intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:DEB-TACE plus GEMOX
Sponsors
First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent; 2. Life expectancy >= 6 months; 3. Aged >= 18 years at the time of signing the informed consent; 4. The investigator judged that the patients could comply with the study protocol; 5. Confirmed by histology/cytology as ICC; 6. Patients who are eligible for DEB-TACE treatment, including those determined by comprehensive assessment to be unresectable, or those who refuse surgery; 7. No previous ICC systemic therapy (including chemotherapy, immunization and targeted drug therapy); 8. The target lesion has not received local treatment in the past, including transarterial embolization (TAE), TACE, transarterial radioactive embolization (TARE), surgery, radiofrequency ablation (RFA), microwave ablation (MWA), other thermal ablation, percutaneous ethanol injection (PEI), radiotherapy, etc.; 9. At least one untreated measurable lesion according to RECIST 1.1 criteria; 10. The ECOG physical status score within the first 7 days of randomization is 0 or 1; 11. Child-Pugh grade A or Child-Pugh grade B (<=7 points) within 7 days prior to randomization.
Exclusion criteria
Exclusion criteria: 1. Evidence of macrovascular infiltration (MVI); 2. Investigatory-identified contraindications to TACE (e.g., absence of main portal blockage forming collateral vessels, etc.); 3. Patients infected with active hepatitis B virus (HBV); 4. Complicated with other serious diseases and unable to complete treatment; 5. Study severe infections that occurred within 4 weeks prior to the start of treatment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; 6. Clinical signs or symptoms of biliary obstruction prior to the initiation of study therapy may be included if effective drainage has been used to relieve symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactZhou Chunze
Outcome results
None listed