[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-cancer-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-cancer-patients":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,56,85,112,137,158,180,205,230,257,283,307,334,355,377,404,431,453,472,495],{"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":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100289723","phase-2-randomizing-two-radiotherapy-boost-options-to-avoid-rectal-cancer-surgery-100289723",false,"NCT03051464","Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery","A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer","MORPHEUS","Inclusion Criteria:\n\n* Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic\u002Ftrans-rectal ultrasound\n* Rectal cancer staged as N0-1 by MRI or EUS\u002FTRUS\n* No metastatic lesion\n* Rectal tumor occupying less than half of the circumference\n* Tumor less than 5 cm on its largest dimension\n* Tumor located at less than 10 cm from the anal verge\n* Tumor penetration less than 5 mm in the mesorectal fat\n* Tumor accessible for brachytherapy\n* Lumen accessible for colonoscopy\n* Patient should be a suitable candidate for brachytherapy and chemotherapy\n* Older than 18 years of age\n* Adequate birth control measures in women of childbearing potential\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients with previous pelvic radiation\n* Evidence of distant metastasis\n* Extension of malignant disease to the anal canal\n* Tumors staged as T4\n* Tumors larger than 5 cm in length","ALL","18 Years","80 Years",{"count":21,"type":22},131,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).",[29,30,31,32,33],"Stage II Rectal Cancer","Organ Preservation","Non-operative Treatment","Rectal Cancer (Stage III)","Rectal Cancer Patients",[35,36,37,38,39,40,41,42],"rectal cancer","non-operative management","rectal preservation","organ preservation","brachytherapy boost for rectal cancer","low rectal cancer curative treatment","mid rectal cancer curative treatment","rectal brachytherapy","RECRUITING","2026-06-25",{"date":46,"type":47},"2026-06-30","ACTUAL",{"date":49,"type":47},"2017-04-25",{"date":51,"type":22},"2030-01",{"name":53,"class":54},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",4,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100642462","transanal-total-mesorectal-excision-vs-robotic-total-mesorectal-excision-100642462","NCT07651553","Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision","A Prospective, Randomized, Parallel-Controlled, Superiority Clinical Study Comparing Transanal Total Mesorectal Excision (taTME) and Robot-Assisted Total Mesorectal Excision (RTME) in the Treatment of Low Rectal Cancer","TaLaR03","Inclusion Criteria:Newly diagnosed patients aged 18-75 years. Pathologically confirmed adenocarcinoma (tubular, papillary, mucinous, or signet-ring). Tumor ≤7 cm from anal verge (MRI or DRE). Clinical stage T1-T3, N+, M0 (AJCC 8th ed.), suitable for sphincter-preserving TME. ASA score I-III.\n\nECOG performance status 0-1. Informed consent obtained.\n\n\\- Exclusion Criteria: Synchronous\u002Fmetachronous colorectal cancers, local recurrence, or distant metastases. Bowel obstruction, perforation, bleeding requiring emergency surgery. Involvement of sphincter or adjacent organs requiring Inter-sphincter Resection (ISR). Poor preoperative anal function\u002Fincontinence. IBD or familial adenomatous polyposis (FAP).\n\nPregnancy or lactation. Severe psychiatric illness. Other malignancies within 5 years. Severe comorbidities or infections making surgery intolerable. Judged unsuitable by investigator.","75 Years",{"count":66,"type":22},216,[68],"NA","TME remains standard treatment for rectal cancer. Both Robotic TME and taTME are innovative surgical techniques with potential advantages in low rectal cancer. To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population. Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.",[33,71],"Robotic Assisted Intervention",[73,74,35],"robotic TME","taTME","2026-06-10",{"date":77,"type":47},"2026-06-16",{"date":79,"type":47},"2025-06-30",{"date":81,"type":22},"2029-04-28",{"name":83,"class":54},"Sun Yat-sen University",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":84},"100606486","phase-2-clinical-trial-of-neoadjuvant-mfolfox-plus-alvenor-for-larc-patients-with-high-ywhab-expression-100606486","NCT07176182","Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression","mFOLFOX6 Combined With Citrus Flavonoid Tablets (Aimailang) as Neoadjuvant Therapy for Locally Advanced Rectal Cancer With High YWHAB Expression: A Prospective, Multi-center, Open-Label, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria\n\n1. Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded. Presence of hemorrhoids confirmed by colonoscopy or clinical physical examination.\n2. Radiographically measurable or clinically evaluable rectal tumor lesion; clinical pathologic stage T2N+ or T3-4aAnyN, M0. Clinical staging is determined by physical examination, contrast-enhanced chest and abdominopelvic CT, and pelvic MRI. For patients with MRI contraindications, staging is performed with contrast-enhanced pelvic CT plus transrectal ultrasound. Staging adheres to the 9th AJCC TNM Staging System (Appendix 1).\n3. Pelvic MRI confirms the tumor is not adherent to the mesorectal fascia (MRF-negative), defined as a tumor-MRF distance ≥ 2 mm (tumor distance \\\u003C 2 mm is defined as MRF involvement).\n4. ectal cancer tumor specimens demonstrate high YWHAB expression by immunohistochemistry.\n5. Age 18-75 years at the time of informed consent.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 3).\n7. No prior systemic anticancer therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitors, molecular targeted agents, or endocrine therapy.\n8. Adequate organ function with screening laboratory parameters meeting the following criteria:\n\n   * White blood cell count ≥ 3 × 10⁹\u002FL\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL\n   * Platelet count ≥ 75 × 10⁹\u002FL\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n   * Serum creatinine ≤ 1.5 × ULN\n9. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study treatment and agree to use a highly effective, medically acceptable contraceptive method (e.g., intrauterine device, combined oral contraceptives, barrier methods) throughout the study and for 3 months after the last study drug administration.\n10. Male patients with partners of childbearing potential must practice effective contraception during the study and for 3 months following the last study drug administration.\n11. The patient voluntarily provides written informed consent and is willing and able to comply with all scheduled study visits, treatment administration, laboratory assessments, and protocol-specified procedures.",{"count":93,"type":22},236,[25],"This study is a prospective, multicenter, open-label, randomized controlled Phase II clinical trial enrolling patients with locally advanced rectal cancer who tested positive for YWHAB (tyrosine 3-monooxygenase\u002Ftryptophan 5-monooxygenase-activating protein β) prior to surgery. The trial aims to evaluate the efficacy of combining the mFOLFOX chemotherapy regimen with citrus flavonoid tablets (Aimilang) for neoadjuvant (preoperative) treatment.\n\nTreatment Regimen 4-6 cycles preoperatively, with each cycle lasting 14 days.\n\nTranslated with DeepL.com (free version)\n\nOxaliplatin: 85 mg\u002Fm² via 180-minute intravenous infusion on Day 1.\n\nLeucovorin: 400 mg\u002Fm² via 120-minute intravenous infusion on Day 1.\n\n5-Fluorouracil: 2400 mg\u002Fm² via continuous intravenous infusion over 46 hours.\n\nCitrus flavonoid tablets (Aimailang) : 500 mg orally twice times daily (Days 1-14), administered with or without the chemotherapy regimen (depending on group assignment).\n\nKey Trial Design Features Dose Adjustments: Permitted during the trial based on patient tolerance.\n\nDiscontinuation Criteria:\n\nPatients with disease progression during neoadjuvant therapy will cease study treatment and proceed to surgery or alternative therapies per local guidelines.\n\nSurgery may be initiated early if patients cannot tolerate the planned 6 cycles of neoadjuvant therapy.\n\nPatients receiving non-protocol anticancer therapies preoperatively will be withdrawn from the study.\n\nPostoperative Management:\n\nPost-treatment plans (e.g., continuation of mFOLFOX + Aimailang) are determined by the investigator.