[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632613":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Zhongnan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Colorectal cancer patients with liver metastases who meet the inclusion criteria will sign an informed consent form and receive FULIRI chemotherapy combined with bevacizumab\u002Fcetuximab targeted therapy. Treatment efficacy will be assessed after every four cycles of treatment. After multidisciplinary team (MDT) discussion, a decision will be made regarding whether to proceed with surgery, ablation, stereotactic radiotherapy, or other treatments. Chemotherapy combined with targeted therapy will continue for a maximum of 12 cycles, until the possibility of curative surgery\u002Fablation or other local treatment arises, disease progression occurs, intolerable toxicity develops, or the patient withdraws informed consent (whichever comes first). The adjuvant and maintenance treatment regimens after curative surgery or achieving NED (no evidence of disease) status will be determined by the investigator.",[13],"Drug: FULIRI combination targeted therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","FULIRI combination targeted therapy","Chemotherapy regimen FULIRI: Irinotecan liposome 70 mg\u002Fm2; leucovorin CF 400 mg\u002Fm2, d1, iv drop; 5-FU 400 mg\u002Fm2, d1, iv drop; 5-FU 2400 mg\u002Fm2, d1, CIV 46-48h; repeated every 2 weeks.\n\nCombined targeted therapy: Based on tumor gene analysis results, investigators may choose to combine bevacizumab (5 mg\u002Fkg, iv drop, d1) or cetuximab (500 mg\u002Fm2, iv drop, d1), repeated every 2 weeks.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yongchang Wei","CONTACT","+8617771886922","weiyongchang@whu.edu.cn",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","430071","China","CN",{"type":36,"coordinates":37},"Point",[38,39],114.26667,30.58333,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":43,"phoneExt":20,"email":26},"+862767812787",{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100632613","phase-2-fuliri-plus-targeted-therapy-for-first-line-conversion-therapy-of-colorectal-cancer-liver-metastases-100632613",false,"NCT07515963","FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases.","A Phase II Clinical Study of FULIRI Regimen Chemotherapy Combined With Targeted Therapy for First-line Conversion Treatment of Colorectal Cancer Liver Metastases.","Inclusion Criteria:\n\n\\- (1) Age 18-75 years; (2) Histologically confirmed colorectal adenocarcinoma; (3) Synchronous liver metastasis of colorectal cancer, or liver metastasis occurring after curative surgery for colorectal cancer, and no prior systemic anti-tumor treatment (including but not limited to systemic chemotherapy, molecular targeted therapy, immunotherapy, biological therapy, and other investigational drugs) after diagnosis of liver metastasis; (4) Liver metastasis deemed unresectable by MDT assessment, or potentially resectable but with a CRS score ≥3; (5) For patients who have received neoadjuvant or adjuvant therapy for colorectal cancer, the date of first diagnosis of liver metastasis must be at least 6 months after the last dose of neoadjuvant or adjuvant therapy; (6) At least one measurable target lesion on CT scan, assessable according to RECIST v1.1 criteria; (7) ECOG performance status 0-2; (8) Good organ function, without severe comorbidities of the heart, liver, lungs, kidneys, brain, etc.; (9) Blood routine: HGB ≥90 g\u002FL, WBC \\>3.5 × 10\\^9\u002FL (NEU ≥1.5 × 10\\^9\u002FL), PLT ≥90 × 10\\^9\u002FL; Liver function: ALT or AST ≤2.5 times the upper limit of normal (ULN); Bilirubin ≤1.5 × ULN; Renal function: serum creatinine ≤1.5 × ULN; (10) Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before starting the study medication and be willing to use a medically approved highly effective contraceptive method during the study and for 3 months after the last dose of study medication; male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of study medication.\n\n(11) The subject has given informed consent and signed the informed consent form, and is willing and able to comply with the planned visits, study treatment, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* (1) Pathological diagnosis reveals the presence of neuroendocrine tumor, squamous cell carcinoma, or adenosquamous carcinoma components; (2) Presence of conditions requiring emergency treatment, such as bowel obstruction, bowel perforation, or bleeding; (3) Presence of multiple metastases in sites other than the liver (excluding localized lung metastases (≤2) or localized retroperitoneal lymph node metastases, provided the investigator assesses that the patient has a chance of achieving NED status); (4) Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) who are deemed suitable for immunotherapy with immune checkpoint inhibitors by the investigator; (5) Previous treatment with irinotecan; (6) Underweight (Body Mass Index \\[BMI\\] \\\u003C 18 kg\u002Fm2); (7) Concurrent or previous history of other malignancies besides cervical carcinoma in situ and basal cell carcinoma of the skin; (8) Concurrent severe infection or active pulmonary tuberculosis; (9) History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; (10) Patients with hepatitis B, if hepatitis B DNA exceeds 1000 copies\u002FmL, should be excluded; patients with hepatitis C, if hepatitis C RNA is positive, should be excluded; (11) Received surgery or other anti-tumor treatments (including chemotherapy, radiotherapy, investigational treatments, etc.) within 4 weeks prior to enrollment; (12) Concurrent severe gastrointestinal dysfunction (\\> Grade I according to NCI-CTCAE v5.0, such as intestinal inflammation or diarrhea); (13) Presence of conditions within the past 6 months that contraindicate targeted therapy, such as arterial embolism, severe bleeding, or bowel perforation (excluding bleeding caused by surgery); (14) Concurrent severe or uncontrolled systemic diseases, including but not limited to hypertension (systolic blood pressure consistently above 150 mmHg, diastolic blood pressure consistently above 95 mmHg), diabetes, heart disease, etc.; (15) Patients who cannot tolerate this study or who may be allergic to the medications used in this study; (16) Patients with cognitive impairment or co-existing severe mental disorders, who are judged by the investigator to have poor adherence to chemotherapy; or other situations deemed unsuitable for participation in clinical research by the investigator.","ALL","18 Years","75 Years",{"count":57,"type":58},24,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","This study is a single-center, prospective, randomized, single-arm phase II clinical trial designed to evaluate the safety and efficacy of FULIRI chemotherapy regimen combined with targeted therapy (bevacizumab\u002Fcetuximab) as first-line conversion therapy for colorectal cancer with liver metastases. Eligible patients with colorectal cancer and liver metastases, after signing informed consent, received FULIRI chemotherapy combined with bevacizumab\u002Fcetuximab targeted therapy. Efficacy was assessed after every four treatment cycles, followed by multidisciplinary team (MDT) discussion regarding potential surgical resection, ablation, or stereotactic radiotherapy. The primary endpoint was the objective response rate (ORR), and secondary endpoints included: disease control rate (DCR), R0 resection rate of liver metastases, progression-free survival (PFS), 3-year\u002F5-year survival rates, and the incidence of acute toxicities of any grade and grades 3\u002F4.",[64],"Colo-rectal Cancer",[66,67,68],"Colorectal cancer","Liver metastasis","FULIRI","NOT_YET_RECRUITING","2026-03-30",{"date":72,"type":73},"2026-04-07","ACTUAL",{"date":75,"type":58},"2026-06-01",{"date":77,"type":58},"2028-02-01",{"name":5,"class":6},1]