[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-adenocarcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,56,82,117,149,199,257,288,318,339,359,386,412,436,468,491,526,550,579,605,645,671,693,713,746],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100603974","family-communications-after-genetic-testing-100603974",false,"NCT07143487","Family Communications After Genetic Testing","Evaluation of Provider vs. Patient Mediated Cascade Genetic Testing of First-Degree Relatives of Patients With Newly Diagnosed Colorectal Cancer","Inclusion Criteria:\n\n* STEP 1 PROBANDS: Age \\>= 18 years\n* STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV\n\n  * Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into\u002Finvolve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary\n  * Patients with more than one primary colon adenocarcinoma are eligible\n* STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer\n* STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers\n* STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible\n* STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes\n* STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis\n* STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish\n* STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members\n\n  \\* No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician\n* STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene\n* FDRs: Age \\>= 18 years\n* FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes\n* FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents\n* FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish\n\nExclusion Criteria:\n\n\\-",true,"ALL","18 Years",{"count":21,"type":22},4186,"ESTIMATED","INTERVENTIONAL",[25],"NA","This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Colon Adenocarcinoma","Colorectal Adenocarcinoma","Rectal Adenocarcinoma","Stage I Colon Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Rectal Cancer AJCC v8","Stage II Colon Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Rectal Cancer AJCC v8","Stage III Colon Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Rectal Cancer AJCC v8","Stage IV Colon Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Rectal Cancer AJCC v8","RECRUITING","2026-07-01",{"date":46,"type":47},"2026-07-02","ACTUAL",{"date":49,"type":47},"2026-04-06",{"date":51,"type":22},"2032-11-05",{"name":53,"class":54},"Alliance for Clinical Trials in Oncology","OTHER",276,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100615328","a-feasibility-study-of-mass-based-response-drug-screening-to-guide-personalized-hyperthermic-intraperitoneal-chemotherapy-for-high-grade-appendiceal-and-colorectal-adenocarcinoma-with-peritoneal-metastasis-100615328","NCT07291180","A Feasibility Study of Mass-Based Response Drug Screening to Guide Personalized Hyperthermic Intraperitoneal Chemotherapy for High-Grade Appendiceal and Colorectal Adenocarcinoma With Peritoneal Metastasis","Inclusion Criteria:\n\n* Has histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV\n\n  1. Appendiceal adenocarcinoma (moderately\u002Fpoorly differentiated, and\u002For signet ring cell tumors)\n  2. Colorectal adenocarcinoma\n  3. Suspected colon, small bowel, or appendiceal adenocarcinoma in setting of unknown primary\n* Limited or no extraperitoneal metastases (any of the below)\n\n  a) Any extraperitoneal metastases must be limited, stable and treatable\n* Has adequate organ function, as described below; all screening laboratory tests should be performed within 30 days prior to the first HIPEC\n* Expected survival at the time of first HIPEC is greater than 3 months\n* Exhibits unresectable disease (bowel or mesenteric involvement) or PCI \\> 19\n\nDemographics\n\n* Adult patient at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.\n* Has an ECOG performance status score of 0-2.\n\nMale Participants\n\n* A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.\n\nFemale Participants\n\n* A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence). Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInformed Consent\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for FBR. However, the participant may participate in the main study without participating in FBR.\n\nAlternative Eligibility\n\n* In addition to the criteria above, if a patient has undergone less than 8 rounds of chemotherapy at another institution (prior to initial diagnostic laparoscopy) and has not undergone radiation, ablative procedures, or cytoreductive surgery, then they are still eligible to enter the study at the second diagnostic laparoscopy step\n\nExclusion Criteria:\n\n* Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has a known allergy to medications used in this study. Note: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.\n* Has hypoxia as defined by pulse oximeter reading \\\u003C92% at rest or requires intermittent or chronic supplemental oxygen.\n* No concurrent malignancy that may interfere with the study aims at the discretion of the investigator.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known significant extraperitoneal metastasis.\n* Has creatine clearance \\\u003C60 mL\u002Fm\\^2 per the Cockcroft-Gault formula\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.\n* Has poorly controlled hypertension defined as SBP ≥150mmHg and\u002For DBP ≥90mmHg.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).\n* Has progressive disease following the first 3 months of systemic chemotherapy prior to HIPEC who is not in a stable condition to continue with the trial.\n\nPrior\u002FConcomitant Therapy\n\n* Has received radiation, ablative procedures, cytoreductive surgery, or systemic therapy including chemotherapy to treat metastatic disease within 3 months of initial laparoscopy.\n\nDiagnostic Assessments\n\n* Has an active infection requiring systemic therapy.\n* Has a known active TB\u002F COVID infection.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.\n* Has a known history of poorly controlled HIV infection despite anti-retroviral therapy.\n* Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \\[qualitative\\] is detected) infection that is poorly controlled.\n\nNote: Testing for HBV and HCV is only required if mandated by the local health authority.\n\nOther Exclusions\n\n* Inability to receive chemotherapy due to medical\u002Finsurance reasons.\n* Requires emergency surgery due to bleeding, perforation, or obstruction.\n* Has undergone previous iterative intraperitoneal therapy.\n* Has contraindication to chemotherapy of choice.","81 Years",{"count":64,"type":22},20,[25],"This study will evaluate the role of mass-based response testing (MRT) to select and deliver personalized hyperthermic intraperitoneal chemotherapy (HIPEC) regimens to patients with peritoneal metastasis (PM) from high-grade appendiceal adenocarcinomas (HGAA) and colorectal cancer (CRC).",[68,29,69],"Appendiceal Cancer","Peritoneal Metastases",[68,29,69,71],"Iterative Hyperthermic Intraperitoneal Chemotherapy (IHIPEC)","2026-06-17",{"date":74,"type":47},"2026-06-22",{"date":76,"type":47},"2026-02-17",{"date":78,"type":22},"2027-12",{"name":80,"class":54},"Yale University",1,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":81},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778","NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",{"count":90,"type":22},70,[25],"Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,29],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin's Lymphoma","Chronic Lymphocytic Leukemia","Follicular Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Colorectal Cancer","Esophageal Squamous Cell Carcinoma","Heart Cancer","Cholangiocarcinoma",{"date":110,"type":47},"2026-06-18",{"date":72,"type":47},{"date":113,"type":22},"2028-07",{"name":115,"class":116},"University Hospital, Angers","OTHER_GOV",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":81},"100641183","phase-1-tlr9-immunotherapy-for-peritoneal-carcinomatosis-100641183","NCT07658196","TLR9 Immunotherapy for Peritoneal Carcinomatosis","TLR9 Immunotherapy for Peritoneal Carcinomatosis (TIPC) - Phase 1 Study of the Safety and Efficacy of ACM-CpG Intraperitoneal Injections for Treatment in Patients With Colorectal or Appendiceal Adenocarcinoma Peritoneal Metastases or Malignant Ascites","TIPC","Inclusion Criteria:\n\n* Patients eligible for inclusion in this study must meet all of the following criteria:\n\n  1. Male or female patients age ≥ 18 years of age at the time of informed consent\n  2. Must be able to provide written informed consent, stating an understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements\n  3. Must have documented CRC or appendiceal adenocarcinoma peritoneal carcinomatosis or malignant ascites. Primary tumor may be intact and limited liver and\u002For lung disease is permitted\n  4. Must have evaluable disease by physical examination, serum tumor markers, radiologic assessment, or laparoscopic visual assessment\n  5. Must have a life expectancy of ≥ 12 weeks as estimated by the investigator\n  6. Must have an ECOG status of ≤ 2\n  7. Patients with acceptable laboratory values defined as:\n\n     * Estimated creatinine clearance (calculated using Cockcroft-Gault formula, or measured) ≥ 60 mL\u002Fmin, not dialysis dependent\n     * Total bilirubin ≤ 1.5 mg\u002Fdl, unless elevated bilirubin is clearly related to Gilbert syndrome (and total bilirubin \\\u003C 6.0 mg\u002Fdl)\n     * Alanine aminotransferase (ALT) ≤ 3.5 x upper limit of normal (ULN)\n     * Aspartate aminotransferase (AST) ≤ 3.5 x ULN\n     * Absolute neutrophil count \\> 1.0 x 109\u002FL (must be independent of blood product administration)\n     * Platelet count \\> 100 x 109\u002FL (must be independent of blood product administration)\n     * Hemoglobin ≥ 8 g\u002FdL (must be independent of blood product administration)\n  8. Surgically sterile patients or patients of childbearing potential (CBP) who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug\n  9. