biliary tract cancer
Conditions
Interventions
Experimental group:Pyrotinib in combination with adebrelimab and bevacizumab
Sponsors
Department of Hepatobiliary and Pancreatic Surgery, First Medical Center, Chinese People's Liberation Army General Hospital.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed informed consent; 2. Age: =18 years old, male or female; 3. Unresectable or recurrent advanced biliary system malignancies confirmed by imaging or pathological diagnosis; 4. Histologically confirmed HER2-positive biliary tract carcinoma. Her2-positive tumors were defined as IHC 3 + or IHC 2 + combined with ISH +, or ERBB2 amplification (=6 copies) of NGS in tumor tissue. 5. Patients have previously received at least first-line systemic therapy for advanced BTC, but the first-line therapy cannot be adbrelimab combined with bevacizumab and pyrotinib; 6. At least one measurable disease per RECIST v1.1; 7.ECOG PS: 0~2 points; 8. Life expectancy =12 weeks; 9. Adequate bone marrow and organ function; 10. Patients who are fertile are willing to use appropriate contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Patients with gene mutation or fusion except HER2, and applicable to BRAF, FGFR2, IDH1/2, NTRK and other approved targeted drug therapy; 2. Have clinical symptoms or diseases of the heart that are not well controlled; 3. Have high blood pressure, and can not be reduced to the normal range by antihypertensive medication; 4. Risk of gastrointestinal bleeding; 5. Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN), with bleeding tendency; 6. Thrombotic or embolic events occurred within 6 months before the start of study therapy; 7. Currently accompanied by interstitial pneumonia or interstitial lung disease; 8. There is active autoimmune disease or a history of autoimmune disease with possible recurrence; 9. Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogitics) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors within 14 days prior to signing the informed consent: 10. Uncontrolled infection occurs during screening; 11. Other situations judged by the researchers not suitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);progression free survival (PFS);Duration of response (DoR);Adverse Events (AEs);Surgical conversion rate; | — |
Countries
China
Contacts
Public ContactRong Liu
PLA General Hospit
Outcome results
None listed