[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-rectal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-rectal-adenocarcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,50,77,107,131,158,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100641505","phase-2-yang-et-al-anti-pd-1ctla-4-dual-immunotherapy-for-larc-100641505",false,"NCT07596290","Yang et al. Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for LARC","Efficacy and Safety of Neoadjuvant Short-Course\u002FLong-Course Radiotherapy Combined With Anti-PD-1\u002FCTLA-4 Dual Immunotherapy for Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial (RADICAL Trial)","RADICAL","Inclusion Criteria:\n\n1. Age between 18 and 80 years; ECOG performance status 0-1;\n2. Histopathologically confirmed rectal adenocarcinoma via colonoscopy; pMMR or MSS phenotype;\n3. Rectal MRI stage II\u002FIII (excluding T4b); distal tumor margin ≤ 12 cm from the anal verge;\n4. Willingness to comply with study procedures; consent to use tissue and blood samples for medical research purposes;\n5. No prior history of radiotherapy, chemotherapy, or immunotherapy;\n6. No immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, hyperthyroidism\u002Fhypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.);\n7. No severe cardiac, pulmonary, hepatic, or renal dysfunction; no jaundice or gastrointestinal obstruction;\n8. No concurrent acute infection;\n9. Baseline laboratory evaluations completed as required, with results obtained within 14 days before randomization, and laboratory values meeting the following criteria (per CTCAE 5.0):\n\n   * White blood cell count ≥ 2000\u002FμL;\n   * Neutrophil count ≥ 1500\u002FμL;\n   * Platelet count ≥ 100×10³\u002FμL;\n   * Hemoglobin ≥ 9.0 g\u002FdL;\n   * Serum creatinine ≤ 1.5×upper limit of normal (ULN) or creatinine clearance \\> 50 mL\u002Fmin (female: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 0.85 \u002F (72 × serum creatinine (mg\u002FdL)); male: creatinine clearance = \\[140 - age (years)\\] × body weight (kg) × 1.00 \u002F (72 × serum creatinine (mg\u002FdL)));\n   * AST ≤ 3×ULN, ALT ≤ 3×ULN, total bilirubin ≤ 1.5×ULN;\n10. No psychiatric\u002Fpsychological disorders affecting social function;\n11. Negative serum pregnancy test (blood HCG) within 1 week before randomization for women of childbearing potential;\n12. Women of childbearing potential must agree to use effective contraception during the study period and for 5 months after the last dose of study drug;\n13. Male subjects who are sexually active with women of childbearing potential must agree to use effective contraception during the study period and for 7 months after the last dose of study drug, and must refrain from sperm donation during this period.\n\nExclusion Criteria:\n\n1. Multiple primary cancers or concurrent other malignant tumors;\n2. Patients requiring emergency surgery due to intestinal obstruction, intestinal perforation, gastrointestinal bleeding, etc.;\n3. Factors affecting oral drug absorption (e.g., inability to swallow, nausea\u002Fvomiting, diarrhea, intestinal obstruction, etc.);\n4. Any uncontrolled, severe concomitant diseases;\n5. Hypersensitivity to any component of the study drugs;\n6. Expected survival \\\u003C 5 years for any reason;\n7. Planned or previous organ\u002Fbone marrow transplantation;\n8. Treatment with immunosuppressants or corticosteroids within 1 month before enrollment;\n9. Central nervous system disorders that may impair ability to provide informed consent or comply with study procedures, as determined by the investigator;\n10. Other conditions that may prevent completion of study treatment (e.g., alcoholism, drug addiction, etc.);\n11. Pregnant or breastfeeding women.","ALL","18 Years","80 Years",{"count":21,"type":22},342,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","This is a prospective, multicenter, randomized controlled trial aimed at comparing different radiotherapy fractionation regimens combined with sequential dual immunotherapy versus traditional chemoradiotherapy in neoadjuvant treatment for locally advanced rectal cancer (LARC). A total of 342 pMMR\u002FMSS LARC patients will be enrolled and randomly assigned in a 1:1:1 ratio to short-course radiotherapy (5×5Gy) followed by sequential dual immunotherapy (paromlimab + tuvonralimab + CAPEOX), long-course radiotherapy followed by sequential dual immunotherapy, or conventional long-course chemoradiotherapy. The primary endpoint is the complete response rate (pCR + cCR). Secondary endpoints include the proportion of patients adopting the \"watch-and-wait\" strategy, disease-free