[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"total-neoadjuvant-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:total-neoadjuvant-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,69,97,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100601652","phase-3-a-clinical-trial-comparing-long-course-versus-short-course-radiotherapy-followed-by-immunotherapy-combined-with-total-neoadjuvant-therapy-tnt-to-long-course-radiotherapy-followed-by-tnt-in-locally-advanced-rectal-cancer-100601652",false,"NCT07113275","A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Histologically confirmed Locally Advanced rectal adenocarcinoma;\n4. Immunohistochemistry and\u002For genetic testing confirmed pMMR\u002FMSS;\n5. inferior margin ≤ 10 cm from the anal verge;\n6. ECOG performance status score is 0-1;\n7. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;\n8. There was no operative contraindication;\n9. Laboratory tests were required to meet the following requirements: white blood cell (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 times the upper limit of normal value or creatinine clearance rate ≥50 mL\u002Fmin; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Urinary protein \\\u003C 2+ or 24-hour urinary protein excretion \\\u003C 1 g at baseline.\n\nExclusion Criteria:\n\n1. Patients with MSI-H\u002FdMMR LARC；\n2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;\n3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).","ALL","18 Years","75 Years",{"count":20,"type":21},444,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.",[27,28,29,30],"Rectal Cancer","Total Neoadjuvant Therapy","Radiotherapy","Immunotherapy","RECRUITING","2026-05-10",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":21},"2026-05-15",{"date":39,"type":21},"2028-12-31",{"name":41,"class":42},"Tao Zhang","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100635794","nodal-downstaging-versus-primary-tumor-regression-as-predictors-of-survival-after-total-neoadjuvant-therapy-for-rectal-cancer-a-retrospective-study-100635794","NCT07557316","Nodal Downstaging Versus Primary Tumor Regression as Predictors of Survival After Total Neoadjuvant Therapy for Rectal Cancer: A Retrospective Study","Inclusion Criteria:\n\npatients who were more than18 years old at time of diagnosis. Pathological confirmation of rectal adenocarcinoma. Locally advanced stage II\\&III rectal carcinoma (≥T3 and or N+) at initial diagnosis.\n\nPatients treated with Total Neoadjuvant Therapy (TNT), including either chemoradiotherapy (CRT) followed by consolidation chemotherapy, induction chemotherapy followed by CRT, or short-course radiotherapy (SCRT) followed by chemotherapy, and subsequently undergoing TME.\n\nAvailable pathological assessment of surgical specimens.\n\nExclusion Criteria:\n\nPatients with distant metastasis at presentation or other comorbid diseases. Patients with incomplete clinical and pathological staging information. Missing key clinical or pathological data. Patients who did not receive TNT or undergo TME surgery.",{"count":51,"type":21},100,"OBSERVATIONAL","To evaluate the prognostic impact of post-TNT pathological nodal status (ypN) on LRFS, DMFS, and OS, and compare it with that of primary tumor response",[55,28],"Rectal Cancer Patients",[57,58,59],"ypN","TNT","ypT","NOT_YET_RECRUITING","2026-04-22",{"date":63,"type":35},"2026-04-29",{"date":32,"type":21},{"date":66,"type":21},"2027-05-10",{"name":68,"class":42},"Sohag University",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100617123","phase-2-evaluating-the-impact-of-glp-1-receptor-agonists-with-total-neoadjuvant-therapy-in-rectal-cancer-100617123","NCT07314528","Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer","A Phase II Multi-institutional Randomized Trial Evaluating the Impact of GLP-1 Receptor Agonists in Combination With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Written informed consent according to local guidelines obtained prior to any study-related activities.\n* Histologically confirmed mismatch repair protein proficient adenocarcinoma of the rectum.\n* BMI ≥25 kg\u002Fm²\n* Radiological confirmed \\>T2, Node positive, Threatened Surgical Margin and\u002For EMVI+ by MRI\n* Imaging available for radiomics analysis\n* Absence of metastatic disease at registration.\n* Adequate renal function is defined as calculated creatinine clearance (CrCl) \\>50ml\u002Fmin.\n* ANC \\> 1.5 cells\u002Fmm3, HGB \\> 8.0 gm\u002Fdl, PLT \\> 150,000\u002Fmm3, total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN\n* Able to tolerate medication.