cholangiocarcinoma
Conditions
Interventions
single arm:duvalizumab combined with GEMOX (gemcitabine+oxaliplatin)
Sponsors
Chinese PLA General Hospital (the 301st Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. First surgery treatment of 18 70 years of age men and women can be; 2. Surgically removed pathological diagnosis confirmed as hilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer; 3. Prior to participating in the study; 4. TNM phase scored I to III; 5. ECOG PS Score 0 to 1 cents; 6. Main organs function normal no serious blood heart, liver, liver and bone marrow and other functions of immune deficiency laboratory test. a. Hemoglobin >= 90 g/L 14 days without blood transfusion; b. Neutrophils absolute count >= 1 5 x 10^9/L; c. Platelet count >= 90 x 10^9/L; d. Total bilirubin <= 2.5 times the upper normal value e glutaucetose and grass valley transaminase <= 2.5 x normal value upper limit f creatinin e<=1.25 times normal value upper limit; g. Thyroid-stimulating hormone TSH <= 1 x ULN if abnormal should simultaneously examine T3, T4 levels such as T3, T4 level normal can enter the group; h. Patients who have not received anticoagulant treatment international standardization ratio of coagulation duration. Patients receiving full or gastrointestinal anticoagulant drug at the upper limit of the in-part coagulant life time Of INR <= 1 5 times the maximum normal value of the drug received the drug, as long as the dose of anticoagulant drugs prior to entering clinical studies was stable for at least 2 weeks and the results of the coagulation test could enter the clinical trial within the limits of local treatment. 7. Women of childbearing age who had to undergo a pregnancy test or urine negative within 14 days of admission and voluntarily given the drug during the observation period and after 8 weeks of the appropriate use of the drug. The patients shall voluntarily participate in and sign the informed consent form during the surgical sterilization or consent to the study drug during observation and within 8 weeks of the last time the drug is given. 8. Patients voluntarily participate and sign the informed consent form. 9. It is expected that compliance will be able to follow up the efficacy and adverse reactions as required by the programme.
Exclusion criteria
Exclusion criteria: 1. Patients treated with PD 1 PD L1 PD L2 CTLA 4 prior to group entry or who received another irritating or co-inhibitive T cell receptor directly, such as CTLA 4 OX 40 CD137. 2. Patients treated with any other research drug in the first 4 weeks of the group. 3. Patients with any active autoimmune disease or autoimmune disease such as interstitinthrotic pneusterisia spharitis inflammatory inflammatory inflammatory inflammatory inflammatory disease. Patients with childhood asthma that have been completely remissioned and who do not need any intervention or vitiligo after adulthood that require sachonoscope medical intervention can not be included in. 4. Patients with congenital or acquired immunodeficiency such as human immunodeficiency virus HIV-infected people active hepatitis B DNA, 500 IU ml hepatitis C hepatitis C antibodies, and HCV RNA is higher than the detection limit of the analytical method or combined with hepatitis B and hepatitis C co-infection. 5. Patients with uncontrolled heart clinical symptoms or diseases such as 1 NYHA II and above heart failure 2 unstable angina 3 1 year have had myocardial infarction 4 clinically significant ventricular or ventricular arrhythmia patients. 6. Patients with concurrent severe infections within 4 weeks prior to the first drug administration, such as those who require intravenous drip antibiotics antifungal or antiviral drugs, or 38.5 degrees C. 7. The history of allogeneic organ transplantation or the history of heterogeneous stem cell transplantation is known. 8. Live detoxification vaccine spent 4 weeks prior to first administration or during study. 9. Developed or accompanied by other systemic malignancies within the last 5 years, except for skin fundamental cell cancer and cervical insitual cancer and ovarian cancer. 10. Known to be allergic to any experimental drug. 11. Pregnant lactating women who have reproductive capacity subjects are not willing to take effective contraception. 12. Suffer from mental illness that is not manageable. 13. Other situations that the researchers consider unsuitable for inclusion, such as patients who have had central nervous system metastases with severe laboratory examination abnormalities accompanied by family or social factors, can affect the safety of subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;QOL, Health related quality of life; | — |
Countries
China
Contacts
Public ContactRong Liu
Chinese PLA General Hospital (the 301st Hospital)
Outcome results
None listed