cancer of biliary duct
Conditions
Interventions
No previous immunotherapy:Disitamab Vedotin + Durvalumab
Previous immunotherapy:Disitamab Vedotin + Durvalumab
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary entry and signed written informed consent; 2. Aged 18-80 years (including 80 years old), male or female; 3. Cholangiocarcinoma confirmed by histology or cytology, IHC HER2 2+ or 3+; 4. According to AJCC, it is classified as advanced cholangiocarcinoma; 5. Radiographically proven unresectable or metastatic cholangiocarcinoma; 6. No previous anti-HER2 drug therapy; 7. At least one lesion can be detected on imaging; 8. ECOG 0-2; 9. Expected survival time > 3 months; 10. The serum pregnancy test results of female patients with fertility (referring to non menopause or non surgical sterilization) within 7 days before the administration of the study drug must be negative; 11. Female or male patients with fertility must take reliable contraceptive measures during the use of the study drug and within 60 days after the last drug use; 12. Normal function of main organs.
Exclusion criteria
Exclusion criteria: 1. Mixed BTC and HCC confirmed by histology or cytology; 2. Previously received HER2-targeting drugs, including but not limited to trastuzumab, pertuzumab, etc.; 3. The first study drug received radiotherapy before administration, which meets one of the following conditions: (1) >= 30% of bone marrow had received radiotherapy within 14 days before treatment; (2) Within 6 weeks before treatment, the patients received radiotherapy for liver lesions and the dose was > 30Gy (the enrolled subjects must recover to grade 1 or below from the toxicity of previous radiotherapy, no glucocorticoid treatment and no history of radiation pneumonia); (3) The end time of palliative radiotherapy was within 7 days before the first study drug administration; 4. Other malignant tumors within 5 years, unless the patient has received possible curative treatment and there is no evidence of the disease within 5 years; 5. Previous or current congenital or acquired immunodeficiency disease; 6. Active or previously documented autoimmune or inflammatory diseases; 7. Previous serious psychiatric history; 8. Have a disease that affects the absorption, distribution, metabolism, or clearance of the studied drug; 9. Major surgery (defined by the investigator) was performed within 4 weeks before enrollment, or major surgery is expected to be performed during the study treatment; 10. Have received allogeneic stem cells or solid organ transplantation in the past; 11. Have received any ADC drug treatment for cholangiocarcinoma in the past; 12. Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or were expected to be required during the study, except for the following: (1) Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection); (2) The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day; (3) Preventive use of corticosteroids for hypersensitivity; 13. Take drugs that may prolong QTc and/or induce torsade de pointes (Tdp) or affect drug metabolism at the same time; 14. The patient is known or suspected to have a history of allergy to RC48 or similar drugs, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of the study drug; 15. Subjects who have uncontrollable hepatic encephalopathy, hepatorenal syndrome, clinically uncontrollable pleural effusion/peritoneal effusion, and do not need to drain the effusion or stop the drainage for 3 days without significant increase in effusion can be included in the group; 16. Active bleeding or coagulation dysfunction, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy; 17. Have a history of gastrointestinal bleeding disease or have a clear gastrointestinal bleeding tendency in the past 4 weeks (for example, it is known that there are local active ulcer lesions, fecal occult blood++or more, and gastroscopy should be performed if fecal occult blood+continues), or other conditions that may cause gastrointestinal bleeding (such as severe gastric fundus/esophageal varices) judged by the researcher; 18. Gastrointestinal perforation, abdominal fistula or abdominal abscess occurred in the past 6 months; 19. Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.; 20. Cardiovascular diseases with significant clinical significan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Duration of duration;Disease control rate;Adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactHu Yi
Chinese PLA General Hospital
Outcome results
None listed