survival, overall survival, and safety. This study innovatively explores the synergistic mechanism of different radiotherapy fractionations with dual immunotherapy, optimizes the timing of immunotherapy initiation, and constructs a clinical-imaging-pathology multimodal efficacy prediction model, aiming to advance LARC treatment from empirical to precision therapy while achieving organ and function preservation.",[29,30,31],"Locally Advanced Rectal Adenocarcinoma","Neoadjuvant Chemoradiation","Neoadjuvant Immunotherapy",[33,34,35,36,37],"Locally advanced rectal cancer","Neoadjuvant chemoradiation","Anti-PD-1\u002FCTLA-4 Dual Immunotherapy","Short-course radiotherapy","Long-course rediotherapy","NOT_YET_RECRUITING","2026-06-16",{"date":41,"type":42},"2026-06-17","ACTUAL",{"date":44,"type":22},"2026-07-15",{"date":46,"type":22},"2030-12-31",{"name":48,"class":49},"Beijing Friendship Hospital","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100580909","phase-2-a-study-of-botensilimab-and-balstilimab-for-rectal-adenocarcinoma-100580909","NCT06843434","A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma","A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for trial.\n\n  a. If participant is unable to provide written informed consent, the legally authorized representative (LAR) of the person who is being asked to participate in this research study may give consent on the participant's behalf.\n* Be ≥18 years of age on the date of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed rectal adenocarcinoma.\n* Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3\u002FcT4 N0 or cT(any) cN1\u002F2.\n* No evidence of distant metastases\n* Radiologically measurable or clinically evaluable disease per Protocol Section 13.0.\n* Tumor specimen that demonstrates intact mismatch repair enzymes by immunohistochemistry or microsatellite stability as demonstrated by NGS or PCR.\n* Negative pregnancy test done within 14 days prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception is required for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n* Nonchildbearing potential is defined as follows (by other than medical reasons):\n\n  1. ≥45 years of age and has not had menses for \\>1 year\n  2. Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n  3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.\n* Demonstrate adequate organ function as defined in the Table 6-1 below within 28 days of Cycle 1 Day 1, and all screening labs should be performed within 28 days of treatment initiation.\n\nHematological Absolute neutrophil count (ANC): ≥1,500 \u002Fmm\\^3 Platelets: ≥100,000 \u002F mcL Hemoglobin: ≥8.0 g\u002FdL\n\nRenal Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥60 mL\u002Fmin for subject with creatinine levels \\> 1.5 × institutional ULN AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN\n\nCoagulation International normalized ratio (INR) or Prothrombin time (PT) or activated partial thromboplastin time (aPTT): For patients not taking warfarin: INR ≤ 1.5 or PT ≤ 1.5 x ULN; and either PTT or aPTT ≤ 1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5\n\nExclusion Criteria:\n\n* Recurrent rectal cancer.\n* Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.\n* Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).\n* Other invasive malignancy ≤ 2 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.\n* Active infection requiring systemic therapy.\n* Other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF\u002FFlk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* Known history of interstitial lung diseases\u002Fpneumonitis\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies)\n* Known active hepatitis B (e.g., HbsAg reactive) or hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Live vaccination within 28 days prior to receiving the first dose of immunotherapy. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.\n* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \\\u003C 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \\> 7 days from C1D1 or \\> 7 days from future cycle on study\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 180 days of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n\n  a. QTcF (QT interval corrected using Fridericia's formula) of ≥450 ms.\n* Known active tuberculosis.\n* Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.\n\n  a. Corticosteroid use as a premedication for IV contrast allergies\u002Freactions is allowed. Subjects who are receiving daily corticosteroid replacement therapy are also an exception to this rule. Daily prednisone at doses of ≤ 7.5 mg or equivalent hydrocortisone dose are examples of permitted replacement therapy. Use of inhaled or topical corticosteroids is permitted.