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to administration of study drug\n\nExclusion Criteria:\n\n1. Has received prior TLR9 therapy\n2. Has received chemotherapy, radiotherapy, or biological cancer therapy within 21 days or 5 half-lives (whichever is shorter) of the start of treatment\n3. Has received an investigational agent within 28 days of the start of treatment\n4. Has received a commercial vaccine (flu, COVID, etc.) within 2 weeks of C1D1\n5. Has any unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve\n6. Has a history of histologically confirmed metastases outside of the peritoneal cavity, liver, or lungs\n7. Has high volume liver or lung metastases, defined as \\> 50% replacement of the liver volume by metastatic disease or \\> 5 lung lesions greater than 1 cm in size\n8. Tumor causing biliary obstruction not amenable to stenting or percutaneous drainage\n9. Ongoing or untreated intra-abdominal infection or bowel obstruction\n10. Has known, clinically active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) (Note: Testing is not required)\n11. Receiving continuous systemic corticosteroid therapy (≥ 10 mg\u002Fday of prednisolone or equivalent)\n12. Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n    * A history of newly diagnosed transmural myocardial infarction, cerebral infarction, or pulmonary embolism within 6 months, except those approved by the medical monitor\n    * A history of newly diagnosed deep vein thrombosis (DVT) within 3 months\n    * Left ventricular ejection fraction (LVEF) \\\u003C 50%\n    * QTc \\>480 msec\n13. Active bacterial, viral, or fungal infection: patients with ongoing use of prophylactic antibiotics, antiviral agents, or antifungal agents remain eligible as long as there is no evidence of active infection\n14. Other active malignancy within 2 years excluding cutaneous squamous or basal cell carcinomas\n15. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results\n16. History of hypersensitivity to TLR9 agonists\n17. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)",{"count":126,"type":22},24,[128],"PHASE1","The goal of this clinical trial is to determine the safety and efficacy of of ACM-CpG for inoperable peritoneal metastases or malignant ascites. The main questions it aims to answer are:\n\n• To determine the safety and maximum tolerated dose (MTD) or optimal biologic dose (OBD) of intraperitoneal injection(s) of ACM-CpG for inoperable peritoneal metastases or malignant ascites? Researchers will assign treatment levels using escalating doses of ACM-CpG Therapy.\n\nParticipants will:\n\n* Will receive at least one dose of ACM-CpG therapy on Day 1 of a 28-day treatment cycle.\n* May receive up to 2 additional injections if they have clinically stable or responsive disease.\n* Must visit the clinic on Days 1, 4, 7, 10, 14, 21, and 28 for checkups and tests.\n* Will have a CT scan or MRI performed every 8 weeks for 3 scans and then continue to receive scans every 12 weeks to monitor their disease.",[131,29,132,133],"Malignant Ascites","Peritoneal (Metastatic) Cancer","Appendiceal Adenocarcinoma",[135,136,137,131,138,133,139],"Metastatic disease must be primarily located in the peritoneal cavity","ACM-CpG","TLR9","Peritoneal Carcinomatosis,","CRC","NOT_YET_RECRUITING","2026-06-16",{"date":110,"type":47},{"date":144,"type":22},"2026-07",{"date":146,"type":22},"2030-07",{"name":148,"class":54},"Brown University",{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":160,"conditions":161,"keywords":178,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":198},"100542405","early-detection-of-advanced-adenomas-and-colorectal-cancer-100542405","NCT06342440","Early Detection of Advanced Adenomas and Colorectal Cancer","A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer","AACRC","Inclusion Criteria:\n\n* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.\n* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer syndromes (identified through genetic testing).\n* Inflammatory bowel diseases.\n* Lack of written informed consent.",{"count":158,"type":22},2000,"OBSERVATIONAL","This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.",[105,162,163,29,164,165,166,167,168,169,170,171,172,173,174,175,176,177],"Colorectal Neoplasms","Colorectal Polyp","Colorectal Disorders","Colorectal Dysplasia","Colorectal Cancer Stage I","Colorectal Cancer Stage II","Colorectal Cancer Stage III","Colorectal Cancer Stage IV","Colorectal Neoplasms Malignant","Colorectal Serrated Adenocarcinoma","Colorectal Adenoma With Severe Dysplasia","Colorectal Adenoma With Mild Dysplasia","Colorectal Adenoma With Moderate Dysplasia","Colorectal Adenoma and Carcinoma 1","Colorectal Adenomatous Polyp","Colorectal Adenocarcinoma Metastatic in the Liver",[179,180,181,182,183,184,185,186,187,188,189,190],"Early detection","Micro RNA","miRNA","Liquid biopsy","Machine learning","Artificial Intelligence","Incidence","Polypectomy","Screening","Surveillance","Exosome","Vascicles","2026-06-15",{"date":72,"type":47},{"date":194,"type":47},"2020-03-15",{"date":110,"type":22},{"name":197,"class":54},"City of Hope Medical Center",6,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":211,"conditions":212,"keywords":230,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":256},"100520064","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-mesothelin-targeting-logic-gated-car-t-in-participants-with-solid-tumors-that-express-msln-and-have-lost-hla-a02-expression-100520064","NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion",{"count":208,"type":22},474,[128,210],"PHASE2","The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[213,105,214,215,216,217,218,219,29,139,220,221,222,223,224,225,226,227,228,229],"Solid Tumor, Adult","NSCLC","Non Small Cell Lung Cancer","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Pancreatic Neoplasm","Colon Cancer","Rectal Cancer","Cancer","Ovarian Cancer","Ovarian Neoplasms","Mesothelioma","Mesothelioma, Malignant","Ovary Cancer","Lung Cancer","MESOM",[231,232,233,234,235,236,237,238,239,240,241,242,222,243,139,105,228,214,244,229,223,225,245],"CAR T Cell","Solid Tumors","Autologous","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","Gene Therapy","blocker","PANC","OVCA","Logic-gate","2026-06-10",{"date":248,"type":47},"2026-06-12",{"date":250,"type":47},"2024-04-03",{"date":252,"type":22},"2029-06",{"name":254,"class":255},"A2 Biotherapeutics Inc.","INDUSTRY",12,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":287},"100419234","minimal-residual-disease-assessment-in-patients-with-colorectal-cancer-the-mirda-c-study-100419234","NCT04739072","Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study","Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histological\u002Fcytological confirmation of colorectal adenocarcinoma.\n3. Patients with any stage colorectal adenocarcinoma deemed potentially eligible for curative intent treatment. Patients with stages II-IV colorectal cancer post-R0 resection may also be enrolled onto the protocol any time before or up to 3 months post-surgery and prior to initiating adjuvant therapy.\n4. Ability to understand and the willingness to sign a written informed consent document.\n5. Willing to pursue standard of care surveillance post completion of curative therapies.\n6. Willing to provide blood samples for correlative research.\n\nExclusion Criteria:\n\n1. Known active malignancies other than colorectal adenocarcinoma that may interfere with detection and \u002F or interpretation of circulating plasma markers. Patients with known clonal hematopoiesis of indeterminate potential are eligible.\n2. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",{"count":265,"type":22},1000,"This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules\u002Fchemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.",[29,32,35,268,269,270,38,271,272,273,274,275,276,277],"Stage IIA Colorectal Cancer AJCC v8","Stage IIB Colorectal Cancer AJCC v8","Stage IIC Colorectal Cancer AJCC v8","Stage IIIA Colorectal Cancer AJCC v8","Stage IIIB Colorectal Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v6","Stage IVA Colorectal Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2026-05-27",{"date":280,"type":47},"2026-05-29",{"date":282,"type":47},"2019-11-22",{"date":284,"type":22},"2028-12-31",{"name":286,"class":54},"M.D. Anderson Cancer Center",10,{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":18,"minAge":295,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":315,"locationsCount":317},"100340699","phase-1-phase-1-study-of-inbrx-109-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-including-sarcomas-100340699","NCT03715933","Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas","An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas","Inclusion Criteria:\n\n1. Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.\n2. Part 3 combination therapy expansion tumor types:\n\n   * Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.\n   * Colorectal adenocarcinoma: Patients who have failed 1 (one) prior line of systemic therapy that did not include irinotecan.