Cholangiocellular Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 Years or over 2) Patients who were fully informed of the study beforehand and signed the informed consent to participate in the study 3) Patients diagnosed with typical cholangiocellular carcinoma by histologically proven and diagnostic imaging 4) Patients with tumor in the liver 5) Patients in whom complete resection of the tumor by hepatectomy cannot be expected to succeed. 6) Patients with an ECOG PS(Performance Status) Score of 0 or 1. 7) Patients who are expected to live more than 12 weeks. 8) Adequate organ function
Exclusion criteria
Exclusion criteria: 1) History of malignant tumor 2) Severe cardiac disease 3) Active infection 4) History of HIV infection 5) Renal dialysis 6) Intracranial tumor 7) Clinically uncontrolled ascites or pleural effusion 8) Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment 9) Prior history of chemotherapy with gemcitabine and cisplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) Progression Free Survival (PFS) 1-year Survival Rate 6 months Progression Free Survival Response Rate (RR) | — |
Countries
Japan
Contacts
Chiba University Hospital Department of Gastroenterology