\n* Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement.\n* Prior allogeneic tissue\u002Fsolid organ transplant, except for corneal transplants.",{"count":58,"type":22},40,[25],"The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT\u002FBAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)\u002Fmicrosatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT\u002FBAL is an effective treatment when given in combination with standard chemotherapy.",[62,29],"Microsatellite Stable Rectal Carcinoma",[62,64,65,66,67,68],"mismatch repair proficient locally advanced rectal adenocarcinoma","locally advanced rectal adenocarcinoma","microsatellite stable locally advanced rectal adenocarcinoma","Memorial Sloan Kettering Cancer Center","24-389","RECRUITING","2026-06-15",{"date":39,"type":42},{"date":73,"type":42},"2025-02-20",{"date":75,"type":22},"2028-02-20",{"name":67,"class":49},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":5},"100490930","phase-2-a-study-of-tucatinib-and-trastuzumab-in-people-with-rectal-cancer-100490930","NCT05672524","A Study of Tucatinib and Trastuzumab in People With Rectal Cancer","A Phase II Study of Induction Tucatinib and Trastuzumab With Total Neoadjuvant Therapy for Locally Advanced HER2-amplified Rectal Adenocarcinoma","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for the trial.\n* Be ≥18 years of age on the date of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed rectal adenocarcinoma.\n* Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3\u002FcT4 N0 or cT(any) cN1\u002F2,\n* No evidence of distant metastases\n* Radiologically measurable or clinically evaluable disease per Protocol Section 13.0.\n* Have confirmed HER2-positive rectal adenocarcinoma, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, meeting at least one of the following criteria:\n\n  1. HER2+ overexpression (3+ immunohistochemistry \\[IHC\\]) by an FDA-approved HER2 IHC test following the package insert's interpretational manual for gastric cancer\n  2. HER2 2+ IHC is eligible if the tumor is amplified by an FDA-approved HER2 in situ hybridization assay (FISH or chromogenic in situ hybridization \\[CISH\\]) following the package insert's interpretational manual for gastric cancer\n  3. HER2 (ERBB2) amplification by CLIA-certified Next Generation Sequencing (NGS) sequencing assay.\n* Tumor specimen that demonstrates intact mismatch repair enzymes by immunohistochemistry or microsatellite stability as demonstrated by NGS or PCR.\n* Tumor specimen that indicates RAS wild-type based on expanded RAS testing including KRAS exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146)\n* Left ventricular ejection fraction \\>=50 assessed by echocardiography\n* Negative pregnancy test done within 14 days prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception is required for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\nNonchildbearing potential is defined as follows (by other than medical reasons):\n\n* ≥45 years of age and has not had menses for \\>1 year\n* Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.\n* Demonstrate adequate organ function as defined in the Table 6-1 below within 14 days of Cycle 1 Day 1, all screening labs should be performed within 14 days of treatment initiation.\n\n  * Absolute neutrophil count (ANC): ≥1,500 \u002Fmm3\n  * Platelets: ≥100,000 \u002F mcL\n  * Hemoglobin: \\>9 g\u002FdL or ≥5.6 mmol\u002FL\n  * Serum creatinine OR Measured or calculated creatinine clearance (Creatinine clearance should be calculated per institutional standard.) (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥60 mL\u002Fmin for subject with creatinine levels \\> 1.5 × institutional ULN\n  * Serum total bilirubin: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with known Gilbert's disease who may enroll if the conjugated bilirubin is ≥1.5 x ULN\n  * AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): For patients not taking warfarin: INR \\\u003C1.5 or PT \\\u003C1.5 x ULN; and either PTT or aPTT \\\u003C1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5\n\nExclusion Criteria:\n\n* Recurrent rectal cancer.\n* Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.\n* Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).\n* Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.\n* Active infection requiring systemic therapy.