[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597503":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":28,"responsibleParty":44,"collaborators":21,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":21,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":70,"whyStopped":21,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Trastuzumab +Cetuximab β+Irinotecan","EXPERIMENTAL","Treatment regimen: All agents will be administered via intravenous infusion, consisting of trastuzumab (4 mg\u002Fkg every 2 weeks), cetuximab beta (500 mg\u002Fm² every 2 weeks) in combination with irinotecan (180 mg\u002Fm² every 2 weeks). Comprehensive radiological and laboratory assessments will be conducted after every 4 treatment cycles (8 weeks).",[13],"Drug: Trastuzumab +Cetuximab β+Irinotecan",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Trastuzumab 4 mg\u002Fkg , Cetuximab β: 500 mg\u002Fm² ,Irinotecan 180 mg\u002Fm², repeat once every 2 weeks",[9],[20],"HER2 and EGFR dual-targeted therapy combined with irinotecan",null,[23],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Yanhong Deng","CONTACT","86-13925106525","13925106525@163.com",[29],{"facility":30,"status":21,"city":31,"state":21,"zip":21,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"The Sixth Affiliated Hospital of Sun Yat-sen University","Guangzhou","China","CN",{"type":35,"coordinates":36},"Point",[37,38],113.25,23.11667,{"lat":38,"lon":37},[41],{"name":24,"role":25,"phone":42,"phoneExt":21,"email":43},"86+13925106525","dengyanh@mail.sysu.edu.cn",{"type":45,"investigatorFullName":24,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Professor","100597503","phase-2-dual-egfrher2-blockade-combined-with-irinotecan-for-the-treatment-of-her2-positive-metastatic-colorectal-cancer-100597503",false,"NCT07059338","Dual EGFR\u002FHER2 Blockade Combined With Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer","Trastuzumab in Combination With Cetuximab and Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer：A Phase II, Open-Label Trial","HERBIC","Inclusion Criteria:\n\n* Signed and dated informed consent must be obtained voluntarily from the subject prior to performing any study-related procedures (non-routine care), in accordance with regulatory and institutional guidelines.\n* 18 to 75 years of age, inclusive.\n* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with evidence of distant metastasis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* HER2-positive tumor with wild-type KRAS, NRAS, and BRAF genes confirmed by testing at any time prior to screening. HER2 positivity is defined as: Immunohistochemistry (IHC) showing HER2 3+ staining in \\>50% of tumor cells; or HER2 2+ by IHC with positive fluorescence in situ hybridization (FISH): HER2\u002FCEP17 ratio ≥2.0 in \\>50% of tumor cells; or Next-generation sequencing (NGS) of tissue or circulating tumor DNA (ctDNA) demonstrating HER2 copy number ≥6.\n* Adequate organ function as evidenced by:\n\nAbsolute neutrophil count ≥1.5×10\\^9\u002FL Platelet count ≥75×10\\^9\u002FL Serum total bilirubin ≤1.5×upper normal limit (UNL) Aspartate aminotransferase (AST) ≤2.5×UNL Alanine aminotransferase (ALT) ≤2.5×UNL Serum creatinine ≤1.5×UNL\n\n* Disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, including: Subjects who received oxaliplatin in the adjuvant setting must have experienced disease progression within 6 months after completing adjuvant therapy.Patients who decline standard therapy due to intolerable toxicity are eligible.\n* Presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Willing and able to comply with the study protocol and visit schedule\n\nExclusion Criteria:\n\n* Known KRAS, NRAS, or BRAF mutations detected by ctDNA testing prior to enrollment; or tumors with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).\n* Concurrent intestinal obstruction, active bleeding, or perforation requiring emergency surgery.\n* Major surgery (e.g., laparotomy, thoracotomy, or organ resection via laparoscopy) or significant trauma within 4 weeks prior to study entry (surgical incision must be fully healed before enrollment).\n* Active coronary artery disease within 12 months before screening, including severe\u002Funstable angina, newly diagnosed angina, or myocardial infarction.\n* History of thrombosis or embolism within 6 months, including cerebrovascular accident (transient ischemic attack included), pulmonary embolism, or deep vein thrombosis.\n* Congestive heart failure classified as New York Heart Association (NYHA) Class II or higher.\n* HIV infection or AIDS; untreated active hepatitis (HBV-DNA ≥500 IU\u002FmL for hepatitis B; detectable HCV-RNA for hepatitis C); or HBV\u002FHCV co-infection.\n* Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia).\n* Persistent ≥Grade 2 toxicities (per CTCAE v5.0) from prior therapies (excluding peripheral neuropathy, anemia, alopecia, or skin hyperpigmentation).\n* Known or suspected hypersensitivity to any study drugs.\n* Pregnancy or lactation.","ALL","18 Years","75 Years",{"count":59,"type":60},34,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","In colorectal cancer (CRC), HER2 has emerged as a critically targeted biomarker in recent years. Although multiple clinical trials have demonstrated the potential of HER2-targeted therapies in HER2-positive (overexpressed\u002Famplified) metastatic CRC (mCRC), the duration of treatment response remains short with rapid disease progression. This underscores the urgent need to develop novel therapeutic strategies for HER2-positive mCRC. The EGFR pathway is constitutively activated in CRC and mediates resistance to HER2-targeted therapies through the formation of EGFR-HER2 heterodimers. Notably, EGFR-targeting antibodies combined with irinotecan can reverse irinotecan chemoresistance. Building upon these mechanisms, this study proposes to evaluate the combination of trastuzumab (anti-HER2), cetuximab beta (anti-EGFR), and irinotecan in chemotherapy-refractory HER2-positive mCRC.",[66,67],"HER2 Positive","Colorectal Cancer (CRC)",[69],"colorectal cancer","NOT_YET_RECRUITING","2025-07-07",{"date":73,"type":74},"2025-07-10","ACTUAL",{"date":76,"type":60},"2025-07-11",{"date":78,"type":60},"2028-12-30",{"name":5,"class":6},1]