\n\nControl Group Restriction: Patients in the control arm are not permitted to self-administer citrus flavonoid tablets (Aimailang) during the trial. Any requirement for this medication must be discussed with the treating physician, who will decide on alternative therapies or trial withdrawal.",[33,97,98],"Rectal Cancer Stage II","Rectal Cancer Stage III",[100,101,102],"Neoadjuvant Therapy","mFOLFOX6","Citrus Flavonoid Tablets (Aimailang)","2026-05-20",{"date":105,"type":47},"2026-05-26",{"date":107,"type":47},"2026-03-20",{"date":109,"type":22},"2031-03-20",{"name":111,"class":54},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":84},"100622918","evaluation-of-gynecological-and-sexual-sequelae-100622918","NCT07389863","Evaluation of Gynecological and Sexual Sequelae","Evaluation of Gynecological and Sexual Sequelae in Patients Treated for Rectal Cancer","GYNERECT","Inclusion Criteria:\n\n* Women aged 18 to 60 at the time of diagnosis\n* Having been treated for rectal cancer between 2020 and 2025\n* Cancer in remission\n* Having been sexually active before receiving treatment for their rectal cancer\n* Having completed the various questionnaires during their treatment\n\nExclusion Criteria:\n\n* Inability to complete questionnaires (cognitive impairment, language barrier)\n* Pregnant women\n* Women with active cancer and\u002For undergoing chemotherapy\n* Women with a history of extensive gynecological surgery\n* Individuals deprived of their liberty by an administrative or judicial decision, or individuals under legal protection\u002Fguardianship or curatorship\n* Individuals without social security coverage","60 Years",{"count":122,"type":22},15,"OBSERVATIONAL","Rectal cancer accounts for approximately 40% of colorectal cancers. In France, there are 15,000 new cases per year, and the 5-year survival rate is 55% across all stages. Treatment involves surgical resection of the rectum, often combined with preoperative chemoradiotherapy and sometimes immunotherapy, depending on the tumor's immunohistochemical status.\n\nThis treatment strategy has improved recurrence-free survival but is associated with long-term functional complications affecting the digestive, urological, gynecological, and sexual systems. Surgery causes anatomical changes and damage to the autonomic nervous system plexuses. Radiotherapy, for its part, causes pelvic inflammation with the development of fibrosis and potential vascular and nerve damage.\n\nVarious disorders can arise as a result of these anatomical changes, such as erectile dysfunction in men; dyspareunia and vaginal dryness in women; urinary incontinence and impaired sexual quality of life in both sexes.",[33],[127],"Gynecological and sexual sequelae","2026-05-04",{"date":130,"type":47},"2026-05-05",{"date":132,"type":47},"2026-02-09",{"date":134,"type":22},"2027-09-01",{"name":136,"class":54},"University Hospital, Rouen",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":84},"100581421","phase-3-neoadjuvant-radiotherapy-for-rectal-adenocarcinoma-with-capecitabine-versus-tas-102-neo-react-a-multi-center-randomized-phase-iii-trial-100581421","NCT06850090","Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial","Inclusion Criteria:\n\n1. Patients aged between 18 and 75 years of either sex.\n2. Histologically confirmed rectal adenocarcinoma with the following conditions:\n\n   1. Clinical stage II (T3-4, N-) or III (any T, N+) as determined by MRI.\n   2. The tumor is located within 12 cm from the anal margin, with at least one high-risk factors (ie, extramural vascular invasion \\[EMVI+\\], mesorectal fascia involved \\[MRF+\\], cT4, cN2, lateral lymph nodes, tumor deposit, or tumor located in the lower rectum \\[≤5 cm from the anal verge\\]).\n3. No other types of rectal cancer (e.g., sarcoma, lymphoma, carcinoid, squamous cell carcinoma) or synchronous colon cancer.\n4. Presence of measurable lesions that meet RECIST v1.1 criteria for evaluation.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Estimated life expectancy \\> 6 months.\n\nExclusion Criteria:\n\n1. Patients of dMMR or MSI-H status.\n2. Unexplained myelosuppression.\n3. Evidence of distant metastasis and inguinal lymph node metastasis based on comprehensive chest and abdominal CT or whole-body PET-CT scans. Retroperitoneal lymph nodes above the iliac vessel bifurcation are considered distant metastasis.\n4. Active autoimmune disease or history of autoimmune disease.\n5. Uncontrolled cardiac symptoms or diseases.\n6. History of other malignancies, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.",{"count":144,"type":22},210,[26],"Neoadjuvant fluoropyrimidine-based chemoradiotherapy followed by total mesorectal excision (TME) is the standard of care for locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates are low. Trifluridine\u002Ftipiracil (TAS-102) is a new oral anti-tumor oral formulation of nucleoside analogue, trifluridine (FTD), and a thymidine phosphorylase inhibitor, tipiracil (TPI). Previous studies have shown that TAS-102 has shown clinically relevant activity after fluoropyrimidine failure in colorectal cancer and may thus be of increased efficacy compared with current standard capecitabine chemoradiation. Also, a phase 2 trials conducted by our team have demonstrated that neoaduvant TAS-102 concurrent with long-course radiotherapy could lead to a high pCR rate of 32% with acceptable toxicity for LARC patients. Herein, we will conduct this multicenter, randomized controlled, phase III trial to explore the safety and efficacy benefit of TAS-102 concurrent with long-course radiotherapy for LARC.",[148,33],"Rectal Cancer","2026-04-27",{"date":151,"type":47},"2026-04-28",{"date":153,"type":47},"2025-07-30",{"date":155,"type":22},"2028-06",{"name":157,"class":54},"Shandong Cancer Hospital and Institute",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":84},"100586154","phase-2-radiotherapy-plus-iparomlimab-and-tuvonralimab-ql1706-regorafenib-and-capox-as-neoadjuvant-therapy-for-pmmrmss-larc-100586154","NCT06911684","Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR\u002FMSS LARC.","Short-Term Radiotherapy Combined With Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX Neoadjuvant Therapy for Locally Advanced Rectal Cancer：A Multicenter, Prospective, Randomized, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Age: 18-75 years.\n2. Pathology: Histologically confirmed rectal adenocarcinoma, with the lower tumor edge ≤12 cm from the anal verge.\n3. Initial Clinical Stage: cT3-4aN0M0 or cT1-4aN+M0, regardless of MRF, EMVI, or LLNM status.\n\n   Preoperative staging methods: chest and abdominal CT, pelvic MRI, endoscopic ultrasound (EUS), or transrectal ultrasonography.\n4. pMMR\u002FMSS Status: pMMR confirmed by immunohistochemistry (IHC) at the study center's pathology department, or MSS\u002FMSI-L confirmed by PCR or NGS.\n5. ECOG Performance Status: 0-1.\n6. Informed Consent: Voluntarily agrees to participate and signs the informed consent form.\n7. No Prior Treatment: No previous therapy targeting rectal adenocarcinoma, including radiotherapy, chemotherapy, or surgery.\n8. Planned Surgery: Surgery is planned upon completion of neoadjuvant therapy.\n9. Expected Survival: ≥6 months.\n10. Adequate Organ and Bone Marrow Function, meeting all of the following (with no blood products, growth factors, or other hematopoietic-supportive medications used within 14 days before first administration):\n\n    Hematology:\n\n    Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL Platelet count ≥100 × 10\\^9\u002FL Hemoglobin ≥90 g\u002FL\n\n    Serum Biochemistry:\n\n    Serum albumin ≥30 g\u002FL Total bilirubin ≤1.5 × ULN ALT ≤2.5 × ULN, AST ≤2.5 × ULN Alkaline phosphatase (ALP) ≤2.5 × ULN\n\n    Serum creatinine ≤1.5 × ULN, or creatinine clearance (CrCl) ≥50 mL\u002Fmin, calculated by the Cockcroft-Gault formula:\n11. Contraception:\n\n    Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first study dose, and must use effective contraception (e.g., intrauterine device, oral contraceptive, or barrier method) during the study and for at least 120 days after the final dose.\n\n    Male participants with partners of childbearing potential must be surgically sterile or must agree to use effective contraception during the study and for 120 days after the final dose.\n12. Compliance and Follow-up: Demonstrates good compliance and agrees to attend follow-up visits.\n13. Biological Samples: Agrees to provide blood, urine, stool, and tumor tissue samples.\n\nExclusion Criteria:\n\n1. Active Autoimmune Disease: Any active autoimmune disease requiring systemic treatment (i.e., disease-modifying medications, corticosteroids, or immunosuppressive agents) within 2 years prior to enrollment (e.g., myasthenia gravis, systemic lupus erythematosus, interstitial pneumonitis, uveitis, ulcerative colitis, autoimmune hepatitis, hypophysitis, systemic vasculitis, nephritis, hyperthyroidism, hypothyroidism, mixed connective tissue disease).