\n* Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF\u002FFlk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* Known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies)\n* Known active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Any known chronic (non-transient) liver disease in the patient's past medical history such as (but not limited to) cirrhosis, NASH (non-alcoholic steatohepatitis) or NAFLD.\n* Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.\n* Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n* Received a live vaccine within 30 days of planned start of study medication.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n* Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Use of a strong cytochrome P450 (CYP)2C8 inhibitor that is not adequately cleared (five half-lives of elapsed time) before study initiation. In addition, use of a strong CYP3A4 or CYP2C8 inducer that is taken within 5 days prior to the first dose of study will also be an exclusion criteria.",{"count":85,"type":22},37,[25],"The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin\u002FFOLFOX), may help participants with rectal cancer.",[89,29,90,91,92],"Adenocarcinoma of the Rectum","Rectal Adenocarcinoma","HER2 Positive Rectal Adenocarcinoma","Rectal Cancer",[94,95,89,29,90,92,96,97,67,98],"HER2 positive rectal adenocarcinoma","Adenocarcinoma","Tucatinib","Trastuzumab","22-185","2026-05-11",{"date":101,"type":42},"2026-05-12",{"date":103,"type":42},"2022-12-30",{"date":105,"type":22},"2030-07-31",{"name":67,"class":49},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100609027","phase-2-ctdna-informed-management-of-early-stage-rectal-cancer-100609027","NCT07209215","ctDNA-Informed Management of Early-Stage Rectal Cancer","ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)","ULTIMATE","Inclusion Criteria:\n\n* Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.\n* Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.\n* Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation.\n* Patients ≥18 years of age at time of consent.\n* Ability to understand and willingness to sign the informed consent form (ICF).\n* Ability and stated willingness to adhere to the study visit schedule and protocol procedures\u002Frequirements.\n\nExclusion Criteria:\n\n* Prior treatment for rectal cancer, except for cohort B.\n* Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.\n* Patients on hemodialysis.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial",{"count":116,"type":22},200,[25],"This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.",[90,92,120,29],"Early-stage Rectal Cancer","2026-01-15",{"date":123,"type":42},"2026-01-20",{"date":125,"type":22},"2026-03",{"date":127,"type":22},"2028-05",{"name":129,"class":49},"University of California, Davis",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100608329","phase-2-simultaneous-boost-in-neoadjuvant-radiotherapy-for-rectal-cancer-100608329","NCT07200141","Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer","Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer：A Phase 2, Randomized Controlled Study","SIB-NCRT-pumch","Inclusion Criteria:\n\n1. Age ≥18 and \\\u003C80 years\n2. Histologically confirmed rectal adenocarcinoma\n3. Tumor located within 10 cm from the anal verge\n4. MRI staging: T3-T4 and\u002For N+, M0 (AJCC 8th edition)\n5. ECOG performance status 0-2\n6. Adequate bone marrow function: WBC ≥3×10⁹\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90 g\u002FL\n7. Adequate liver function: TBIL ≤1.5 × ULN, ALT\u002FAST ≤2.5 × ULN\n8. Adequate renal function: Cr ≤1.5 × ULN or CCr ≥60 mL\u002Fmin\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. Prior rectal cancer surgery\n2. Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy\n3. History of other malignancies\n4. History of chronic colitis, ulcerative colitis, or nonspecific proctitis\n5. Pregnant or breastfeeding women\n6. Active infection or fever\n7. Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders)\n8. Inability to comply with study protocol",{"count":140,"type":22},156,[25],"The goal of this clinical trial is to learn whether new adjuvant radiotherapy with gross tumor volume(GTV) escalated to 58.75 Gy can improve complete response (CR) rates compared with GTV dose of 50 Gy in adult patients (18-79 years) with locally advanced rectal adenocarcinoma (T3-T4\u002FN+, M0) located ≤10 cm from the anal verge.The main questions it aims to answer are:\n\n1. Does GTV simultaneously boost to 58.75 Gy\u002F25f increase complete response (pCR or cCR) compared with 50 Gy\u002F25f?\n2. How do the two regimens differ in terms of progression-free survival (PFS), pelvic local control (LC), tumor regression grade (TRG), organ preservation, and treatment-related toxicity? Researchers will compare GTV 58.75 Gy\u002F25f (experimental arm) versus GTV 50 Gy\u002F25f (control arm) to see if dose escalation improves tumor response rate.