\n   * Colorectal adenocarcinoma: Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD\u002FTPI-naïve.\n3. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.\n4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years).\n6. Estimated life expectancy of at least 12 weeks.\n7. Availability of archival tissue or fresh cancer biopsy are mandatory.\n\nExclusion Criteria:\n\n1. Prior treatment with or exposure to DR5 agonists.\n2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.\n3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.\n4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.\n5. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.\n6. Prior or concurrent malignancies. Exceptions per protocol.\n7. Hematologic malignancies.\n8. Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded.\n9. Chronic liver diseases including fatty liver. Exception: Patients \\\u003C 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion\u002Fexclusion criteria is confirmed.\n10. Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.\n11. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.\n12. Known sensitivity or contraindications to the following drugs:\n\n    * Ewing sarcoma: irinotecan or TMZ\n    * colorectal adenocarcinoma: FU, leucovorin, irinotecan, bevacizumab or FTP\u002FTPI\n13. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.\n14. Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment.\n15. Major surgery within 4 weeks prior to enrollment on this trial.\n16. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.\n17. Other exclusion criteria per protocol.","12 Years","85 Years",{"count":298,"type":22},411,[128],"This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).",[302,29],"Ewing Sarcoma",[304,305,232,306,307,302,139,308],"Phase 1","Phase 1 Clinical Trial","Sarcoma","DR5","colorectal adenocarcinoma","2026-05-20",{"date":311,"type":47},"2026-05-22",{"date":313,"type":47},"2018-10-08",{"date":252,"type":22},{"name":316,"class":255},"Inhibrx Biosciences, Inc",36,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100635354","phase-2-testing-the-combination-of-anti-cancer-drugs-botensilimab-agen1181-and-balstilimab-agen2034-after-standard-treatment-for-colorectal-cancer-combat-trial-100635354","NCT07551596","Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial","A Phase 2 Study of Microsatellite Stable Colorectal Cancer (Stage 2 or 3) With Radiographic Occult Molecular Residual Disease Treated With Botensilimab (AGEN1181; Bot) Plus Balstilimab (AGEN2034, Bal) After Established Definitive Therapy (COMBAT Study)","Inclusion Criteria:\n\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of botensilimab (AGEN1181) in combination with balstilimab (AGEN2034) in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 (or Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)\n\n  * Patients with documented Gilbert's syndrome may be included if total bilirubin is ≤ 3 x ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Creatinine clearance ≥ 40 mL\u002Fmin\n\n  * Creatinine clearance (Clcr) can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation\n* Histological confirmation of colorectal cancer (adenocarcinoma) (CRC)\n* Post-R0 resection of stages II and III CRC and all planned adjuvant therapies have been completed\n* No evidence of radiographic disease within 28 days (before or after) of a positive ctDNA assay\n* Evident MRD as defined by positive ctDNA (Signatera MRD) assay. MRD status will be confirmed with the Signatera™ assay prior to initiation of therapy. The MRD status should be assessed at least 4 weeks post-surgery and at least 3 weeks after last chemo to avoid transient false positives. The window from MRD positivity to first dose should be no more than 90 days\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The effects of botensilimab (AGEN1181) and balstilimab (AGEN2034) on the developing human fetus are unknown. Women of child-bearing potential \\[refer to MD Anderson (MDA) Policy CLN 1114\\] must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 4 months after the last dose. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months)\n  * History of hysterectomy or bilateral salpingo-oophorectomy\n  * Ovarian failure (follicle stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy)\n  * History of bilateral tubal ligation or another surgical sterilization procedure.)\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of administration. In addition, women of childbearing age should not donate egg(s) and men should not donate sperm for the duration of study participation and 6 months after completion of the last dose of botensilimab (AGEN1181) and balstilimab (AGEN2034).\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to botensilimab (AGEN1181) and balstilimab (AGEN2034)\n* Patients that are pregnant, breast feeding, or planning to become pregnant while enrolled in the study, up to the end of treatment (EOT) visit, are excluded from this study because botensilimab (AGEN1181) and balstilimab (AGEN2034) are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with botensilimab (AGEN1181) and balstilimab (AGEN2034), breastfeeding should be discontinued if the mother is treated with botensilimab (AGEN1181) and balstilimab (AGEN2034)\n* Patients with microsatellite instability (MSI-high) or deficient mismatch repair (dMMR) CRC (MMR\u002FMSI testing is required prior to enrollment)\n* Concurrent treatment with a drug with which the interactions are considered clinically significant by the investigator. Major surgical procedure or significant traumatic injury within 21 days before start of study medication \\* Note: If participants received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment\n* Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for metastatic (m)CRC\n* Receipt of any organ transplantation, including allogeneic stem cell transplantation (exception: transplants that do not require immunosuppression, such as hair transplant)\n* Patients with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent\n* Patients with known severe hypersensitivity reactions to monoclonal antibodies (grade ≥ 3 National Cancer Institute \\[NCI\\]-Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\] 5.0), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients with clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial. Stable, well-controlled conditions such as vitiligo, type 1 diabetes, or hypothyroidism on replacement can be allowed\n* Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ grade 2\n* Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted)\n* Evidence of any serious bacterial, viral, parasitic, or systemic fungal infections within the 30 days prior to the first dose of study drug\n* Patients with a history of (non-infectious) pneumonitis that required steroids, ongoing pneumonitis, or history of interstitial lung disease\n* Patients with grade \\> 3 proteinuria (\\> 3.5 g\u002F24 hours)\n* Patients with grade \\> 3 hypertension (systolic blood pressure \\> 160 or diastolic blood pressure \\> 100)\n* Active autoimmune disease requiring systemic treatment in the past 2 years (e.g., steroids \\> 10 mg prednisone equivalent, biologics, other immunosuppressants)\n* Active or prior inflammatory bowel disease (Crohn's, ulcerative colitis, microscopic colitis). This is especially critical in colon cancer patients where you might otherwise capture inflammatory bowel disease (IBD)-associated CRC",{"count":64,"type":22},[210],"This phase II trial tests the effect of the botensilimab in combination with balstilimab in treating patients with stage II\u002FIII colorectal adenocarcinoma with detectable circulating tumor (ct) deoxyribonucleic acid (DNA) in the blood. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab may be an effective combination to remove any remaining microscopic cancer cells in the bloodstream in patients with stage II\u002FIII colorectal adenocarcinoma. In addition, clearing the ctDNA from the blood may serve as an early indicator of treatment response.",[29,35,38],"2026-05-14",{"date":331,"type":47},"2026-05-15",{"date":333,"type":22},"2026-08-14",{"date":335,"type":22},"2026-09-30",{"name":337,"class":338},"National Cancer Institute (NCI)","NIH",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":81},"100533376","phase-1-fluoxetine-for-the-modification-of-colorectal-tumor-immune-cells-before-surgery-in-patients-with-colorectal-cancer-100533376","NCT06225011","Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer","Repurposing Drugs as Immunotherapeutic Agents: Changes in Colorectal Tumor Immune Cells After Targeting Serotonin","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age at visit 1\n* Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study\n* World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥ 1.5x10\\^9\u002FL\n* Platelets ≥ 100x10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Serum creatinine (sCr) ≤ 1.5 x upper limit of normal (ULN)\n* Creatinine clearance (Ccr) ≥ 40 mL\u002Fmin (as calculated by Modified Cockcroft-Gault formula)\n* Serum total bilirubin ≤ 1.5 x ULN\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.5 x ULN\n* Baseline corrected QT (QTc) within normal limits per the Bazett formula. Any electrocardiogram (EKG) done prior to consent is acceptable for baseline QTc monitoring.