[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-rectal-cancer-larc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-rectal-cancer-larc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,44,70,99,125,156,177,204,231,257,280,303,330,355,378,407],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100551421","phase-1-ng-350a-plus-chemoradiotherapy-for-locally-advanced-rectal-cancer-100551421",false,"NCT06459869","NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer","A Multicentre, Open-label, Non-randomized, Phase 1b Trial of NG-350A, a Tumour-selective Anti-CD40-expressing Adenoviral Vector, in Combination With Chemoradiotherapy in Locally Advanced Rectal Cancer (FORTRESS)","FORTRESS","Selected Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the rectum.\n* Locally advanced disease (clinical stage II-III based on pelvic MRI) selected by a multidisciplinary team for treatment with neoadjuvant CRT (which may be followed by CNCT to comprise planned TNT). Patients with oligometastatic disease are permitted provided that the site-specific multidisciplinary team deems them suitable for radical treatment\u002Fchemoradiation.\n* Confirmed microsatellite stable (MSS)\u002Fproficient mismatch repair (pMMR) status.\n* Provide written informed consent to participate.\n* ECOG Performance Status 0 or 1.\n* Must not be pregnant or breastfeeding.\n* Patients who are sexually active (with either sex) must agree to comply with contraceptive requirements.\n* Adequate lung reserve, renal function, hepatic function, and bone marrow\u002Fhematological function assessed ≤ 10 days prior to first dose.\n\nSelected Exclusion Criteria:\n\n* Recurrent rectal cancer.\n* Distant metastatic disease not amenable to radical treatment\u002Fchemoradiation.\n* Other prior malignancy active within the previous 3 years, except for local or organ confined early-stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the trial, including response rate and safety.\n* Splenectomy (patients with prior partial resection remain eligible if the Investigator considers splenic function to not be significantly compromised).\n* Active autoimmune disease that has required systemic therapy in the past 2 years, immunocompromised status in the opinion of the Investigator, or current treatment with systemic immunosuppressive therapy (daily prednisone equivalent for chronic system replacement not to exceed 10mg per day).\n* Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment.\n* Any clinically significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic event in the last 1 month before the first dose of study treatment.\n* Major surgery in the 14 days before the first dose of study treatment or any surgical wounds that are not fully healed and free of infection or dehiscence.\n* Any prior surgery for rectal cancer or pelvic radiotherapy.\n* Any other anti-cancer or experimental therapy within the previous 12 months or that is planned during the active study treatment period.\n* Treatment with any other enadenotucirev-based virus (parent virus or transgene-modified variants), or anti-CD40 antibody at any time.\n* History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment.\n* Any ongoing Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 coagulation abnormality\u002Fcoagulopathy.\n\nURL:\n\nhttps:\u002F\u002Fwww.FortressStudy.org","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence.",[27],"Locally Advanced Rectal Cancer (LARC)",[29,30],"Treatment naive","Oligometastatic","RECRUITING","2026-06-10",{"date":34,"type":35},"2026-06-12","ACTUAL",{"date":37,"type":35},"2025-04-07",{"date":39,"type":21},"2028-12-30",{"name":41,"class":42},"Akamis Bio","INDUSTRY",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100638101","phase-2-short-course-online-adaptive-radiotherapy-combined-with-chemotherapy-targeted-therapy-and-immunotherapy-as-total-neoadjuvant-therapy-tnt-for-locally-advanced-rectal-cancer-100638101","NCT07581626","Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer","A Single-Arm, Phase 2 Clinical Study on the Efficacy and Safety of Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Voluntarily signed the informed consent form.\n* Aged 18-75 years (inclusive of 18 and 75 years).\n* pMMR\u002FMSS.\n* Middle or low rectal cancer located ≤10 cm from the anal verge as assessed by MRI.\n* Histopathologically confirmed locally advanced rectal adenocarcinoma and high-risk features confirmed by pelvic MRI (meeting any of the following criteria: clinical stage cT3N+ or cT4N0\u002F+; MRF+ or EMVI+; enlarged lateral pelvic lymph nodes).\n* ECOG PS of 0-1.\n* Expected survival ≥2 years.\n* No prior anti-tumor therapy.\n* At least one measurable lesion with a longest diameter ≥10 mm measured by MRI (by RECIST version 1.1).\n* Organ functions meeting the following requirements (no blood products or cell growth factors allowed within 14 days prior to enrollment):\n\nAbsolute neutrophil count ≥1.5×10⁹\u002FL; Platelet count ≥100×10⁹\u002FL; Hemoglobin ≥90 g\u002FL; Total bilirubin \\\u003C1.5×ULN; ALT and\u002For AST \\\u003C2.5×ULN; Serum creatinine \\\u003C1.5×ULN; Creatinine clearance ≥50 mL\u002Fmin.\n\n* Women of childbearing potential must use effective contraceptive measures.\n* Good compliance and willingness to comply with follow-up requirements.\n\nExclusion Criteria:\n\n* Unable to comply with the study protocol or study procedures.\n* Patients with contraindications to surgery.\n* Patients with metastatic disease or recurrent rectal cancer.\n* Uncontrolled active autoimmune disease or active inflammatory disease at enrollment, or receiving immunosuppressive therapy.\n* History of organ transplantation.\n* Known interstitial lung disease (ILD) or unexplained persistent cough and dyspnea.\n* Patients with familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), active Crohn's disease, or active ulcerative colitis.\n* Other malignancy diagnosed within 5 years prior to enrollment, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Severe cardiovascular disease within 6 months prior to enrollment, including unstable angina pectoris or myocardial infarction.\n* Subjects with hypersensitivity to the investigational product or any of its excipients.\n* Participation in another clinical trial of an unapproved\u002Finvestigational drug within 4 weeks prior to enrollment and having received the corresponding investigational product.\n* Clinically significant electrolyte abnormalities judged by the investigator.\n* Uncontrolled hypertension prior to enrollment, defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg despite medication.\n* Poorly controlled diabetes mellitus prior to enrollment (fasting glucose concentration ≥ CTCAE Grade 2 after standard treatment).\n* Any disease or condition affecting drug absorption prior to enrollment, or inability of the patient to take oral medication.\n* Active gastrointestinal diseases such as gastric and duodenal ulcer, ulcerative colitis prior to enrollment, or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.\n* Severe active bleeding within 3 months prior to enrollment, hemoptysis (\\>5 mL fresh blood within 4 weeks), or thromboembolic event (including stroke and\u002For transient ischemic attack) within 12 months.\n* Clinically significant cardiovascular disease including but not limited to: acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) classification \\> Grade 2; ventricular arrhythmia requiring pharmacotherapy; left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Active or uncontrolled severe infection (≥ CTCAE v5.0 Grade 2).\n* Known human immunodeficiency virus (HIV) infection. Known clinically significant liver disease history, including viral hepatitis:\n* Hepatitis B virus (HBV) carriers with active HBV infection (HBV DNA positive: \\>1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL);\n* Known hepatitis C virus (HCV) infection with positive HCV RNA (\\>1×10³ copies\u002FmL).\n* Unresolved toxicities higher than CTCAE v5.0 Grade 1 resulting from any prior anti-cancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity ≤ Grade 2.\n* Female subjects who are pregnant (positive pregnancy test before treatment) or breastfeeding.\n* Urinalysis showing urine protein ≥ 2+ and 24-hour urinary protein \\> 1.0 g.