-low-rectal-cancer-integrated-clinical-and-translational-analysis-of-tumor-tissue-100612010","NCT07248020","A Phase II Single-Arm Study of High-Bioavailability Curcumin as Neoadjuvant Chemoradiotherapy in Mid-to-Low Rectal Cancer: Integrated Clinical and Translational Analysis of Tumor Tissue","BCMRECRAD","Inclusion Criteria:\n\n(A) Males and females more than 20 years of age (B) Signed informed consent (C) Patients with a pathologically proven rectal adenocarcinoma located less than 10 cm to the anus.\n\n(D) Clinical staging (AJCC 8th ed.): T2-4 N0 M0 or T any N1-2 M0 (E) Distal metastasis has been excluded by imaging study: by chest-to-pelvic computed tomography or Positron Emission Tomography (F) Preoperative pelvic staging by pelvic Magnetic Resonance Imaging (preferred) or trans-rectal ultrasound (G) Patients with WHO\u002FECOG performance scale 0 or 1\n\nExclusion Criteria:\n\n(A) Refuse to sign the informed consent (B) Distal metastasis revealed by the imaging study (C) Patients does not receive radiotherapy (D) Unable to receive further curative resection (E) Patients receive tumor resection before the neoadjuvant treatment (F) Patients have history of more than 5 Gy of pelvic radiation (G) Patients in pregnancy or lactation status (H) Patients have allergic history to curcumin, 5-fluouracil or oxaliplatin (I) Patients of childbearing potential can not cooperate with appropriate contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) (J) Patients with any concurrent malignancy; patients with history of malignancy should be cancer-free for more than 5 years (K) Patients with New York Heart Association (NYHA) class III or IV heart failure, unstable angina pectoris, unstable cardiac arrhythmia or tachycardia (heart rate \\> 100 beats\u002Fminute) (L) Patients have concurrent uncontrolled medical conditions, such as illness ongoing or requiring IV antibiotics, severe chronic renal failure (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) or severe active hepatitis(AST\u002FALT\\>3x upper normal limit)、Total Bilirubin\\>2 mg\u002Fdl (M) Patients with previous or current drug abuse (N) Patients underwent major surgery within 28 days of study enrollment (except diverting colostomy) (O) Patients have Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis (P) Patients have known dipyrimidine dehydrogenase deficiency (DPD) (Q) Patients with congenital iron metabolic or hematopoietic diseases (R) Patients with synchronous colon cancer (S) The Patients with hematologic abnormalities (INR \\> 1.5, white blood cell (WBC) count \\\u003C 3,000\u002FμL, absolute neutrophil count (ANC) \\\u003C 1,500\u002FμL, platelet count \\\u003C 100,000\u002FμL, hemoglobin \\\u003C 9.0 g\u002FdL not caused by tumor treatment) or known hematologic diseases (aplastic anemia, myelodysplastic syndrome (MDS), leukemia, malignant lymphoma, multiple myeloma, hereditary hematologic diseases such as thalassemia, sickle cell anemia, etc.).\n\n(T) The patient has diabetes mellitus (U) The patient is taking the immunosuppressants Cyclosporine, Tacrolimus, Sirolimus, and Everolimus and antigoagulants (warfarin、NOACs、aspirin) (V) Patients with The medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements","20 Years",{"count":284,"type":22},72,[25],"This clinical study investigates the anti-inflammatory and anti-cancer properties of a high-bioavailability formulation of curcumin (BCM-95) in patients with mid-to-low rectal cancer receiving neoadjuvant chemoradiotherapy (nCRT). Curcumin, a polyphenolic compound derived from Curcuma longa, has demonstrated potent anti-inflammatory and anti-neoplastic activities through the modulation of multiple molecular signaling pathways. It has been recognized by the U.S. Food and Drug Administration (FDA) as \"Generally Recognized as Safe\" (GRAS; GRN No. 686), with an excellent safety profile when administered orally. Reported adverse effects are rare and primarily related to interference with bile secretion or iron metabolism.\n\nDespite its biological potential, conventional curcumin exhibits extremely low oral bioavailability due to its lipophilic nature, rapid metabolism, and systemic elimination. Clinical studies have reported that even at an oral dose of 12 grams per day, the maximum plasma concentration reaches only about 0.051 mg\u002FmL, with up to 75% of the administered dose excreted in feces. To overcome this limitation, the current trial utilizes a curcumin formulation with enhanced absorption (BCM-95), which combines curcumin with essential oils of turmeric to improve systemic bioavailability.\n\nThe primary objective of this single-arm, phase II trial is to evaluate whether oral curcumin supplementation can mitigate radiation-induced gastrointestinal toxicity-particularly radiation enteritis-during neoadjuvant chemoradiotherapy for rectal cancer. The secondary objectives include assessing its effect on treatment response, such as the pathological complete response (pCR) rate, tumor regression grade, and patient-reported outcomes related to bowel function and quality of life.\n\nIn addition, a translational research component is embedded within this study. Serial tumor tissue and blood samples will be collected at predefined time points to explore the molecular and immunological mechanisms underlying curcumin's therapeutic effects. Analyses will include assessments of inflammatory cytokines, oxidative stress markers, and tumor microenvironmental changes using molecular and histopathologic methods.\n\nOverall, this study aims to provide both clinical and mechanistic evidence supporting the potential of high-bioavailability curcumin as a safe, adjunctive therapeutic strategy to improve treatment tolerance and oncologic outcomes in rectal cancer patients undergoing chemoradiotherapy.",[288,28,289,290,291],"Rectal Cancer","Radiation-Induced Enteritis","Radiation Proctitis","Chemoradiotherapy-Related Toxicity",[293,294,295],"Curcumin","Rectal cancer","Chemoradiotherapy","2025-11-18",{"date":298,"type":33},"2025-11-25",{"date":300,"type":22},"2026-01-01",{"date":174,"type":22},{"name":303,"class":40},"Chang Gung Memorial Hospital",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":41},"100604548","phase-2-long-course-chemoradiotherapy-or-short-course-radiotherapy-combined-with-capox-pd-1antibody-and-cox-2-inhibitor-for-mss-locally-advanced-rectal-cancer-serrac-100604548","NCT07150949","Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)","A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)","Inclusion Criteria:\n\n1. Age 18-75 years, gender not limited\n2. Pathologically confirmed rectal adenocarcinoma\n3. ≤10 cm from the anus\n4. Baseline stage T3-4\u002FN+\n5. No distant metastasis\n6. MSI\u002FMMR status MSS\u002FpMMR\n7. Karnofsky performance status score ≥70\n8. No prior chemotherapy or other anti-cancer treatment prior to enrollment\n9. No prior immunotherapy prior to enrollment\n10. Ability to comply with the study protocol\n11. Written informed consent\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;\n4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n7. Uncontrolled infection which needs systemic therapy;\n8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection\n10. Allergic to any component of the therapy.",{"count":312,"type":22},138,[25],"SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4\u002FN+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy\u002F25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy\u002F5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.",[28,168],"2025-08-27",{"date":318,"type":33},"2025-09-02",{"date":320,"type":22},"2025-08-28",{"date":322,"type":22},"2028-08-31",{"name":176,"class":40},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":41},"100597330","phase-2-involved-field-radiotherapy-tnt-combined-with-pd-1-inhibitor-for-pmmr-locally-advanced-rectal-cancer-neo-field-i-100597330","NCT07057089","Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)","Clinical Exploration of Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer: a Prospective, Open-label, Randomized Controlled Trial (Neo-Field I)","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n3. Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;\n4. Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);\n5. The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;\n6. Pre-enrollment laboratory indicators meet the following indicator ranges： 1)Blood: absolute neutrophils ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, hemoglobin ≥90g\u002FL; 2)Liver and kidney function: ALT\u002FAST ≤ 2.5 x ULN, total bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60mL\u002Fmin (Cockcroft-Gault formula)； 3)Coagulation: INR ≤ 1.5, APTT ≤ 1.5 x ULN (for those not receiving anticoagulation)；\n7. Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatment session;\n8. Voluntary written informed consent and commitment to complete the full treatment and follow-up program.\n\nExclusion Criteria:\n\n1. Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;\n2. Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;\n3. Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；\n4. Presence of active infection (e.g. HIV, HBV\u002FHCV viral load positive requiring stabilization on antiretroviral therapy)；\n5. Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \\>160\u002F100 mmHg)；\n6. History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years)；\n7. Uncontrolled diabetes mellitus (HbA1c \\> 8%), abnormal thyroid function (TSH outside normal range and requiring pharmacologic intervention)；\n8. Severe chronic bowel disease (e.g., Crohn's disease, active ulcerative colitis)； Patients deemed by the investigator to be unsuitable for participation in this study.",{"count":332,"type":22},90,[25],"The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.",[28],"2025-08-11",{"date":338,"type":33},"2025-08-14",{"date":340,"type":33},"2025-07-01",{"date":342,"type":22},"2030-12-01",{"name":344,"class":40},"Hebei Medical University Fourth Hospital",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":41},"100598658","phase-3-irinotecan-liposomes-in-total-neoadjuvant-therapy-in-locally-advanced-rectal-cancer-100598658","NCT07074353","Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer","A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer","CinClare-2","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years, both male and female are eligible;\n2. Histologically confirmed rectal adenocarcinoma;\n3. Clinical stage assessed by MRI as T3-4 or N+ (according to the 8th edition of the AJCC);\n4. Distance from the lower edge of the tumor to the anal verge ≤ 10 cm;\n5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;\n6. UGT1A1\\*6 and UGT1A1\\*28 gene phenotypes are either wild-type (GG+6\u002F6) or single-site mutant (GG+6\u002F7 or GA+6\u002F6);\n7. No prior anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.;\n8. Normal function of major organs.\n\nExclusion Criteria:\n\n1. Previous or ongoing treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.\n2. Known MSI-H (high microsatellite instability) by genetic testing or dMMR (deficient mismatch repair) by immunohistochemistry.\n3. Known hypersensitivity, allergic reaction, or contraindication to irinotecan liposomes\u002Fvehicle, irinotecan, other liposomal products, 5-FU, leucovorin, oxaliplatin, or any of these agents.\n4. Uncontrolled cardiac symptoms or disease.\n5. Severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging showing active pulmonary inflammation; signs and symptoms of infection within 14 days prior to the first use of the study drug or requiring oral or intravenous antibiotic therapy, excluding prophylactic use of antibiotics.\n6. Severe gastrointestinal dysfunction (inflammation or diarrhea greater than Grade 1).",{"count":354,"type":22},360,[356],"PHASE3","This study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. The study endpoints were the complete response rate (cCR + pCR), 3-year event-free survival (EFS) rate, and overall survival (OS). The aim was to compare the efficacy and safety of irinotecan liposomes combined with or without standard TNT.",[28],"2025-07-21",{"date":361,"type":33},"2025-07-25",{"date":363,"type":22},"2025-07-20",{"date":365,"type":22},"2030-07-01",{"name":367,"class":40},"Zhejiang Cancer Hospital",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":411},"100488930","phase-3-tnt-of-scrtcapox-vs-scrtcapoxiri-for-locally-advanced-rectal-cancer-100488930","NCT05646511","TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer","A Multicenter Randomized Phase III Study of Short-term Radiotherapy Plus CAPOX and Short-term Radiotherapy Plus CAPOXIRI as Preoperative Treatment for Locally Advanced Rectal Cancer","ENSEMBLE","Inclusion Criteria:\n\n1. The content of this research was fully explained, and written informed consent was obtained from the subject.\n2. Histologically confirmed rectal adenocarcinoma.\n3. Radical resection is clinically possible without any distant metastases on imaging studies.\n4. Age of 18 years or older on the date of consent acquisition.\n5. Eastern Cooperative Oncology Group (ECOG) PS 0-1 (PS 0 if aged 70 years or older on consent acquisition date).\n6. Inferior margin of the tumor is within 12 cm of the AV.\n7. No prior tumor treatment.\n8. No history of radiation therapy to the pelvis, including treatment for other cancer types.\n9. Cases with cT3-4N0M0\\*or T1-4N1-2M0 based on Union Internationale Contre le Cancer (UICC) 8th edition.\n\n   (\\*5 cm\\\u003C AV ≤ 10 cm, T3a\u002FbN0M0, extramural venous invasion (EMVI) -, mesorectal fascia (MRF) clear and 10 cm \\\u003C AV ≤ 12 cm, T3a\u002FbN0-1M0, EMVI-, MRF clear are eligible only for those who refused surgery)\n10. UGT1A1 is wild-type or single heterozygous.\n11. Criteria for major organ function within 28 days prior to enrollment. If there are multiple test results within this period, the most recent one will be used, and blood transfusions and hematopoietic factor preparations will not be administered within 14 days before the test date for measurements before registration.