[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-carcinoma-crc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-carcinoma-crc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,85,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100642818","phase-1-the-0504-in-patients-with-solid-tumors-100642818",false,"NCT07646106","THE-0504 in Patients With Solid Tumors","NANOFER-THE-0504: A Trial to Assess the Safety and Tolerability of an Investigational Drug THE-0504 for Patients With Solid Tumors","Inclusion Criteria:\n\nPatients will be enrolled in the study if they meet all the following criteria:\n\n1. written informed consent obtained;\n2. both gender adult (≥ 18 years) patients;\n3. diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Pancreas Adenocarcinoma (PaAdCa), Gastric Cancer (GC) and Triple Negative Breast Cancer (TNBrCa);\n4. measurable metastatic disease or locally advanced unresectable tumors;\n5. have exhausted all EMA-approved treatment options;\n6. ECOG Performance Status graded as 0 or 1;\n7. patients able to understand the full nature and the purpose of the trial, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire trial (ability to attend all the planned trial visits according to the time limits included) based on Investigator's judgement;\n8. adequate liver function as assessed by following laboratory tests to be conducted within 28 days before the first dose of study treatment:\n\n   * Total bilirubin ≤ 1.5 × ULN (or ≤ 3 X ULN for patients with documented Gilbert-Meulengracht Syndrome, or for patients with hyperbilirubinemia considered due to liver metastasis).\n   * Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor);\n9. adequate kidney function as assessed by following laboratory test to be conducted within 28 days before the first dose of study treatment:\n\n   • Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin per 1.73 m2 according to the CKD-EPI formula.\n10. adequate bone marrow function as defined as:\n\n    * Hgb ≥ 9 g\u002FdL\n    * ANC ≥1.5x109\u002FL\n    * PLT≥100.0 x109\u002FL\n11. Female patients of childbearing potential and male patients who are sexually active with women of childbearing potential will have to mandatorily use an appropriate method of contraception, according to the definition of Note 3 of ICH M3 Guideline, for the entire duration of the trial and for a minimum of 12 months after last administration of the IMP.\n\nExclusion Criteria:\n\nPatients will not be enrolled if they meet any of the following criteria:\n\n1. pregnant (as determined by a blood pregnancy test at the screening visit) or lactating women;\n2. male patients who are willing to father children during the trial or in the 12 months after the end of IMP administration;\n3. additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;\n4. have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enrol after agreement between the Investigator and Sponsor;\n5. ECOG Performance Status \\> 2;\n6. had not tolerated previously administered Top1 inhibitor treatments;\n7. known active CNS metastatic disease (patients with CNS metastases that are treated with radiotherapy and are stable for at least 28 days before study treatment start could be considered eligible);\n8. serious concurrent illness;\n9. Hgb \\\u003C 9 g\u002FdL;\n10. Transfusion dependent anemia with transfusion dependency of ≥3 months;\n11. Clinically significant iron metabolism disorders (e.g., sickle cell anemia) or use of iron chelators treatments;\n12. Iron overload, hereditary hemochromatosis and similar;\n13. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;\n14. Prolonged QTc interval;\n15. Multiple Sclerosis (MS) or other demyelinating disease, Eaton-Lambert syndrome, history of haemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;\n16. Non-healing wound(s), except for ulcerative lesions caused by the underlying neoplasm;\n17. History of severe allergic or anaphylactic reactions to previous protein-based therapy;\n18. Currently receiving anticoagulation therapy with warfarin;\n19. Known history of HIV infection, unless all the following are applicable:\n\n    * receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥ 3 months prior to the planned first study intervention;\n    * CD4 T-cell count \\> 350 cells\u002FμL\n    * CD4 T-cell nadir (lowest historical count) \\> 350 cells\u002FμL, and • viral load confirmed as \\\u003C 50 copies\u002FmL.\n20. HBV infection, unless on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable; and HCV infection, unless the participant has received curative treatment and viral load was confirmed as undetectable;\n21. Known autoimmune disease, uncontrolled diabetes, vitiligo, or stable thyroid disease;\n22. Patients on chronic (more than 10 days) administration of systemic, high-dose corticosteroids (≥4 mg Dexamethasone or equivalent), not amenable for reduction or suspension;\n23. Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations;\n24. History of drugs and\u002For alcohol abuse;\n25. Patients considered to be unsuitable to participate, in the Investigator's opinion, for any other reason (e.g. consequences of previous medical and\u002For surgical procedures or other medical or ethical reasons);\n26. Planned relocation during the study, which would make impossible to attend the scheduled visits and follow-ups;\n27. Concomitant participation in other clinical trials or participation in the evaluation of any investigational drugs\u002Fproducts up to 4 weeks before this trial (in any case, enrolment procedure should start only after the complete washout of the drugs\u002Fproducts under investigation\\*\\*); or previous participation in the same trial or planned to receive other investigational products during the study.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.",[26,27,28,29,30],"Small Cell Lung Cancer (SCLC)","Colorectal Carcinoma (CRC)","Gastric Cancer (GC)","Triple -Negative Breast Cancer","Pancreas Adenocarcinoma",[32,33,34,35,36,37,38,39],"THE-0504","Solid tumors","Cancer","Single-centre","Thena Biotech","Italy","Phase 1","Europe","RECRUITING","2026-06-09",{"date":43,"type":44},"2026-06-12","ACTUAL",{"date":46,"type":44},"2024-11-13",{"date":48,"type":20},"2027-05-01",{"name":50,"class":51},"Thena Biotech S.r.l.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":52},"100625464","perioperative-outcomes-after-neoadjuvant-therapy-in-colorectal-cancer-100625464","NCT07422974","Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer","The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection","Neocolon","Inclusion Criteria:\n\n* Adults aged ≥18 years with histologically confirmed colorectal cancer\n* Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy)\n* Ability to understand the study protocol and provide written informed consent.\n* Both sexes\n* ASA classification II or III\n* Patients who received neoadjuvant therapy is investigational group and patients who did not receive neoadjuvant therapy is control group\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patients who are not conscious, not oriented, or unable to provide informed consent\n* Patients unable to understand the study protocol\n* Emergency surgical cases\n* Patients on chronic corticosteroid therapy",{"count":62,"type":20},68,"2 Months","OBSERVATIONAL","This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.",[27,67,68,69],"Complications","Neoadjuvant Therapy","Endothelial Dysfunction",[71,68,72,73,74,75],"Colorectal Carcinoma","Microvascular Density","Treatment Outcome","Wound Healing","Critical care","2026-02-13",{"date":78,"type":44},"2026-02-20",{"date":80,"type":44},"2026-01-09",{"date":48,"type":20},{"name":83,"class":84},"Osijek University Hospital","OTHER",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":52},"100603618","the-intraoperative-technical-errors-of-robotic-vs-laparoscopic-radical-right-hemiclectomy-100603618","NCT07138859","The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy","Prospective, Multiceter, Randomized, Controlled Study on the Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy (Superiority Design，ROBOGEON® 2501study)","Inclusion Criteria:\n\n1. 18 years old\\\u003Cage\\\u003C80 years old, regardless of gender;\n2. The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology;\n3. The preoperative clinical staging was cStage I-III (cT1-4a, N0\u002F+, M0) (according to UICC\u002FAJCC-8thTNM tumor staging);\n4. The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers);\n5. Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs;\n6. Preoperative ECOG physical status score ≤ 2;\n7. Preoperative ASA scores I-III;\n8. Patient informed consent.\n\nExclusion Criteria:\n\n1. History of colon surgery (excluding ESD\u002FEMR for colon cancer);\n2. History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy);\n3. Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;\n4. Pregnant or lactating women;\n5. Suffering from severe mental illness;\n6. Multiple primary cancers;\n7. History of other malignant diseases within 5 years;\n8. Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented;\n9. History of unstable angina or myocardial infarction within 6 months;\n10. Heart, lung, liver, kidney dysfunction or history of cerebral infarction;\n11. Simultaneous surgical treatment is required for other diseases;\n12. Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.","80 Years",{"count":94,"type":20},368,[96],"NA","Experimental design: This study is a multicenter, prospective, randomized, controlled phase III clinical trial that identifies, classifies, defines, and quantitatively analyzes technical errors between robotic and laparoscopic radical right hemicolectomy (D3 lymph node dissection), identifies surgical risk areas, compares intraoperative performance, and patient short-term and long-term clinical outcomes.