[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655716":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":16,"studyPopulation":16,"armGroups":37,"interventions":43,"overallOfficials":16,"centralContacts":49,"locations":55,"responsibleParty":70,"collaborators":16,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":16,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":16,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":16,"overallStatus":93,"whyStopped":16,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate","The proportion of subjects achieving complete response or partial response, assessed by investigators according to RECIST 1.1 criteria.","Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall",[14,17,20,24,27],{"measure":15,"description":16,"timeFrame":12},"Major Pathological Response Rate",null,{"measure":18,"description":19,"timeFrame":12},"Surgical Conversion Rate","The proportion of subjects with successful conversion surgery. The criteria for successful conversion are as follows: evaluation of liver metastases achieves partial response after the conversion therapy; liver tumor-free status can be achieved through surgical resection ± ablation or stereotactic radiotherapy, with a residual liver volume exceeding 40%; liver function is classified as Child-Pugh Class A, and other liver function and laboratory parameters meet surgical and anesthesia requirements.",{"measure":21,"description":22,"timeFrame":23},"Progression-free Survival","The time from the initiation of treatment until disease progression or death from any cause, whichever occurs first.","assessed up to 18 months",{"measure":25,"description":26,"timeFrame":23},"Overall Survival","Description: The time from the initiation of treatment until death from any cause.",{"measure":28,"description":29,"timeFrame":30},"Safety","Incidence, severity (NCI-CTCAE v5.0) of treatment-emergent adverse events (TEAE), treatment-related adverse events (TRAE), immune-related adverse events (irAE), serious adverse events (SAE), and post-operative complications.","From first dose through 90 days after last study-drug administration.",{"allocation":32,"interventionModel":33,"interventionModelDescription":16,"primaryPurpose":34,"observationalModel":16,"timePerspective":16,"maskingInfo":35},"NA","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":16,"whoMasked":16},"NONE",[38],{"label":39,"type":40,"description":16,"interventionNames":41},"Experimental Arm (2-cohort single-group）","EXPERIMENTAL",[42],"Drug: Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":16},"DRUG","Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy","Cohort 1 (RAS\u002FBRAF wild-type, left-sided primary colon cancer):\n\n* Retlirafusp alfa 1800 mg IV D1 every 3 weeks\n* Cetuximab 500 mg\u002Fm² IV D1 every 2 weeks\n* mFOLFOX6: Oxaliplatin 85 mg\u002Fm² IV D1 q2w; Leucovorin 400 mg\u002Fm² IV D1 q2w; 5-FU 400 mg\u002Fm² IV bolus D1 q2w plus 2400 mg\u002Fm² 48-h continuous infusion q2w.\n\nCohort 2 (RAS\u002FBRAF mutant OR RAS\u002FBRAF wild-type right-sided primary colon cancer):\n\n* Retlirafusp alfa 1800 mg IV D1 every 3 weeks\n* Bevacizumab 7.5 mg\u002Fkg IV D1 every 3 weeks\n* CAPEOX: Oxaliplatin 130 mg\u002Fm² IV D1 q3w; Capecitabine 1000 mg\u002Fm² orally twice daily D1-14 q3w.",[39],[50],{"name":51,"role":52,"phone":53,"phoneExt":16,"email":54},"Kun Wang","CONTACT","+86 13910726401","wang-kun@vip.sina.com",[56],{"facility":5,"status":16,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Beijing","Beijing Municipality","100142","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},[69],{"name":51,"role":52,"phone":53,"phoneExt":16,"email":54},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Wang Kun","MD, Prof","100655716","phase-2-retlirafusp-alfa-plus-targeted-therapy-and-chemotherapy-for-unresectable-colorectal-liver-limited-metastases-100655716",false,"NCT07815288","Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases","Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy as Conversion Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: An Exploratory Phase II Study","Inclusion Criteria:\n\n1. Signed written informed consent before any trial-related procedure.\n2. Age ≥18 and ≤79 years, male or female.\n3. Histopathologically confirmed colorectal adenocarcinoma; liver metastasis confirmed by pathology or imaging.