intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:irinotecan DEB-TACE with GEMOX
Control group:GEMOX treatment
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis: patients with unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma. 2. Pathological confirmation; 3. At least one untreated measurable target lesion; 4. ECOG score 0-1; 5. The liver function status was Child-Pugh A or B; 6. Life expectancy is at least 3 months. 7. Male or female patients over 18 years old and under 85 years old. 8. Women and men of childbearing age must agree to use birth control measures from the time of signing the informed consent form; Bone marrow function, liver function and renal function requirements of patients: Hemoglobin concentration > 85 g/L; WBC > 3x10*9/L in peripheral blood; Platelet count (>50x10*9/L); Total bilirubin concentration 28 g/L); Alpha-alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 5 times the normal upper limit (ULN); PT-INR < 2.3 times of ULN; Serum creatinine < 1.5 times of ULN; Lipase and amylase <2 times of ULN.
Exclusion criteria
Exclusion criteria: (1) Diffuse tumors; (2) Tumor volume accounted for more than 70% of the whole liver; (3) Cancer thrombus in the main portal vein; (4) Uncontrolled ascites (defined as diuretic or puncture therapy that is not easy to control); (5) Infection beyond control; (6) Arteriovenous fistula is not suitable for hepatic artery treatment; (7) The lesion had received any other treatment before; (8) History of previous or concurrent tumors other than ICC; (9) History of drug allergy; (10) HIV infection; (11) Pregnancy; (12) Within the first 30 days, severe bleeding symptoms or a clear tendency of gastrointestinal bleeding (fecal occult blood + + and above can not be included in the group).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Time-to-progression;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactChen Rongxin
Zhongshan Hospital of Fudan University
Outcome results
None listed