\n\n   Exceptions: vitiligo, or childhood asthma that has fully resolved in adulthood without therapy.\n\n   Asthma requiring bronchodilator therapy is ineligible. Physiologic replacement therapy (e.g., thyroid hormone, insulin, or low-dose steroids for adrenal\u002Fpituitary insufficiency) is not considered systemic treatment.\n2. Concurrent Systemic Therapy: Use of systemic corticosteroids (≥10 mg\u002Fday of prednisone or equivalent) or other immunosuppressants (e.g., cyclosporine, cyclophosphamide, azathioprine, methotrexate, thalidomide) within 14 days before the first dose, or use of immunostimulants (e.g., interferon, interleukin-2) within 4 weeks before the first dose.\n3. Live Vaccines: Receipt of a live or attenuated live vaccine within 30 days before the first dose or potentially during the study period.\n4. Antibiotic Use: Administration of broad-spectrum antibiotics by any route within 30 days prior to the first dose.\n5. Previous Anticancer Therapies: Any prior antitumor treatments (radiotherapy, chemotherapy, surgery \\[excluding biopsy\\], PD-1\u002FCTLA-4 dual immunotherapy, regorafenib, or other tyrosine kinase inhibitors).\n6. Unresectable Factors: Tumors deemed unresectable or participants with surgical contraindications, or who refuse surgery.\n7. Immunodeficiency: HIV infection, any other acquired or congenital immunodeficiency disorder, or a history of organ or allogeneic bone marrow transplantation (excluding corneal transplantation).\n8. Hepatitis B\u002FC Co-infection:\n\n   HBsAg-positive and\u002For HBcAb-positive with HBV DNA \\>10\\^4 copies\u002FmL (≈2000 IU\u002FmL).\n\n   Anti-HCV antibody-positive with HCV-RNA \\>10\\^3 copies\u002FmL. Patients positive for both HBsAg and HCV-RNA are excluded.\n9. Other Malignancies: Any other malignancies within the past 5 years or concurrent malignancies, except for treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n10. Uncontrolled Effusions: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage.\n11. Severe Pulmonary Conditions: Known active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other severe pulmonary diseases\u002Fimpairments.\n12. Renal Failure: Renal failure requiring hemodialysis or peritoneal dialysis.\n13. Active Infection or Fever: Active infection, unexplained fever ≥38.5°C within 7 days prior to study treatment, or baseline WBC count \\>15 × 10\\^9\u002FL.\n14. Cardiac Conditions: Poorly controlled or clinically significant cardiac conditions, including:\n\n    NYHA Class II or higher heart failure, LVEF \\\u003C50% Unstable angina Myocardial infarction within 1 year prior to randomization Clinically significant arrhythmias requiring treatment or intervention QTc \\>450 ms (men), or QTc \\>470 ms (women)\n15. Hypertension: Poorly controlled (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) despite antihypertensive therapy, or a history of hypertensive crisis\u002Fencephalopathy.\n16. Recent Thrombosis: Arterial or venous thrombosis within 6 months prior to enrollment (e.g., stroke, transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism).\n17. Coagulopathy: Known hereditary or acquired bleeding\u002Fthrombotic disorders (e.g., hemophilia, coagulopathy).\n18. Significant Bleeding: Evidence or history of bleeding. Any Grade ≥3 hemorrhage within 4 weeks prior to study treatment (per CTCAE v5.0).\n19. Vascular Invasion: Tumor invasion of major blood vessels or a high likelihood thereof during the study, potentially leading to life-threatening bleeding as judged by imaging.\n20. Wounds or Ulcers: Severe, unhealed or dehiscent wounds, active ulcers, or untreated fractures.\n21. Major Vascular Disease: Major vascular disorders within 6 months prior to study treatment (e.g., requiring surgical repair for an aneurysm or recent peripheral arterial thrombosis).\n22. Major Surgery: Major surgery (other than diagnostic) within 4 weeks prior to study treatment, or planned major surgery during the study period (excluding the planned study-related procedure).\n23. Abdominal Fistula, Perforation, or Abscess: Such events within 6 months prior to study treatment.\n24. Long-Term NSAIDs or Anticoagulants: Need for long-term or high-dose NSAIDs (≥325 mg aspirin) or anticoagulant therapy.\n25. Known Drug Allergy: Suspected or known allergy to any study drug or its components relevant to this trial.\n26. Monoclonal Antibody Hypersensitivity: History of severe hypersensitivity reactions to any monoclonal antibody, or known hypersensitivity\u002Fallergy to QL1706, regorafenib, oxaliplatin, capecitabine, or any of their components.\n27. Difficulty Swallowing: Inability or difficulty swallowing oral study drugs.\n28. Pregnant or Breastfeeding: Women who are pregnant or lactating.\n29. Other Factors: Any other factors that may affect study outcomes or lead to premature termination, including a history of alcohol or drug abuse, severe diseases (including psychiatric disorders) requiring combination treatment, significant laboratory abnormalities, or family\u002Fsocial circumstances that, in the investigator's judgment, compromise patient safety or study integrity.",{"count":166,"type":22},88,[25],"This study is a multicenter, prospective, randomized, double-arm, Phase II clinical trial designed to evaluate the efficacy of short-term radiotherapy combined with Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as neoadjuvant therapy for locally advanced rectal cancer. Additionally, the study seeks to explore the relationship between biomarkers in blood, urine, feces, and tumor tissue and treatment efficacy.\n\nEligible participants (pMMR\u002FMSS locally advanced rectal cancer) were randomly assigned in a 1:1 ratio to two groups, with randomization stratified by MRF (+ vs. -).\n\nParticipants will:\n\n* Group A patients received two cycles of QL1706, regorafenib, and CAPOX induction therapy, followed by sequential short-course radiotherapy, and then continued with four cycles of QL1706, regorafenib, and CAPOX consolidation therapy.\n* Group B patients received short-course radiotherapy followed by six cycles of QL1706, regorafenib, and CAPOX consolidation therapy.\n\nAfter two cycles of neoadjuvant therapy in Group A and six cycles in Group B, efficacy was evaluated and decisions regarding surgery or watchful waiting were made based on efficacy.",[33],[148,100,171,172],"pMMR\u002FMSS","immunotherapy","2026-04-24",{"date":151,"type":47},{"date":176,"type":47},"2025-04-30",{"date":178,"type":22},"2031-12-31",{"name":83,"class":54},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":84},"100635794","nodal-downstaging-versus-primary-tumor-regression-as-predictors-of-survival-after-total-neoadjuvant-therapy-for-rectal-cancer-a-retrospective-study-100635794","NCT07557316","Nodal Downstaging Versus Primary Tumor Regression as Predictors of Survival After Total Neoadjuvant Therapy for Rectal Cancer: A Retrospective Study","Inclusion Criteria:\n\npatients who were more than18 years old at time of diagnosis. Pathological confirmation of rectal adenocarcinoma. Locally advanced stage II\\&III rectal carcinoma (≥T3 and or N+) at initial diagnosis.\n\nPatients treated with Total Neoadjuvant Therapy (TNT), including either chemoradiotherapy (CRT) followed by consolidation chemotherapy, induction chemotherapy followed by CRT, or short-course radiotherapy (SCRT) followed by chemotherapy, and subsequently undergoing TME.\n\nAvailable pathological assessment of surgical specimens.\n\nExclusion Criteria:\n\nPatients with distant metastasis at presentation or other comorbid diseases. Patients with incomplete clinical and pathological staging information. Missing key clinical or pathological data. Patients who did not receive TNT or undergo TME surgery.",{"count":187,"type":22},100,"To evaluate the prognostic impact of post-TNT pathological nodal status (ypN) on LRFS, DMFS, and OS, and compare it with that of primary tumor response",[33,190],"Total Neoadjuvant Therapy",[192,193,194],"ypN","TNT","ypT","NOT_YET_RECRUITING","2026-04-22",{"date":198,"type":47},"2026-04-29",{"date":200,"type":22},"2026-05-10",{"date":202,"type":22},"2027-05-10",{"name":204,"class":54},"Sohag University",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":226,"leadSponsor":228,"locationsCount":84},"100633047","phase-2-short-course-radiotherapy-nal-iri-capecitabine-and-camrelizumab-for-locally-advanced-mss-rectal-cancer-100633047","NCT07521605","Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer","Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR\u002FMSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol","Inclusion Criteria:\n\n1. Aged 18 to 75 years, male or female.