\n\n  * Normal QTc ranges from 350-450 ms for adult men and from 360-460 ms for adult women\n\nExclusion Criteria:\n\n* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data\n* A diagnosis of metastatic colorectal adenocarcinoma\n* Individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection\n* Individuals with absolute or relative contraindications to fluoxetine\n\n  * Baseline prolonged QTc\n  * Concurrently taking tamoxifen, pimozide, or thioridazine\n* Individuals using other SSRIs, serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), lithium or other antidepressants at time of initial biopsy\n* Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)",{"count":287,"type":22},[128],"This phase I trial tests whether fluoxetine (prozac) works to modify the tumor immune cells before surgery in patients with colorectal cancer. Fluoxetine is a commonly used selective serotonin reuptake inhibitor (SSRI) prescribed for major depressive disorder and generalized anxiety. Giving fluoxetine may modify the immune cell composition in the tumor and its microenvironment and may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread in patients with colorectal cancer.",[29],"2026-05-07",{"date":352,"type":47},"2026-05-11",{"date":354,"type":47},"2025-03-20",{"date":356,"type":22},"2027-07-01",{"name":358,"class":54},"Jonsson Comprehensive Cancer Center",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100594490","phase-1-a-study-of-225acac-aky-1189-in-patients-with-solid-tumors-100594490","NCT07020117","A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors","NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologic or cytologic confirmation of locally advance or metastatic disease\n* Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Documented disease progression on prior line of therapy for metastatic disease\n\nExclusion Criteria:\n\n* Prior treatment with a therapeutic radiopharmaceutical\n* Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin\n* Received an investigational agent within the previous 28days\n* Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity",{"count":367,"type":22},150,[128],"This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\\[225Ac\\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.",[371,372,373,215,374,29,375],"Urothelial Carcinoma Bladder","Triple Negative Breast Cancer (TNBC)","Hormone Receptor Positive Breast Adenocarcinoma","Cervical Adenocarcinoma","Head and Neck Cancer","2026-04-17",{"date":378,"type":47},"2026-04-21",{"date":380,"type":47},"2025-08-22",{"date":382,"type":22},"2032-06",{"name":384,"class":255},"Aktis Oncology, Inc.",9,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":81},"100589542","measurement-of-mmp-14-protein-a-potential-new-marker-for-colorectal-cancer-detection-in-plasma-vesicles-named-exosomes-100589542","NCT06955767","Measurement of MMP-14 Protein, a Potential New Marker for Colorectal Cancer Detection, in Plasma Vesicles Named Exosomes","Performance of Serum Matrix Metalloproteinase (MMP14) Assay as a Novel Biomarker for Colorectal Cancer Screening in Subjects From 50 to 74 Years Old Referred for Colonoscopy After Positive FIT","EXOSCOL02","Inclusion criteria:\n\n* Individuals presenting for colonoscopy with a positive FIT result.\n* Positive fecal immunoassay requiring total colonoscopy under general anesthesia.\n* Persons having agreed to participate in the study (signed consent form)\n* Adults affiliated to a health insurance scheme.\n\nExclusion criteria:\n\n* History of other cancer not in remission or in remission for less than five years (with the exception of cervical cancer or basal cell skin cancer treated with curative intent)\n* Patients undergoing chemotherapy\n* Legally protected individuals",{"count":395,"type":22},650,[25],"Colorectal cancer is the third most common cancer in men, and the second most common in women. Screening for colorectal cancer is based on the search for blood in the stool using fecal immunochemical test (FIT). Occult bleeding is an indication for colonoscopy. In a FIT positive population, 60% of colonoscopies are negative, 34% diagnose an adenomatous lesion, and 6% a cancer. The identification of new biological markers could reduce the number of colonoscopies performed. Cancer cells release extracellular vesicles that contain proteins, mRNAs, DNA, which they can transfer to neighbouring or distant cells. The use of exosomal proteins as novel tumor markers looks very promising. We performed a pilot study comparing the levels of different exosomal proteins in 74 subjects which was recently accepted for publication in Journal of Clinical Laboratory Analysis. Comparison of results showed that only matrix metalloproteinase 14 (MMP14) was significantly higher in patients with colorectal cancer or adenoma than in people with normal colonoscopy.\n\nThe primary objective of the current study is to determine the best cut-off value of MMP-14 for colorectal cancer screening and to evaluate the performance (Sensitivity, Specificity…) associated to this cut-off value. The secondary objective will be to determine the best cut-off value of MMP-14 for colorectal adenomas screening and to evaluate its performance.\n\nFor this purpose, 650 patients, seen for diagnostic colonoscopy following a positive FIT test, will be included in the study. After blood collection and exosome isolation, MMP-14 will be measured using a quantitative test (enzyme-linked immunosorbent assay) and the results will be associated with colonoscopy results to determine the sensitivity, specificity, positive predictive value (PPV) and net present value (NPV).",[29],[29,400,401,402],"Exosomes","Matrix Metalloproteinase 14","MMP-14","2026-04-08",{"date":405,"type":47},"2026-04-09",{"date":407,"type":47},"2026-04-02",{"date":409,"type":22},"2028-04-02",{"name":411,"class":54},"CHU de Reims",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":419,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100589214","phase-3-ak112-and-chemotherapy-in-first-line-metastatic-colorectal-cancer-100589214","NCT06951503","AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer","A Randomized, Controlled, Multicenter Phase III Clinical Study of AK112 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy in First-line Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥ 18 years and ≤ 75 years.\n3. ECOG status of 0 or 1.\n4. Estimated survival ≥ 3 months.\n5. Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.\n6. Subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. Subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll.\n7. At least one measurable disease based on RECIST v1.1.\n8. Adequate organ function per protocol-defined criteria.\n9. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.\n2. Participating in other interventional study within 4 weeks prior to the first study drug administration.\n3. Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.\n4. Current presence of uncontrolled combined disease.\n5. Active clinical infections.\n6. History of severe bleeding tendency or coagulation dysfunction.\n7. Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.\n8. Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.\n9. Current presence of significant radiographic or clinical manifestations of GI obstruction.\n10. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).\n11. Pregnant or lactating women.\n12. Any condition considered by the investigator to be inappropriate for enrollment.\n13. Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and\u002For uncertainty in survival.","75 Years",{"count":421,"type":22},560,[423],"PHASE3","This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.",[29],"2026-03-03",{"date":428,"type":47},"2026-03-04",{"date":430,"type":47},"2025-05-27",{"date":432,"type":22},"2029-01-07",{"name":434,"class":255},"Akeso",2,{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":453,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":5},"100624271","phase-2-upfront-trastuzumab-deruxtecan-plus-capecitabine-and-bevacizumab-for-patients-with-her-2-positive-metastatic-colorectal-cancer-100624271","NCT07407465","Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.","Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.","CHIMERA","Inclusion Criteria:\n\n* Written informed consent obtained from the patient\u002Flegal representative before performing any protocol-related procedures, including screening evaluations.\n* Patient state to comply with all the study procedures and treatments. Patients must be accessible for treatment and follow-up. Patients registered for this trial must be treated and followed at the participating Centre.\n* Age ≥ 18 years at the time of informed consent.\n* ECOG Performance Status ≤ 2.\n* Life expectancy of ≥ 3 months.\n* Have histologically documented adenocarcinoma of the colon or rectum, which is initially metastatic or unresectable locally advanced.\n* Subjects must be willing to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks (or at least 25 freshly sectioned slides) for translational analyses (sampled before 1st treatment course). If archival tissue is not available for HER2 testing or for exploratory aims, then a newly obtained baseline biopsy of an accessible tumor lesion is required before Cycle 1 Day 1 timeframe. Biopsy must contain adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.\n* Presence of locally determined HER2 overexpression\u002Famplification defined as IHC 3+ or 2+\u002FISH amplified on archival\u002Fnewly obtained tumor tissue, according to the American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines for gastric\u002Fgastroesophageal cancer.