\n\n    1. Neutrophil count: ≥1,500\u002Fmm3\n    2. Platelet count: ≥10.0×10 4\u002Fmm3\n    3. Hemoglobin concentration: ≥9.0 g\u002FdL\n    4. Total bilirubin: ≤2.0 mg\u002FdL\n    5. Aspartate transaminase (AST): ≤100 IU\u002FL or less\n    6. Alanine transaminase (ALT): ≤100 IU\u002FL or less\n    7. Serum creatinine: Creatinine clearance ≥30 mL\u002Fmin (by Cockcroft \\& Gault formula)\n\nExclusion Criteria:\n\n1. Extensive surgery (excluding colostomy and central venous port construction) within 4 weeks before starting protocol treatment.\n2. Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, and severe emphysema).\n3. Colonic stent in place.\n4. Contraindications for MRI such as cardiac pacemakers.\n5. Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and active inflammatory bowel disease).\n6. Patients with multiple active cancers (simultaneous multiple cancers or metachronous multiple cancers with a disease-free interval of 5 years or less). However, carcinoma in situ or lesions equivalent to intramucosal carcinoma, which can be cured by local treatment, are not treated as active multiple cancers.\n7. Pregnant women, lactating women, positive pregnancy test, or unwillingness to use contraception.\n8. Hepatitis B surface (HBs) antigen positive or hepatitis C virus (HCV) antibody-positive. However, HCV-RNA-negative can be registered.\n9. Have human immunodeficiency virus (HIV) infection.\n10. MSI-high (MSI-H) or defective mismatch repair (dMMR) is known.\n11. Unwilling to donate specimens for \"Research on gene profiling and clinical significance using clinical specimens from cancer patients\" for whole-genome analysis based on the \"Action Plan for Whole-Genome Analysis, etc.\" (CONDUCTOR study).\n12. Any other patients the principal investigator or co-investigator deems inappropriate for study participation.",{"count":377,"type":22},608,[356],"This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.",[28],[382,383,60,294,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401],"Radiation","CAPOXIRI","Total neoadjuvant therapy","Rectal Neoplasms","Colorectal Neoplasms","Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Capecitabine","Oxaliplatin","Irinotecan","Antineoplastic Agents","Chemotherapy","Non-operative management","Surgery","MRI","Restaging","QOL","Organ preservation","TNT","2025-03-31",{"date":404,"type":33},"2025-04-03",{"date":406,"type":33},"2022-11-21",{"date":408,"type":22},"2030-12-31",{"name":410,"class":40},"National Cancer Center Hospital East",34,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":41},"100584856","preoperative-chemoradiotherapy-combined-with-consolidation-or-induction-nalirifox-in-rectal-cancer-100584856","NCT06894797","Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer.","The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.","Inclusion Criteria:\n\n1. Subjects participate in the study need to sign the informed consent, and demonstrate good compliance.\n2. Age: 18\\~75 years old.\n3. Histopathologically confirmed rectal adenocarcinoma.\n4. Locally advanced rectal cancer, determined at baseline.\n5. No prior systemic therapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0\\~1.\n7. Expected survival ≥ 12 months.\n8. Adequate bone marrow function (In the absence of blood transfusion within 14 days, correction with granulocyte colony-stimulating factor or other hematopoietic stimulating factor was not used within 7 days prior to laboratory examination) :\n\n   ①Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, Platelet count ≥100×10\\^9\u002FL, Hemoglobin (Hb) ≥9g\u002FdL.\n\n   ② Liver function: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, liver metastasis, AST and ALT≤5×ULN.\n\n   ③ Renal function: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin.\n\n   ④International Normalized Ratio (INR) ≤ 1.5 ULN, Prothrombin time and activated partial thromboplastin time (APTT) ≤ 1.5 ULN\n9. Microsatellite Stability (MSS) or proficient MisMatch Repair (pMMR).\n\nExclusion Criteria:\n\n1. Within 4 weeks prior to treatment, subjects must not have received radiotherapy, surgery, chemotherapy, immunotherapy for tumors, molecular targeted therapies, or other investigational drugs.\n2. microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)\n3. Distant metastasis\n4. Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (bleeding \\> 30ml within 3 months), hematemesis, black stool, blood in the stool), hemoptysis (\\> 5 mL of fresh blood within 4 weeks), etc. Treatment of venous\u002Fvenous thrombotic events within the first 6 months, such as cerebrovascular accidents (including transient brain lesions) Ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Or need to use warfarin or Long-term anticoagulant therapy with heparin, or long-term antiplatelet therapy (aspirin ≥300 mg\u002Fday or chlorine) is required Picogrel ≥75 mg\u002Fday).\n5. During screening, tumors were found to invade large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava that there was a risk of major bleeding by the investigator judged.\n6. Active heart disease, including myocardial infarction, severe\u002Funstable angina, occurred 6 months before treatment. ultrasonic Left ventricular ejection fraction \\\u003C50% was detected by cardiogram, indicating poor arrhythmia control.\n7. High blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg and\u002For diastolic pressure ≥90 mmHg).\n8. Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.\n9. Known or suspected allergy to the investigational drug or a similar drug.\n10. Active or uncontrolled severe infection.\n11. Known human immunodeficiency virus (HIV) infection.\n12. Any other disease with clinically significant metabolic abnormalities, physical abnormalities, or laboratory abnormalities Often, in the investigator's judgment, there is reason to suspect that the patient has a disease or condition that is not suitable for use of the investigational drug state (such as having a seizure and requiring treatment) that will either affect the interpretation of the study results or make the patient In a high-risk situation.\n13. Patients who have been co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing\n14. Inability to comply with study protocols or study procedures.\n15. Patients who are not suitable to participate in this trial judged by the investigator.",{"count":420,"type":22},68,[106],"The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined with Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.",[28],"2025-03-19",{"date":426,"type":33},"2025-03-25",{"date":428,"type":22},"2025-04-01",{"date":430,"type":22},"2027-10-31",{"name":432,"class":40},"Peking University Cancer Hospital & Institute",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":41},"100580697","phase-2-mr-guided-adaptive-radiotherapy-combined-with-pd-1-antibody-and-capox-for-locally-advanced-rectal-cancer-100580697","NCT06840665","MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer","A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Age 18-70 years old, male or female\n2. Pathologically confirmed rectal adenocarcinoma\n3. The distance from anal verge ≤ 10 cm\n4. Clinical stage T3-4 and\u002For N+\n5. No evidence of distance metastases\n6. MSI\u002FMMR status: MSS\u002FpMMR\n7. Karnofsky score \\>=70\n8. Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy\n9. No chemotherapy or any other anti-tumor therapy prior to enrollment\n10. No immunotherapy prior to enrollment\n11. With good compliance during the study\n12. Signed written informed consent\n\nExclusion Criteria:\n\n1. Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ\n2. Pregnancy or breast-feeding women\n3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications\n4. Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months\n5. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy\n6. Individuals with autoimmune diseases\n7. Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases\n8. Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g\u002FL; NEU ≥1.5×109\u002FL; PLT ≥100×109\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB \\\u003C1.5 times the upper limit of normal; Cr \\\u003C1 time the upper limit of normal; Alb ≥30g\u002FL\n9. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency\n10. Individuals allergic to any drug component of the study",{"count":441,"type":22},46,[25],"NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4\u002FN+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy\u002F6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.",[28],"2025-02-19",{"date":447,"type":33},"2025-02-21",{"date":449,"type":33},"2024-08-13",{"date":451,"type":22},"2027-02-12",{"name":176,"class":40},{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":41},"100577774","phase-2-short-course-radiotherapy-followed-by-ak112-and-capox-as-neoadjuvant-therapy-for-locally-advanced-rectal-cancer-100577774","NCT06802666","Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study","Inclusion Criteria:\n\n1. The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance；\n2. Age ≥18 years and ≤75 years, without gender restriction.\n3. Histopathologically confirmed locally advanced rectal adenocarcinoma.\n4. Participants who are not suitable for standard therapy due to intolerable toxicity, lack of standard therapy, or refusal of standard therapy.\n5. Hematological parameters at baseline\\* (within 7 days prior to the first dose of study drug) must meet the following criteria: • Hemoglobin ≥90 g\u002FL • Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL • Platelet count ≥100×10\\^9\u002FL • Eosinophils ≤1.5×upper limit of normal (ULN). \\*Participants may not have received blood products (including red cell suspensions, plateletpheresis, cryoprecipitate), erythropoietin, or colony-stimulating factor supportive treatment within 7 days prior to blood sampling.\n6. Serum biochemical tests at baseline (within 7 days prior to the first dose) must meet the following criteria: • Total bilirubin ≤1.5×ULN (if total bilirubin \\>1.5×ULN, direct bilirubin ≤ULN is acceptable for inclusion). • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN. • Serum creatinine ≤1.5×ULN or creatinine clearance (CCr) ≥45 mL\u002Fmin, calculated using the Cockcroft-Gault formula (Appendix 4) using actual body weight. • Albumin ≥30 g\u002FL.\n7. Coagulation tests at baseline (within 7 days prior to the first dose) must meet the following criteria: • International normalized ratio (INR) ≤1.5×ULN (≤3×ULN if on stable anticoagulant therapy). • Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN (≤3×ULN if on stable anticoagulant therapy).\n8. Urinalysis at baseline (within 7 days prior to the first dose) must meet the following criteria: urine protein (UPRO) \\\u003C2+ or 24-hour urinary protein \\\u003C1 g.\n9. At least one measurable lesion according to RECIST v1.1 (solid tumors) criteria.\n10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n11. Expected survival ≥3 months.\n12. Women of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Exclusion of patients not diagnosed with locally advanced rectal adenocarcinoma.\n2. Participants who have previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1\u002FL1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or any other treatments targeting tumor immunological mechanisms, such as immune cell therapy.\n3. Pregnant or breastfeeding women, or women planning to become pregnant during the period from before the administration of the study drug, during treatment, or up to 6 months after the last dose.\n4. Known history of active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, or new onset of brain or leptomeningeal metastases.\n5. Significant cardiovascular diseases of clinical importance.\n6. History of allergic constitution, asthma, or atopic dermatitis.\n7. Participants with large pleural effusion or ascites.\n8. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatment.\n9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n10. Participants known or suspected to be allergic to the investigational product or any of its excipients.\n11. Participants with a history of significant toxicities associated with prior administration of immune checkpoint inhibitors or treatment with bevacizumab\u002Fpirfenidone-like agents that required permanent discontinuation of such treatment.\n12. Participants with unresolved toxicity \\> Grade 1 related to any prior anticancer therapy (excluding persistent alopecia Grade 2, peripheral neuropathy, anemia, or hypomagnesemia).\n13. Active uncontrolled bleeding or known bleeding diathesis, serious non-healing wounds, ulcers, or bone fractures, such as esophageal or gastric varices requiring immediate intervention (e.g., band ligation or sclerotherapy), or signs of portal hypertension where the Investigator believes the risk of bleeding is high.\n14. Participants with a history of bowel obstruction (excluding those who have undergone curative surgery or have had complete resolution) or gastrointestinal perforation risk within 28 days prior to the first dose of this study (including but not limited to acute diverticulitis, abdominal abscess, peritoneal carcinomatosis, history of gastrointestinal perforation and\u002For fistula within 6 months prior to study entry).\n15. Current or recent (within 6 months) major gastrointestinal diseases or conditions in participants, including:\n\n    1. Clinically significant history of gastrointestinal bleeding.\n    2. Active peptic ulcer disease.\n    3. ≥Grade 2 diarrhea occurring within 2 weeks prior to the first dose of the study drug.\n16. Participants who have received chemotherapy, small molecule inhibitors, immunotherapy (such as interleukins, interferons, or thymosin) for cancer treatment within 28 days before this study, or traditional Chinese medicine with anti-cancer indications within 14 days prior to dosing.\n17. Known positive HIV test result, active hepatitis B, hepatitis C (HCV), tuberculosis, or a history of infection with these diseases.\n18. Serious\u002Factive\u002Funcontrolled infection or infection requiring systemic intravenous antibiotics, or fever of unknown origin (\\>38°C) within 2 weeks prior to the first dose of the study drug.\n19. Diagnosis of another malignancy within 5 years prior to the first dose, except for cases such as adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been surgically resected, as well as localized prostate cancer or papillary thyroid cancer post-radical surgery.