[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,64,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100442011","phase-2-a-phase-2-single-arm-open-label-pilot-trial-evaluating-zanidatamab-zw25-in-patients-with-early-stage-her2neu-positive-her2-breast-cancer-bc-100442011",false,"NCT05035836","A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2\u002FNeu Positive (HER2+) Breast Cancer (BC)","Inclusion Criteria:\n\n1. Ability to give written informed consent\n2. Age \\> 18 years at time of study entry.\n3. Patient would be willing to undergo surgery is appropriate for surgery\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).\n5. Tumor size \\> 1 cm to ≤ 3 cm assessed by ultrasound and clinically and radiographically node negative with no known metastatic disease.\n6. HER2+ BC as defined by American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines.31 Patients may have ER+ or ER- negative disease, as defined by ASCO-CAP guidelines.\n7. Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, documented within 4 weeks prior to first dose of study drug.\n8. Adequate normal organ and marrow function as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (≥ 1500 per mm3)\n   * Platelet count ≥ 100 x 109\u002FL (≥100,000 per mm3)\n   * Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). The maximum allowable bilirubin is ≤ 2.5 x ULN for patients with Gilbert's disease.\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n   * Calculated glomerular filtration rate \\>50 mL\u002Fmin\n9. Patients must either be of non-reproductive potential or willing to undergo appropriate contraception. Male subjects must agree not to donate sperm and female subjects must agree not to donate oocytes starting at screening and throughout the study period, and for at least 12 months after treatment discontinuation.\n10. Patient with reproductive potential must have a negative pregnancy test ≤3 days prior to the first dose of zanidatamab.\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Involvement in the planning and\u002For conduct of the study.\n2. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n3. Has received therapy for this current diagnosis of BC including investigational therapy, endocrine therapy, targeted therapy, or chemotherapy, surgery or radiation.\n4. Mean QT interval corrected for heart rate (QTc) ≥ 470 ms.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, active bleeding diatheses, , or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.\n6. Female patients who are pregnant, breast-feeding, or of reproductive potential who are not employing an effective method of birth control.\n7. Patients with uncontrolled seizures.\n8. Any major surgery for any reason, within 4 weeks of the enrollment. Portacath placement will be allowed.\n9. Clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, , myocardial infarction, unstable angina (within 6 months prior to first dose of study drug), any history of cardiac failure, and uncontrolled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg on antihypertensive medications).\n10. Known active Hepatitis B and\u002For Hepatitis C. Hepatitis testing is not required unless the patient has a history of Hepatitis B or C.\n11. Known to be HIV positive. HIV testing is not required for those patients who are not known to be positive.\n12. Total lifetime anthracycline load exceeding 360 mg\u002Fm2 doxorubicin or equivalent\n13. Any condition that requires systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days prior to randomization. Note: Subjects who are currently or have previously been on any of the following steroid regimens are not excluded:\n\n    1. Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)\n    2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption\\\\\n    3. Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)\n14. History of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation\n15. Known distant metastatic disease including (CNS) metastases, symptomatic CNS metastases, and leptomeningeal disease (LMD).\n16. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of subjects with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment)\n17. Symptomatic pulmonary embolism ≤28 days\n18. Administered a live vaccine ≤4 weeks prior to randomization. Patients can get COVID vaccine that are not alive before ot during the study period, with 48 hours between vaccine administration and investigation agent administration.","FEMALE","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC.\n\nThe primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2\u002Fneu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR) .",[25,26],"Breast Cancer","HER2-positive","RECRUITING","2026-06-03",{"date":30,"type":31},"2026-06-05","ACTUAL",{"date":33,"type":31},"2021-11-16",{"date":35,"type":19},"2028-12-29",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100601256","phase-2-efficacy-and-safety-of-trastuzumab-biosimilars-and-pertuzumab-biosimilars-combined-with-chemotherapy-for-neoadjuvant-treatment-of-patients-with-locally-advanced-her2-positive-rectal-cancer-100601256","NCT07108127","Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer","Phase II Clinical Study on the Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Treatment of Patients With Locally Advanced HER2-positive Rectal Cancer","NePHera","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Patients