\n\nThis experimental design was based on a 1:1 effective target case ratio between the experimental group and the control group for enrollment. The experimental group underwent robotic radical right hemicolectomy (D3 lymph node dissection), while the control group underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection). The unedited surgical videos of patients were analyzed, and relevant indicators and adverse events were recorded. Patients were followed up in the outpatient department after discharge until 3 years after surgery or until death or recurrence.\n\nSample size calculation: In this study, the calculation of sample size was based on pre experiments and hypotheses, and a goodness test was conducted by selecting the means of two independent samples. Referring to the results of the pilot study, based on a 1:1 random (random number table method) ratio, assuming a significance level of unilateral α=0.025, a test power of 1- β=80%, and a superiority margin of 20% in reducing the number of errors, and considering the maximum dropout rate of 0.1 in this clinical study, the total sample size for this study was determined to be 368 patients (184 in the RRC group and 184 in the LRC group).\n\nPrimary endpoint: incidence of technical errors during right hemicolectomy. Secondary endpoint: incidence of intraoperative complications; The incidence of complications within 30 days after surgery; Total surgical time, robot\u002Flaparoscope time; Estimate the amount of blood loss; Conversion to open surgery rate; Postoperative hospitalization time; Total number of lymph nodes cleared and positive rate of lymph nodes; Early postoperative recovery process (time of first defecation and defecation); 30 day readmission rate and unplanned reoperation rate after surgery; Postoperative nutritional status, inflammation, and immune response; 3-year disease-free survival rate DFS; 3-year overall survival rate (OS).\n\nInclusion criteria: 1) 18 years old\\\u003Cage\\\u003C80 years old, regardless of gender; 2) The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology; 3) The preoperative clinical staging was cStage I-III (cT1-4a, N0\u002F+, M0) (according to UICC\u002FAJCC-8thTNM tumor staging); 4) The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers); 5) Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs; 6) Preoperative ECOG physical status score ≤ 2; 7) Preoperative ASA scores I-III; 8) Patient informed consent.\n\nExclusion criteria: 1) History of colon surgery (excluding ESD\u002FEMR for colon cancer); 2) History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy); 3) Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment; 4) Pregnant or lactating women; 5) Suffering from severe mental illness; 6) Multiple primary cancers; 7) History of other malignant diseases within 5 years; 8) Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented; 9) History of unstable angina or myocardial infarction within 6 months; 10) Heart, lung, liver, kidney dysfunction or history of cerebral infarction; 11) Simultaneous surgical treatment is required for other diseases; 12) Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.",[27,99],"Right Hemicolectomy",[27,101,102,103,104,105,106],"right hemicolectomy","Robotic surgery","Errors","Intraoperative bleeding","Dangerous areas","Clinical outcome","NOT_YET_RECRUITING","2025-08-17",{"date":110,"type":44},"2025-08-24",{"date":112,"type":20},"2025-08",{"date":114,"type":20},"2030-12",{"name":116,"class":84},"The Affiliated Hospital of Qingdao University",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100563239","patient-led-follow-up-from-home-after-surgery-for-colorectal-carcinoma-100563239","NCT06613581","Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma","Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE","PROMISE","inclusion criteria\n\n* Age ≥ 21 years\n* Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago\n* Scheduled or currently undergoing postoperative surveillance according to national guidelines\n* Written informed consent by the patient\n* Access to a smartphone\n\nExclusion criteria\n\n* Patients with a severely complicated postoperative course, needing in hospital follow- up longer than 6 months postoperatively\n* Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and\u002For thorax\n* Patients with comorbidity or other malignancy that requires imaging of the abdomen and\u002For thorax every year or more frequent\n* Patients with active implantable devices - e.g. pacemaker or implantable defibrillator\n* Inability to complete the questionnaires due to illiteracy and\u002For insufficient proficiency of the Dutch language","21 Years",{"count":127,"type":20},200,[96],"The primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status.\n\nA series of assessments are performed in the home setting:\n\n* Blood withdrawal for CEA determination\n* Quality of life questionnaires to assess both mental and physical symptoms\n* Vital parameters using a Smart Sensor",[27],[132,133,134,135,136,137],"Colorectal carcinoma","Home-based follow-up","Patient-led","Capillary blood sampling","Biosensor","EORTC","2024-09-23",{"date":140,"type":44},"2024-09-26",{"date":142,"type":44},"2024-07-18",{"date":144,"type":20},"2031-09",{"name":146,"class":84},"Erasmus Medical Center",5]