\n\nParticipants will:\n\n1. Receive neoadjuvant radiotherapy with one of the two PGTV dose escalated regimens (with concurrent chemotherapy: oral capecitabine or XELOX).\n2. Undergo restaging with imaging and clinical assessment before surgery or observation.\n3. Proceed to total mesorectal excision (TME), local excision, or \"watch-and-wait\" strategy depending on treatment response and patient preference.\n4. Be followed regularly with clinical exams, imaging, endoscopy, and laboratory tests to assess efficacy, safety, and long-term outcomes.",[29],[145,146,147,148],"locally advanced rectal cancer","Neoadjuvant Chemoradiotherapy","Dose Escalation","Simultaneous Integrated Boost","2025-09-22",{"date":151,"type":42},"2025-09-30",{"date":153,"type":22},"2025-10-01",{"date":155,"type":22},"2028-12-01",{"name":157,"class":49},"Peking Union Medical College Hospital",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100602076","phase-3-study-evaluating-two-treatment-strategies-for-rectal-cancer-in-patients-75-years-old-100602076","NCT07118800","Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old","Randomized Phase III Study Evaluating Two Treatment Strategies for Locally Advanced Rectal Cancer in Patients ≥75 Years Old","NACRE-2","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of adenocarcinoma of the rectum\n2. Age ≥75 years\n3. WHO performance status 0-1\n4. cT3a-b with maximum diameter \\> 5 cm, T3c-d or cT4 tumor on pretreatment pelvic MRI\n5. General condition considered suitable for radical pelvic surgery and a systemic therapy with FOLFOX,\n6. Distal part of the tumor ≤10 cm from the anal margin, the measurement done by pelvic MRI\n7. Oncogeriatrician approval\n8. Adequate biological function defined by:\n\n   1. Neutrophils ≥ 1500\u002Fmm3\n   2. Platelets ≥ 100 000\u002Fmm3\n   3. Hemoglobin ≥ 10g\u002FdL\n   4. Total bilirubin ≤ 1,5 x ULN\n   5. Alkaline phosphatases ≤ 1,5 x ULN\n   6. Creatinine clearance \\>50mL\u002Fmn (MDRD)\n9. Men must agree to use adequate contraception methods for the duration of study treatment and for within 6 months after completing treatment\n10. Patients must be affiliated to a Social Security System (or equivalent).\n11. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent\n12. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Metastatic disease\n2. Other cancer within 3 years prior to rectal cancer diagnosis (except for in situ cancer and basal cell carcinoma of the skin)\n3. Non resectable cancer, including extension to prostate or extension to perineal muscles\n4. History of pelvic irradiation\n5. Contraindication to FOLFOX 4s chemotherapy and\u002For radiotherapy and\u002For TME surgery\n6. Contraindication to MRI\n7. Microsatellite instability (MSI) and\u002For mismatch repair deficiency (dMMR)\n8. Complete or partial Dihydropyrimidine Deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng\u002FmL)\n9. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of treatment\n10. Any other serious concomitant disease or disorder that may interfere with the patient's participation in the study and safety during the study (e.g., severe liver, heart, kidney, lung, metabolic, or psychiatric disorders).\n11. Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization\n12. Any psychiatric disorder precluding understanding of information of trial related topics and giving informed consent\n13. No prior chemotherapy or surgery for rectal cancer\n14. Any serious underlying medical condition (as judged by the investigator) that could impair the ability of the patient to participate in the trial\n15. Persons deprived of their liberty or under protective custody or guardianship.\n16. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.","75 Years",{"count":168,"type":22},160,[26],"The primary objective of the NACRE-2 trial is to assess whether the addition of chemotherapy after short-course radiotherapy is more effective than short-course radiotherapy alone in elderly patients with locally advanced rectal cancer. Secondary objectives will assess the efficacy and safety profile of the combination, as well as its effect on patients' quality of life.