biliary tract cancer
Conditions
Interventions
Experimental group:nab-paclitaxel + sintilimab
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed local advanced or metastatic adenocarcinoma or cholangiocellular carcinoma in biliary tract, including intrahepatic bile duct, extrahepatic bile duct and gallbladder; 2. Aged 18 to 75 years, either sex; 3. Life expectancy of >=3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0~1; 5. Documented disease progression after prior gemcitabine or fluorouracil-based systemic chemotherapy; not received taxol drugs treatment, including but not limited to paclitaxel, paclitaxel liposome, nab-paclitaxel and docetaxel; 6. Measurable disease according to RECIST criteria version 1.1. 7. Adequate hematologic, hepatic and renal functions: hemoglobin >=90 g/L, neutrophils >=1500/mm3, platelets >=75,000/mm3; aspartate aminotransferase and alanine aminotransferase =50 mL/min; activated partial thromboplastin time, prothrombin time and international normalized ratio <=1.5 x ULN; 8. In case of active hepatitis B or C, antiviral therapy starting at least 14 days before experimental drug administration and HBV DNA<=2500 copies/mL or <=500IU/mL and HCV RNA within the lower limit of detection; 9. Informed consent form signed.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed squamous-cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, or sarcoma, et al; 2. Malignancies of ampulla; 3. Severe hepatic or renal insufficiency; 4. Myocardial infarction within 3 months; 5. Other malignancy history with disease free survival <5 years, except for curative in situ cervical cancer, curative skin basal cell carcinoma and curative gastrointestinal cancer by endoscopic mucoresection; 6. Current or past history of autoimmune diseases, including but not limited to: interstitial lung disease, uveitis, enteritis, nephritis, hyperthyroidism and hypothyroidism; 7. Active pulmonary tuberculosis within one year; 8. Severe and uncontrolled internal medicine diseases; 9. Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al; 10. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures; 11. Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion; 12. Ever received treatment of immune checkpoint inhibitors; 13. Allergic disease history, severe hypersensitivity to experimental drugs; 14. Congenital or acquired immunodeficiency such as HIV infection; 15. Psychiatric disorders that would interfere with cooperation with the requirements of the study; 16. Other conditions that investigators consider not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time;Progression free survival time;Adverse reaction; | — |
Countries
China
Contacts
Public ContactGou Hongfeng
West China Hospital of Sichuan University
Outcome results
None listed