\n2. Histologically confirmed diagnosis of rectal adenocarcinoma.\n3. Confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) status by immunohistochemistry or PCR methods.\n4. Locally advanced disease assessed by pelvic MRI, classified as cT3-4aN0M0 or any T stage with node-positive (N+) disease, without distant metastasis (M0), according to the AJCC 8th edition staging system.\n5. The lower edge of the tumor is located within 10 cm from the anal verge (defined as low\u002Fmid rectal cancer).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate bone marrow, hepatic, and renal function, defined as: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹\u002FL，Platelet count ≥ 100 x 10⁹\u002FL，Hemoglobin ≥ 90 g\u002FL，Total Bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN)，Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 x ULN，Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. Voluntarily participates in the study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow-up procedures.\n\nExclusion Criteria:\n\n1. Evidence of distant metastasis (M1 disease) on baseline imaging.\n2. Previous radiotherapy to the pelvis, or any prior systemic chemotherapy, targeted therapy, or immunotherapy for colorectal cancer.\n3. History of other active malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other localized tumors considered cured by local treatment.\n4. Any of the following uncontrolled conditions or comorbidities:\n\n1）Severe active infection requiring systemic therapy. 2）Unstable angina, myocardial infarction, or congestive heart failure (NYHA Class II-IV) within the last 6 months.\n\n3）Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that would compromise the ability to provide informed consent or comply with study procedures.\n\n5\\. Known history of severe immunodeficiency or active autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids at doses \\> 10mg\u002Fday prednisone equivalent) within the past 2 years.\n\n6\\. Known history of hypersensitivity to any component of the study drugs (Liposomal Irinotecan, Capecitabine, Camrelizumab) or history of severe hypersensitivity reactions to other monoclonal antibodies.\n\n7\\. Pregnant or lactating women, or subjects of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 6 months after the last dose of study treatment.\n\n8\\. Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or adherence to the protocol (e.g., inability to swallow oral medications, active gastrointestinal bleeding, intestinal obstruction).",{"count":213,"type":22},44,[25],"This study is for adults with locally advanced rectal cancer that has not spread to distant organs, and is classified as pMMR or MSS (which means it typically does not respond well to immunotherapy alone). The purpose is to see if a new combination of treatments given before surgery (neoadjuvant therapy) can more effectively shrink the tumor and increase the chance of curing the cancer or avoiding surgical removal of the rectum.\n\nThe main things you will do in this study are:\n\n1. Receive a Short Course of Radiation Therapy (5 treatments over 1 week).\n2. After a 1-week break, receive a combination of three drugs:\n\n1）Nal-IRI (a special form of the chemotherapy drug Irinotecan, designed to have fewer side effects) 2）Capecitabine (a chemotherapy pill) 3）Camrelizumab (an immunotherapy drug) 3. This drug combination is given in 8 cycles, with each cycle lasting 3 weeks. 4. After finishing all cycles, the doctors will carefully check how the tumor responded.\n\nThe most important goal of this research is to see how many patients achieve a \"Complete Response,\" which means:\n\n1. No sign of cancer cells in the surgically removed tissue (Pathological Complete Response, pCR), or\n2. No sign of cancer can be found through clinical exams, scans, and scopes, allowing the patient to avoid immediate surgery under a \"Watch and Wait\" strategy (Clinical Complete Response, cCR).\n\nResearchers will also monitor:\n\n1. The safety of the treatment and its side effects.\n2. How well the cancer is controlled over time (e.g., 3-year survival without cancer recurrence).\n3. The rate of successful tumor removal and the rate of preserving the anus.",[33],[218,171,219,220,221],"Locally advanced rectal cancer","Short-course radiotherapy","Liposomal irinotecan","Neoadjuvant immunochemoradiotherapy","2026-04-08",{"date":224,"type":47},"2026-04-13",{"date":103,"type":22},{"date":227,"type":22},"2034-12-31",{"name":229,"class":54},"Guangdong Provincial People's Hospital",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":84},"100565861","phase-2-neoadjuvant-chemotherapy-and-pd-1-inhibitor-for-locally-advanced-rectal-cancercontrol-01-100565861","NCT06647680","Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）","Neoadjuvant Chemotherapy and Tislelizumab (PD-1 Inhibitior) for Locally Advanced Rectal Cancer: a Single-center, Prospective, Phase II Study","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial\n* Age 18 years or greater\n* Pathologically proven diagnosis of adenocarcinoma of the rectum\n* Clinically determined to be stage T3 or T4, N0-N2, and M0\n* Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity.\n* Contrast-enhanced imaging of the abdomen and chest by CT to exclude distant metastases and provide local tumor stage\n* Preoperative ECOG status score 0-1\n* Preoperative ASA grade I-III\n* Adequate bone marrow function\n* Adequate renal and liver function\n* No active second cancers\n* Be willing and able to comply with all aspects of the protocol\n* Women of childbearing potential must have used reliable contraception or have had a pregnancy test result within 7 days prior to enrollment. Be negative and willing to use an adequate method of contraception for the duration of the trial and for 8 weeks after the last administration of the trial drug.\n* Adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells\u002Fmm3 Platelets ≥ 100,000 cells\u002Fmm3 Hemoglobin ≥ 8.0 g\u002Fdl.\n* Adequate hepatic function within within 28 days before registration on this study:total bilirubin must be ≤ ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation \\> ULN to 1.5 x ULN due to Gilbert\\'s disease or similar syndrome involving slow conjugation of bilirubin; and AST and ALT must be ≤3 x ULN for the lab If AST and\u002For ALT is ≥ ULN but ≤ 3 x ULN, serologic testing for Hepatitis B and C must be performed and results for viral infection must be negative.\n* Adequate renal function within 28 days before randomization defined as serum creatinine ≤ 1.5 x ULN for the lab or calculated creatinine clearance \\> 30 mL\u002Fmin\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnant or breastfeeding women\n* Prior invasive malignancy unless disease free for a minimum of three years\n* Preoperative body temperature ≥ 38°C or concurrent infectious diseases requiring systemic therapy;\n* Severe mental illness;\n* Severe abnormal heart, lung and kidney function\n* History of unstable angina pectoris or myocardial infarction within 6 months;\n* History of cerebral infarction or cerebral hemorrhage within 6 months;\n* Patients with abnormal coagulation function;\n* Have a history of psychotropic drug abuse or have a mental disorder;\n* Continuous use of glucocorticoids within 1 month (except topical application);\n* Patient has participated in or is participating in other clinical studies (within 6 months);\n* According to the judgment of the investigator, it endangers the patient\\'s health or affects the experimental results.",{"count":238,"type":22},35,[25],"To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.",[33],[243,244,245,246,247],"Rectal cancer","Chemotherapy","Tislelizumab","Complete response","Recurrence free survival","2026-03-05",{"date":250,"type":47},"2026-03-06",{"date":252,"type":47},"2025-06-01",{"date":254,"type":22},"2027-12-01",{"name":256,"class":54},"The Affiliated Hospital of Qingdao University",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":84},"100620486","postoperative-outcomes-of-single-stapled-anastomosis-combined-with-transanal-natural-orifice-specimen-extraction-100620486","NCT07358247","Postoperative Outcomes of Single-stapled Anastomosis Combined With Transanal Natural Orifice Specimen Extraction","Postoperative Outcomes of Transanal Transection and Single-stapled Technique Combined With Transanal Natural Orifice Specimen Extraction: a Single-center Retrospective Cohort Study","NOSE","Inclusion Criteria:\n\n* Adult patients aged more than 18 years old at the time of surgery\n* Patients with a histological diagnosis of rectal adenocarcinoma\n* Patients who underwent surgery between January 2017 and January 2023\n* Patients with a low rectal tumor meeting the Low Rectal Cancer Development Programme (LOREC) criteria\n\nExclusion Criteria:\n\n* Patients who underwent non-restorative procedures (including abdominoperineal resection or Hartmann's procedures).