\n* Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, renders the patient unsuitable for the study drug (e.g., seizure disorder requiring treatment), interferes with the interpretation of study results, or places the patient at high risk.\n* Patients considered unsuitable for inclusion in this study by the investigator.","75 Years",{"count":53,"type":21},60,[55],"PHASE2","Standard treatment for patients with proficient mismatch repair (pMMR) \u002F microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery. Several studies (including the UNION, STELLAR, TORCH, and SPRING-01 trials, etc) have demonstrated that the neoadjuvant strategy of short-course radiotherapy followed by chemotherapy combined with immunotherapy can improve pCR rate in patients with pMMR\u002FMSS LARC, and might also provide higher organ preservation rates and long-term survival benefits. The study aims to explore the efficacy and safety of a TNT regimen comprising short-course radiotherapy combined with chemotherapy, cetuximab N01 (for patients with wild-type RAS\u002FBRAF) or bevacizumab (for patients with mutant RAS\u002FBRAF), and sintilimab in patients with high-risk LARC.",[27],"NOT_YET_RECRUITING","2026-05-14",{"date":61,"type":35},"2026-05-18",{"date":63,"type":21},"2026-05-01",{"date":65,"type":21},"2028-04-01",{"name":67,"class":68},"Chinese PLA General Hospital","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":69},"100635345","phase-3-scrt-based-itnt-vs-lcrt-based-tnt-for-mss-locally-advanced-rectal-cancer-100635345","NCT07551479","SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer","SCRT Followed by CAPOX and PD-1 Inhibitor Versus LCCRT Followed by CAPOX in Total Neoadjuvant Treatment for High-risk LARC: A Prospective, Randomized, Multicenter, Phase III Study","TORCH-STAR","Inclusion Criteria\n\n1. Age 18-75 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, positive tumor deposit or positive lateral lymph node;\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.",{"count":79,"type":21},612,[81],"PHASE3","In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4\u002FN+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be included, and randomly assigned to TNT group and iTNT group (1:1). TNT group receives long-course chemoradiotherapy (50Gy\u002F25Fx concurrent with oral capecitabine) followed by 6 cycles of CAPOX. iTNT group receives short-course radiotherapy (25Gy\u002F5Fx) followed by 6 cycles of Serplulimab combined with CAPOX. After the efficacy evaluation, the patients who achieves clinical complete response (cCR) will be managed by a watch and wait (W\\&W) protocol and non-cCR patients will be recommended surgery. The primary endpoint is 3-year event-free survival rate (3yEFS%). The secondary endpoints include the complete response (CR, pathological complete response \\[pCR\\] plus cCR) rate, 3-year organ preservation rate, 3-year disease-free survival rate (3yDFS%), 3-year local recurrence free survival rate (3yLRFS%), 3-year distant metastasis free survival rate (3yDMFS%), 3-year overall survival rate (3yOS%), grade 3-4 acute adverse effects (AE) rate, rate of surgical complications, anal functions and quality of life, etc.",[27,84],"MSS (Microsatellite Stable)",[86,87,88,89,90],"Total Neoadjuvant Therapy","Immunotherapy","Survival Rate","Organ preservation","Locally advanced rectal cancer","2026-04-22",{"date":93,"type":35},"2026-04-24",{"date":63,"type":21},{"date":96,"type":21},"2035-12-31",{"name":98,"class":68},"Fudan University",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":106,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":69},"100623162","application-and-exploration-of-personalized-ctdna-mrd-detection-technology-in-predicting-the-efficacy-of-neoadjuvant-therapy-for-rectal-cancer-100623162","NCT07393048","Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer","ctDNA-MRD-RC","Inclusion Criteria:\n\n* 1: Signed a written informed consent form and voluntarily participated in this study\n* 2: Aged 18-75 years, regardless of sex\n* 3: Histopathologically confirmed rectal adenocarcinoma\n* 4: Clinical stage II-III as assessed by MRI (according to the AJCC 8th edition)\n* 5: Distance from the lower tumor margin to the anal verge ≤10 cm\n* 6: Surgically resectable\n* 7: Able to swallow tablets normally\n* 8: ECOG PS 0-1\n* 9: No prior antitumor therapy for rectal cancer, including radiotherapy, chemotherapy, or surgery\n* 10: Scheduled to undergo surgical treatment after completion of neoadjuvant therapy\n* 11: No surgical contraindications\n* 12: Normal function of major organs, including: complete blood count, blood biochemistry, and coagulation function\n\nExclusion Criteria:\n\n* 1: History of allergy to monoclonal antibodies, any component of tislelizumab, or capecitabine\n* 2: Prior or ongoing receipt of any tumor-directed surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc\n* 3: Presence of any active autoimmune disease or history of autoimmune disease\n* 4: History of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation\n* 5: Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: heart failure of NYHA class II or above, unstable angina, myocardial infarction within the past year, or clinically significant supraventricular or ventricular arrhythmia that remains poorly controlled without or despite clinical intervention\n* 6: Diagnosis of another malignancy within 5 years prior to the first use of the study drug, except for malignancies with low risk of metastasis or death (5-year survival rate \\>90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, which may be considered for inclusion\n* 7: Pregnant or lactating women\n* 8: Other factors, as judged by the investigator, that may lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, alcohol abuse, drug abuse, family or social factors, or any condition that may affect the safety or compliance of the participant",{"count":53,"type":21},"OBSERVATIONAL","This study is a single-center, prospective, observational clinical trial enrolling patients with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0). By collecting tissue and blood samples at multiple timepoints, and integrating multi-omics data including ctDNA mutations, copy number variations, and mtDNA profiles, a multi-omics model will be constructed to predict the efficacy of neoadjuvant therapy for rectal cancer.",[27],[111,112,113,114,115],"ctDNA-MRD","Rectal Cancer","Neoadjuvant Therapy","Predicting the Efficacy","Detection Technology","2026-04-20",{"date":118,"type":35},"2026-04-21",{"date":120,"type":35},"2026-02-15",{"date":122,"type":21},"2028-12-31",{"name":124,"class":68},"Beijing Friendship Hospital",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":20},"100622296","phase-2-xelox-plus-dostarlimab-versus-xelox-alone-as-consolidation-treatment-after-standard-chemoradiation-in-pmmrmss-or-msi-low-locally-advanced-rectal-cancer-larc-patients-100622296","NCT07381777","XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR\u002FMSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients","Phase II Randomized Trial of XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR\u002FMSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients - IMMUNOSTAR Trial GOIRC-02-2024","IMMUNOSTAR","Inclusion Criteria:\n\n* Histologically proven rectal adenocarcinoma with distal extension less 16 cm from the anal verge.\n* Stage cT3-4 cN0 cM0, any cT cN+ M0 \\[N+ stage, three or more lymph nodes of diameter \\>0.5 cm measured by endorectal ultrasound, or one or more lymph nodes of diameter \\>1 cm measured by magnetic resonance (MRI)\\].\n* Proficient mismatch repair (pMMR)\u002Fmicrosatellite stable status (MSS) or microsatellite instability (MSI)-low (MSI-L)\n* ECOG-Performance Status 0-1\n* No previous treatment with chemotherapy or radiation therapy.\n* No prior exposure to immune-mediated therapy, excluding therapeutic anticancer vaccines.\n* Neutrophil count \\>1,500\u002FmL, platelet count \\>100.000\u002FmL, hemoglobin \\>9.0 g\u002FdL, serum creatinine \\\u003C1.5 3 upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase 2.5 3 ULN, total bilirubin \\\u003C1.5 3 ULN.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Subjects with active, known, or suspected autoimmune disease requiring systemic treatment (systemic steroids or immunosuppressive agents), except for subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune conditions only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Distant metastases documented.