\n20. Participants who have received radical radiotherapy within 3 months prior to this study; palliative radiotherapy is allowed if administered at least 2 weeks prior to dosing and the radiation dose is consistent with local standards for palliative care.\n21. Presence of any medical condition, therapy, laboratory abnormality, or history of drug abuse, or current evidence thereof, which in the opinion of the investigator might jeopardize the safety of the participant, interfere with obtaining informed consent, affect the participant's compliance, or impact the assessment of the safety of the study drug.\n22. Patients whom the investigator deems unsuitable for participation in the clinical trial.",{"count":461,"type":22},45,[25],"This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer",[28,168],"2025-01-24",{"date":467,"type":33},"2025-01-31",{"date":469,"type":33},"2024-10-16",{"date":125,"type":22},{"name":472,"class":40},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":4},"100574533","phase-2-short-course-radiotherapy-followed-by-capox-and-ivonescimab-for-locally-advanced-rectal-cancer-100574533","NCT06760520","Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer","A Single-arm, Prospective, Phase II Clinical Study of Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Low-middle Rectal Cancer with a High Risk of Recurrence","Inclusion Criteria:\n\n* ECOG score of 0-1;\n* histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis\n* Tumor distance from anal verge ≦10cm\n* at least one high-risk criterion defined by pelvic MRI: cT stage \\>T2 (tumor invades intrinsic muscularis propria by more than 5 mm); Extramural vascular invasion; cN2; Involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); Lateral lymph node short diameter ≥5mm\n* enough organ function\n\nExclusion Criteria:\n\n* with known MSI-H or dMMR\n* Multiple primary adenocarcinomas\n* History of pelvic radiotherapy\n* Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.",{"count":481,"type":22},40,[25],"This study is a single-arm, prospective, phase II clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(TME) surgery in patients with advanced rectal cancer.",[28],"2025-01-06",{"date":487,"type":33},"2025-01-08",{"date":489,"type":22},"2025-01-20",{"date":491,"type":22},"2031-12-20",{"name":493,"class":40},"The First Affiliated Hospital of Zhengzhou University",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":41},"100534067","phase-2-short-course-radiotherapy-followed-by-fruquintinib-plus-adebrelimab-and-capox-in-the-full-course-neoadjuvant-treatment-of-locally-advanced-rectal-cancer-a-multicenter-single-arm-open-label-study-100534067","NCT06234007","Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study","Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study (UNION PRECISION-I)","Inclusion Criteria:\n\n1. Signed written informed consent and volunteered to participate in the study;\n2. Age 18-75 years old (including the cut-off value), male or female;\n3. Locally advanced rectal adenocarcinoma confirmed by histopathology;\n4. High risk on pelvic MRI \\[one of the following criteria\\] :\n\n   * Clinical tumor (cT) stage cT4a or cT4b (according to the AJCC, 8th edition)\n   * Extramural vascular infiltration\n   * Clinical lymph node (cN) stage cN2 (according to the AJCC, 8th edition)\n   * Involvement of the mesenteric fascia\n   * Enlarged lateral lymph nodes\n5. The distance between the lower edge of the tumor and the anal edge is ≤10cm;\n6. Able to swallow tablets and capsules normally;\n7. ECOG PS 0-1\n8. Have not received any anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.\n9. Plan to undergo surgery after completion of total neoadjuvant therapy;\n10. No surgical contraindications;\n11. Normal major organ function, including:\n\n    1. Routine blood test (no blood transfusion and blood products within 14 days prior to the first treatment, no correction with G-CSF and other hematopoietic stimulating factors) :\n\n       * Neutrophil count ≥ 1.5×109\u002FL\n       * Platelet count ≥ 100×109\u002FL\n       * Hemoglobin ≥ 90 g\u002FL\n       * White blood cell count ≥ 3.0×109\u002FL\n    2. Blood biochemical tests:\n\n       * Total bilirubin ≤ 1.5×ULN (Gilbert's syndrome subjects, ≤3×ULN; Tumor liver metastasis, total bilirubin ≤3×ULN)\n       * ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN (≤5×ULN for patients with liver metastases)\n       * Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL\u002Fmin (Cocheroft-Gault formula, see Annex 2)\n    3. Coagulation function:\n\n       * International Normalized ratio (INR) ≤ 1.5×ULN\n       * Activated partial thromboplastin time (APTT) ≤ 1.5×ULN\n       * Prothrombin time (PT) ≤1.5×ULN\n    4. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%\n12. Female subjects of childbearing potential were required to have a negative serum pregnancy test within 14 days before starting the trial drug and to have used an effective contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) during the trial and for at least 6 months after the last dose; Male participants whose partner is a woman of childbearing potential should use effective contraception during the trial and for 6 months after the last dose;\n\nExclusion Criteria:\n\n1. Previous allergic history to any anti-angiogenesis targeted drug, any component of monoclonal antibody, capecitabine, oxaliplatin, or other platinum drugs;\n2. Have received or are receiving any of the following:\n\n   * being treated with an immunosuppressive drug, or systemic hormone, for immunosuppression within 2 weeks before the first dose of the study drug (dose\\> 10mg\u002F day prednisone or equivalent); Inhaled or topical steroid use and dosage are allowed in the absence of active autoimmune disease; Prednisone 10mg\u002F day or equivalent dose of adrenocortical hormone replacement;\n   * received live attenuated vaccine within 4 weeks before the first dose of study drug;\n   * major surgery or severe trauma within 4 weeks before the first dose of study drug;\n3. Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy); Patients with psoriasis or complete remission of childhood asthma\u002Fallergies without any intervention in adulthood were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included.\n4. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation;\n5. The presence of uncontrolled cardiac symptoms or diseases, including but not limited to: (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias without or poorly controlled after clinical intervention; (5) patients with hypertension that is not well controlled with a single antihypertensive drug (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100mmHg), or patients using two or more antihypertensive drugs to control blood pressure; (6) New York Heart Association (NYHA) functional class \\> Grade II or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n6. Severe infection (CTCAE \\> 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were excluded if there was active pulmonary inflammation on baseline chest imaging, if there were signs and symptoms of infection within 14 days before the first dose of study drug, or if oral or intravenous antibiotics were required;\n7. Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;\n8. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody positive, and HCV RNA above the detection limit of the analytical method);\n9. The patient had a second primary malignancy;\n10. Pregnant or lactating women;\n11. History of arterial\u002Fvenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;\n12. Persons with a history of psychotropic drug abuse and inability to quit or with mental disorders;\n13. Patients with any constitutional sign or history of bleeding regardless of severity;\n14. Patients with high risk of bleeding, such as active bleeding or bleeding tendency;\n15. Urine routine test showed urine protein ≥++, and confirmed 24-hour urine protein quantitation \\> 1.0 g;\n16. According to the investigator's judgment, there are other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, alcohol abuse, drug abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.",{"count":461,"type":22},[25],"To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.",[28],[506,507,508],"Neoadjuvant","Fruquintinib","Colorectal cancer","2024-03-14",{"date":511,"type":33},"2024-03-18",{"date":513,"type":33},"2023-12-01",{"date":515,"type":22},"2027-12-31",{"name":472,"class":40},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":539},"100509334","phase-1-preoperative-radiotherapy-and-astx660-in-rectum-cancer-100509334","NCT05912075","Preoperative Radiotherapy And ASTX660 in Rectum Cancer","An Open-Label Multicenter Phase 1b Study of Tolinapant (ASTX660) in Combination With Radiotherapy\u002FChemoradiotherapy (RT\u002FCRT) in Preoperative Treatment of Patients With Rectum Cancer (PRAAR 1: Preoperative Radiotherapy And ASTX660 in Rectum Cancer)","PRAAR1","Inclusion Criteria:\n\nLocally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by:\n\n* a distance between the tumor or its lymph node and the mesorectal fascia ≤ 2 mm on the pelvic MRI at diagnosis.\n\n  * \\*and\u002For N2\n* No evidence of metastatic disease on CT-scan (chest and abdomen), including resectable metastases\n* Age : ≥ 18 years old at the time of informed consent\n* Successfully received at least 4 cycles and up to 6 cycles of mFOLFIRINOX (LCRT arm only)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1\n* Acceptable organ functions, as evidenced by the following laboratory data:\n\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×upper limit of normal (ULN)\n  * Total serum bilirubin ≤1.5×ULN\n  * Absolute neutrophil count (ANC): ≥2,000 cells\u002Fmm\\^3\n  * Platelet count: ≥100,000 cells\u002Fmm\\^3\n  * Hemoglobin: ≥ 9.0 g\u002FdL\n  * Serum creatinine levels ≤1.5×ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measured creatinine clearance ≥50 mL\u002Fmin\n  * Amylase and lipase ≤1.5xULN\n  * Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5.\n* Women of childbearing potential must have a negative serum β-HCG pregnancy test within 3 days prior to the administration of the first study treatment and\u002For urine pregnancy 12 hours prior to the administration of the first study treatment.\n* Female subjects of childbearing potential should be willing to use a highly effective method of contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n\n  * Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.\n  * Also, it is recommended that women of childbearing potential partner use a highly effective method of contraception.\n* Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient must be able and willing to comply with study visits and procedures as per protocol.\n* Patient must be affiliated to a social security system or beneficiary of the same.\n\nExclusion Criteria:\n\n* Any contraindications to MRI (e.g. subjects with pacemakers, claustrophobia, excessive weight, etc).\n* Participation in another clinical study with an investigational product during the last 3 months.\n* No other anticancer therapy during study participation. (however, informed consent can be signed during mFOLFIRINOX for patients willing to enter the LCRT arm).\n* Hypersensitivity to tolinapant (ASTX660) or excipients of the drug product, or to any other component of the study treatment regimen, including:\n\n  * 5-FU, capecitabine and known dihydropyrimidine dehydrogenase (DPD) deficiency, or\n  * Oxaliplatin, or\n  * Irinotecan and known Gilbert disease or genotype UGT1A1 (LCRT arm only)\n* Previous radiotherapy in the pelvic region\n* Preexisting condition that would deter radiotherapy, e.g. fistulas, severe ulcerative colitis (including subjects currently taking sulphasalazine), active Crohn's disease, prior adhesions\n* Preexisting condition that would deter chemotherapy, e.g. pneumonitis, pulmonary fibrosis, pernicious anemia or other anemias caused by vitamin B12 deficiency\n* Prior rectal surgery\n* Prior investigational treatment for rectal cancer\n* Poor medical risk because of systemic diseases (e.g., uncontrolled infections, uncontrolled diabetes) in addition to the qualifying disease under study\n* Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise subject safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of tolinapant (ASTX660)\n* A history of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:\n\n  * Abnormal left ventricular ejection fraction (LVEF; \\\u003C50%) on echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n  * Congestive cardiac failure of ≥ Grade 3 severity according to New York Heart Association (NYHA) functional classification defined as subjects with marked limitation of activity and who are comfortable only at rest\n  * Unstable cardiac disease including unstable angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days)\n  * History or presence of complete left bundle branch block, third-degree heart block, cardiac pacemaker, or clinically significant arrhythmia\n  * Concurrent treatment with any medication that prolongs QT interval and may induce torsades de pointes and which cannot be discontinued at least 2 weeks before treatment with tolinapant (ASTX660)\n  * Personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy\n  * Screening 12-lead ECG with measurable QTc interval (according to either Fridericia's or Bazett's correction) of ≥470 msec)\n  * Any other condition that, in the opinion of the investigator, could put the subject at increased cardiac risk\n* Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease and\u002For bowel obstruction), or significant bowel resection that may impair adequate absorption and bioavailability of study drug. Major disturbance of bowel function (e.g. gross fecal incontinence or requiring \\> 6 mg loperamide each day).\n* Known history of human immunodeficiency virus (HIV) infection; or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Peripheral sensory neuropathy grade \\>2\n* Pregnancy or ongoing breastfeeding\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.\n\nYellow fever vaccine and live attenuated vaccines are contraindicated due to risk of severe vaccine-induced infection.\n\nNB :\n\n* The currently authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered.\n* For patients registered in LCRT, all eligibility criteria will be fulfilled during mFOLFIRINOX (until 2 weeks after the end of mFOLFIRINOX).\n* For patients registered in SCRT, all eligibility criteria will be fulfilled before any treatment.",{"count":526,"type":22},78,[238],"Compare two arms:\n\n* Chemotherapy followed by tolinapant (ASTX660) in combination with Long-Course Radio Chemotherapy (LCRT), and\n* Tolinapant (ASTX660) in combination with Short-Course Radiotherapy (SCRT) followed by chemotherapy For each patient, the treatment arm will be allocated on the following basis: patients will be allocated to the chemotherapy followed by LCRT arm unless they present at least one of the following criteria: contraindication to receive mFOLFIRINOX (including intolerance to irinotecan and UGT1A1\\*28 polymorphism), age \\> 75, general condition incompatible with the radiotherapy schedule of LCRT. In such case, patients will be allocated to the SCRT arm.\n\nTolinapant (ASTX660) will be administered orally once a day for 7 consecutive days every other week during 10 weeks (One week On \u002F One week Off during 10 weeks).\n\nBoth treatment arms will have a dose escalation part to determine the MTD and\u002For RP2D, followed by an expansion part where up to 21 subjects will be dosed at the RP2D. Both arms will enroll simultaneously.",[530],"Locally-advanced Rectal Cancer",{"date":532,"type":33},"2024-02-08",{"date":534,"type":33},"2023-12-19",{"date":536,"type":22},"2029-01",{"name":538,"class":40},"Gustave Roussy, Cancer Campus, Grand Paris",2,{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100458119","phase-2-neoadjuvant-long-course-chemoradiation-plus-pd-1-blockade-for-mid-low-locally-advanced-rectal-cancer-100458119","NCT05245474","Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer","Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)","Inclusion Criteria:\n\n* aged 18\\~75\n* ECOG score 0\\~2\n* biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge\n* no distant metastasis, staged II\u002FIII (T4b excluded) by MRI\n* maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MRI (i.e. a \"measurable lesion\" as per RECIST 1.1 criteria)\n* willing and able to comply with study protocol\n* consent to the use of blood and tissue specimens for study\n* no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.)\n* no disorders\u002Fdiseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism\u002Fhypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.)\n* no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.)\n* no jaundice or gastrointestinal obstruction\n* no acute\u002Fongoing infection\n* no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109\u002FL, HGB≥80g\u002FL, platelet≥100×109\u002FL, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN\n* no social or mental disorder\n* for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required\n\nExclusion Criteria:\n\n* multiple cancers, or with concomitant malignant tumors besides rectal cancer\n* having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years\n* history of recent major surgery\n* with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)\n* with uncontrolled, severe, concomitant diseases of any sort\n* allergic to any of the ingredients under study\n* estimated survival ≤ 5 years due to any reason\n* preparing for or having previously received organ or bone marrow transplant\n* having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion\n* for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance\n* with other conditions\u002Fissues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.)\n* pregnant or lactating women, or women intending on conception during treatment period",{"count":548,"type":22},186,[25],"This is a phase II\u002FIII, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).",[28],[553,554,555,556,557,64,558,559],"LARC","radiation","chemoradiation","PD-1","Tislelizumab","randomized","controlled","2024-01-09",{"date":562,"type":33},"2024-01-10",{"date":564,"type":33},"2022-04-01",{"date":566,"type":22},"2029-09-01",{"name":568,"class":40},"Beijing Friendship Hospital",8,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":589,"locationsCount":41},"100515946","phase-2-total-neoadjuvant-chemoradiotherapy-plus-anti-pd-1-in-subperitoneal-patients-with-locally-advanced-rectal-cancerpatients-with-locally-advanced-rectal-cancer-a-prospective-single-arm-exploratory-study-100515946","NCT05998122","Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study","Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal High-Risk or Very High-Risk Patients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study","Inclusion Criteria:\n\n1. The patients and their families are able to understand and are willing to participate in this clinical study, and sign an informed consent form.\n2. Age: 18\\~75 years old, no gender limit;\n3. Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as pMMR\u002FMSS.\n4. The initial TNM risk category (from Rectal cancer: ESMO Clinical Practice Guidelines, 2017 edition) is as follows: 1) \"Bad\": cT3c\u002Fd or very low localisation levators threatened, MRF clear; cT3c\u002Fd mid-rectum, cN1-N2 (extranodal), EMVI+, limited cT4aN0; 2) \"Advanced\": cT3 with any MRF involved, any cT4a\u002Fb, lateral node+.\n5. The lower edge of the tumor is located below the peritoneal reflex;\n6. No distant transfer;\n7. ECOG PS score 0-1 within 7 days before the first medication;\n8. Hepatitis B Surface Antigen (HBsAg) (-) and Hepatitis B Core Antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be less than 1000 copies\u002FmL or 200 IU\u002FmL before entering the group.\n9. HCV antibody (-)\n10. The main organ function is normal.\n11. No history of pelvic radiotherapy;\n12. No history of rectal cancer surgery or chemotherapy;\n13. Not accompanied by systemic infections requiring antibiotic treatment;\n14. Heart, lung, liver, and kidney functions can tolerate surgery;\n15. Others, based on the results of previous medical history, vital signs, physical examination or laboratory examination, the research doctor judges that you are suitable for participating in this clinical study.\n\nExclusion Criteria:\n\n1. Recurrent rectal cancer;\n2. Patients who are planning to undergo or have previously received organ or bone marrow transplantation;\n3. Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia formula);\n4. Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) \\\u003C50%;\n5. Human immunodeficiency virus (HIV) infection;\n6. Suffer from active tuberculosis;\n7. Past and present patients with interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc., which may interfere with the detection and treatment of suspected drug-related lung toxicity;\n8. Patients with active or suspicious autoimmune disease, or with a history of that;\n9. Received treatment with live vaccines within 28 days before the first administration; except for inactivated viral vaccines for seasonal influenza;\n10. Have received other antibody\u002Fdrug treatments against immune checkpoints in the past, such as PD-1, PD-L1, CTLA4, etc.;\n11. Known to have a history of severe allergies to any monoclonal antibody or research drug excipients;\n12. In the past 5 years, patients have suffered from malignant tumors whose survival rate is significantly lower than the historical data of our rectal cancer survival rate (properly treated basal cell carcinoma, skin squamous cell carcinoma, small kidney cancer, breast cancer, and papillary thyroid carcinoma are not included here. range);\n13. The patient has had arterial embolism diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.;\n14. Have received other types of anti-tumor or experimental treatments;\n15. The patient is a female during pregnancy or lactation;\n16. The patient has other diseases or abnormal mental states, which may affect the patient's participation in this study;\n17. There are patients who may increase the risk of participating in research and research medication, or other severe, acute and chronic diseases, who are not suitable for clinical research based on the judgment of the investigator.",{"count":461,"type":22},[25],"Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.",[28,581,582],"Total Neoadjuvant Treatment","Anti-PD-1","2023-08-11",{"date":585,"type":33},"2023-08-18",{"date":587,"type":22},"2023-09-01",{"date":174,"type":22},{"name":590,"class":40},"The First Hospital of Jilin University",{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":604,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":4},"100500322","phase-2-assess-the-efficacy-of-radiotherapy-and-sequential-chemotherapy-and-ak104-before-tme-surgery-for-local-crcak104-iit-13-100500322","NCT05794750","Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）","A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer","AK104-IIT-13","Inclusion Criteria:\n\n* 1\\. Age 18-75 years old, gender is not limited;\n* 2\\. Stage II\u002FIII under MRI or endoscopic ultrasound ;\n* 3\\. Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;\n* 4\\. Rectal adenocarcinoma confirmed or revisited by pathology;\n* 5\\. Karl Fischer score ≥ 80 points or ECOG score of 0-1;\n* 6\\. Meet the following laboratory diagnostic indicators: hemoglobin ≥ 100g\u002FL, white blood cell ≥ 3.5×109\u002FL; neutrophils≥ 1.5×109\u002FL, platelet ≥ 100×109\u002FL; creatinine ≤ 1.0× upper limit of normal (UNL), urea nitrogen (BUN) ≤ 1.0× upper limit of normal (UNL); Alanine aminotransferase (ALT) ≤1.5× upper limit of normal (UNL); Aspartate aminotransferase (AST) ≤1.5× upper limit of normal (UNL); Alkaline phosphatase (ALP) ≤1.5× upper limit of normal (UNL); Total bilirubin (TBIL) ≤ 1.5× upper limit of normal (UNL); urine protein (-); Clotting time is normal.\n* 7\\. No history of allergy to 5-Fu drugs, no history of allergy to platinum drugs;\n* 8\\. With primary rectal cancer required to undergo surgery (except palliative ostomy), chemotherapy or other anti-tumor therapy before diagnosis to enrollment;\n* 9\\. Not received radiation before;\n* 10\\. Sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Previous anti-PD-1\u002FL1 and anti-CTLA-4 immune drugs or other immunoassay drugs;\n* 2\\. With severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;\n* 3\\. Symptomatic interstitial lung disease or active infection\u002Fnon-infectious pneumonia;\n* 4\\. Patients have risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for intestinal perforation;\n* 5\\. History of other malignant tumors, excluding curable non-melanogenic skin cancer and carcinoma in situ of the cervix;\n* 6\\. Active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within 6 months;\n* 7\\. Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the patient's risk of treatment complications, or other uncontrollable diseases;\n* 8\\. Breastfeeding or pregnant women;\n* 9\\. Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or organ transplantation, allogeneic stem cell transplantation;\n* 10\\. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), active tuberculosis infection;\n* 11\\. Vaccinated against tumors, or received other vaccines within 4 weeks before starting treatment (Note: Because the seasonal influenza vaccine for injection is mostly an inactivated vaccine, it is allowed to be vaccinated, while intranasal preparations are usually live attenuated vaccines, so it is not allowed)\n* 12\\. Use other immunological agents, chemotherapy drugs, drugs in other clinical studies, and long-term cortisol therapy are not enrolled\n* 13\\. With mental illness, substance abuse, and social problems that affect compliance will not be enrolled after a doctor's review\n* 14\\. Allergic or contraindicated to the treatment of drugs.",{"count":600,"type":22},50,[25],"This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + TME surgery in patients with advanced rectal cancer.",[28],[605,606,607,608,609],"AK104","colorectal cancer","Pelvic short-course radiotherapy","TME surgery","pCR","2023-04-04",{"date":612,"type":33},"2023-04-06",{"date":614,"type":22},"2023-04-24",{"date":616,"type":22},"2027-04-24",{"name":618,"class":40},"JIN JING",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":4},"100478218","phase-2-time-in-immunotherapy-combined-with-ncrt-for-rectal-cancer-100478218","NCT05507112","TIME in Immunotherapy Combined With nCRT for Rectal Cancer","The Therapeutic and Prognostic Implications of Tumor Immune Microenvironment in The Neoadjuvant Immunotherapy Combined With Chemoradiotherapy for Rectal Cancer","TIMENT-R","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤75 years on the day of signing informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n3. Histologically proven rectal adenocarcinoma.\n4. \\\u003C12 cm from anal verge.\n5. Clinical stage of T3\u002FT4 or N positive and M0\n6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment\n7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease, dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC), autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection.\n8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery.\n9. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Allergic to any component of chemotherapy or immunotherapy;\n2. Patients with multiple primary colorectal cancer;\n3. Other malignant tumors within 5 years, except for adequately treated cervical carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled localized prostate cancer or surgically excised ductal carcinoma in situ of breast;\n4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection;\n5. Prior or planed organ\u002Fbone marrow transplant\n6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study;\n7. Pregnant or lactating women\n8. Patients with a history of severe mental illness or being unable to comply with the research protocols.\n9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery.\n10. Patients who have any other conditions that investigator judges unsuitable to participate.",{"count":628,"type":22},100,[25],"This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.",[28],[288,633,634,635],"Immunotherapy","neoadjuvant therapy","Tumor Immune Microenvironment","2022-09-16",{"date":638,"type":33},"2022-09-21",{"date":640,"type":22},"2022-09-20",{"date":642,"type":22},"2029-12-01",{"name":644,"class":40},"Peking Union Medical College Hospital"]