biliary tract tumors
Conditions
Interventions
IHC 2+ or 3+ group:ZW25 20 mg/kg, IV Q2W
IHC 0 or 1+ group:ZW25 20 mg/kg, IV Q2W
Sponsors
Affiliated Third Hospital of Navy Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. BTC was confirmed by histology or cytology, including ICC, ECC or GBC; 2. Locally advanced or metastatic BTC is not suitable for radical resection, transplantation or ablation; 3. Have received at least one previous systemic treatment for advanced diseases, including one containing gemcitabine, and developed disease progression or intolerance after the latest previous treatment. For subjects who have received previous adjuvant or neoadjuvant therapy, if progression occurs within 1.5 x 10^9 / L, platelets > 75 x 10^9 / L; 9. Sufficient renal reserve: creatinine < 130 µ mol / L; 10. No heart failure, chest pain (uncontrollable in medicine), no myocardial infarction occurred in 12 months before the start of the study; 11. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Received systemic anti-tumor therapy 3 weeks before the first administration of zw25. He received radiotherapy 2 weeks before the first administration of zw25; 2. Major surgery was performed 4 weeks before the first administration of zw25; 3. Previous HER2 targeted drug therapy; 4. Previous history of other system tumors, except: 1) Carcinoma in situ of cervix 2) Treated basal cell carcinoma 3) Superficial bladder cancer (TA, tis and T1) 4) Any cancer that received radical treatment three years ago 5. Severe heart, brain, lung, kidney and blood system diseases; 6. There was brain or meningeal metastasis; 7. Patients who had arteriovenous thrombosis within 6 months before enrollment, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism; 8. Pregnant or lactating women; 9. Participants in other clinical trials; 10. Have a history of allogeneic organ transplantation; 11. Known or suspected history of allergy to biological agents, allergic constitution or in allergic state; 12. Bleeding events, unhealed wounds, ulcers or fractures occurred at any site 4 weeks before medication; 13. Untreated intestinal obstruction that can not eat or affect systemic administration; 14. HIV infection or AIDS related diseases; 15. Inflammatory infection in the active phase of infection receiving planned treatment 16. According to the investigator's judgment, patients with concomitant diseases that may seriously endanger their own safety or may affect the completion of the study 17. Those who had a history of mental illness or abnormal behavior were not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactXie Feng
Affiliated Third Hospital of Navy Medical University
Outcome results
None listed