\n* Patients who underwent immediate or delayed coloanal anastomosis.\n* Patients who underwent open surgery.\n* Patients who underwent unplanned conversion from minimally invasive to open approach.\n* Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD).",{"count":266,"type":22},190,"Natural Orifice Specimen Extraction (NOSE) eliminates the need for additional abdominal incisions in minimally invasive colorectal procedures, potentially reducing the risk of wound complications and postoperative pain. In the context of restorative Total Mesorectal Excision (TME), single-stapling (SS) techniques facilitate NOSE through transanal rectal transection, as opposed to the conventional double-stapling technique. This study aims to explore the potential advantages of NOSE combined with SS anastomosis compared to conventional abdominal extraction in minimally invasive restorative TME.",[33,269],"Rectal Cancer Surgery",[271,272,243,273],"Single-stapled anastomosis","Natural orifice specimen extraction","Wound complications","2026-01-13",{"date":276,"type":47},"2026-01-22",{"date":278,"type":22},"2026-01-31",{"date":280,"type":22},"2026-04-30",{"name":282,"class":54},"Istituto Clinico Humanitas",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":84},"100618914","selective-total-mesorectal-excision-based-on-intra-operative-frozen-section-from-local-excision-in-rectal-cancer-undergoing-neoadjuvant-chemoradiotherapy-100618914","NCT07337811","Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy","Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy: A Prospective, Single-arm, Phase II Superiority Trial","Inclusion Criteria:\n\n1. Pathologically confirmed rectal adenocarcinoma.\n2. Neoadjuvant therapy based on radiotherapy; post-radiotherapy evaluation ≥8 weeks later shows near clinical complete response (near-cCR) or partial response (PR) with residual tumor \\\u003C2 cm.\n3. Tumor distance from the anal verge ≤5 cm.\n4. Age 18-75 years.\n5. No synchronous multiple primary cancers.\n6. No contraindications to pre-operative radiotherapy or chemotherapy.\n7. Adequate organ function (cardiac, hepatic, renal, hematologic).\n8. Patient or legally authorized representative able to understand the study protocol, willing to participate, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>75 years.\n2. Concurrent or previous malignancy within the past 5 years (except adequately treated basal-cell or squamous-cell skin carcinoma or carcinoma in situ of the cervix).\n3. Emergency surgery required for bowel obstruction, perforation, or bleeding.\n4. Prior colorectal surgery that may compromise intestinal reconstruction.\n5. Need for en-bloc multivisceral resection.\n6. ASA physical status IV or V.\n7. Pregnant or lactating women.\n8. a) Women of child-bearing potential with a positive serum pregnancy test at baseline or who have not undergone pregnancy testing; post-menopausal women must have been amenorrheic for ≥12 months.\n9. b) Men or women of reproductive potential unwilling to use effective contraception throughout the study period.\n10. Severe psychiatric illness precluding informed consent or compliance.\n11. Severe COPD, interstitial lung disease, or ischemic heart disease precluding safe surgery.\n12. Continuous systemic corticosteroid therapy within 1 month before enrolment.\n13. Contraindications to laparoscopic surgery.\n14. Patient or legally authorized representative unable to understand the study conditions and objectives.",{"count":291,"type":22},27,[68],"This study is a prospective, single-arm, phase II superiority trial to determine whether a selective organ-preserving strategy based on immediate intra-operative frozen-section results can achieve favorable 2-year local control while lowering morbidity in patients with low rectal cancer (tumor ≤5 cm from the anus) who have a near clinical complete response (near-cCR) or partial response (residual tumor \\\u003C2 cm) after radiation therapy.\n\nPopulation: Adults with primary rectal adenocarcinoma located ≤5 cm from the anal verge who, after neoadjuvant radiotherapy, are judged to have near-cCR or partial response (residual tumor \\\u003C2 cm).\n\nIntervention: All participants undergo local excision under general anesthesia. The specimen is sent for intra-operative frozen section.\n\nypT0-1 on frozen section → procedure concluded; patient enters watch-and-wait. ypT2-3 or R1 on frozen section → immediate completion total mesorectal excision (TME).\n\nFrozen-section ypT1-2 but final paraffin section up-staged to ypT2-3 or R1 → elective TME within 8 weeks.\n\nPrimary Endpoint: a composite outcome of 2-year local recurrence rate, surgical complications (≤30 days), and long-term functional impairment (anorectal, urogenital, and quality-of-life scales).\n\nSecondary Endpoints: Agreement between intra-operative frozen-section pathology and final paraffin-section pathology, 3-year disease-free survival (DFS), 3-year overall survival (OS), surgery-sparing rate, post-operative recovery metrics, Quality-of-life scores.\n\nEstimated Enrollment: 27 participants.",[33],[296,297,298,299],"Local Excision","Frozen Pathology","Chemoradiotherapy","Total Mesorectal Excision","2026-01-12",{"date":274,"type":47},{"date":303,"type":47},"2025-08-01",{"date":305,"type":22},"2028-07-31",{"name":83,"class":54},{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":322,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"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":315,"type":22},42,[25],"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",[33,319,320,190,321],"Obesity &Amp; Overweight","Locally Advanced Rectal Cancer (LARC)","GLP-1",[323,190,324],"Locally Advanced Rectal Cancer","GLP-1 Receptor Agonist","2025-12-17",{"date":327,"type":47},"2026-01-02",{"date":329,"type":22},"2026-04",{"date":331,"type":22},"2028-09",{"name":333,"class":54},"St. James's Hospital, Ireland",{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":84},"100615345","phase-2-radiotherapy-plus-capox-and-iparomlimab-and-tuvonralimab-ql1706-as-neoadjuvant-therapy-for-larc-100615345","NCT07291401","Radiotherapy Plus CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as Neoadjuvant Therapy for LARC","Neoadjuvant Chemoradiotherapy Combined Cith Iparomlimab and Tuvonralimab (QL1706) Therapy for Locally Advanced Rectal Cancer：a Single-center, Prospective, Randomized, Phase II Clinical Trial","Inclusion Criteria:\n\n* (1) The patient is histologically diagnosed with rectal adenocarcinoma. (2) Age ≥18 years, \\\u003C75 years (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (4) AJCC stage of rectal cancer: cT3-4N0M0 or TanyN1-2M0 (5) The lower margin of the rectal tumor is ≤10cm from the anus. (6) At least one evaluable lesion based on RECIST 1.1 assessment. (7) Subjects should have adequate bone marrow and liver and kidney function reserves:\n\n  * Neutrophils ≥1.5×10⁹\u002FL, platelets ≥75×10⁹\u002FL, and hemoglobin ≥9 g\u002FdL\n\n    * Total bilirubin ≤1.5×Upper limit of normal (UNL); ASAT (SGOT) and\u002For ALAT (SGPT) ≤2.5×UNL (≤5×UNL if liver metastasis occurs); alkaline phosphatase ≤2.5×UNL (≤5×UNL if liver metastasis occurs, ≤10×UNL if bone metastasis occurs); LDH \\\u003C1500 U\u002FL\n\n      * Creatinine clearance (calculated according to the Cockcroft and Gault formula) \\>60 mL\u002Fmin or serum creatinine ≤1.5×UNL; (8) Voluntarily participate in this study and sign the informed consent form\n\nExclusion Criteria:\n\n* (1) Histopathological examination confirms the presence of other pathological types, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc.\n\n  (2) Pathological examination confirms microsatellite highly unstable dMMR\u002Fmsi-H (3) Presence of intestinal obstruction, intestinal perforation, bleeding, or other conditions requiring emergency surgery (4) History of pelvic radiotherapy (5) Comorbid malignant tumors (excluding cervical carcinoma in situ that has been cured for more than 2 years) (6) Receiving any other anti-tumor treatment (chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy) or participating in other new drug clinical trials within the past 4 weeks (7) Presence of the following cardiovascular and cerebrovascular diseases or risks:\n  1. Myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (Class 2 or above as determined by the New York Heart Association functional classification) within 6 months prior to randomization, symptomatic or poorly controlled arrhythmia\n  2. 3 years prior to first use of the drug a. History of pulmonary embolism or other serious thromboembolism within the past month\n  3. Presence of aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis or other major vascular diseases that may endanger life or require surgery within the past 6 months\n  4. History of myocarditis or cardiomyopathy or current examination suggests myocarditis\n  5. Left ventricular ejection fraction (LVEF) \\\u003C50%\n  6. Complete left bundle branch block, third-degree atrioventricular block (8) Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or an autoimmune disease that the investigator judges may relapse or is planned for treatment. The following are excluded:\n\n  \u003C!-- -->\n\n  1. Skin diseases that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema)\n  2. Hypothyroidism caused by autoimmune thyroiditis that requires only stable doses of hormone replacement therapy\n  3. Type I diabetes that requires only stable doses of insulin replacement therapy\n  4. Childhood asthma that has completely resolved and requires no intervention in adulthood\n  5. The investigator determines that the disease will not recur without external triggering factors (9) Known or suspected active pulmonary tuberculosis (10) Subjects with active hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (HBsAg positive) with HBV DNA \\> 500 IU\u002FmL or \\> 2500 copies\u002FmL), and subjects with active hepatitis C should be excluded. Inactive or asymptomatic carriers of hepatitis B who are treated and stable and meet the criteria of HBV DNA ≤500 IU\u002FmL or ≤2500 copies\u002FmL are eligible for enrollment. Subjects with cured hepatitis C who are HCVAb positive and HCV RNA negative are eligible for enrollment. (11) Subjects who require systemic treatment with glucocorticoids (\\>10 mg\u002Fday prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to randomization. The following are exceptions:\n\n  a. Inhaled, ophthalmic, or topical corticosteroids are permitted if there is no active autoimmune disease.\n\n  b. Corticosteroids are used as a pretreatment for infusion-related reactions or allergic reactions (e.g., medication before CT scans).\n\n  (12) Pregnant or lactating women (13) Patients with currently uncontrolled comorbidities, such as decompensated cirrhosis, nephrotic syndrome, uncontrolled hyperglycemia, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, severe bleeding tendency, or coagulation disorders.\n\n  (14) Patients with known allergies to any component of the study drug (oxaliplatin, capecitabine, QL1706); a history of severe allergic reactions to other monoclonal or bispecific antibodies; or known allergies to multiple substances or severe allergic diseases.\n\n  (15) Patients who have received a live vaccine within 30 days prior to randomization or who plan to receive a live vaccine during the study period.\n\n  (16) Patients with cognitive impairment or severe comorbid mental disorders, or those deemed by the investigator to have poor chemotherapy adherence; or other cases deemed unsuitable for participation in clinical trials by the investigator.",{"count":342,"type":22},108,[25],"This study is a single-center, prospective, randomized, double-arm, Phase II clinical trial designed to evaluate the efficacy of radiotherapy combined with CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as neoadjuvant therapy for locally advanced rectal cancer. Additionally, the study seeks to explore the relationship between biomarkers in blood and tumor tissue and treatment efficacy.\n\nEligible participants (locally advanced rectal cancer) were randomly assigned in a 1:1 ratio to two groups.\n\nParticipants will:\n\nGroup A patients received radiotherapy, chemotherapy, and immunotherapy. During the first week of radiotherapy, they received one cycle of CAPOX concurrent chemoradiotherapy. Two weeks after the completion of radiotherapy, they continued with four cycles of CAPOX combined with QL1706 immunotherapy.\n\nGroup B patients received radiotherapy and chemotherapy. After completing the concurrent radiotherapy and chemotherapy, they rested for 2-3 weeks before completing 3 cycles of CAPOX consolidation chemotherapy.\n\nTwo to three weeks after the completion of neoadjuvant therapy in groups A and B, the efficacy was evaluated, and a decision was made on whether to proceed with surgery or watchful waiting based on the efficacy.",[33],"2025-12-05",{"date":348,"type":47},"2025-12-18",{"date":350,"type":22},"2026-01-01",{"date":352,"type":22},"2029-01-01",{"name":354,"class":54},"Zhongnan Hospital",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":4},"100609404","phase-2-total-neoadjuvant-therapy-with-pd-1-for-locally-advcancer-rectal-cancer-100609404","NCT07214142","Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer","Efficacy and Safety of Total Neoadjuvant Chemoradiotherapy Combined With PD-1 Therapy for Locally Advanced Rectal Cancer With High Risk of Recurrence","TNT-Immunity","Inclusion Criteria:\n\n1. Pathologically confirmed rectal adenocarcinoma;\n2. Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge;\n3. Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter \\> 8 mm); patients with potentially resectable disease;\n4. Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type;\n5. No prior antitumor therapy, such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy;\n6. Age between 18 and 75 years;\n7. ECOG Performance Status (PS) score of 0-1;\n8. Laboratory test results: WBC ≥ 3.5 × 10\\^9\u002FL, Hb ≥ 100 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL; normal liver and kidney function;\n9. Absence of severe comorbidities, and ability to tolerate surgical treatment;\n10. The patient or their immediate family member voluntarily agrees to participate in this study and provides written informed consent.\n\nExclusion Criteria:\n\n1. Recurrent rectal cancer;\n2. Synchronous colorectal cancer;\n3. Pregnant or lactating patients;\n4. History of other malignant tumors;\n5. Previous antitumor therapy, including chemotherapy or radiotherapy;\n6. Dysfunction of vital organs such as cardiac or pulmonary insufficiency;\n7. History of autoimmune diseases or immunodeficiency disorders;\n8. Use of immunosuppressive drugs within the past year;\n9. Distant metastasis to organs such as the abdominal cavity, pelvis, liver, or lungs;\n10. Active bleeding;\n11. Tumor involvement of adjacent structures such as the prostate or sacral organs, making the tumor unresectable;\n12. Allergy to chemotherapeutic agents, immune checkpoint inhibitors, or cetuximab;\n13. Psychiatric disorders or lack of capacity for civil conduct, unable to provide informed consent.",{"count":364,"type":22},30,[25],"Research Objective:To investigate the efficacy and safety of the \"total neoadjuvant chemoradiotherapy combined with immunotherapy\" regimen for the treatment of locally advanced rectal cancer with high-risk features for recurrence.\n\nStudy Design:A single-arm, multicenter clinical study.\n\nStudy Population: Patients with locally advanced rectal cancer presenting with high-risk features for local recurrence.",[33],"2025-10-08",{"date":370,"type":47},"2025-10-09",{"date":372,"type":22},"2025-10-01",{"date":374,"type":22},"2030-12-31",{"name":376,"class":54},"The First Affiliated Hospital of University of Science and Technology of China",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":394,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":402,"locationsCount":84},"100608177","phase-2-scrt-followed-by-capox--bev--pd-1-inhibitor-for-tnt-in-larc-100608177","NCT07198165","SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC","Short-Course Radiotherapy Combined With CAPOX and Bevacizumab, With or Without PD-1 Inhibitors, as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.\n* Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.\n* Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET\u002FCT.\n* Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.\n* Age 18 to 75 years.\n* ECOG Performance Status of 0 to 1, without severe comorbid medical conditions.