Extrahepatic cholangiocarcinoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, both male and female; 2. Pathologically confirmed as inoperable advanced extrahepatic cholangiocarcinoma; 3. Tumor portal vein or hepatic artery invasion (tumor-vascular interface >= 180 degrees); 4. CT can assess lymph node metastasis, tumor diameter > 1cm; 5. According to the RECIST 1.1 standard, there is at least one measurable lesion; 6. The patient has not yet received PD-1/PD-L1 antibody treatment; 7. ECOG: 0-1; 8. Expected survival period >= 12 weeks; 9. The baseline blood count test and blood biochemistry must meet the following standards: Serum CA199 >= 450 U/mL; Hemoglobin >= 90 g/L; The absolute count of neutrophils >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 30 g/L; 10. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy tests are negative within 7 days before study entry, And must be a non-lactating patient; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 11. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, Hyperthyroidism; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included); 2. During pregnancy or lactation; 3. Previous system chemotherapy or radiotherapy; 4. Complicated with malignant pleural effusion or ascites; 5. History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); 6. Complicated infection, anti-infective treatment is needed; 7. Complicated peripheral nervous system disease or obvious history of mental disease and central nervous system disease; 8. Other types of malignant tumors are diagnosed within 5 years, except for non-melanoma skin cancer and cervical carcinoma in situ; 9. Uncorrectable coagulation disorders; 10. Obviously abnormal ECG or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), coronary heart disease with obvious clinical symptoms, uncontrollable arrhythmia and hypertension; 11. History of myocardial infarction within 12 months, or heart function grade III or IV; 12. Severe liver disease (such as cirrhosis), kidney disease, respiratory system disease, uncontrollable diabetes or other types of system diseases; 13. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactWenlong Zhai
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed