[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654357":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":37,"overallOfficials":24,"centralContacts":43,"locations":49,"responsibleParty":65,"collaborators":24,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":24,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":24,"overallStatus":87,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Objective response rate (ORR)","The proportion of patients with a confirmed complete response or partial response","24 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Progress-free Survival(PFS)","The time from enrollment until tumor progression or death from any cause, whichever occurred first",{"measure":18,"description":19,"timeFrame":12},"Overall Survival (OS)","The time from randomization to death from any reason",{"measure":21,"description":22,"timeFrame":23},"Incidence of Adverse Events","Incidence of Adverse Events According to the CTCAE 6.0","90 days",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32],{"label":33,"type":34,"description":24,"interventionNames":35},"The Retlirafusp alfa in combination with XELOX and bevacizumab treatment group","EXPERIMENTAL",[36],"Drug: Retlirafusp alfa+XELOX+Bevacizumab Treatment",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":24},"DRUG","Retlirafusp alfa+XELOX+Bevacizumab Treatment","Enrolled subjects received Retlirafusp alfa injection (1800 mg, IV, Day 1, every 3 weeks) + bevacizumab (7.5 mg\u002Fkg, IV, Day 1, every 3 weeks) plus XELOX (capecitabine 1,000 mg\u002Fm², oral, twice daily, Days 1-14; and oxaliplatin 130 mg\u002Fm², IV, Day 1, every 3 weeks). Oxaliplatin was discontinued after a maximum of 8 cycles, while the other agents were continued, marking the transition to the maintenance phase. Immunotherapy was administered for no more than 2 years.",[33],[44],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},"Guanghai Dai, MD","CONTACT","01066947252","daigh301@vip.sina.com",[50],{"facility":51,"status":24,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Chinese PLA General Hospital, Beijing","Beijing","Beijing Municipality","100142","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.39723,39.9075,{"lat":61,"lon":60},[64],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Dai, Guanghai","Professor,Chief Physician","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":79,"type":80},46,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86],"Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)","NOT_YET_RECRUITING","2026-08-28",{"date":90,"type":91},"2026-09-01","ACTUAL",{"date":93,"type":80},"2026-10-29",{"date":95,"type":80},"2029-10",{"name":67,"class":6},1]