\n* Adequate organ function:\n\nHematopoietic: Hemoglobin ≥90 g\u002FL, Platelets ≥80 × 10\\^9\u002FL, Absolute Neutrophil Count ≥1.5 × 10\\^9\u002FL.\n\nHepatic: ALT and AST \\\u003C 2.5 × ULN. Renal: Serum Creatinine \\\u003C 1.5 × ULN.\n\n* Provision of signed and dated written informed consent.\n\nExclusion Criteria:\n\n* Patients found to have BRAF mutations or MSI-H status.\n* Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.\n* History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.\n* Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.\n* Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.\n* Patients with active infections.\n* Poor overall health status, with an ECOG performance status ≥2.\n* Patients who have undergone organ transplantation requiring immunosuppressive therapy, or those requiring long-term corticosteroid treatment for autoimmune diseases.\n* Patients with comorbid conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study.\n* Known hypersensitivity to any of the study drugs.",{"count":385,"type":22},104,[25],"This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.",[148,389,390,33,391,190,392,393,298],"Rectal Adenocarcinoma","Rectal Cancer, Radiotherapy","Immunotherapy","Total Neoadjuvant Treatment","Targeted Therapy",[243,190,391,395,298],"Targeted therapy","2025-09-27",{"date":398,"type":47},"2025-09-30",{"date":400,"type":47},"2025-09-05",{"date":374,"type":22},{"name":403,"class":54},"Ruijin Hospital",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":55},"100607904","rectal-cancer-ctc-trial-100607904","NCT07194616","Rectal Cancer CTC Trial","Impact of Neoadjuvant Chemoradiotherapy Versus Surgery Alone on Circulating Tumor Cells in Patients With Stage II-III Rectal Cancer and Negative Circumferential Resection Margin: a Multicenter Randomized Clinical Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed rectal adenocarcinoma within 12 cm from anal verge\n* Stage II (cT3-4 N0 M0) or stage III (cT1-4 N1-2, M0)\n* Negative circumferential resection margin on staging MRI\n* ASA physical status I-III\n* Signed informed consent\n\nExclusion Criteria:\n\n* Tumor infiltration beyond fascia recti propria on MRI\n* Metastatic disease (stage IV)\n* Recurrent rectal cancer\n* Other concurrent malignancies\n* Emergency surgery required\n* Contraindication to surgery under general anesthesia",{"count":412,"type":22},120,[68],"This prospective, multi-centre, randomised clinical trial aims to compare the effect of neoadjuvant chemoradiotherapy versus primary surgery on circulating tumor cells (CTCs) in patients with stage II-III rectal cancer without circumferential resection mar-gin involvement. CTCs are considered a promising biomarker for disease dissemination and treatment response. Patients will be randomized to either primary surgical resection with total mesorectal excision or long-course neoadjuvant chemoradiotherapy followed by surgery. Serial blood samples will be collected at predefined time points to assess the presence and dynamics of CTCs. Secondary endpoints include perioperative morbidity and mortality, local recurrence rate, disease-free survival, and overall survival. The results of this study may provide new insights into the prognostic role of CTCs and contribute to optimising treatment strategies for rectal cancer.",[33],[417,418,419,420,35,421],"circulating tumor cells","liquid biopsy","neoadjuvant chemoradiotherapy","prognostic biomarkers","surgical resection","2025-09-18",{"date":424,"type":47},"2025-09-26",{"date":426,"type":47},"2025-04-01",{"date":428,"type":22},"2028-03-30",{"name":430,"class":54},"University Hospital Ostrava",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":84},"100579468","single-port-versus-multi-port-robotic-surgery-for-rectal-cancer-100579468","NCT06824688","Single-port Versus Multi-port Robotic Surgery for Rectal Cancer","Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2a Non-randomized Controlled Study Based on the IDEAL Framework","Inclusion criteria comprised: (1) MRI-confirmed distal tumor margin \\\u003C15 cm from the anal verge, (2) biopsy-proven adenocarcinoma, (3) clinical stage I-III (AJCC 8th edition) with potential downstaging post-neoadjuvant therapy, (4) intent-to-treat with sphincter preservation and primary anastomosis, (5) documented informed consent, and (6) adult patients (≥18 years).",{"count":439,"type":22},40,[68],"Single-port versus multi-port robotic surgery for rectal cancer",[33,443],"Robotic Surgical Procedures","2025-09-15",{"date":446,"type":47},"2025-09-19",{"date":448,"type":47},"2024-10-23",{"date":450,"type":22},"2025-12-31",{"name":452,"class":54},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":123,"phases":4,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":84},"100601626","the-effect-of-multimodal-treatment-of-rectal-cancer-on-circulating-tumor-cells-a-prospective-observational-study-100601626","NCT07112937","The Effect of Multimodal Treatment of Rectal Cancer on Circulating Tumor Cells: A Prospective, Observational Study","Inclusion Criteria: rectal cancer -\n\nExclusion Criteria: no other cancer\n\n\\-",{"count":460,"type":22},150,"The prospective study will focus on patients undergoing multimodal treatment for rectal cancer. The main objective of the study will be to monitor changes in circulating tumor cells (CTCs) in the peripheral blood of patients during multimodal treatment. For each patient enrolled in the study, peripheral blood samples will be collected at specified time intervals to determine the presence and quantity of CTCs.\n\nThe CTCs levels will be compared among rectal cancer patients with neoadjuvant chemoradiotherapy and without neoadjuvant chemotherapy.",[33],[417],{"date":465,"type":47},"2025-08-08",{"date":467,"type":47},"2023-05-02",{"date":469,"type":22},"2027-12-31",{"name":471,"class":54},"The Institute of Molecular and Translational Medicine, Czech Republic",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":491,"leadSponsor":493,"locationsCount":84},"100595680","walking-and-sitting-difficulties-after-rectal-cancer-surgery-100595680","NCT07035600","Walking and Sitting Difficulties After Rectal Cancer Surgery","WASA - Walking and Sitting Difficulties After APE","WASA","Inclusion Criteria:\n\n* Patients with rectal cancer to be treated with\u002Fwithout neoadjuvant (chemo)radiation and abdominoperineal excision with or without mesh (APE\u002FELAPE) Informed consent Able to read and understand Swedish or Danish\n\nExclusion Criteria:\n\n* Patients with rectal cancer to be operated by extended abdominoperineal excision (ELAPE) requiring musculocutaneous or muscular flaps to be operated by Hartmann's procedure to be operated by anterior resection (low or high) participation in other randomized trials in conflict with the protocol and endpoints of the WASA trial Not understanding Swedish or Danish Patients reporting habit of physical activity exceeding the WHO-recommendations (150 min + two strength sessions) at baseline.",{"count":481,"type":22},300,[68],"Earlier studies have shown that many patients (up to 30%) who have had a major surgery for rectal cancer, called a rectum amputation (where the entire rectum and anus are removed and the person gets a permanent stoma), still have trouble sitting and walking three years after the surgery. These problems are then seen as long-term or chronic.\n\nWASA is a randomized multicenter international study that will test a way to reduce these problems. It will start in fall 2025 and go on for 3.5 years. About 300 patients will take part.\n\nThe patients will be randomly divided into two groups. One group will get guided online training twice a week, specially made for their needs. The other group will get information about the World Health Organization's (WHO) general advice on physical activity.\n\nThe idea is that special training during the first year after surgery will reduce problems with walking and sitting. If the hypothesis can be confirmed, it could lead to an easy and low-cost way to help many rectal cancer patients feel and function better.",[33,269,390,148],[243,486],"Rectal cancer complications","2025-06-16",{"date":489,"type":47},"2025-06-25",{"date":444,"type":22},{"date":492,"type":22},"2031-04-01",{"name":494,"class":54},"Sahlgrenska University Hospital",{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":502,"sex":17,"minAge":18,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":84},"100569371","phase-2-to-evaluate-dose-and-safety-of-nanoecho-particle-1-using-nanoecho-imaging-device-examinations-of-rectal-lymph-nodes-in-healthy-volunteers-and-rectal-cancer-patients-100569371","NCT06693375","To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients.","A Phase 2a, Exploratory, Two-Part, Open-Label Trial to Evaluate Dose and Safety of NanoEcho Particle-1 (Ferumoxtran) Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers, Part A, and Rectal Cancer Patients, Part B.","Inclusion Criteria:\n\nPart A\n\n1. Willing and able to give written informed consent for participation in the trial.