\n* Participants have received a live vaccine within 30 days of the planned start of study therapy. COVID-19 vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered non-live.\n* Participants have a current active history of pneumonitis or interstitial lung disease.",{"count":134,"type":21},270,[55],"This is a phase II, multicenter, randomized (2:1) controlled, clinical trial to evaluate the preliminary efficacy and safety of consolidation chemotherapy (XELOX) plus dostarlimab after standard long-course CRT (ARM A) compared to XELOX alone (ARM B) in patients with pMMR\u002FMSS or MSI-Low LARC (cT3-4 cN0, any cT cN+) candidate to receive standard long course CRT followed by TME. After the surgery, the patients in ARM A will be randomized (1:1) to receive adjuvant dostarlimab (ARM A1) versus follow-up (ARM A2), and in ARM B only follow-up.\n\nIf clinical complete responses (cCR) are documented after consolidation treatment, the patient may choose not to proceed with surgery and pursue nonoperative management (NOM).",[27],[139,140,141,142,143,144,145,146],"Consolidation chemotherapy","dostarlimab","pMMR\u002FMSS","MSI-Low","LARC","phase II","clinical complete response (cCR)","safety","2026-01-26",{"date":149,"type":35},"2026-02-02",{"date":151,"type":21},"2026-01-31",{"date":153,"type":21},"2030-12-31",{"name":155,"class":68},"Gruppo Oncologico Italiano di Ricerca Clinica",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":69},"100582492","phase-2-scrt-combined-with-chemotherapy-and-iparomlimab-and-tuvonralimab-in-mss-or-pmmr-patients-with-locally-advanced-rectal-cancer-100582492","NCT06864013","SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer","Short-course Neoadjuvant Radiotherapy Combined With Chemotherapy and Iparomlimab and Tuvonralimab in Microsatellite Stability (MSS) or Mismatch-repair-proficient (pMMR) Patients With Locally Advanced Rectal Cancer: A Randomized Controlled Clinical Study","Inclusion Criteria:\n\n1. Sign a written Informed Consent Form (ICF) and be able to comply with the visits and related procedures stipulated in the protocol\n2. Age between 18 and 75 years old\n3. Histologically confirmed rectal adenocarcinoma\n4. According to the AJCC 8th Edition staging, imaging evaluation (enhanced CT or enhanced MRI) confirms resectable locally advanced rectal cancer (AJCC 8th Edition staging cT3-4 \u002F cN+)\n5. Patients with microsatellite stability (MSS) or proficient mismatch repair (pMMR) rectal cancer\n6. At least one evaluable lesion according to RECIST v1.1 criteria\n7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1\n8. Adequate organ and bone marrow function, defined as follows:\n\n   * Blood count: Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL; Platelet (PLT) ≥100×10\\^9\u002FL; Hemoglobin (HGB) ≥10.0 g\u002FdL.\n   * Liver function: Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN); Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤3×ULN. Serum albumin (ALB) ≥35 g\u002FL.\n   * Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml\u002Fmin (calculated using the Cockcroft-Gault formula or standard 24-hour urine collection method); Urine dipstick test shows urine protein \\\u003C2+; For subjects with baseline urine dipstick test showing urine protein ≥2+, a 24-hour urine collection should be performed, and the protein content in the 24-hour urine should be \\\u003C1 g.\n   * Coagulation function: International Normalized Ratio (INR) ≤1.5, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Certain anticoagulant drugs (such as antiplatelet drugs, vitamin K antagonists, etc.) need to be discontinued 7\\~14 days before surgery and replaced with other drugs (such as low molecular weight heparin)\n9. No serious concomitant diseases that threaten the subject's survival (resulting in an expected survival time of less than 5 years)\n10. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the treatment period. Female subjects must have evidence of postmenopausal status or a negative urine or serum pregnancy test result for premenopausal female subjects.\n\nExclusion Criteria:\n\n1. Patients with rectal cancer who have been tested for microsatellite instability as MSI-H or mismatch repair as dMMR\n2. Patients who have previously received any anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. This includes previous treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.), as well as adoptive cell immunotherapy\n3. Simultaneous participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study\n4. Treatment with any investigational drug or device within 4 weeks prior to the first dose of the study drug\n5. History of blood transfusion within 14 days before the screening laboratory tests, or use of Granulocyte-colony stimulating factor (G-CSF), Granulocyte-Macrophage-colony stimulating factor (GM-CSF), erythropoietin (EPO), thrombopoietin (TPO), or IL-11\n6. Use of immunosuppressive drugs within 4 weeks prior to the first dose of the study drug, excluding: intranasal inhaled local steroid therapy or local steroid injections (such as intra-articular injections); systemic corticosteroid therapy not exceeding 10 mg\u002Fday of prednisone or its equivalent physiological dose; glucocorticoids as preventive medication for allergic reactions (such as pre-CT medication); use of Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications (including thymosin, interferon, interleukin, etc.) within 1 week prior to the first dose of the study drug\n7. Receipt of live or attenuated live vaccines within 4 weeks prior to the first dose of the study drug or expected during the study period\n8. Major surgical procedures (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study drug, anticipated need for major surgery during the study treatment period (except for radical rectal cancer surgery as specified in the protocol), or presence of unhealed wounds, ulcers, or fractures\n9. Known active or suspected autoimmune disease or history of autoimmune disease within the past 2 years (subjects with eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in the past 2 years, history of hypothyroidism requiring only thyroid hormone replacement therapy or autoimmune hypothyroidism, and type I diabetes requiring only insulin replacement therapy may be enrolled)\n10. Known history of primary immunodeficiency\n11. Active tuberculosis, currently receiving anti-tuberculosis treatment or having received anti-tuberculosis treatment within 1 year prior to the first dose of the study drug\n12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n13. Known allergy to capecitabine, oxaliplatin, anti-PD-1 monoclonal antibody, anti-CTLA-1 monoclonal antibody, anti-PD-1\u002FCTLA-4 antibody preparation, or other monoclonal antibody components\n14. Ascites and pleural effusion requiring clinical intervention in the short term, symptomatic or requiring drainage of pericardial effusion\n15. Human immunodeficiency virus (HIV) infection (HIV antibody positive)\n16. Acute or chronic active hepatitis B (defined as HBsAg or only HBcAb positive and HBV DNA ≥2000 IU\u002FmL or ≥1×10\\^4 copies\u002FmL), acute or chronic active hepatitis C (defined as HCV antibody positive and HCV-RNA level above the lower limit of detection)\n17. HBV DNA ≥2000 IU\u002FmL or ≥1×10\\^4 copies\u002FmL), acute or chronic active hepatitis C (defined as HCV antibody positive and HCV-RNA level above the lower limit of detection)\n18. Active syphilis infection requiring treatment\n19. Severe infection occurring within 4 weeks prior to the first dose of the study drug or during the active phase or poorly controlled, including but not limited to hospitalization for infection, bacteremia, or complications of severe pneumonia, therapeutic oral or intravenous antibiotics within two weeks prior to the first dose\n20. Symptomatic congestive heart failure (New York Heart Association class II\\~IV) or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography; symptomatic or poorly controlled arrhythmia; history of congenital long QT syndrome or corrected QTc \\>500 ms at screening (calculated using Fridericia's method)\n21. Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), history of hypertensive crisis or hypertensive encephalopathy\n22. Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy\n23. Any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack\n24. Esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy) or considered at high risk of bleeding by the investigator or after consultation with a gastroenterologist or hepatologist, evidence of portal hypertension (including splenomegaly on imaging) or history of variceal bleeding, subjects must undergo endoscopic evaluation within 3 months prior to enrollment\n25. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of the study drug\n26. Any life-threatening bleeding event within 3 months prior to the first dose of the study drug, or grade 3 or 4 gastrointestinal\u002Fvariceal bleeding event requiring transfusion, endoscopy, or surgical treatment\n27. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months prior to the first dose of the study drug (implantable venous port or catheter-related thrombosis, or superficial venous thrombosis is not considered \"severe\" thromboembolism)\n28. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or cancer-related reactions that may lead to higher medical risks and\u002For uncertainty in survival evaluation\n29. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B \\>7 points or more severe cirrhosis\n30. Intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition) and not relieved by the screening period; subjects at risk of intestinal perforation (including but not limited to acute diverticulitis, abdominal abscess, history of abdominal cancer); history of extensive intestinal resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea\n31. Interstitial lung disease requiring treatment; history and current presence of pulmonary fibrosis, pneumoconiosis, drug-related pneumonia, organic pneumonia (such as bronchiolitis obliterans), severe pulmonary impairment, etc.\n32. Significant malnutrition (weight loss of 5% within 1 month or 15% within 3 months prior to signing the informed consent, or reduction in food intake by 1\u002F2 or more within 1 week), or patients requiring intravenous nutritional support. However, malnutrition corrected more than 4 weeks prior to the first dose of the study drug is excluded\n33. History of other primary malignancies, except: malignancies that have been cured, with no known active disease for ≥2 years prior to the first dose of the study drug and with a very low risk of recurrence\n34. Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of disease recurrence\n35. Adequately treated carcinoma in situ with no evidence of disease recurrence\n36. Other acute or chronic diseases that may result in: increased risk related to study participation or study drug administration, or interference with the interpretation of study results, and in the investigator's judgment, render the subject ineligible for participation in this study\n37. Neurological, psychiatric disorders, or social conditions that: affect compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent, such as history of schizophrenia, drug abuse, etc.\n38. Alcohol, drug, or substance use that may hinder drug administration or affect toxicity analysis\n39. Pregnant or breastfeeding female subjects\n40. Other situations deemed unsuitable for enrollment by the investigator",{"count":164,"type":21},116,[55],"Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4\u002FN+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative treatment remains a formidable clinical challenge. This study aims to evaluate the efficacy and organ preservation rates of a novel neoadjuvant regimen comprising short-course radiotherapy followed by four cycles of CAPEOX combined with Iparomlimab and Tuvonralimab in patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) LARC. Furthermore, the project will investigate potential predictive biomarkers for complete response (CR) within this immunotherapy-based total neoadjuvant therapy (iTNT) paradigm.",[27],"2026-01-13",{"date":170,"type":35},"2026-01-14",{"date":172,"type":35},"2025-01-06",{"date":174,"type":21},"2029-12-31",{"name":176,"class":68},"First Affiliated Hospital of Zhejiang University",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":69},"100619694","phase-2-a-single-center-phase-ii-study-on-efficacy--safety-of-scrtcapoxserplulimabbevacizumab-for-mss-rectal-cancer-100619694","NCT07347951","A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer","A Single-Center, Prospective, Phase II Clinical Study to Evaluate the Preliminary Efficacy and Safety of Short-Course Radiotherapy Followed by CAPOX Chemotherapy Combined With Serplulimab and Bevacizumab as Total Neoadjuvant Therapy for MSS-Type, Mid-Low Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Patients who have a desire to preserve the anus and are willing to receive the entire course of neoadjuvant therapy.\n\n  * Aged between 18 and 75 years, with no gender restrictions.\n\n    * Diagnosed via pelvic MRI and rectoscopy with a tumor located ≤10 cm from the anal verge, with a clinical stage of cT3-4N0\u002F+M0, and lymph nodes confined within the mesorectum.\n\n      * Histologically diagnosed with rectal adenocarcinoma; genetic testing indicates MSS or MSI-L, or immunohistochemistry of tumor biopsy indicates pMMR (positive for MSH1, MSH2, MSH6, and PMS2 proteins).\n\n        * ECOG performance status score of 0-1.\n\n          ⑥ No prior antitumor therapy, immunotherapy, anti-angiogenic therapy, or pelvic radiotherapy before inclusion.\n\n          ⑦ Laboratory tests must meet the following criteria: i. White blood cell count ≥3.5×10⁹\u002FL, absolute neutrophil count ≥1.8×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, and hemoglobin ≥100 g\u002FL; ii. INR ≤1.5, and APTT ≤1.5 times the upper limit of normal, or partial thromboplastin time (PTT) ≤1.5 times the upper limit of normal; iii. Total bilirubin ≤1.25 times the upper limit of normal; ALT and AST ≤3 times the upper limit of normal; serum albumin ≥28 g\u002FL; iv. 24-hour creatinine clearance rate ≥50 mL\u002Fmin or serum creatinine ≤1.5 times the upper limit of normal.\n\n          ⑧ Willing to participate in this study voluntarily, sign the informed consent form, and comply with the scheduled outpatient visits and related procedural requirements to complete follow-up.\n\nExclusion Criteria:\n\n* In addition to a confirmed diagnosis of rectal cancer, there is a current or past history of active malignant tumors.\n\n  * Patients with metastases to other sites indicated by preoperative staging.\n\n    * Patients with suspicious positive lymph nodes in non-draining areas of the rectum, such as the internal and external iliac lymph nodes, as assessed by preoperative MRI or CT.\n\n      * Patients requiring emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal hemorrhage.\n\n        * Patients with severe comorbid conditions and an estimated life expectancy of ≤5 years.\n\n          * Patients with known allergies to any components in the study.\n\n            ⑦ Patients who have received immunosuppressive or systemic corticosteroid therapy for immunosuppressive purposes within 30 days prior to the initiation of study treatment.\n\n            ⑧ Patients who have received any other investigational drug treatment (including immunotherapy) or participated in another interventional clinical trial within 30 days prior to screening.\n\n            ⑨ Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases requiring combined treatment (including psychiatric disorders), and severe laboratory abnormalities.\n\n            ⑩ Patients with congenital or acquired immunodeficiency (such as HIV infection).\n\n            ⑪ Vulnerable populations, including individuals with psychiatric disorders, cognitive impairments, critically ill patients, minors, pregnant women, illiterate individuals, etc.\n\n            ⑫ Other circumstances where, in the investigator's judgment, the patient is deemed unsuitable to participate in the clinical trial.",{"count":20,"type":21},[55],"In a single-center, prospective, phase II study (ClinicalTrials registration number: \\[to be filled in\\]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy. It is anticipated that 30 subjects with locally advanced rectal cancer will be enrolled between September 2025 and September 2027.