Extrahepatic Cholangiocarcinoma
Conditions
Interventions
Experimental group:Toripalimab+TACE
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >18 years and =12 weeks; 5. Patients with extrahepatic cholangiocarcinoma confirmed by histology or cytology, and patients with obstructive jaundice need to return to normal after drainage; 6. At least one measurable lesion [spiral CT >=10 mm (CT thickness =1.5x10^9/L; (2) Platelet >=75x10^9/L; (3) Hemoglobin >=8g/dL; (4) Serum albumin >=2.8g/dL; (5) Bilirubin =50mL/min (Cockcroft-Gault); (7) Normal thyroid function; (8) Adequate cardiac function, left ventricular ejection fraction (LVEF)>50% by 2-D echocardiography; 8. No history of severe drug allergy; 9. Women of childbearing age must already be using reliable contraceptive methods or have undergone a pregnancy test before being enrolled; 10. Patients volunteered to join the study. Signed informed consent, good compliance, cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; 2. Present with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood who can be included in adulthood without any intervention; Patients with asthma requiring medical intervention with bronchodilators are not included); 3. Patients who were taking immunosuppressant or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continued to use within 2 weeks prior to enrollment; 4. Lactating patients; 5. Other malignancies diagnosed within 5 years prior to the first use of the investigational drug, other than effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected cervical and/or breast cancer in situ; 6. Patients prone to infection and poor blood sugar control; 7. Incomplete important imaging examination and incomplete adverse reaction record; 8. Previously received surgery, chemotherapy, targeting, radiotherapy and immune-related therapy; 9. The investigator determines other conditions that may affect the conduct of clinical studies and the determination of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease control rate (DCR);Overall survival;Safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactDuan Xuhua
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed