[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mss-metastatic-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mss-metastatic-colorectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100627260","phase-2-folfiri-and-bevacizumab-with-or-without-pelareorep-for-second-line-treatment-of-metastatic-ras-mutated-microsatellite-stable-colorectal-cancer-100627260",false,"NCT07446322","FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer","An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed cancer of the colon or rectum with documented metastasis\n* Measurable disease per RECIST v. 1.1\n* Not candidates for curative surgery or curative radiation\n* Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin\n* Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab\n* Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H\u002Fnon dMMR) tumor status per a standard local testing method\n* Tumor confirmed to harbor a known RAS mutation per a standard local testing method\n* ECOG performance status of 0 or 1\n* Patients must have adequate hematological, renal, and hepatic function\n* Female patients of childbearing potential must have a negative pregnancy test\n* Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Undergone systemic chemotherapy, radiotherapy, or surgery, \\\u003C4 weeks before study treatment\n* Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment\n* Prior treatment with irinotecan\n* Symptomatic brain metastases\n* Active autoimmune disease\n* Receiving immunosuppressive or myelosuppressive medications\n* Active, uncontrolled infections\n* Known HIV infection or active hepatitis B or C that requires anti-viral treatment\n* History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ\n* History of allergy or known hypersensitivity to any of the study drugs, study drug classes,\n* Uncontrolled or severe cardiac disease\n* Received any vaccine within 28 days prior to first study treatment","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.",[26,27,28],"Ras-mutated Metastatic Colorectal Cancer","mCRC","MSS Metastatic Colorectal Cancer","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2026-04-30",{"date":37,"type":20},"2030-04-30",{"name":39,"class":40},"Oncolytics Biotech","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100624138","phase-2-lubiprostone-combined-with-maintenance-therapy-for-prevention-of-postoperative-recurrence-in-peritoneal-metastatic-colorectal-cancer-100624138","NCT07405736","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer, A Randomized Controlled Phase II Study","Inclusion Criteria:\n\n* Voluntarily participates and provides written informed consent.\n* Histologically confirmed colon\u002Frectal adenocarcinoma with molecular status confirmed as pMMR or MSS.\n* Cytoreductive surgery (CRS) achieves CC0\u002FCC1 cytoreduction.\n* No extraperitoneal metastasis prior to treatment.\n* ECOG performance status 0-1 with adequate organ function per protocol requirements.\n\nExclusion Criteria:\n\n* Extensive multisystem metastases on baseline imaging assessment.\n* Tumor carrying BRAF V600E mutation.\n* dMMR\u002FMSI-H, or confirmed pathogenic POLE\u002FPOLD1 mutation(s).\n* Cachexia or decompensated organ dysfunction.\n* History of another malignancy within the past 5 years.\n* Known or suspected hypersensitivity\u002Fallergy to the study drug or related formulations.\n* Multiple primary cancers.\n* Any serious disease or other medical, psychological, or social condition that, in the investigator's judgment, may compromise participant safety or affect study results.","75 Years",{"count":50,"type":20},124,[23],"The goal of this phase II randomized controlled clinical trial is to evaluate whether adding lubiprostone to standard postoperative maintenance therapy can delay disease progression and recurrence in adult patients with colorectal cancer and peritoneal metastases (PM-CRC) who have undergone cytoreductive surgery with or without HIPEC after systemic treatment. The main questions it aims to answer are:\n\nDoes lubiprostone plus maintenance therapy improve the 1-year progression-free survival (PFS) rate compared with maintenance therapy alone?\n\nIs lubiprostone safe and feasible for long-term use during the maintenance period in this PM-CRC population?\n\nResearchers will compare lubiprostone + maintenance therapy versus maintenance therapy alone to see if the addition of lubiprostone prolongs PFS, reduces the risk of distant metastasis, improves overall survival, and maintains or improves quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive maintenance therapy with lubiprostone or maintenance therapy alone after surgery (CRS ± HIPEC) and prior systemic therapy, according to the study protocol.\n\nUndergo scheduled follow-up assessments for disease status (progression\u002Frecurrence), survival outcomes, treatment-related toxicity, and quality of life using the EORTC QLQ-C30 (v3.0) questionnaire.",[54,55,56,57,28],"Colorectal Cancer Metastatic","Peritoneal (Metastatic) Cancer","Peritoneal Metastasis","Colorectal Cancer (CRC)",[59,60,61,62,63,64],"Peritoneal metastasis","Colorectal cancer","Maintenance therapy","Lubiprostone","Cytoreductive Surgery","Progression-free survival","NOT_YET_RECRUITING","2026-02-10",{"date":68,"type":33},"2026-02-12",{"date":70,"type":20},"2026-02-24",{"date":72,"type":20},"2028-06-01",{"name":74,"class":75},"Sun Yat-sen University","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100563203","fruquintinib-combined-with-adebrelimab-and-high-and-low-dose-radiotherapy-in-the-treatment-of-second-line-and-above-failure-mss-metastatic-colorectal-cancer-100563203","NCT06613113","Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.","A Single-arm, Single-center Clinical Study of Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender not limited；\n2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1；\n3. Previously identified as MSS type mCRC；\n4. Metastatic colorectal cancer (mCRC) with disease progression after receiving standard second-line treatment according to Chinese Society of Clinical Oncology ( CSCO) guidelines；\n5. At least one measurable lesion (RECIST 1.1)；\n6. Be able to adhere to the protocol during the research period；\n7. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. For individuals with a history of uncontrolled epilepsy, central nervous system disorders, or mental disorders, the clinical severity of which may hinder the signing of informed consent forms or affect the patient's adherence to oral medication, as determined by the researcher；\n2. Accompanied by other malignant tumors that have not been cured；\n3. The baseline blood routine and biochemical indicators of the subject do not meet the following criteria: hemoglobin ≥ 90g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelets ≥ 100 × 109\u002FL; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the normal upper limit; Alkaline phosphatase (ALP) ≤ 2.5 times the normal upper limit value; Serum total bilirubin\\\u003C1.5 times the normal upper limit value; Serum creatinine\\\u003C1 times the upper limit of normal; Serum albumin ≥ 30g\u002FL；\n4. Serious (i.e. active) heart disease in clinical practice, such as symptomatic coronary heart disease, congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the past 12 months；\n5. Irreversible coagulation dysfunction or concurrent active massive bleeding；\n6. Combination of active infections requiring antibiotic treatment；\n7. Individuals who are allergic to any research drug ingredients；\n8. Women with concurrent pregnancy or lactation；\n9. Organ transplantation requires immunosuppressive therapy and long-term hormone therapy；\n10. Patients with autoimmune diseases；\n11. There is a history of drug treatment in previous plans。",{"count":84,"type":20},30,[86],"NA","The goal of this clinical trial is to learn about Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the treatment of second-line and above failure MSS(microsatellite stability) metastatic colorectal cancer.\n\nThe main question it aims to answer is: The efficacy and safety of Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the third line and beyond treatment of MSS metastatic colorectal cancer.\n\nParticipants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred.",[28],[28,90,91,92],"Fruquintinib","Adebrelimab","High and Low Dose Radiotherapy","2024-09-22",{"date":95,"type":33},"2024-09-25",{"date":97,"type":33},"2024-08-07",{"date":99,"type":20},"2027-07-31",{"name":101,"class":102},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",1]