\n4. No prior first-line systemic therapy (targeted, immunotherapy, systemic chemotherapy) specifically for liver metastases.\n5. At least 1 measurable lesion per RECIST 1.1.\n6. Multidisciplinary-team-confirmed initially unresectable colorectal liver metastases (cannot achieve R0\u002FR1 resection; or predicted future remnant liver volume \\\u003C 30 %; or insufficient hepatic inflow\u002Foutflow). Patients with extra-hepatic metastases (excluding brain \u002F bone metastases) amenable to local therapy are eligible.\n7. Microsatellite-stable (MSS) \u002F mismatch-repair-proficient (pMMR) confirmed by IHC or PCR.\n8. ECOG Performance Status 0-1.\n9. Expected survival ≥12 weeks.\n10. No urgent-surgery indications (e.g., primary-tumor bleeding, obstruction).\n11. Adequate organ function within 14 days prior to first study-drug:\n\n    * ANC ≥1.5 × 10⁹\u002FL; Platelets ≥75 × 10⁹\u002FL; Hb \\> 70 g\u002FL\n    * Total bilirubin ≤1.5 × ULN; Albumin ≥28.0 g\u002FL\n    * AST \u002F ALT ≤5 × ULN\n    * Creatinine ≤1.5 × ULN; Cockcroft-Gault creatinine clearance ≥60 mL\u002Fmin\n    * INR \u002F PT ≤1.5 × ULN\n12. Females of reproductive potential \u002F males with reproductive-potential partners agree to highly-effective contraception starting 7 days prior first dose until 24 weeks after last dose.\n13. Serum pregnancy test negative within 7 days before first dose (women of child-bearing potential).\n14. Willing and able to comply with all trial visits, treatment and assessments.-\n\nExclusion Criteria:\n\n* 1\\. Inability to tolerate systemic chemotherapy or subsequent surgery. 2. Liver metastases occurring during or within 6 months after completion of oxaliplatin-based adjuvant chemotherapy for primary colorectal tumor.\n\n  3\\. Major surgery within 6 weeks before study entry; severe trauma \u002F non-healing wounds \u002F fractures.\n\n  4\\. Myocardial infarction, unstable angina, coronary-artery-bypass-graft within prior 3 months; NYHA class III-IV heart failure.\n\n  5\\. Prior treatment with immune-checkpoint-inhibitors (anti-PD-1\u002FPD-L1, anti-CTLA-4 etc.).\n\n  6\\. Concurrent or prior other malignancy whose expected survival is shorter than colorectal-liver-metastasis prognosis.\n\n  7\\. History of allogeneic hematopoietic-stem-cell or solid-organ transplant (except corneal transplant).\n\n  8\\. History of moderate-severe hypersensitivity \u002F anaphylaxis to antibody-based therapeutics.\n\n  9\\. Clinically-significant bleeding diathesis or major bleeding episode within prior 3 months (e.g., gastrointestinal bleeding, esophageal varices, hematemesis, hemoptysis).\n\n  10\\. Symptomatic large-volume ascites \u002F pleural effusion \u002F pericardial effusion requiring intervention.\n\n  11\\. Primary-tumor perforation, abdominal infection occurring within prior 3 months without adequate management.\n\n  12\\. Known hypersensitivity to active ingredients or excipients of study drugs. 13. Active peptic ulcer, gastrointestinal obstruction, active GI bleeding, perforation, malabsorption, uncontrolled inflammatory bowel disease.\n\n  14\\. Pregnant or lactating women. 15. Concurrent participation in another interventional clinical trial. 16. Any other condition judged by investigator to make subject unsuitable for trial participation.","ALL","18 Years","79 Years",{"count":85,"type":86},80,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","This is a single-center, open-label, exploratory phase II trial to evaluate efficacy and safety of Retlirafusp alfa (PD-L1\u002FTGF-βRII bispecific fusion protein) combined with standard first-line targeted-chemotherapy as conversion therapy in adult patients with initially unresectable microsatellite-stable (MSS\u002FpMMR) colorectal adenocarcinoma liver metastases. Two pre-defined cohorts are enrolled: Cohort 1 for RAS\u002FBRAF wild-type left-sided primary tumor (mFOLFOX6 + cetuximab + Retlirafusp alfa); Cohort 2 for RAS\u002FBRAF-mutant or right-sided primary tumor (CAPEOX + bevacizumab + Retlirafusp alfa).",[92],"Colorectal Adenocarcinoma Metastatic in the Liver","NOT_YET_RECRUITING","2026-09-06",{"date":96,"type":97},"2026-09-11","ACTUAL",{"date":99,"type":86},"2026-09-30",{"date":101,"type":86},"2029-12-30",{"name":5,"class":6},1]