\n* Have RAS known status and pMMR\u002FMSS status by standard local testing.\n* Have radiographically measurable disease per RECIST v1.1.\n* Have adequate hematological, hepatic, renal, cardiac and coagulation function, as defined below, obtained ≤ 7 days prior to enrollment (Cycle 1 Day 1):\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3. (Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).\n  * Platelet count ≥ 100000\u002Fmm3. (Platelet transfusion is not allowed within 1 week prior to C1D1)\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present).\n  * Serum albumin ≥ 2.5 g\u002FdL.\n  * Creatinine clearance ≥ 60 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight).\n  * Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before enrollment.\n  * International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 x ULN.\n* Have had adequate washout period from previous treatment before screening, defined as:\n\n  * ≥ 4 weeks from major surgery.\n  * ≥ 4 weeks from radiation therapy, including palliative stereotactic radiation therapy to the chest.\n  * ≥ 3 weeks from anti-cancer chemotherapy \\[immunotherapy (non-antibody-based therapy)\\], retinoid therapy, hormonal therapy.\n  * ≥ 4 weeks from antibody-based anti-cancer therapy\n  * ≥ 2 weeks or 5 half-lives (whichever is longer) from targeted agent- and small molecule-based therapy\n  * ≥ 6 weeks from nitrosureas or mitomycin C\n  * ≥ 1 week from TKIs approved for treatment of patients with non-small-cell lung cancer (baseline CT must be completed after discontinuation of TKI)\n  * \\> 2 weeks from chloroquine\u002Fhydroxychloroquine\n  * ≥ 2 weeks from cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of ascites, pleural or pericardial effusion.\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta- human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of IP. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1. From the time of screening and must agree to continue using such precautions for 7 months after the last dose of investigational product (IP). Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female participants must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.\n* Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, by employing protocol-recommended methods. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomization\u002Fenrollment, throughout the study and for 4 months after the last dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Preservation of sperm should be considered prior to enrollment in this study.\n\nExclusion Criteria:\n\n* Have previously received any systemic anticancer therapy for CRC in the metastatic\u002Flocally advanced unresectable setting or have participated in any interventional clinical trial for CRC in the metastatic\u002Flocally advanced unresectable setting. Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed \\> 6 months before enrollment.\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.\n* Have previously been treated with an anti-HER2 agent and\u002For a topoisomerase I inhibitor.\n* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medications.\n* Have substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n* Patients with a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at screening (as defined by the manufacturer) and without any myocardial-related symptoms should undergo a cardiologic consultation before enrollment to rule out MI.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening 12-lead ECG.\n* Symptomatic arterial hypertension or uncontrolled arterial hypertension, as determined by the investigator.\n* Have a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Any autoimmune, connective tissue, or inflammatory disorders (e.g., Rheumatoid arthritis, Sjögren's, sarcoidosis etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.\n* Prior pneumonectomy (complete).\n* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n* Have unresolved toxicities from previous anticancer therapy, defined as toxicity (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\> 2 for at least 3 months before enrollment\u002Fcycle 1 day 1 and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy such as: chemotherapy-induced neuropathy and fatigue.\n* Patients with known hypersensitivity to the study drug or to its excipients.\n* Patients with known hypersensitivity to other monoclonal antibodies.\n* Pregnant or breastfeeding female patients, or patients who are planning to become pregnant. Sexually active men not willing to use adequate contraception during whole study period.\n* Previous or concurrent malignancy within 3 years of study entry. Exceptions are adequately resected non-melanoma skin cancer, curatively treated in-situ diseases, and other solid tumors that have been curatively treated.\n* Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G\\>A); DPYD13 (c.1679 T\\>G); DPYD D949V (c.2846 A\\>T). French and German patients may undergo baseline uracilemia assessment as detailed below in spite of polymorphism testing.\n* Have a history of transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to enrollment (Cycle 1 Day 1).\n* Have a history of a significant bleeding event (e.g., bleeding needing medical intervention) within 6 months prior to enrollment (Cycle 1 Day 1) unless the source of bleeding has been definitively treated.\n* Have a history of GI perforation within 12 months prior to enrollment (Cycle 1 Day 1).\n* Major surgical procedure or significant traumatic injury ≤ 28 days prior to enrollment (≤ 56 days for hepatectomy, open thoracotomy or major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Prior organ transplantation, including allogenic stem-cell transplantation.\n* Known history of HIV infection.\n* Active infection including tuberculosis, hepatitis B, hepatitis C. Patients positive for hepatitis C (HCV) antibody are eligible only if HCV RNA polymerase chain reaction (PCR) is negative. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible only if meeting the following criteria:\n\n  * HBsAg negativity (for more than 6 months off anti-viral treatment).\n  * Anti-HBc positivity (IgG or total Ig).\n  * Absence of cirrhosis or fibrosis on prior imaging or biopsy.\n  * Absence of HCV co-infection and no history of HCV co-infection.\n  * Access to a local HBV expert during and after the study Patients meeting all abovementioned criteria must be closely monitored for HBV reactivation.\n* Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP\n* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements.\n* Use of any disallowed drugs (see Section 7.5).\n\nAdditional exclusion criteria for France and Germany:\n\n* Patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (uracilemia ≥ 16 ng\u002FmL)\n* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.",{"count":445,"type":22},42,[210],"The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic\u002Flocally advanced unresectable colorectal cancer",[105,29,30,449,450,451,452],"Rectal Cancer, Adenocarcinoma","Rectal Cancer, Metastatic","Colon Cancer Metastatic","Colon Cancer Adenocarcinoma",[454,455,456,457,458,459],"colorectal cancer","HER-2 positive","Trastuzumab-deruxtecan","Capecitabine","Bevacizumab","mCRC","2026-02-15",{"date":76,"type":47},{"date":463,"type":47},"2025-10-20",{"date":465,"type":22},"2027-10-20",{"name":467,"class":54},"Gruppo Oncologico del Nord-Ovest",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":81},"100620742","study-comparing-the-quality-of-colon-cleanliness-with-prepackaged-lrd-low-residue-diet-vs-guided-pog-100620742","NCT07361575","Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).","A Single-blind, Randomized Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).","POG","Inclusion Criteria:\n\n* Patient of one of the investigators for total colonoscopy (no prior colonic surgery);\n* Patient aged 18 years or older;\n* Patient classified as ASA 1, ASA 2, or ASA 3;\n* Not participating in any other current clinical trial;\n* Free, informed, and signed consent;\n* Patient affiliated with or a beneficiary of a social security scheme, according to Article L.1124-1 of the French Public Health Code;\n\nExclusion Criteria:\n\n* Patient taking major psychotropic medications;\n* Patient with uncontrolled diabetes;\n* Patient with coagulation abnormalities preventing polypectomy: PT \\\u003C50%, Platelets \\\u003C50,000\u002Fmm³, current effective anticoagulation therapy (clopidogrel, prasugrel, or ticagrelor);\n* Patient referred for removal of a known polyp;\n* Chronic inflammatory bowel disease;\n* Known colonic stenosis;\n* Diverticulitis of less than 6 weeks duration;\n* Pregnant, parturient, or breastfeeding woman;\n* Patient deprived of liberty by administrative or judicial order, or under guardianship or limited legal protection;\n* Patient unable to understand the objectives and constraints of the study.",{"count":477,"type":22},230,[25],"Low-residue diet (LRD) in patient improves the quality of the colon cleanliness and thus the adenoma detection rate (ADR). This is a key criterion in colonoscopy screening for colorectal cancer (CRC). The benefit of an LRD lasting more than 24 hours before colonoscopy has not been demonstrated compared to a 24-hour LRD.\n\nFew studies have evaluated the benefit of a prepackaged 24-hour LRD compared to simply receiving oral and written LRD instructions during a consultation.