with rectal cancer confirmed by histology or cytology; locally advanced (cT3\u002FT4, N+, distance from the lower edge of the tumor to the anal verge ≤ 12 cm) rectal adenocarcinoma (using the 8th edition of the AJCC TNM staging);\n3. HER2 positive after detection: HER2 positive is defined as IHC test result 3+, or IHC test result 2+ and FISH method confirms positive HER2 gene amplification;\n4. Tumor tissue gene test RAS\u002FBRAF is wild type (previous test results are acceptable);\n5. Previous treatment meets the following requirements: no previous anti-tumor treatment;\n6. ECOG PS score 0-1;\n7. Expected survival period of at least 3 months;\n8. Adequate organ function, laboratory tests meet the following criteria (no blood transfusion or hematopoietic stimulating factor treatment within 14 days):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL\n   2. Hemoglobin (Hb) ≥ 90g\u002FL\n   3. Platelets ≥ 100×109\u002FL\n   4. Albumin ≥ 30g\u002FL\n   5. Serum creatinine ≤ 1.5×ULN and creatinine clearance \\> 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula)\n   6. Total bilirubin ≤ 1.5×ULN;\n   7. Alanine aminotransferase, aspartate aminotransferase ≤ 2.5×ULN, alanine aminotransferase, aspartate aminotransferase ≤ 5×ULN for patients with liver metastasis;\n   8. Activated partial thromboplastin time ≤ 1.5×ULN; international normalized ratio ≤ 1.5×ULN.\n9. Eligible individuals (male and female) of childbearing potential must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods or abstinence) with their partners during the trial and for at least 6 months after the last dose. Female individuals of childbearing age must have a negative blood pregnancy test within 7 days before enrollment;\n10. Fully understand this clinical trial and voluntarily sign a written informed consent.\n\nExclusion Criteria:\n\n1. Patients who have received anti-HER2 drug treatment in the past;\n2. Patients with known clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence that individual central nervous system metastasis or meningeal metastasis has not been controlled, and are judged by the investigator to be unsuitable for inclusion;\n3. Patients who are receiving long-term immunosuppressive therapy (such as cyclosporine) or require daily systemic steroid therapy (such as \\>20 mg prednisone or equivalent drugs), except those who use local glucocorticoids by nasal spray, inhalation or other routes;\n4. The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤1 (except for toxicities such as alopecia that the investigator judges to have no safety risks);\n5. Clinically significant gastrointestinal diseases, including but not limited to severe liver disease, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease;\n6. Peripheral neuropathy of grade 3 or above;\n7. Known low level or deficiency of dihydropyrimidine dehydrogenase (DPD);\n8. Individuals who have undergone major surgery or invasive intervention within 28 days before the first dose (excluding puncture biopsy, central venous catheter chemotherapy, infusion port, stent implantation and bile duct drainage for relieving biliary obstruction, and cholecystostomy surgery);\n9. Participating in another clinical trial at the same time;\n10. Using any Chinese herbal medicine or Chinese patent medicine with anti-cancer activity approved by the State Food and Drug Administration within 14 days before the first dose (regardless of the type of cancer);\n11. Known to have severe allergic reactions to the study drug or other ingredients or excipients in the preparation;\n12. Active bacterial, fungal or viral infection within 14 days before the first dose (defined as requiring intravenous antibacterial, antifungal or antiviral drug treatment). Individuals who have no clinical manifestations of active infection before the first dose and are given preventive treatment for infection may be considered for inclusion in the group;\n13. Within 7 days before the first dose, there is uncontrolled serous effusion that requires frequent drainage or medical intervention (such as pleural effusion, peritoneal effusion, pericardial effusion, etc., which requires additional intervention within 2 weeks after intervention, excluding exfoliative cytology testing of exudate);\n14. Suffering from autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (exceptions are shown below), autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. The following conditions are excluded: type 1 diabetes, hypothyroidism that is stable with hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic treatment;\n15. HBsAg positive and HBV-DNA higher than the measurable lower limit or 1000 copies\u002FmL (500 IU\u002FmL) (whichever is lower), HCV antibody positive and HCV-RNA higher than the measurable lower limit or 1000 copies\u002FmL (whichever is lower); HIV antibody test positive;\n16. History of non-infectious interstitial lung disease, or interstitial pneumonia requiring hormone treatment;\n17. History of severe cardiovascular disease, including but not limited to:\n\n    1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.;\n    2. QTcF \\> 450 milliseconds at rest (if the first 12-lead electrocardiogram QTcF \\> 450 milliseconds, can be repeated twice, take the average of 3 times);\n    3. Acute coronary syndrome, congestive heart failure, heart or other vascular stent implantation, angioplasty or cardiac surgery, stroke or other cardiovascular events of grade 3 or above within 6 months before the first administration;\n    4. New York Heart Association heart function grade ≥ II or left ventricular ejection fraction \\\u003C50%;\n    5. Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death of first-degree relatives under 40 years old, use of any concomitant drugs known to prolong the QT interval;\n    6. Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg during the screening period). 18) History of other malignant tumors within 5 years or other active malignant tumors at the same time (cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included);\n\n19\\) Vaccinated with live vaccine within 28 days before randomization. Note: Seasonal influenza vaccine is an inactivated vaccine in a broad sense and is allowed to be used; intranasal influenza vaccine is a live vaccine and is not allowed to be used (applicable to immunotherapy); 20) Known mismatch repair protein deficiency (dMMR) or microsatellite high instability (MSI-H) 21) Current psychiatric disorders that affect compliance; 22) Pregnant or lactating women; 23) Patients who have used strong CYP3A4 inhibitors or strong inducers, or strong UGT1A1 inhibitors within 2 weeks before the first dose (applicable to FOLFIRI regimen treatment); 24) The investigator believes that the patient is not suitable for participating in this clinical trial for other reasons, including but not limited to: patients with concurrent serious or uncontrollable medical conditions, safety risks, interference with the interpretation of research results, and impact on trial compliance, etc.","ALL",{"count":50,"type":19},24,[22],"The purpose of this study was to evaluate the complete response rate (CR) of trastuzumab biosimilars and pertuzumab biosimilars combined with oxaliplatin and capecitabine in neoadjuvant treatment of patients with locally advanced (cT3\u002FT4, N+, distance from the lower edge of the tumor to the anal verge ≤12 cm) HER2-positive rectal adenocarcinoma.",[54,26],"Rectal Cancer","2025-07-31",{"date":57,"type":31},"2025-08-06",{"date":59,"type":31},"2025-06-20",{"date":61,"type":19},"2026-12-31",{"name":63,"class":38},"Peking Union Medical College Hospital",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":48,"minAge":16,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":75,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":39},"100597503","phase-2-dual-egfrher2-blockade-combined-with-irinotecan-for-the-treatment-of-her2-positive-metastatic-colorectal-cancer-100597503","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.","75 Years",{"count":74,"type":19},34,[22],"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.",[78,79],"HER2 Positive","Colorectal Cancer (CRC)",[81],"colorectal cancer","NOT_YET_RECRUITING","2025-07-07",{"date":85,"type":31},"2025-07-10",{"date":87,"type":19},"2025-07-11",{"date":89,"type":19},"2028-12-30",{"name":91,"class":38},"Sun Yat-sen University",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":48,"minAge":16,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":20,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100579013","phase-4-inetetamab-plus-chemotherapy--pd-1pd-l1-in-her2-advanced-biliary-cancer-100579013","NCT06818773","Inetetamab Plus Chemotherapy ± PD-1\u002FPD-L1 in HER2+ Advanced Biliary Cancer","Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1\u002FPD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n* Males or females aged ≥18 years;\n* Histologically confirmed HER2-positive metastatic biliary tract cancer;\n* ECOG performance status of 0 to 1;\n* No prior treatment with anti-HER2 therapies;\n* Patients have not received any systemic anticancer treatment in the recurrent\u002Fmetastatic setting;\n* Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and\u002For radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;\n* Presence of at least one measurable lesion;\n* Adequate function of major organs as defined by the following criteria;\n* Estimated survival of ≥3 months;\n* Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to any component of the study drugs;\n* Previous treatment with anti-HER2 therapies;\n* Prior use of immunotherapy;\n* Use of immunosuppressive agents within 14 days before the first dose, except:\n\nIntranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg\u002Fday prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)\n\n* Known active central nervous system metastases or carcinomatous meningitis;\n* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;\n* Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;\n* Severe cardiac disease;\n* Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;\n* Neuropathy ≥ Grade I per NCI criteria;\n* Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;\n* History of immunodeficiency;\n* Participation in another drug trial within 4 weeks before screening;\n* Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;\n* Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.",{"count":100,"type":19},35,[102],"PHASE4","To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.",[105,78],"Metastatic Biliary Tract Cancer","2025-02-07",{"date":108,"type":31},"2025-02-10",{"date":110,"type":19},"2025-02",{"date":112,"type":19},"2027-12-31",{"name":114,"class":38},"Eastern Hepatobiliary Surgery Hospital"]