biliary tract cancer
Conditions
Interventions
Untreated patients of advanced Biliary tract tumor:Gemcitabine based chemotherapy plus sintilimab
Sponsors
Eastern Hepatobiliary Surgery Hospital Second, Military Medical University, Shanghai, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathological or cytological diagnosis is biliary tract cancer; 2. At least one Measurable evaluation according to RECIST v1.1 standard; 3. Age from 18 to 75 years old; 4. The WHO/ECOG physical strength score reaches 0-2; 5. Sufficient bone marrow hematopoietic function reserve (white blood cell count> 3.0 x 10^9/L, platelet count> 100 x 10^9/L); 6. Sufficient liver reserve (bilirubin 60 ml/min; creatinine = 3 months; 10. Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. After systemic treatment, including chemotherapy, targeted therapy and immunotherapy; 2. Concomitant secondary malignant tumors or other tumors, with brain or meningeal metastasis within 3 years before the start of the study; 3. Contraindications associated with drug,such as severe hypertension, high blood risk, severe nephrotic syndrome, etc. 4. Chronic diarrhea or colorectal inflammatory conditions, or untreated obstruction or sub-obstruction affecting systemic administration; 5. Active infection period or other serious infections that may prevent the patient from receiving the planned treatment. For example, long-term uncontrolled destruction of the branch of the biliary tract bacterial cholangitis; 6. Cardiac insufficiency, unstable angina pectoris, congestive heart failure, failure myocardial infarction and severe uncontrolled arrhythmia within 6 months before the enrollment; 7. Patients with a history of drug abuse or mental disorders that are difficult to control; 8. According to the judgment of the investigator, patients with accompanying diseases that may seriously endanger their safety or may affect the completion of the study; 9. Participated in other clinical trials; 10. Pregnant or lactating female; 11. Individuals undergoing correction monitoring or supervision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Objective response rate;Disease control rate;duration of response;Safety; | — |
Countries
China
Contacts
Public ContactZhen-gang Yuan
Eastern Hepatobiliary Surgery Hospital Second, Military Medical University, Shanghai, China
Outcome results
None listed