\n\nThe aim of the study is to evaluate the usefulness of a prepackaged LRD (Colobox®) compared to simple LRD instructions on colon cleanliness (Boston score) in patients examined by endoscopy.",[481,482,29],"Colorectal Cancer Prevention","Colorectal Cancer (Diagnosis)","2026-02-13",{"date":76,"type":47},{"date":486,"type":22},"2026-01-30",{"date":488,"type":22},"2026-11-30",{"name":490,"class":54},"Clinique Paris-Bercy",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":501,"briefSummary":502,"conditions":503,"keywords":512,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":525},"100575944","phase-1-a-study-of-clsp-1025-in-adult-patients-with-solid-tumors-that-harbor-the-p53-r175h-mutation-100575944","NCT06778863","A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation","GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation","GUARDIAN-101","Key Inclusion Criteria:\n\n* Patients must be at least 18 years of age at the time of signing the informed consent.\n* Patients must be willing and able to provide written informed consent\n* Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists\n* Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test\n* Patients must be HLA-A\\*02:01 positive by central assay\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n* Adequate hematological, renal and hepatic function\n* Per Investigator judgement, patient is willing and able to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation\n\nKey Exclusion Criteria:\n\n* Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation\n* Patients who have received other p53 R175H-directed therapies\n* Patients who have not fully recovered from adverse events due to previous anticancer therapies\n* Patients with active infection requiring systemic antimicrobial therapy\n* Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission.\n* Known active central nervous system metastases and\u002For carcinomatous meningitis",{"count":500,"type":22},90,[128],"Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.",[504,505,506,29,507,228,223,508,509,510,511],"Advanced Solid Tumor","Unresectable Solid Tumor","Metastatic Solid Tumor","Pancreatic Adenocarcinoma","Breast Cancer","Head and Neck Squamous Cell Carcinoma","Prostate Cancer","Bladder Cancer",[513,514,515,516],"CLSP-1025","T Cell Engager","TCE","TP53","2026-02-12",{"date":483,"type":47},{"date":520,"type":47},"2025-02-28",{"date":522,"type":22},"2028-06",{"name":524,"class":255},"Clasp Therapeutics, Inc.",21,{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":535,"conditions":536,"keywords":537,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":287},"100521993","danishmrd-danish-assessment-of-minimal-residual-disease-by-liquid-biopsies-100521993","NCT06076811","DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies","Danish Assessment of Minimal Residual Disease by Liquid Biopsies","DANISH.MRD part I - Surgery\n\nInclusion Criteria:\n\n* Colon or rectal cancer, clinical tumor stage I-III.\n* Patient able to understand and sign written informed consent.\n* Scheduled for curative-intent resectional surgery (including \"compromised\" curative resections).\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.\n* Inflammatory bowel disease (Crohn's disease or ulcerative colitis).\n* Verified distant metastases.\n* Malignant colorectal polyps diagnosed after polypectomy.\n* Patients who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and\u002For otherwise considered by the Investigator to be unlikely to complete the study.\n\nDANISH.MRD part II - Surveillance\n\nInclusion Criteria:\n\n* Participation in DANISH.MRD part I - Surgery.\n* Colorectal cancer, UICC stage III.\n* Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime).\n\nExclusion Criteria:\n\n* Not treated with adjuvant chemotherapy\n* Treated with neoadjuvant chemo-radiation therapy.\n* Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma).\n* Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening.\n* Patients who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and\u002For otherwise considered by the Investigator to be unlikely to complete the study.",{"count":534,"type":22},1600,"Approximately two-thirds of all colorectal cancer patients undergo surgery with the aim of curing them. However, despite the surgery, 20-25% of them experience relapse. It is possible to reduce the risk of relapse with chemotherapy, but as chemotherapy is associated with significant side effects, it is only given to patients at high risk of relapse. Currently, the risk is assessed based on an examination of the removed tumor tissue.\n\nIn a previous research project, blood samples were taken after patients' surgery and examined for the presence of circulating tumor DNA (ctDNA). When cancer cells in solid tumors die, they release DNA, which can be detected in the blood. DNA in the blood has a half-life of less than 2 hours, so if ctDNA is found in a blood sample taken, e.g., 14 days after surgery, the patient most likely still has cancer cells in their body.\n\nThe results show that if a patient has ctDNA in their blood after surgery, the risk of relapse is high. The presence of ctDNA in the blood has the potential to be a better indicator of the risk of future relapse than the tumor examination used today. Therefore, ctDNA analysis has the potential to become a marker that will be used in the future clinical setting for monitoring colorectal cancer.\n\nThe overall objective of this study is to confirm that ctDNA found in a blood sample after intended curative treatment for CRC is a marker of residual disease and risk of recurrence and is applicable in clinical practice.",[162,105,29,166,167,168],[538,188,539,540],"Circulating tumor DNA","Risk stratification","Recurrence detection","2026-02-03",{"date":543,"type":47},"2026-02-04",{"date":545,"type":47},"2023-08-01",{"date":547,"type":22},"2030-07-30",{"name":549,"class":54},"University of Aarhus",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":578},"100542402","early-onset-colorectal-cancer-detection-100542402","NCT06342401","Early Onset Colorectal Cancer Detection","Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer","ENCODE","Inclusion Criteria:\n\n* Stage I, II, III, IV colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50 (EOCRC cases)\n* Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment\n* Colonoscopy-proven cancer-free status at the time of study inclusion (Non-disease controls)\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer syndromes (identified through genetic testing)\n* Inflammatory bowel diseases\n* Lack of written informed consent","50 Years",{"count":560,"type":22},400,"Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.\n\nThis study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid)",[105,162,29,166,169,167,168,170],[564,565,566,567,568,569,570,182],"Early onset","Young onset","Young adult","micro-RNA","Rectal cancer","Cancer of the young","Cancer detection","2026-01-27",{"date":573,"type":47},"2026-01-28",{"date":575,"type":47},"2023-04-15",{"date":110,"type":22},{"name":197,"class":54},13,{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":601,"leadSponsor":603,"locationsCount":81},"100515218","performance-and-safety-of-miwendo-assisted-colonoscopy-miwendo-ii-100515218","NCT05988645","Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)","Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)","Inclusion Criteria:\n\n\\- Patients with a previously detected polyp in the rectum referred for resection.\n\nThese criteria will ensure the probability of finding polyps during the explorations.\n\nAll the patients will give written informed consent.\n\nExclusion Criteria:\n\n* Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant\u002Fclopidogrel therapy during procedure, inadequate bowel cleansing.\n* ASA-IV patients.\n* Urgent colonoscopy.",{"count":587,"type":22},50,[25],"The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)",[105,163,591,176,29,162],"Colorectal Adenoma",[593,594,595,596],"microwave imaging","colonoscopy","early diagnosis","colorectal cancer screening","2025-09-23",{"date":599,"type":47},"2025-09-29",{"date":545,"type":47},{"date":602,"type":22},"2025-12-29",{"name":604,"class":255},"MiWEndo Solutions S.L.",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":627,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":287},"100568558","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-a2b395-an-allogeneic-logic-gated-car-t-in-participants-with-solid-tumors-that-express-egfr-and-have-lost-hla-a02-expression-100568558","NCT06682793","A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","DENALI-1","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site).\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long-term safety follow-up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion\n5. Radiotherapy within 28 days of A2B395 infusion\n6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n8. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n9. Requires supplemental home oxygen\n10. Females of childbearing potential who are pregnant or breastfeeding\n11. