[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-ras-mutated-colorectal-cancer-with-liver-metastases-crlm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-ras-mutated-colorectal-cancer-with-liver-metastases-crlm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100654357","phase-2-a-single-arm-phase-ii-study-of-retlirafusp-alfa-in-combination-with-xelox-and-bevacizumab-for-the-first-line-treatment-of-advanced-ras-mutated-colorectal-cancer-with-liver-metastases-crlm-100654357",false,"NCT07797244","A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)","Inclusion Criteria:\n\n1. Age: 18-75 years;\n2. Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;\n3. MSS\u002FpMMR;\n4. RAS-mutant;\n5. ECOG PS score of 0-1;\n6. No prior systemic treatment;\n7. At least one measurable liver metastasis;\n8. Expected survival of ≥3 months;\n9. Normal function of major organs; no severe abnormalities in hematological, cardiac, pulmonary, hepatic, renal, or bone marrow function; and no immunodeficiency. Laboratory test results must meet the following requirements:\n\n   ① Hemoglobin (Hb) ≥90 g\u002FL;\n\n   ② White blood cell (WBC) count ≥ 3.0 × 10⁹\u002FL; neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL;\n\n   ③ Platelet (PLT) count ≥ 100 × 10⁹\u002FL\n\n   ④ Renal function (serum creatinine, sCr) ≤ 1.5 times the upper limit of normal (ULN);\n\n   ⑤ Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);\n10. Participants voluntarily enroll in this study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up;\n11. The investigator believes the participant may benefit from treatment.\n\nExclusion Criteria:\n\n1. History of or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;\n2. History of severe cardiovascular disease, such as congestive heart failure (New York Heart Association Class III-IV), myocardial infarction within the past 6 months, unstable angina, or severe arrhythmias;\n3. Presence of active infections (e.g., sepsis, active tuberculosis) or uncontrolled autoimmune diseases;\n4. History of severe gastrointestinal diseases, such as active peptic ulcers, intestinal obstruction, or gastrointestinal bleeding, which may affect drug absorption or increase treatment-related risks;\n5. History of active cirrhosis, uncontrolled comorbidities, chronic myopathy, active hepatitis, or persistent unexplained elevation of serum transaminases;\n6. Coagulation disorders with a tendency to bleed (must meet the following criterion 14 days prior to enrollment: INR within the normal range without the use of anticoagulants); Subjects receiving treatment with anticoagulants or vitamin K antagonists, such as warfarin, heparin, or their analogs; low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) is permitted for prophylactic purposes, provided that the International Normalized Ratio (INR) of prothrombin time is ≤ 1.5;\n7. Allergy to or contraindications for the study drug;\n8. Pregnant or breastfeeding women, or patients planning to become pregnant during the study or within 6 months after the study ends and who are not using effective contraception;\n9. Presence of other serious, uncontrolled medical conditions or psychiatric disorders that may affect the patient's ability to participate in the study or undergo evaluation;\n10. History of thyroid dysfunction, where thyroid function cannot be maintained within the normal range even with medication;\n11. Patients with severe, uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg despite antihypertensive medication), or a history of hypertensive crisis or hypertensive encephalopathy;\n12. Patients with a history of severe bleeding or a high risk of bleeding, including but not limited to: clinically significant bleeding (e.g., ≥ Grade 2 gastrointestinal bleeding) occurring within 3 months prior to the first administration of the study drug; active hemoptysis (hemoptysis volume ≥ half a teaspoon, approximately 2.5 mL of fresh blood, within the past month); imaging evidence of tumor invasion of major blood vessels; or an untreated coagulation disorder (however, patients receiving a stable dose of anticoagulant therapy with an INR within the therapeutic range may be considered for enrollment following the investigator's assessment);\n13. Patients who have experienced the following arterial or venous thromboembolic events within 6 months prior to the first administration of the study drug: cerebrovascular accident (including ischemic stroke and transient ischemic attack), myocardial infarction, acute coronary syndrome, uncontrolled deep vein thrombosis, or pulmonary embolism (superficial venous thrombosis, such as PICC-related upper extremity venous thrombosis, may be considered on a case-by-case basis if assessed by the investigator as low risk);\n14. Patients deemed unsuitable for inclusion in this study by the investigator.","ALL","18 Years","75 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This single-arm phase II trial enrolls patients with RAS-mutant, microsatellite-stable (MSS) unresectable colorectal cancer liver metastases receiving first-line treatment with Retlirafusp alfa combined with XELOX (capecitabine plus oxaliplatin) and bevacizumab. The primary endpoint is objective response rate (ORR). A total of 46 patients will be enrolled, and the study is expected to be completed between 2026 and 2029.",[26],"Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)","NOT_YET_RECRUITING","2026-08-28",{"date":30,"type":31},"2026-09-01","ACTUAL",{"date":33,"type":20},"2026-10-29",{"date":35,"type":20},"2029-10",{"name":37,"class":38},"Dai, Guanghai","OTHER"]