intrahepatic cholangiocarcinoma
Conditions
Interventions
experimental group:gemcitabine and cisplatin in unresectable intrahepatic cholangiocarcinoma patients
experimental group:pembrolizumab in unresectable intrahepatic cholangiocarcinoma patients
experimental group:transarterial embolization in unresectable intrahepatic cholangiocarcinoma patients
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged =18 years; 2. Intrahepatic cholangiocarcinoma patients confirmed by histology/cytology; 3. Unresectable intrahepatic cholangiocarcinoma patients who can not be treated with systemic chemotherapy, or have failed systemic chemotherapy; 4. PS score: = 1.5x10^9/L; (2) Platelet count (platelet, PLT) >= 100x10^9/L; (3) Hemoglobin content (hemoglobin, HGB) >= 9.0 g/dL; (4) Serum total bilirubin (total bilirubin, TBIL) = 28 g/L; (8) Alkaline phosphatase (ALP) = 50 mL/min (Cockcroft-Gault formula); (10) Urine routine test results show urine protein = 2+, 24-hour urine collection and 24-hour urine protein quantitative <1g should be performed; (11) International normalized ratio (INR) or activated partial thromboplastin time (APTT) <= 1.5 times ULN. 8. Patients with mixed HCC/cholangiocarcinoma can be included 9. Female patients of childbearing age or male patients whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the last medication; 10. Be able to sign written informed consent and be able to comply with the visits and related procedures stipulated in the plan.
Exclusion criteria
Exclusion criteria: 1.History of contrast agent allergy; 2.Patients with known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation; 3.There is any active autoimmune disease or a history of autoimmune disease; 4.PS score:= 2 points; 5.Subjects received gemcitabine and/or cisplatin in the neoadjuvant/adjuvant treatment 6.Previously received immunotherapy or anti-tumor treatment for advanced unresectable cholangiocarcinoma within 4 weeks (such as radiotherapy/TACE/palliative surgery/ablation, etc.) 7.Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), HBV or HCV infection; 8.Diagnosed with any other malignant tumors (Includes ampullary carcinoma/small cell carcinoma/neuroendocrine tumors/lymphoma/sarcoma/mixed tumor histology and/or mucinous cystic neoplasm); 9.Any life-threatening bleeding event occurred within 6 months before enrollment; 10.Symptomatic congestive heart failure (Class II-IV of the New York Heart Association), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or QTc> 500ms corrected during screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy; 11.Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases; 12.Severe infections in active phase or poor clinical control or severe infections within 4 weeks before enrollment; 13.Have used immunosuppressive drugs within 4 weeks before enrollment (excluding local glucocorticoids or physiological doses of systemic glucocorticoids, ie <10mg/day, prednisone or equivalent doses of other glucocorticoids); 14.Women during pregnancy and breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Safety;The incidence of drug-related adverse events;Incidence of adverse events;Incidence of death;Incidence of adverse events leading to treatment cessation and early withdrawal from the study; | — |
Countries
China
Contacts
Public ContactLi Xiao
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed