Biliary tract cancer
Conditions
Interventions
A:Disitamab Vedotin combined with Zimberelizumab
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
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 overexpression (HER2 overexpression 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, as well as for other biomarker detection; Considering the accessibility of clinical specimens, there are no mandatory requirements for specimens; 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=10 mm or enlarged lymph node short diameter>=15 mm; Lesions that have received local treatment in the past 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=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. If the subject has active hepatitis B virus (HBV) infection: HBV deoxyribonucleic acid (DNA) must be less than 1000 IU/ml and willing to receive antiviral treatment throughout the entire study period; 12. 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
Exclusion criteria
Exclusion criteria: 1. Participated in clinical trials of other drugs within 4 weeks prior to the start of study administration; 2. Prior treatment with antibody-conjugated drugs targeting HER2; Patients who had previously received trastuzumab, pertuzumab, pyrrolitinib and other anti-HER2 therapy were eligible; Patients who had previously received PD-1 mab could be included; Patients who have previously been treated with taxoid-based drugs need to be eluted for more than 2 weeks. 3. Known prior allergy to monoclonal antibodies or to any of the test drug components; 4. Past history of other active malignancies within the past 5 years. Complete remission of basal cell carcinoma of the skin, superficial bladder, squamous cell carcinoma of the skin, carcinoma of the prostate in situ, or carcinoma of the cervix in situ for at least 2 years as of the date of first administration of the study drug and no additional treatment is required or expected during the study period; Subjects with active central nervous system (CNS) metastases. Subjects with a current history or evidence of meningeal metastasis. Subjects are eligible to participate if CNS metastases are adequately treated (surgery or radiation) and their neurological function returns to baseline (other than residual signs or symptoms associated with CNS treatment) for at least 2 weeks prior to enrollment; 6. Clinically significant or poorly controlled heart disease, such as a history of unstable angina; Patients who were newly diagnosed with angina pectoris within 3 months before screening or had myocardial infarction within 6 months before screening; Arrhythmias (including QTcF: >=450 ms for men and >=470 ms for women) requiring long-term use of antiarrhythmic drugs and New York Heart Association classification >=II cardiac insufficiency; 7. Patients with severe exudation accompanied by clinical symptoms (such as massive pleural effusion, ascites or pericardial effusion) and requiring repeated therapeutic puncture and drainage (allowing the use of catheters) before the first drug administration in the study; 8. A history of human immunodeficiency virus infection or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 9. Severe infection, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia complications, within 2 weeks prior to the start of study treatment; Oral or intravenous administration of therapeutic antibiotics within 1 week prior to initiation of study treatment (allowing prophylactic antibiotics, such as those to prevent urinary tract infections or exacerbations of chronic obstructive pulmonary disease, to qualify for study); 10. There is active autoimmune disease or a history of autoimmune disease and may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function decrease [just by hormone replacement therapy can control subjects can be incorporated into]); Subjects with skin diseases that do not require systematic treatment, such as vitiligo and psoriasis, controlled type I diabetes treated with insulin, or asthma that has been completely resolved in childhood and does not require any intervention as adults may be included; Asthma patients requiring medical intervention with bronchodilators were excluded; 11. Subjects requiring systematic treatment with corticosteroids (>10
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;duration of remission, DOR;disease control rate, DCR;overall survival, OS;Biomarker; | — |
Countries
China
Contacts
Public ContactXiaofeng Chen
Jiangsu Province Hospital
Outcome results
None listed