\n2. Healthy male participant, or female participant of non-childbearing potential aged 18 to 50 years, inclusive.\n3. Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg\u002Fm2 at the time of the screening visit.\n4. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator. (Discussion is encouraged between the Investigator and the Sponsor Medical Representative regarding the clinical relevance of any abnormal laboratory value during the pre dose period).\n5. Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone \\[FSH\\] \\>25 IU\u002FL is confirmatory).\n\nMale participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the administration of IMP until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of childbearing potential must use contraceptive methods with a failure rate of \\\u003C 1% to prevent pregnancy (see above) from at least 2 weeks prior to the administration of IMP to 4 weeks after the administration of IMP.\n\nPart B\n\n1. Willing and able to give written informed consent for participation in the trial aged 18 to 99 years, inclusive.\n2. Participant with primary rectal cancer planned for surgery with suspected spread to lymph nodes. No suspicion of systemic tumour spread. MRI must have been performed within the last 3 months before administration of IMP.\n3. Diagnosed with clinical stage T1-T4.\n4. It should be possible to use a probe in rectum (no tumour that blocks).\n5. Male participant, or female participant of non-childbearing potential ≥ 18 years of age.\n6. Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of FSH \\>25 IU\u002FL is confirmatory).\n\nMale participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the administration of IMP until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of childbearing potential must use contraceptive methods with a failure rate of \\\u003C 1% to prevent pregnancy (see above) from at least 2 weeks prior to the administration of IMP to 4 weeks after the administration of IMP.\n\nExclusion Criteria:\n\nPart A\n\n1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.\n2. Any clinically significant illness, medical\u002Fsurgical procedure or trauma within 4 weeks of the administration of IMP.\n3. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.\n4. Any planned major surgery within the duration of the trial.\n5. Any previous or current anorectal disorder which may increase risk or burden of trial participation.\n6. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and\u002For human immunodeficiency virus (HIV).\n7. After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: \\\u003C90 or ≥140 mmHg, or - Diastolic blood pressure \\\u003C50 or ≥90 mmHg, or - Pulse \\\u003C40 or ≥90 bpm\n8. Prolonged QTcF (\\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.\n9. History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to the IMP, IMP excipients or other parenteral iron products, or excipients of the enema to be used in the trial.\n10. Person with pacemaker.\n11. Person with metal implants.\n12. Previous history of full radiation of rectum.\n13. Regular use of any prescribed or non-prescribed medications, including antacids, analgesics, herbal remedies, vitamins and minerals, within 2 weeks prior to the (first) administration of IMP, except occasional intake of paracetamol (maximum 2000 mg\u002Fday and not exceeding 3000 mg\u002Fweek), as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.\n14. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants consented and screened but not dosed in previous phase I trials are not to be excluded.\n15. Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times\u002Fweek is allowed before the screening visit.\n16. Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the (first) administration of the IMP. (Positive results that are expected given the participant's medical history and prescribed medications can be disregarded as judged by the Investigator.)\n17. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.\n18. Presence or history of drug abuse, as judged by the Investigator.\n19. History of, or current use of anabolic steroids, as judged by the Investigator.\n20. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.\n\nPart B History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.\n\n2\\. Person with any kind of stoma. 3. Person with pacemaker. 4. Person with metal implants. 5. Previous history of radiation of rectum. 6. Prescence of malignancy other than rectal cancer. 7. After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: \\\u003C90 or ≥140 mmHg, or - Diastolic blood pressure \\\u003C50 or ≥90 mmHg, or - Pulse \\\u003C40 or ≥90 bpm 8. Prolonged QTcF (\\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.\n\n9\\. History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to the IMP, IMP excipients or other parenteral iron products.\n\n10\\. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants consented and screened but not dosed in previous phase I trials are not to be excluded.\n\n11\\. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.",true,"99 Years",{"count":505,"type":22},12,[25],"Clinical nodal staging for rectal cancer tumours in early stages, is today shown to be unreliable and no precise or accurate methods exist. Thus, there is an unmet need for better clinical staging of rectal cancer in early stages. If new imaging techniques for clinical staging of early rectal cancer are developed an opportunity for increased treatment by local excision and decreased unnecessary radical surgery would be possible.\n\nNanoEcho Particle-1 (NEP-1, Ferumoxtran Lyophilisate 20 mg Fe\u002FmL) will be used, in combination with NanoEcho Imaging Device, to enhance the signal in the detection and identification of possible spread of rectal cancer to nearby rectal regional lymph nodes by magnetomotive ultrasound (MMUS) technology.\n\nNEP-1 is an ultrasmall superparamagnetic iron oxide (USPIO)-based contrast agent. It belongs to the specific contrast agents-group, which are specific to reticuloendothelial system (liver, spleen, lymph nodes, bone marrow), mainly represented by iron oxide nanoparticles coated with macromolecules such as dextran in the presence of adjuvants (mineral salts, polyhydric alcohols, etc.). It belongs to the USPIO sub-group (with a mean particle diameter of 30 nm.\n\nThe NanoEcho Imaging Device is based on the MMUS technology. It aims to identify possible spread of rectal cancer to nearby rectal regional lymph nodes by visualisation of the movement, generated by the nanoparticles (nTrace).\n\nThe iron oxide-based nanoparticles, NEP-1, are administered submucosally at four separate administration sites locally in rectum, close to the suspected tumour area. After some time allowing the particles to spread, the MMUS probe, dressed in a probe cover with ultrasound gel inside, is inserted into the rectum. The nanoparticles are set in motion by a magnetic field, introduced by a rotating magnet located inside the probe. The motion of the tissue, the so-called tissue displacement, is detected with ultrasound and called NanoEcho visualisation of the movement generated by the nanoparticles (nTrace) and is visualised on the screen of the NanoEcho Imaging Device. The higher the concentration of the nanoparticles, the stronger the nTrace signal. Based on the distribution pattern of the particles, the system aims to support the user in distinguishing between healthy and metastatic lymph nodes located nearby the tumour within the rectal region.\n\nPart A In Part A (healthy volunteers) of the trial, NEP-1 will be administered on a single occasion, followed by four MMUS-assessments, in four ascending dose groups of three participants each.\n\nPart B In Part B (rectal cancer patients) of the trial, NEP-1 will be administered on a single occasion, followed by a MMUS assessment in a maximum of ten patients with rectal cancer. The dose level of NanoEcho Particle-1 (Ferumoxtran) to be used and the timepoint for the MMUS assessment will be decided based on Part A.",[509,33],"Healthy Volunteers","2024-11-14",{"date":512,"type":47},"2024-11-18",{"date":514,"type":47},"2024-10-29",{"date":516,"type":22},"2026-06",{"name":518,"class":519},"NanoEcho AB","INDUSTRY"]