biliary tract cancer
Conditions
Interventions
single arm:Gemcitabine +Cisplatin + Serplulimab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily joined the study, signed informed consent, and cooperated with follow-up 2. Age 18-75 3. Advanced biliary cancer confirmed by histopathology 4. In situ hybridization tested positive for EBERs, or blood EBV-DNA 5. Has not received palliative chemotherapy 6. At least one measurable lesion, =10mm on CT scan 7. ECOG : 0~1 8. Organ function is basically normal (Neutrophil count=2.0×109/L,platelets=2.0×109/L, Hb=90g/L, AST/ALT=2.5 UN, TBIL=1.2×UNL, CRE=1.25 UNL, Creatinine clearance=60mL/min ) 9. Life expectancy is greater than 3 months 10. At least 4 weeks after surgery, and the wound was completely healed 11. No history of other malignancies (except cured cervical carcinoma in situ, basal carcinoma of the skin) 12. Consent to contraception
Exclusion criteria
Exclusion criteria: 1.The investigator assessed the patient as unsuitable for the study, including (but not limited to) Had other malignancies within the previous 5 years With symptomatic brain metastases Previous treated with PD-1 antibody A history of heart disease, such as myocardial infarction, severe unstable angina, congestive heart failure, or congenital heart disease Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication Severe complications include intestinal paralysis, ileus, interstitial pneumonia, pulmonary fibrosis, renal insufficiency and cirrhosis Chronic nausea, vomiting, or diarrhea Gastrointestinal bleeding requires frequent blood transfusions Suffer from AIDS Suffer from mental illness Known neuropathy, grade 2 or higher in severity Infectious disease or uncontrolled active infection 2. Known allergies to any of the drugs in the study 3. Using or has participated in a clinical trial of another drug within 4 weeks 4. A concomitant disease that, as assessed by the investigator, seriously endangers the patient's safety or interferes with the patient's completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactLiang-ping Xia
Sun yat-sen university cancer center
Outcome results
None listed