\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Received prior chemotherapy or radiotherapy\n* Previous or concurrent active malignancy ≤ 5 years prior to registration, with the exception of non-melanotic skin cancer or carcinoma in situ of any type, or other cancers that the treating investigator does not feel will impact the study objectives.\n* Locally advanced disease T3N+ or T4 disease.\n* Recurrent rectal cancer\n* Metastatic disease at presentation\n* Patients unable to undergo MRI\n* Patients having already received weight-loss intervention (pharmacological or surgical)",{"count":77,"type":21},42,[79],"PHASE2","The goal of this clinical trial is to see if adding a weight loss medication (GLP-1 receptor drug) to patients with an increased BMI receiving treatment for rectal cancer prior to surgery (total neoadjuvant chemoradiotherapy) improves cancer outcomes. The main questions it aims to answer is\n\n1. Does the drug increase weight loss in rectal cancer patients with a high BMI\n2. Does the drug improve response rates to chemotherapy and radiotherapy\n3. Does the drug improve survival outcomes and if cancer returns\n\nResearchers will compare this drug in one group against a group of patients receiving preoperative total neoadjuvant chemoradiotherapy without the drug\n\nPatients will be required to\n\n1\\) take the GLP-1 receptor agonist drug during TNT or just having TNT alone as per standard hospital protocols\n\nBody weight will be measured at three predefined time points:\n\n1. Baseline: Prior to initiation of semaglutide or TNT\n2. Pre-TNT: Start of TNT (for the intervention arm, this is 4 weeks after semaglutide initiation)\n3. Post-TNT: Within 7 days following completion of TNT and prior to definitive surgery\n\nPatients will complete their treatment and go on to have surgery as per standard methods for treating rectal cancer",[55,82,83,28,84],"Obesity &Amp; Overweight","Locally Advanced Rectal Cancer (LARC)","GLP-1",[86,28,87],"Locally Advanced Rectal Cancer","GLP-1 Receptor Agonist","2025-12-17",{"date":90,"type":35},"2026-01-02",{"date":92,"type":21},"2026-04",{"date":94,"type":21},"2028-09",{"name":96,"class":42},"St. James's Hospital, Ireland",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":114,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":43},"100608177","phase-2-scrt-followed-by-capox--bev--pd-1-inhibitor-for-tnt-in-larc-100608177","NCT07198165","SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC","Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.\n* Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.\n* Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET\u002FCT.\n* Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.\n* Age 18 to 75 years.\n* ECOG Performance Status of 0 to 1, without severe comorbid medical conditions.\n* Adequate organ function:\n\nHematopoietic: Hemoglobin ≥90 g\u002FL, Platelets ≥80 × 10\\^9\u002FL, Absolute Neutrophil Count ≥1.5 × 10\\^9\u002FL.\n\nHepatic: ALT and AST \\\u003C 2.5 × ULN. Renal: Serum Creatinine \\\u003C 1.5 × ULN.\n\n* Provision of signed and dated written informed consent.\n\nExclusion Criteria:\n\n* Patients found to have BRAF mutations or MSI-H status.\n* Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.\n* History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.\n* Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.\n* Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.\n* Patients with active infections.\n* Poor overall health status, with an ECOG performance status ≥2.\n* Patients who have undergone organ transplantation requiring immunosuppressive therapy, or those requiring long-term corticosteroid treatment for autoimmune diseases.\n* Patients with comorbid conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study.\n* Known hypersensitivity to any of the study drugs.",{"count":105,"type":21},104,[79],"This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.",[27,109,110,55,30,28,111,112,113],"Rectal Adenocarcinoma","Rectal Cancer, Radiotherapy","Total Neoadjuvant Treatment","Targeted Therapy","Chemoradiotherapy",[115,28,30,116,113],"Rectal cancer","Targeted therapy","2025-09-27",{"date":119,"type":35},"2025-09-30",{"date":121,"type":35},"2025-09-05",{"date":123,"type":21},"2030-12-31",{"name":125,"class":42},"Ruijin Hospital",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":43},"100594500","phase-3-personalized-long-course-radiotherapy-plus-chemotherapy-with-or-without-immunotherapy-for-larc-palace-study-100594500","NCT07020247","Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study","Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for Locally Advanced Rectal Cancer：A Randomized Controlled Study (PALACE Study)","Inclusion Criteria:\n\n1. Age: ≥18 years old; sex is not limited.\n2. Patients with stage II\u002FIII rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a and invasion of intestinal lumen for more than 1\u002F2 week (measured by MRI)；cT4b(resectable)；cT3c-d with EMVI+ (upper middle rectum)；cN2；MRF+ (≤2mm)；lower rectal cancer is located on the anterior wall and tumor reaching T3 and occupying the intestinal cavity for more than 1\u002F2 week; lower rectal cancer is mainly located on the lateral posterior wall need invading the intestinal wall (anal sphincter) ≥ 5mm； tumor of lower rectal cancer invades the external anal sphincter or levator ani muscle (stage 4) . \\[According to the 8th edition of the 2018 AJCC Cancer Staging Manual and the 2008 ESMO Lower Segment Colorectal Cancer Staging Criteria\\] . The preoperative T stage is referred to endoscopic ultrasonography or rectal MRI. The N stage is referred to abdominal CT. The M stage is referred to abdominal and thoracic CT. If symptoms occur, other appropriate imaging examinations are needed (cranial MRI or ECT) . Patients with contraindications to MRI can be interpreted with caution based on CT and endoluminal ultrasound staging. MDT should review the staging of all patients.\n3. The lower edge of lesion is less than 10cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.\n4. No distant metastasis after a thorough examination .\n5. Pathological diagnosis of rectal adenocarcinoma,and Immunohistochemistry and\u002For genetic testing for MSS\u002FpMMR;\n6. ECOG score: 0-1.\n7. Patients with primary rectal cancer who had not received surgery prior to surgery (except for palliative ileostomy or colostomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy.\n8. The main organ function is normal, including the following characteristics:\n\n   ①Blood routine examination: HB ≥9g\u002FdL, WBC ≥ 3.5\u002F4.0×109\u002FL，NE≥ 1.5×109\u002FL，PLT≥ 100×109\u002FL\n\n   ②Biochemical examination：Crea and BIL ≤ 1.0 upper normal limit（ULN），ALT and AST≤ 2.5 upper normal limit（ULN）, ALP≤2.5×UNL，Tbil≤1.5×UNL。\n9. Not allergic to 5-Fu or Platinum.\n10. The site of radiotherapy had not previously received radiation.\n11. If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF (Informed Consent Form) is signed until 8 weeks after the last dose of study drug.\n12. Participants are volunteered to participate in this study, sign informed consent, good compliance, cooperation with follow-up.\n\nExclusion Criteria:\n\n1. Patients who have previously received pelvic radiotherapy.\n2. Presence of active or progressive infection requiring systemic treatment, such as active tuberculosis, active hepatitis, etc.\n3. Presence of systemic diseases that are not stably controlled by the investigator, including diabetes mellitus, hypertension, liver cirrhosis, rheumatic immune diseases, and severe lung diseases.\n4. Have had prior or concurrent cancer distinct in primary site or histology (including synchronous colon cancer) , except for curatively treated cervical cancer in situ, Basal cell carcinoma of skin.\n5. Has any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition for which the study drug is inappropriate for use, or that would affect the interpretation of the study results, or place the patient in a high-risk condition.\n6. Estimated inadequate patient compliance to participate in this clinical study.\n7. History of gastrointestinal fistula, perforation, bleeding or severe ulceration or presence of severe gastrointestinal disease that affects the absorption of oral chemotherapy drugs.\n8. Patients who have received solid organ transplantation or bone marrow transplantation, or have had active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.",{"count":134,"type":21},184,[24],"The study is a multicenter, randomized controlled, phase III clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) sustained for over one year) of patients with locally advanced rectal cancer(LARC) treated with personalized long-course radiotherapy plus chemotherapy with or without Serplulimab. A total of 184 patients were included in this study.",[83,30,29,28,138],"Anal Function Preservation","2025-06-04",{"date":141,"type":35},"2025-06-13",{"date":143,"type":35},"2024-11-19",{"date":145,"type":21},"2028-01-31",{"name":147,"class":42},"West China Hospital"]