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395",{"count":614,"type":22},240,[128,210],"The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\n* Phase 1: What is the recommended dose of A2B395 that is safe for patients\n* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\n* Enrollment in BASECAMP-1 (NCT04981119)\n* Preconditioning lymphodepletion (PCLD) regimen\n* A2B395 Tmod CAR T cells at the assigned dose",[213,105,618,619,222,220,221,228,139,620,621,622,623,624,625,626,29],"Non-Small Cell Lung","NSCLC (Non-small Cell Lung Cancer)","Head and Neck Squamous Cell Cancer","HNSCC","Renal Cell Carcinoma","RCC","Kidney Cancer","Triple Negative Breast Cancer","TNBC",[231,232,628,234,629,237,630,139,631,240,241,632,222,214,633,228,634,623,624,635,636,626],"Allogeneic","EGFR","Solid tumors expressing EGFR","Colorectal","Blocker","Non small Cell Lung Cancer","renal cell carcinoma","Renal cell cancer","Triple negative breast cancer","2025-09-03",{"date":639,"type":47},"2025-09-09",{"date":641,"type":47},"2025-05-22",{"date":643,"type":22},"2030-03-31",{"name":254,"class":255},{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":654,"conditions":655,"keywords":657,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":669,"locationsCount":670},"100540293","stage-iiiii-colorectal-cancer-recurrence-100540293","NCT06314958","Stage II\u002FIII Colorectal Cancer Recurrence","Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment","CENSURE","Inclusion Criteria:\n\n* Stage II (high-risk) or III colorectal cancer (TNM classification, 8th edition).\n* Received standard diagnostic, staging, and therapeutic procedures as per local guidelines\n* Received stage-specific curative-intent resection followed by adjuvant chemotherapy.\n* Confirmed cancer-free survivorship confirmed at the time of study inclusion.\n\nExclusion Criteria:\n\n* Lack of written informed consent.\n* Development of recurrence in the first 6 months following adjuvant chemotherapy completion.\n* Hereditary colorectal cancer syndromes (identified through genetic testing)\n* Inflammatory bowel diseases",{"count":560,"type":22},"This study will develop an assay to predict disease recurrence in patients with stage II\u002FIII CRC after receiving adjuvant chemotherapy, using genome-wide DNA methylation.",[105,29,167,168,656],"Colorectal Cancer Recurrent",[658,659,660,661,662],"Recurrence-free Survival (RFS)","Overall Survival (OS)","Methylation","DNA methylation","carcinoembryonic antigen (CEA)","2025-07-02",{"date":665,"type":47},"2025-07-04",{"date":667,"type":47},"2023-03-15",{"date":110,"type":22},{"name":197,"class":54},4,{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":419,"enrollmentInfo":678,"targetDuration":4,"studyType":23,"phases":679,"briefSummary":680,"conditions":681,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":81},"100588624","phase-1-ak129-combination-therapy-for-advanced-solid-tumors-100588624","NCT06943820","AK129 Combination Therapy for Advanced Solid Tumors","A Phase Ib\u002FII Study of Anti-PD-1\u002FLAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);\n2. ≥18 years old and ≤ 75 years (regardless of sex);\n3. ECOG performance status 0-1;\n4. Life expectancy longer than 3 months;\n5. 1)Histologically or cytologically confirmed diagnosis of Stage IIIB\u002FC or IV NSCLC (American Joint Committee on Cancer \\[AJCC\\]); 2)No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy;\n6. 1)Histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC (American Joint Committee on Cancer \\[AJCC\\]); 2)No prior systemic anti-tumor therapy for recurrent or metastatic HNSCC ;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy;\n7. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stabilization;\n8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;\n9. Adequate organ function.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed the presence of small cell carcinoma components\u002FEGFR-sensitive mutations or ALK fusion positivite\u002Fknown ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;\n2. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable\u002Fmismatch repair gene expression defect (MSI-H\u002FdMMR)or histopathological examination confirmed other pathological types;\n3. Participating in another clinical research;\n4. Has known active central nervous system (CNS) metastases, brain stem\u002Fmeningeal metastasis, spinal cord metastasis or compression;\n5. Has an active autoimmune disease that has required systemic treatment in the past 2 years;\n6. Has known active tuberculosis (TB) and suspected active TB should be ruled out by clinical examination; known active syphilis infection; known active Hepatitis B or Hepatitis C;\n7. Past or currently has non-infectious pneumonia\u002Finterstitial lung disease that requires systemic glucocorticoid therapy;\n8. Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage;\n9. Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia;\n10. Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies;\n11. Pregnant or lactating female.",{"count":477,"type":22},[128,210],"This is an open, multicenter phase Ib\u002FII clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.",[682,683,29,684],"Non-small Cell Lung Cancer Stage IIIB\u002FIV","Head and Neck Squamous Cell Carcinoma (HNSCC)","Advanced Solid Tumors","2025-05-28",{"date":687,"type":47},"2025-06-03",{"date":689,"type":47},"2025-05-21",{"date":691,"type":22},"2028-05",{"name":434,"class":255},{"id":694,"slug":695,"hasResults":12,"nctId":696,"briefTitle":697,"officialTitle":697,"acronym":4,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":18,"minAge":699,"maxAge":700,"enrollmentInfo":701,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":702,"conditions":703,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":4},"100593233","evaluation-of-tumor-budding-in-colorectal-adenocarcinoma-100593233","NCT07003776","Evaluation of Tumor Budding In Colorectal Adenocarcinoma","Inclusion Criteria:\n\n* Specimens from patients with Colorectal Carcinoma. Tissue blocks with sufficient material. Specimens with sufficient clinical data.\n\nExclusion Criteria:\n\n* Tissue blocks with insufficient, destroyed or necrotic material. Specimens with insufficient clinical data.","20 Years","90 Years",{"count":587,"type":22},"Colorectal cancer (CRC) is among the most prevalent cancers globally, with approximately one to two million new cases diagnosed each year. This makes CRC the third most common cancer and the fourth leading cause of cancer-related deaths, with 700,000 deaths per year, exceeded only by lung, liver and stomach cancers. CRC accounts for about 10% of all cancer diagnoses worldwide (Sung et al., 2021; Masetti et al., 2022) .\n\nCRC affects different races and ethnicities at various age groups in distinct ways. Among patients younger than 50 years old, the proportion of CRC is nearly double for Black individuals (16%) compared to White individuals (9%) and Hispanic individuals (6%). In Egypt, CRC ranked the seventh among cancers, following lung, breast, prostate, liver, and bladder cancers (Mounir et al., 2022).\n\nTumor budding (TB) is characterized by the presence of individual tumor cells or small clusters of up to four cells at the invasive margin of a tumor. This histological feature, which indicates the separation of malignant cells from the main tumor mass, has intrigued pathologists since it was first identified in the 1950s (Giordano et al., 2024).\n\nEvaluating TB is crucial for improving prognostic accuracy and informing treatment decisions. Tumors with high-grade TB exhibit a significantly lower 5-year Disease-Free Survival (DFS) rate compared to those with low-grade TB. High-grade TB is regarded as a negative prognostic factor and is associated with an increased risk of recurrence (Kyong Shin et al., 2023).\n\nTB can be observed in conventional slides when prominent, but careful observation is necessary. A more thorough assessment of TB is more easily achieved if the neoplastic epithelium is highlighted using pan-cytokeratin immunostains (Mishra et al., 2022).\n\nPan-keratin (Pan-CK) antibodies are proteins derived from cytoskeletal intermediate filaments. These antibodies are a mixture designed to detect multiple low and high molecular weight keratins. Their primary purpose is to allow for the immunohistochemical identification of all epithelial cell types, regardless of their tissue of origin, using a single diagnostic tool.\n\nIn surgical pathology, Pan-CK antibodies are commonly used to confirm the epithelial origin of both neoplastic (tumorous) and non-neoplastic tissues, as well as to identify small metastases in lymph nodes. However, there are limitations to the assumption that Pan-CK antibodies will stain all epithelial tumors and that non-epithelial tissues will be \"keratin negative.\" It has been reported that a diverse range of epithelial tumors can be Pan-CK negative, challenging the notion that these antibodies are universally applicable (Wick et al., 1986; Badzio, 2019).\n\nPan-CK can help diagnose disease like breast cancer, lung cancer, prostate cancer, and colorectal cancer. It is often used in conjunction with other antibodies for these specific cancers (Chu and Weiss, 2002).",[29],"2025-05-26",{"date":706,"type":47},"2025-06-04",{"date":708,"type":22},"2025-10-01",{"date":710,"type":22},"2026-05-03",{"name":712,"class":54},"Sohag University",{"id":714,"slug":715,"hasResults":12,"nctId":716,"briefTitle":717,"officialTitle":717,"acronym":718,"eligibilityCriteria":719,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":720,"targetDuration":4,"studyType":23,"phases":721,"briefSummary":722,"conditions":723,"keywords":729,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":745},"100565283","phase-2-encorafenib--cetuximab-beyond-progression-in-combination-with-folfiri-in-patients-with-braf-v600e-mutated-metastatic-colorectal-cancer-progressing-on-encorafenib--cetuximab-100565283","NCT06640166","Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.","ECLYPse","Inclusion Criteria:\n\n* written informed consent to study procedures;\n* age ≥ 18 years;\n* histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma;\n* radiological evidence of metastatic disease;\n* evidence of measurable disease according to RECIST 1.1 criteria;\n* presence of BRAF V600E mutation in tumor tissue (primary CRC and\u002For related metastasis) as previously determined by a local assay at any time prior to screening (only PCR and NGS-based local assays results will be acceptable);\n* disease progression while on treatment with EC received in 2nd line setting\n\n  * EC administered after disease relapse during treatment or within 6 months following adjuvant therapy will be second line;\n  * maintenance therapy given in the metastatic setting after a first line doublet or triplet chemotherapy will not be considered a separate regimen;\n* best response to previous treatment with EC: CR, PR or SD lasting for at least 3 months.\n* patient fit for a subsequent treatment line with FOLFIRI. Patients exposed to irinotecan and fluoropyrimidines during previous line for metastatic disease are eligible, provided that the patient has recovered from G3 toxicity;\n* life expectancy ≥ 3 months;\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1.\n* Adequate bone marrow function at screening:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n  * Platelets ≥ 100 × 10\\^9\u002FL;\n  * Hemoglobin ≥ 9.0 g\u002FdL;\n  * Note: Transfusions will be allowed to achieve this. Transfusions will be permitted provided that the patient has not received more than 2 units red blood cells in the prior 4 weeks to achieve this criteria.\n* Adequate renal function at screening: serum creatinine ≤ 1.5 × upper limit of normal (ULN), or calculated by Cockroft-Gault formula, or directly measured creatinine clearance ≥ 50 mL\u002Fmin at screening.\n* Adequate hepatic function at screening:\n\n  * serum total bilirubin ≤ 1.5 × ULN;\n  * alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases.\n* Adequate cardiac function characterized by the following at screening: QT interval corrected for heart rate using Fridericia's formula (QTcF) value ≤480 msec.\n* Availability of treatment-naïve, archival FFPE tumor tissue sample.\n* Ability to take oral medications.\n* Male subjects with female partners of childbearing potential must be willing to use adequate contraception, starting with the first dose of study therapy through 180 days after the last dose of treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n* Women of childbearing potential must have a negative blood or urine pregnancy test at the baseline visit.\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study starting with the first dose of study therapy through 180 days after the last dose of treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n* Will and ability to comply with the protocol.\n\nExclusion Criteria:\n\n* patients experiencing PD as best response to EC;\n* patients with specific BRAFi\u002FAntiEGFR contraindications;\n* patients with specific irinotecan or fluoropyrimidines contraindications;\n* patients with DPYD deficiency;\n* life expectancy ≤3 months;\n* ECOG PS \\>1.\n* Any of the following in the 6 months prior to treatment start: myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft \\[CABG\\], coronary angioplasty or stenting), congestive heart failure (≥ New York Heart Association Classification Class II), serious cardiac arrhythmia (except atrial fibrillation and appropriately controlled paroxysmal supraventricular tachycardia), cerebrovascular accident, symptomatic pulmonary embolism.\n* Congenital long QT syndrome.\n* Impaired gastrointestinal function or disease that may significantly alter the absorption of encorafenib (uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption).\n* Uncontrolled coagulopathy.\n* Patients has a known history of Gilbert's syndrome or is known to have any of the following genotypes: UGT1A1\\*6\u002F\\*6, UGT1A1\\*28\u002F\\*28, or UGT1A1\\*6\u002F\\*28.\n* Active infection requiring systemic therapy.\n* Known history of acute or chronic pancreatitis.\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).\n* Symptomatic brain metastasis or leptomeningeal disease. Prior hypersensitivity or toxicity that would suggest an inability to tolerate administration of the planned dose of investigational products.\n* Residual CTCAE \\> Grade 2 toxicity from any prior anticancer therapy, with the exception of alopecia or neuropathy.\n* Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies, including current treatment with a non-topical medication known to be a strong inhibitor of cytochrome P450 (CYP) 3A4 ≤ 1 week prior to the start of study treatment.\n* Concomitant use of St. John's Wort (hypericum perforatum).\n* Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study.\n* Concurrent or previous other malignancy within the past 3 years, with the exception of effectively treated squamous cell or basal cell skin cancer, melanoma in situ, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, carcinoma in situ of the colon or rectum, or other noninvasive or indolent malignancy without Sponsor approval.\n* Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 180 days after the last trial treatment.",{"count":7,"type":22},[210],"The aim of this study is to determine the activity of encorafenib plus cetuximab in combination with FOLFIRI in patients with BRAF V600E mutated metastatic colorectal cancer progressing on encorafenib plus cetuximab administered in second line.",[724,162,725,29,726,105,220,28,727,728],"Colorectal Carcinoma","Colorectal Tumor","Colorectal Cancer (CRC)","Colon Carcinoma","Colon Neoplasm",[730,731,732,733,454,734,735],"BRAF","V600E","encorafenib","cetuximab","FOLFIRI","BRAF V600E","2025-02-11",{"date":738,"type":47},"2025-02-12",{"date":740,"type":47},"2024-06-03",{"date":742,"type":22},"2026-06-30",{"name":744,"class":54},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",3,{"id":747,"slug":748,"hasResults":12,"nctId":749,"briefTitle":750,"officialTitle":751,"acronym":4,"eligibilityCriteria":752,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":419,"enrollmentInfo":753,"targetDuration":4,"studyType":23,"phases":755,"briefSummary":756,"conditions":757,"keywords":761,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":765,"lastUpdatePostDateStruct":766,"startDateStruct":768,"completionDateStruct":770,"leadSponsor":772,"locationsCount":81},"100542913","a-randomized-multicenter-phase-ii-basket-study-of-hypofractionated-radiotherapystereotactic-body-radiotherapy-followed-by-immunotherapy-based-systemic-therapy---l-rhamnosus-m9-for-the-first-line-treatment-of-advanced-digestive-system-malignancies-100542913","NCT06349044","A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy\u002FStereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +\u002F- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies.","A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy\u002FStereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +\u002F- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies","Inclusion Criteria:\n\n* histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract (including Her-2 negative adenocarcinoma of the gastroesophageal junction\u002Fgastric adenocarcinoma, hepatocellular carcinoma, malignant tumors of the biliary system, colorectal cancer);\n* advanced patients evaluated as initially non-operable resectable who have not received any antitumor therapy;\n* have at least one measurable or evaluable lesion according to RECIST v1.1 criteria in addition to the primary lesion, with non-operable resectable lymph node metastases to the liver, lung, bone, pelvis, retroperitoneum and\u002For superficial sites (except for brain metastases), as evaluated by discussion in the framework of the MDT\n* age 18-75 years;\n* ECOG score of 0-1;\n* be able to accept the treatment regimen during the study;\n* sign a written informed consent.\n\nExclusion Criteria:\n\n* a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder of clinical severity that, in the judgment of the investigator, may preclude the signing of an informed consent form or interfere with the patient's adherence to oral medication;\n* prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies;\n* clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months;\n* organ transplantation requiring immunosuppressive therapy;\n* a history of other malignant disease within the last five years;\n* persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;\n* Subjects whose baseline blood routine and biochemical indexes do not meet the following criteria: hemoglobin ≥80g\u002FL; absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C1 times the upper limit of normal; and serum creatinine \\\u003C1 times the upper limit of normal. times the upper limit of normal;\n* the patient currently has active gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;\n* persons with active bleeding or bleeding tendencies;\n* women who are pregnant or breastfeeding;\n* allergy to any of the study drug ingredients.",{"count":754,"type":22},120,[25],"Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors.",[758,759,760,29],"Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction\u002FGastric Adenocarcinoma","Hepatocellular Carcinoma","Biliary Tract Carcinoma",[762,763,764],"radiotherapy","immunotherapy","L. rhamnosus M9","2024-08-22",{"date":767,"type":47},"2024-08-27",{"date":769,"type":47},"2024-03-20",{"date":771,"type":22},"2025-12-31",{"name":773,"class":54},"Zhejiang Cancer Hospital"]