\n\nThis phase II exploratory study targets patients with locally advanced mid-low MSS\u002FpMMR rectal cancer. It employs short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy, aiming to clarify the efficacy and safety of this new combined radiotherapy, chemotherapy, targeted therapy, and immunotherapy approach, while also assessing the rectal\u002Fanal preservation rate and quality of life of patients. After neoadjuvant therapy, patients will undergo imaging and endoscopic evaluations to determine subsequent treatment strategies. Radical surgical resection will be performed on patients after neoadjuvant immunotherapy, followed by further analysis of the pathological complete response (pCR) rate. The primary study endpoint is the pCR rate, and secondary study endpoints include the objective response rate, organ preservation rate, 3-year disease-free survival (DFS), 3-year overall survival (OS), incidence of adverse events, and quality of life scores (EORTC QLQ-C30, EORTC QLQ-CR29, Wexner).",[27],[189,190,191,192,193,194],"Rectal cancer","MSS","neoadjuvant immunotherapy","neoadjuvant chemoradiotherapy","Target therapy","locally advanced","2026-01-11",{"date":197,"type":35},"2026-01-16",{"date":199,"type":35},"2025-12-01",{"date":201,"type":21},"2030-12-01",{"name":203,"class":68},"First Affiliated Hospital of Wenzhou Medical University",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":219,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"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":212,"type":21},42,[55],"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",[216,217,27,86,218],"Rectal Cancer Patients","Obesity &Amp; Overweight","GLP-1",[220,86,221],"Locally Advanced Rectal Cancer","GLP-1 Receptor Agonist","2025-12-17",{"date":224,"type":35},"2026-01-02",{"date":226,"type":21},"2026-04",{"date":228,"type":21},"2028-09",{"name":230,"class":68},"St. James's Hospital, Ireland",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100613642","real-world-efficacy-and-safety-of-neoadjuvant-dostarlimab-in-patients-with-dmmrmsi-h-locally-advanced-rectal-cancer-100613642","NCT07269249","Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR\u002FMSI-H Locally Advanced Rectal Cancer","RW-NEDOS","Inclusion Criteria:\n\n* Signed informed consent form\n* Age \\> 18 years\n* Histologically confirmed stage II-III rectal cancer\n* dMMR\u002FMSI status assessed locally by Immunohistochemistry, next-generation sequencing or PCR\n\nFor the retrospective part of the study:\n\n* At least one dose of neoadjuvant dostarlimab from November 2023 (i.e. within the period of AIFA dostarlimab monitoring registry activation for the indication in rectal cancer, which is reimbursed according to the Italian law 648\u002F1996, GU n.252 as of 27\u002F10\u002F2023)\n* Eligible deceased or unreachable patients will also be included to avoid selection biases, in respect of the article 110 bis, paragraph 4 of the Italian Privacy Code (a Data Protection Impact Assessment will be produced and published on the Sponsor website before study initiation, and patients explicitly unwilling before death will be not included).\n\nFor the prospective part of the study:\n\n\\- Inclusion in the AIFA dostarlimab monitoring registry for the indication in rectal cancer, to receive dostarlimab according to the Italian law 648\u002F1996, GU n.252 as of 27\u002F10\u002F2023\n\nExclusion Criteria:\n\n* \\- Distant metastasis\n* Major cognitive dysfunction or psychiatric disorders\n* Any previous systemic or local treatment for rectal cancer\n* Dostarlimab received within an interventional clinical trial",{"count":239,"type":21},50,"This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR\u002FMSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.",[27],[140,243,244,245,246],"mismatch repair-deficient LARC","real-world","retrospective-prospective study","neoadjuvant setting","2025-11-25",{"date":249,"type":35},"2025-12-08",{"date":251,"type":35},"2025-09-01",{"date":253,"type":21},"2027-12",{"name":255,"class":68},"National Cancer Institute, Naples",2,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":4},"100611696","phase-2-phase-ii-basket-trial-zanidatamab-plus-tislelizumab-in-her2-positive-gi-tumors-union-her2-basket-100611696","NCT07243938","Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)","A Prospective, Multi-cohort Clinical Study to Explore the Preliminary Efficacy and Safety of Zanidatamab in Combination With Tislelizumab for HER2-Positive GI Tumors: the UNION-HER2-BASKET Study","Inclusion Criteria:\n\n* Clinical diagnosis of gastric cancer and colorectal cancer\n* Aged 18 to 75 years:\n* Able to sign a written informed consent form and understand and comply with the requirements and evaluation schedule of this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* HER2-Positive: Immunohistochemistry (IHC) 3+ or IHC 2+ with FISH+ or NGS testing for high expression\n* Locally advanced rectal cancer cohort:\n\n  1. Histopathologically confirmed rectal adenocarcinoma\n  2. Tumor tissue confirmed by immunohistochemistry (IHC) as pMMR (high expression of MLH1, MSH2, MSH6, and PMS2 proteins), or confirmed by PCR or NGS as MSI-L or MSS\n  3. Tumor lower margin ≤10 cm from anal margin confirmed by colonoscopy, digital rectal examination, or MRI\n  4. Clinical stage cT3-4N0M0\u002FcTanyN+M0 (TNM staging per UICC\u002FAJCC 8th edition; T and N stages assessed by MRI)\n  5. Patients with one or more risk factors identified by MRI assessment: T4, tumor involvement of the mesorectal fascia (high MRF expression), extramural vascular invasion (high EMVI expression), ≥4 regional lymph node metastases (cN2), high lateral lymph node expression, or tumor margin ≤5 cm from the anal verge with strong organ preservation intent\n  6. No prior antitumor therapy for rectal cancer (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine\u002Fformulated Chinese medicine treatment)\n* Locally Advanced Gastric\u002FGastroesophageal Junction Cancer Cohort:\n\n  1. Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n  2. Clinical stage III-IVa (i.e., TNM staging T3\\~4aN+M0 or T4bNanyM0, refer to UICC\u002FAJCC 8th edition)\n  3. No prior antitumor therapy for gastric or gastroesophageal junction adenocarcinoma (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; excludes traditional Chinese medicine\u002FChinese patent medicine treatment)\n* Advanced colorectal cancer cohort:\n\n  1. Histopathologically confirmed advanced colorectal cancer\n  2. Previous systemic anticancer therapy for metastatic colorectal cancer with documented failure, including fluoropyrimidine, oxaliplatin, irinotecan, cetuximab, or bevacizumab (excluding contraindications). Prior anti-HER2 therapy permitted\n  3. At least one measurable lesion defined according to RECIST 1.1\n  4. Expected survival \\> 3 months\n* Good organ function within ≤7 days prior to first study drug administration, as demonstrated by the following laboratory values:\n\n  1. No blood or platelet transfusions or growth factor support therapy within ≤14 days prior to blood sample collection during the screening period, and must meet:\n  2. ANC ≥ 1.5 x 10⁹\u002FL\n  3. Platelet count ≥ 100 x 10⁹\u002FL\n  4. Hemoglobin ≥ 90 g\u002FL\n  5. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN)\n  6. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases)\n  7. Serum total bilirubin ≤ 1.5 times ULN (≤ 3 times ULN for patients with liver metastases)\n  8. International Normalized Ratio (INR) ≤ 1.5 or Prothrombin Time ≤ 1.5 times ULN\n  9. Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN\n  10. Serum albumin ≥ 30 g\u002FL\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must be willing to use highly effective contraception during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 120 days after the last dose.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible for inclusion in this study:\n\n* History of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ, provided complete remission was achieved at least 5 years prior to screening and no additional treatment is required or anticipated during the study period.