Biliary Tract Tumor
Conditions
Interventions
Experimental Group:DisitamabVedotin with lenvatinib
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined this study and signed an informed consent form; 2. Age range from 18 to 75 years old, regardless of gender; 3. Non resectable locally advanced or metastatic biliary tract malignant tumors confirmed by histopathology or cytology, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma, excluding ampullary carcinoma; 4. Before enrollment, provide a test report that can confirm HER2 expression (HER2 expression is defined as an immunohistochemical IHC score of 2+or 3+), and try to provide sufficient tumor tissue sample slices (archived or fresh biopsy samples) to evaluate and confirm HER2 expression; 5. Subjects who have progressed after receiving first-line or above systemic treatment in the past, and those who have progressed during (new) adjuvant treatment or within 6 months after the end of the treatment can be selected; 6. AE requiring previous medication/medical intervention has returned to baseline or = level 1 (NCI-CTCAE v5.0), except for AE that does not affect subsequent treatment such as hair loss or fatigue; According to RECIST v1.1 standard, subjects have at least one measurable lesion. CT or MRI measurable target lesions are defined as: according to the RECIST v1.1 standard, measurable lesion length = 10 mm or enlarged lymph node short diameter = 15 mm; Lesions that have previously received local treatment can be identified as target lesions after progression according to the RECIST v1.1 standard; 8. ECOG score: 0-2 points; 9. Expected survival time = 12 weeks; 10.The main organ function is good, that is, the relevant examination indicators within 7 days before the study administration meet the following requirements: a) Blood routine examination: i. Hemoglobin = 90 g/L (no blood transfusion within 14 days); Ii. Neutrophil count>1.5 × 109/L; Iii. Platelet count = 80 × 109/L; b) Biochemical examination: i. Total bilirubin = 2.5 × ULN (upper limit of normal value); Ii. Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) = 2.5 × ULN; If there is intrahepatic invasion (such as iCCA or liver metastasis), ALT or AST= 5 × ULN; Iii. Endogenous creatinine clearance rate = 60 ml/min (Cockcroft Fault formula); c) Cardiac Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) = 50%; d) There was no significant abnormality in the myocardial enzyme spectrum; 11. For female subjects: they should be surgical sterilized, postmenopausal patients, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period; The serum or urine pregnancy test must be negative within 7 days before enrollment and must be non lactating. Male subjects: patients who agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period; Specific contraceptive measures and the definition of women of childbearing age can be found in Annex 1: Contraceptive Measures, Definition of Women of Childbearing Age, and Contraceptive Requirements.
Exclusion criteria
Exclusion criteria: 1. Participated in clinical trials of other drugs within 4 weeks before the start of study administration; 2. Previously received treatment with antibody conjugated drugs targeting HER2; Patients who have previously received anti HER2 therapy such as trastuzumab, paclitazumab, and pyrrolitinib can be selected; Patients who have previously received PD-1 monoclonal antibody treatment can be selected; Patients who have previously received treatment with paclitaxel drugs require elution for at least 2 weeks. 3. Previously used anti angiogenic targeted drugs; 4. Those who are known to have previous allergies to monoclonal antibodies or any component of the investigational drug; 5. Previous medical history of other active malignant tumors within the past 5 years. Except for the following cases: as of the date of the first administration of the study drug, skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, prostate carcinoma in situ or cervical carcinoma in situ have completely alleviated for at least 2 years, and no other treatment is required or expected during the study period; 6. Heart diseases with clinical significance or poor control, such as a history of unstable angina; Newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction events occurring within 6 months prior to screening; Arrhythmias (including QTcF: = 450 ms for males and = 470 ms for females) require long-term use of antiarrhythmic drugs and a New York Heart Association grade of = II cardiac dysfunction; 7. Patients with severe exudation accompanied by clinical symptoms (such as large amounts of pleural effusion, ascites, or pericardial effusion) and requiring repeated therapeutic puncture drainage (allowing the use of catheters) before the first administration of the study treatment; 8. Have a history of infection with human immunodeficiency virus, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 9. If there is a severe infection within 2 weeks prior to starting the study treatment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; Oral or intravenous administration of therapeutic antibiotics within one week prior to the start of the study treatment (allowing patients with prophylactic antibiotics, such as preventing urinary tract infections or exacerbation of chronic obstructive pulmonary disease, to be eligible to participate in the study); 10. Existence of active autoimmune diseases or a history of autoimmune diseases that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [only subjects that can be controlled through hormone replacement therapy can be included]); Subjects with skin diseases such as vitiligo and psoriasis that do not need systematic treatment, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma patients who require medical intervention with bronchodilators cannot be included; 11. Subjects who require systemic treatment with corticosteroids (>10 mg/day prednisone equivalent dose) or other immunosuppressants within 14 days prior to the first use of the study drug; 12. Inject live vaccines (such as influenza v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival,PFS;overall survival,OS;duration of remission;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactJun Xue
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed