advanced and or unresectable intrahepatic cholangiocarcinoma
Conditions
Interventions
Treatment group:DEB-TACE+GP chemotherapy combined with Tislelizumab
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old and = 75 years old; 2. Locally advanced or metastatic intrahepatic cholangiocarcinoma confirmed by histology / cytology; 3. Measurable lesions meeting RECIST 1.1 standard on baseline imaging examination; 4. Recurrence after initial treatment or radical operation without local or systemic antitumor treatment; 5. The grade of liver function is child Pugh score = 7; 6. ECOG PS score = 1; 7. Estimated survival time = 3 months; 8. The laboratory test values within 7 days before joining the group meet the following requirements: a) Leukocyte count = 3.0 × 10^9/L; b) Neutrophil count = 1.5 × 10^9/L; c) Platelet count = 100 × 10^9/L; d) Hemoglobin content = 90.0 g / L; e) Serum total bilirubin (TBIL) = 2 × ULN; f) Alanine aminotransferase (ALT) = 5 × ULN; g) Aspartate aminotransferase (AST) = 5 × ULN; h) Serum creatinine (CR) = 1.5 × ULN or creatinine clearance (CCR) = 50ml / min (Cockcroft Gault formula); i) International normalized ratio (INR) or activated partial thromboplastin time (APTT) = 1.5 times ULN. 9. Women of childbearing age must have a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test and within 8 weeks after the last administration of the test drug; For men, they should be sterilized surgically or agree to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug; 10. If the patient has active hepatitis B virus (HBV) infection: HBV deoxyribonucleic acid (DNA) must be = 2000 IU / ml (if the research center has only copy / ml detection unit, it must be = 12500 copy / ml), and receive anti HBV treatment for at least 14 days before the start of research treatment (according to local standard treatment, such as entecavir) and are willing to receive antiviral treatment throughout the study period; 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation; 2. Any active autoimmune disease or history of autoimmune disease; 3. Positive anti-HCV antibody; 4. People infected with human immunodeficiency virus (HIV) (HIV 1/2 antibody positive); 5. Have been diagnosed as any other malignant tumor (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma or carcinoma in situ after radical resection); 6. Any life-threatening bleeding occurred within 6 months before enrollment; 7. Arterial and venous thromboembolism events within 6 months before enrollment; 8. There is a high risk of bleeding, including: a) Major trauma or major surgery occurred within 30 days before enrollment; b) There are any hemorrhagic diseases, such as hemophilia, vascular hemophilia, etc; c) They are receiving thrombolytic therapy, anticoagulant therapy or antiplatelet therapy. 9. Symptomatic congestive heart failure (New York Heart Association Class II-IV), symptomatic or poorly controlled arrhythmia, congenital long QT syndrome or QTc corrected at screening>500ms, uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy; 10. Previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases; 11. Serious infection in active stage or under poor clinical control or severe infection within 4 weeks before enrollment; 12. Immunosuppressive drugs (excluding local glucocorticoids or systemic glucocorticoids with physiological dose, i.e.<10 mg/day prednisone or other glucocorticoids with equivalent dose) were used within 4 weeks before enrollment; 13. Pregnant and lactating women; 14. Inoculate live vaccine within 30 days before enrollment; 15. Severe hypersensitivity (= grade 3) to tirelizumab, gemcitabine, cisplatin and/or any other excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Disease control rate;Adverse event; | — |
Countries
China
Contacts
Public ContactYu Wenchang
Fujian Cancer Hospital
Outcome results
None listed