\n* Any of the following cardiovascular criteria:\n\n  1. Cardiac chest pain occurring ≤28 days prior to the first study drug administration, defined as moderate pain limiting daily activities or exercise\n  2. Symptomatic pulmonary embolism within ≤28 days prior to the first dose of study drug\n  3. History of any acute myocardial infarction within ≤6 months prior to the first dose of study drug\n  4. History of any New York Heart Association (NYHA) Class III or IV heart failure within ≤6 months prior to the first dose of study drug\n  5. Any ventricular arrhythmia event of severity ≥ Grade 2 within ≤ 6 months prior to the first dose of the study drug\n  6. History of any cerebrovascular accident within ≤6 months prior to the first dose of the study drug\n  7. Corrected QT interval (QTc) (corrected using Fridericia's formula) ≥ 470 msec in females or ≥ 450 msec in males\n\n  i) Note: If any patient's initial ECG shows a QTc interval \\> 450 msec (male) or \\> 470 msec (female), a follow-up ECG will be performed to verify the result h) Left ventricular ejection fraction (LVEF) ≤50% as assessed by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO). Follow-up assessment must use the same modality as the baseline assessment\n* Any syncope or seizure occurring ≤28 days prior to the first study drug administration.\n* Active autoimmune disease requiring systemic treatment within the past 2 years.\n* Known history of human immunodeficiency virus (HIV) infection\n* Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \\> 500 IU\u002FmL) or active HCV carriers with detectable HCV RNA; Note: Inactive hepatitis B surface antigen (HBsAg) carriers and treated, stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL) are eligible for enrollment\n* History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary conditions, including pulmonary fibrosis, acute pulmonary disease, etc.\n* Severe chronic or active infections (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first study drug dose. Note: Antiviral therapy is permitted for patients with viral hepatitis.\n* Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent \\>10 mg\u002Fday) or other immunosuppressive agents within ≤14 days prior to the first dose of study drug\n* Hypersensitivity to any component of tislelizumab, zanidatamab，capecitabine, S-1, oxaliplatin, or any component of the container\n* Any major surgery requiring general anesthesia within ≤28 days prior to the first dose of study drug\n* Bleeding, thrombotic disorders, or use of anticoagulants (e.g., warfarin) or similar agents requiring therapeutic INR monitoring within 6 months prior to the first dose of study drug\n* History of allogeneic stem cell transplantation or organ transplantation\n* Live vaccine administration within ≤28 days prior to the first study drug dose. Note: Seasonal influenza vaccines, broadly classified as inactivated vaccines, are permitted. Inactivated COVID-19 vaccines are permitted. mRNA COVID-19 vaccines are not permitted. Intranasal influenza vaccines are live vaccines and are not permitted.\n* Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the participant is in the follow-up period of an interventional study\n* Inability to swallow tablets or diseases significantly affecting gastrointestinal function\n* Pregnant or lactating women\n* Other conditions deemed ineligible by the investigator.\n* Locally Advanced Rectal Cancer Cohort:\n\n  1. Previous treatment for rectal cancer, or clinical or imaging evidence of existing or potential distant metastasis\n  2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation with bleeding, prior abdominal abscess, or recent (within 3 months) occurrence of gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding\n  3. Assessed by the investigator as initially unresectable or unable to tolerate surgery\n  4. Patient assessed by the investigator as having factors rendering them unsuitable for radiotherapy\n  5. The patient has ≥2 concurrent colorectal cancer lesions\n  6. Patient has contraindications for MRI examination\n* Locally Advanced Gastric\u002FGastroesophageal Junction Cancer Cohort:\n\n  1. Previous treatment for gastric\u002Fgastroesophageal junction cancer, or clinical\u002Fimaging evidence of existing or potential distant metastasis\n  2. Clinical or imaging evidence of intestinal obstruction, gastrointestinal perforation, or bleeding; prior abdominal abscess; or recent (within 3 months) gastrointestinal perforation, abdominal abscess, or intestinal obstruction; or investigator assessment indicating high risk of perforation or bleeding\n  3. Initial inoperability as assessed by the investigator, or inability of the patient to tolerate surgery\n* Advanced colorectal cancer cohort:\n\n  1. Patients with any prior histopathological or hematological ctDNA testing demonstrating mismatch repair gene deficiency (dMMR) or microsatellite instability (MSI-H)\n  2. Presence of active leptomeningeal disease or uncontrolled brain metastases. Patients with previously treated brain metastases may be eligible if imaging shows stability, confirmed by repeat imaging demonstrating no progression for at least 4 weeks (Note: repeat imaging must occur during the study screening period).",{"count":265,"type":21},70,[55],"This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy\u002Fradiotherapy for patients with HER2-positive locally advanced or metastatic gastrointestinal tumors.",[27,269,270,113],"Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Metastatic Colorectal Cancer (mCRC)","2025-11-21",{"date":273,"type":35},"2025-11-24",{"date":275,"type":21},"2026-01-15",{"date":277,"type":21},"2031-06-01",{"name":279,"class":68},"Tao Zhang",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":287,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":4},"100606444","phase-2-ql1706-with-short-course-radiotherapy-and-chemotherapy-for-mss-rectal-cancer-100606444","NCT07175636","QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer","A Multicenter, Prospective, Phase II Clinical Trial of Short-Course Radiotherapy Followed by QL1706 Plus mFOLFOX6 as Total Neoadjuvant Therapy for Patients With pMMR\u002FMSS Locally Advanced Rectal Cancer","Inclusion Criteria:\n\nAge 18-75 years, male or female.\n\nHistologically confirmed rectal adenocarcinoma.\n\nLocally advanced disease (cT3-4 and\u002For N+, M0) based on pelvic MRI and\u002For CT.\n\nTumor located within 12 cm from the anal verge.\n\nProven microsatellite stability (MSS) or proficient mismatch repair (pMMR) status.\n\nECOG performance status 0-1.\n\nAdequate organ function:\n\nAbsolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n\nPlatelet count ≥ 100 × 10⁹\u002FL\n\nHemoglobin ≥ 90 g\u002FL\n\nALT\u002FAST ≤ 2.5 × ULN\n\nTotal bilirubin ≤ 1.5 × ULN\n\nSerum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin\n\nNo prior pelvic radiotherapy, chemotherapy, immunotherapy, or targeted therapy for rectal cancer.\n\nSigned written informed consent\n\nExclusion Criteria:\n\nEvidence of distant metastasis.\n\nPrevious or concurrent malignant tumor (except cured basal cell carcinoma of skin or cervical carcinoma in situ).\n\nActive autoimmune disease requiring systemic immunosuppressive therapy.\n\nActive infection including hepatitis B, hepatitis C, HIV, or tuberculosis.\n\nKnown allergy or hypersensitivity to study drugs or excipients.\n\nUncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure, arrhythmia).\n\nPregnant or breastfeeding women.\n\nAny condition judged by investigators to make the patient unsuitable for the study.",{"count":288,"type":21},66,[55],"This is a multicenter, prospective, phase II study evaluating total neoadjuvant therapy (TNT) consisting of short-course radiotherapy (SCRT; 5×5 Gy) followed by QL1706 (a bifunctional MabPair antibody targeting PD-1 and CTLA-4, code name only) plus mFOLFOX6 chemotherapy in patients with locally advanced rectal cancer (LARC) with proficient mismatch repair\u002Fmicrosatellite-stable (pMMR\u002FMSS) biology. Patients with pMMR\u002FMSS disease derive limited benefit from immune checkpoint inhibition alone. Preclinical and clinical evidence suggests that SCRT and oxaliplatin-based chemotherapy can enhance antitumor immunity (e.g., antigen release, T-cell infiltration), providing a biological rationale for combining QL1706 with SCRT-primed TNT.