\n\nPatients will be separated into two groups to receive their assigned treatment:\n\n* Group 1: Short-duration radiotherapy according to standard practice lasting one week, followed by chemotherapy with FOLFOX4s consisting of oxaliplatin (85 mg\u002Fm²), folinic acid (400 mg\u002Fm²) and 5-Fluoro-Uracil (400 mg\u002Fm² administered in hospital, followed by 2400 mg\u002Fm² administered over 46 hours at home) every two weeks for 3 months\n* Group 2: Short-duration radiotherapy according to standard practice, lasting one week To receive treatment, patients must come to the hospital where, at each visit, the medical team will carry out medical examinations, prior to administering treatment, to assess the patient's general state of health and tolerance to treatment.\n\nA radiological assessment of the disease will be carried out 11 weeks after the end of radiotherapy. Patients whose tumors have not shrunk will undergo surgery to remove them and enter the follow-up phase. Patients whose tumors have shrunk will not undergo surgery, and will enter a surveillance phase. At 21 weeks, patients whose tumors are still present will undergo surgery and enter the follow-up phase. Patients whose tumors have disappeared will remain in a surveillance phase.\n\nDuring the surveillance or follow-up phases, patients will be monitored in hospital every 3 months (if no progression is observed). In the case of surgery, patients will be monitored every 6 months. The maximum duration of treatment is 3 years.",[29],[173,174,175,95,176,177,178,179,180],"Locally advanced","Rectum","Resectable","FOLFOX","Total neoadjuvant treatment","watch and wait","Non operative management","Short Course Radiotherapy","2025-08-05",{"date":183,"type":42},"2025-08-12",{"date":185,"type":22},"2025-12-15",{"date":187,"type":22},"2032-01-15",{"name":189,"class":49},"UNICANCER",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":130},"100580194","phase-1-papaverine-in-combination-with-radiation-therapy-for-the-treatment-of-locally-advanced-rectal-cancer-dinomite-trial-100580194","NCT06834126","Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial","DINOMITE (Decreasing Hypoxia With Mitochondrial Inhibition in Locally Advanced Rectal Cancer): Phase 1 Trial of Papaverine in Combination With Radiation","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Willingness to participate in all correlative studies: fMRI, and tissue collection of tumor and normal rectum (ribonucleic acid \\[RNA\\]\u002Fdeoxyribonucleic acid \\[DNA\\]\u002Fprotein), blood (plasma\u002Fperipheral blood mononuclear cell \\[PBMC\\]) draws and stool collection\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed rectal adenocarcinoma\n* Patient wants to pursue an organ preservation\u002Fnon-operative management (NOM) approach after completion of total neoadjuvant therapy (TNT)\n* Locally advanced rectal cancer (T3-4 or node+, M0)\n* Tumor is microsatellite stable (MSS) (defined as not microsatellite instability-high \\[MSI-H\\] or mismatch repair deficient \\[dMMR\\])\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (within 30 days of start). NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 100,000\u002Fmm\\^3 (within 30 days of start). NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL (within 30 days of start). NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (within 30 days of start)\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (within 30 days of start)\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (within 30 days of start)\n* Creatinine clearance of ≥ 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 30 days of start)\n* For patients with known infections only: seropositive for HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial (within 28 days of start)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 30 days of start)\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy\n* Prior pelvic irradiation resulting in overlapping fields\n* Use of levodopa in the last 30 days\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Unable to undergo MRI and endoscopic procedures\n* History of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), or priapism\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":198,"type":22},36,[200],"PHASE1","This phase I trial studies the side effects and best dose of papaverine (PPV) when given together with radiation therapy (RT) and tests how well it works in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). PPV is an enzyme inhibitor, and it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving PPV with RT may be safe, tolerable, and\u002For effective in treating patients with locally advanced rectal cancer.",[29,203,204],"Stage II Rectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","2025-07-16",{"date":207,"type":42},"2025-07-18",{"date":209,"type":42},"2025-04-07",{"date":211,"type":22},"2028-09-19",{"name":213,"class":49},"City of Hope Medical Center"]