\n\nEligible adults with cT3-4 and\u002For N+ mid-to-low rectal adenocarcinoma (without distant metastasis), confirmed pMMR\u002FMSS, and ECOG 0-1 will receive: SCRT (total 25 Gy over 5 fractions), then several cycles of QL1706 plus mFOLFOX6 as neoadjuvant systemic therapy. Definitive total mesorectal excision (TME) is planned per multidisciplinary assessment; a watch-and-wait approach may be considered for patients achieving a stringent clinical complete response per institutional criteria. Standard perioperative care and postoperative follow-up will be performed.\n\nPrimary endpoint is pathologic complete response (pCR, ypT0N0) rate at surgery. Key secondary endpoints include: clinical complete response (cCR) rate, major pathologic response rate, R0 resection rate, tumor downstaging, radiologic response, disease-free survival (DFS), overall survival (OS), organ preservation rate (for patients managed non-operatively), surgical morbidity, and safety\u002Ftolerability (CTCAE v5.0). Exploratory endpoints include correlations between efficacy and baseline clinicopathologic features; optional translational analyses may investigate immune-inflammation markers related to response and resistance.\n\nThis trial aims to determine whether SCRT-primed QL1706 plus mFOLFOX6 TNT can improve tumor eradication and organ preservation while maintaining acceptable safety in pMMR\u002FMSS LARC-a population with unmet need for effective immunotherapy-based strategies.",[27,292,293],"Mismatch Repair-Proficient (pMMR) Rectal Cancer","Non-metastatic Rectal Cancer","2025-09-09",{"date":296,"type":35},"2025-09-16",{"date":298,"type":21},"2025-09-20",{"date":300,"type":21},"2029-09-20",{"name":302,"class":68},"Sun Yat-sen University",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":256},"100588360","phase-2-total-neoadjuvant-treatment-with-or-without-tislelizumab-for-locally-advanced-rectal-cancer-100588360","NCT06940388","Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.","Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer: An Open-label Randomized Controlled Phase II Study (The TOTAL Trial)","TOTAL","Inclusion Criteria:\n\n* Subjects with histologically confirmed primary (non-recurrent) LARC (tumor 12 cm or less from the anal verge, as assessed by rigid proctoscopy), stage T3-4 N0 or TX N+ according to base-line pelvic MRI and PET-CT.\n* Patients who are planned for TNT and are surgical candidates as determined by the treating physician.\n* No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer.\n* No prior radiotherapy to the pelvis, for any reason.\n* Able to provide the FFPE block or 10 unstained slides from the colonoscopy for confirmation of the diagnosis, CPS status and for investigational purposes.\n* Age 18 years or more.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C 2.\n* Screening laboratory values must meet the following criteria (using CTCAEv5.0):\n\n  i) WBC \\> 2000\u002FµL ii) Neutrophils \\> 1500\u002F µL iii) Platelets \\> 100 x 103\u002F µL iv) Hemoglobin \\> 9.0 g\u002FdL v) Serum creatinine \\\u003C 1.5 x ULN or calculated creatinine clearance \\> 60 mL\u002Fmin (using the Cockcroft Gault formula) vi) AST and ALT \\\u003C 2.5 x ULN. vii) Total bilirubin \\\u003C 1.5 x ULN (total bilirubin must be \\\u003C 3 x ULN for patients with Gilberts syndrome).\n* Ability to swallow tablets.\n* Adequate contraception in fertile patients; using a highly effective method of birth control for the duration of the study, and for at least 9 months after the last dose of chemotherapy and 120 days after the last dose of immunotherapy.\n* Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to the start of treatment.\n* Women must not be breastfeeding.\n* Signed written IRB approved informed consent. This must be obtained before the performance of any protocol related procedure that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatments, and laboratory testing.\n\nExclusion Criteria:\n\n* Active or background history of an autoimmune disease except for type I diabetes mellitus, hypothyroidism requiring hormone replacement only and skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.\n* Medical history of vasculitis.\n* Prior organ transplant, including allogenic bone marrow transplantation.\n* Grade \\> 1 peripheral sensory neuropathy.\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co- stimulation or checkpoint pathways.\n* Any prior active malignancy \\\u003C 2 years before trial entry except for any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapy.\n* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Known acute hepatitis B, known chronic hepatitis B infection with active untreated disease, or known active hepatitis C infection. In participants with a history of HBV or HCV, participants with detectable viral loads will be excluded.",{"count":312,"type":21},134,[55],"This prospective, multi-center, phase II randomized controlled trial will evaluate the actual benefit of adding immunotherapy with tislelizumab to the currently most effective approach against LARC, namely TNT. In this trial, we will harness several elements that may each potentially contribute to an overall high efficacy, at least in local outcomes: nCRT rather than SCRT, full length (8 cycles of mFOLFOX6) of consolidation chemotherapy, CIMT following nCRT (exploiting the upregulation of the immune response induced by the latter) and tislelizumab (with its theoretical advantage over other CPIs). In line with the changing treatment paradigms in LARC, in which high therapeutic efficacy translates into the possibility to avoid TME, the trial will have a novel primary endpoint of long-term unmaintained cCR, i.e. 3 year TME-free survival.",[27],[317,318,319,320],"rectal cancer","locally advanced rectal cancer","total neoadjuvant treatment","immunotherapy","2025-07-22",{"date":323,"type":35},"2025-07-24",{"date":325,"type":35},"2025-07-23",{"date":327,"type":21},"2030-08",{"name":329,"class":68},"brenner baruch",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":256},"100596026","phase-2-optimizing-immunotherapy-combined-with-neoadjuvant-chemoradiotherapy-for-locally-advanced-rectal-cancer-100596026","NCT07040098","Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer","A Prospective, Multicenter, Randomized Clinical Trial of Optimizing Immunotherapy Combined With Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer (STELLARIII)","STELLARIII","Inclusion Criteria:\n\n1. Age 18-75 years, regardless of gender;\n2. Pathologically confirmed rectal adenocarcinoma with immunohistochemical results indicating pMMR (proficient mismatch repair) or genetic testing confirming MSS (microsatellite stability);\n3. Staged as clinical stage II\u002FIII (cT3-T4N0 or cT2-4N+, no distant metastasis, per the 8th Edition AJCC Cancer Staging Manual, 2018) via MRI or endoscopic ultrasound, and meeting any one of the following:\n\n   * cT3 with tumor inferior margin ≤ 6 cm from the anal verge;\n\n     * cT3c\u002Fd with tumor inferior margin ≥ 6-12 cm from the anal verge; ③ cN2; ④ cT4; ⑤ MRF+ (mesorectal fascia involvement); ⑥ EMVI+ (extramural vascular invasion);\n4. ECOG performance status 0-1;\n5. Meeting basic laboratory criteria (e.g., hematologic, hepatic, and renal function);\n6. No history of hypersensitivity to 5-Fu-based agents or platinum-based drugs;\n7. Patients with primary rectal cancer must have received no prior surgery (excluding palliative colostomy), chemotherapy, or other antitumor therapies from diagnosis to enrollment;\n8. No prior radiation to the planned radiotherapy site;\n9. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-PD-1\u002FL1 and\u002For anti-CTLA-4 immunotherapy or other investigational immunotherapeutic agents;\n2. History of severe autoimmune diseases, including active inflammatory bowel disease (IBD) (e.g., Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., granulomatosis with polyangiitis);\n3. Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonitis;\n4. Risk factors for bowel perforation, such as active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis, or other known predisposing conditions;\n5. History of other malignancies, except for cured non-melanoma skin cancer or cervical carcinoma in situ;\n6. Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or uncontrolled arrhythmia;\n7. Physical examination findings or clinical laboratory abnormalities deemed by the investigator to interfere with study outcomes or increase treatment-related risks, or other uncontrolled comorbidities;\n8. Pregnant or breastfeeding women;\n9. Congenital or acquired immunodeficiency disorders, including HIV infection, or history of organ\u002Fstem cell transplantation;\n10. Active hepatitis B (HBV-DNA ≥2000 U\u002FmL), hepatitis C (HCV), or active tuberculosis infection;\n11. Prior administration of cancer vaccines or receipt of any vaccine within 4 weeks before treatment initiation (Note: Seasonal inactivated influenza vaccines are permitted; live-attenuated intranasal vaccines are prohibited);\n12. Concurrent use of immunomodulators, chemotherapy, investigational drugs, or long-term corticosteroids (≥10 mg\u002Fday prednisone equivalent);\n13. Patients with psychiatric disorders, substance abuse, or social circumstances that may compromise compliance, as assessed by the investigator;\n14. Hypersensitivity or contraindications to the study medications.",{"count":339,"type":21},228,[55],"This study explores the key clinical issues in the field of neoadjuvant therapy for locally advanced rectal cancer. There are three core problems with the currently recommended total neoadjuvant therapy (TNT) in the guidelines: the lack of evidence-based consensus on the timing of radiotherapy and chemotherapy, the undefined number of chemotherapy cycles, and the uncertainty in the selection of the precise radiotherapy mode. In recent years, the combination of immune checkpoint inhibitors (ICIs) with the PD-1\u002FPD-L1 inhibitors as the core and the TNT regimen has shown a trend of further enhancing tumor regression, providing a possibility for the organ function preservation of rectal cancer. However, existing clinical studies exhibit a high degree of heterogeneity in treatment strategies. In particular, there is a lack of high-quality evidence-based medical evidence in core aspects such as the timing of ICIs intervention and the combination of treatment regimens. This study is designed as a prospective, multicenter, randomized controlled phase II study. The \"pick the winner\" strategy for screening the optimal regimen is adopted to evaluate the efficacy of four neoadjuvant regimens (Group SCRT-4: short-course radiotherapy → 4 cycles of chemotherapy + ICIs; Group SCRT-6: short-course radiotherapy → 6 cycles of chemotherapy + ICIs; Group LCRT-4: concurrent chemoradiotherapy → 4 cycles of chemotherapy + ICIs; Group LCRT-6: concurrent chemoradiotherapy → 6 cycles of chemotherapy + ICIs). By evaluating indicators such as the complete response rate, organ preservation rate, safety, long-term survival, as well as the anal function and quality of life of patients, treatment strategies with clinical advantages will be screened out, providing an evidence-based basis for subsequent phase III confirmatory trials.",[27],[90,344,87,345],"TNT","CR rate","2025-06-19",{"date":348,"type":35},"2025-06-26",{"date":350,"type":35},"2025-06-01",{"date":352,"type":21},"2030-06-30",{"name":354,"class":68},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":69},"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":363,"type":21},184,[81],"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.",[27,87,367,86,368],"Radiotherapy","Anal Function Preservation","2025-06-04",{"date":371,"type":35},"2025-06-13",{"date":373,"type":35},"2024-11-19",{"date":375,"type":21},"2028-01-31",{"name":377,"class":68},"West China Hospital",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":69},"100574592","optimizing-patient-selection-for-surgery-using-pathologic-analysis-following-neoadjuvant-therapy-in-locally-advanced-rectal-cancer-100574592","NCT06761287","Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer","Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study","OPAL","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Signed informed consent\n* Patients diagnosed with locally advanced rectal cancer showing complete or near-complete clinical response after neoadjuvant therapy without evidence of invasive disease (\\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.\n* Patients diagnosed with locally advanced rectal cancer showing incomplete response with presence of superficial residual lesions, without invasive features on endoscopic evaluation, without evidence of invasive disease (\\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.\n* Without previous medical history of rectal cancer or rectal surgery\n\nExclusion Criteria:\n\n* Previous medical history of rectal cancer\n* Previous rectal surgery",{"count":387,"type":21},20,[389],"NA","This interventional, non-randomized, prospective trial aims to evaluate the role of endoscopic resection following neoadjuvant treatment in patients with locally advanced rectal cancer.\n\nPhase I focuses on assessing the feasibility, safety and efficacy of endoscopic resection of residual scar or superficial residual neoplastic tissue following neoadjuvant treatment.\n\nPhase II explores the potential of this approach to guide patient selection for total mesorectal excision and to serve as a definitive treatment option for those with limited residual disease.",[27],[318,393,394,395,396,397,146],"neoadjuvant","endoscopic resection","endoscopic submucosal dissection","endoscopic intermuscular dissection","feasibility","2025-05-25",{"date":400,"type":35},"2025-05-30",{"date":402,"type":35},"2025-03-28",{"date":404,"type":21},"2030-12",{"name":406,"class":68},"Centre Hospitalier Universitaire Saint Pierre",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":69},"100566305","application-of-petmri-in-the-evaluation-of-the-efficacy-of-neoadjuvant-therapy-for-locally-advanced-rectal-cancer-100566305","NCT06653452","Application of PET\u002FMRI in the Evaluation of the Efficacy of Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* (1) Age 18-75 years old; (2) ECOG score 0-2; (3) Pathologically confirmed as rectal adenocarcinoma; (4) The lower edge of the tumor is within 12cm from the anal edge; (5) Clinically staged as cT3-4N0M0 or cTanyN+M0; (6) Untreated patients who have not received radiotherapy, chemotherapy, and surgery, etc.; (7) Good liver and kidney function, can tolerate radiotherapy and surgery; (8) Patients and their families can understand the research plan, voluntarily participate in this research and sign the informed consent form.\n\nExclusion Criteria:\n\n* (1) ECOG score \\> 2; (2) Patients with multiple primary colorectal cancers; (3) Patients with a history of other malignant tumors within the past 5 years (except for cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically removed breast ductal carcinoma in situ); (4) Patients with intestinal obstruction, intestinal perforation, gastrointestinal bleeding, and other emergencies requiring emergency surgery; (5) Pregnant or lactating women; (6) Patients with a history of severe mental illness, immune diseases, and hormone medication; (7) Patients with contraindications for MRI, PET examination, radiotherapy, immunotherapy, or surgical treatment; (8) Patients who have participated in other clinical studies within the last 3 months; (9) Any other conditions deemed unsuitable for inclusion by the researcher.",{"count":20,"type":21},[389],"This study plans to include LARC patients receiving neoadjuvant therapy at this center, conducting PET\u002FCT and PET\u002FMR examinations before treatment, and PET\u002FMR examinations before surgery after neoadjuvant therapy. The changes in the lesion before and after treatment will be compared to evaluate the efficacy of neoadjuvant therapy, including: the relief situation of the rectal primary lesion ; lymph node metastasis; local infiltration around the tumor; peritoneal and other distant metastases , etc. The pathological relief diagnosed by surgical pathology is the gold standard, and the predictive efficacy of PET\u002FMR will be evaluated, comparing the advantages and disadvantages of 18F-FDG and 68Ga-FAPI PET\u002FMR, and comparing with traditional PET\u002FCT and rectal MRI to explore the value of PET\u002FMRI in predicting the efficacy of neoadjuvant therapy in LARC patients.",[27],"2024-10-20",{"date":419,"type":35},"2024-10-22",{"date":421,"type":35},"2024-07-01",{"date":423,"type":21},"2026-12-01",{"name":425,"class":68},"Peking Union Medical College Hospital"]