Locally advanced perihilar cholangiocarcinoma Perihilar cholamgiocarcinoma, chemotherapy, GCS therapy
Conditions
Interventions
Neoadjuvant cgemotherapy using GCS (combination of gemcitabine, cysplatin and S-1) is performed.
Patients receive 4 courses of following regimen: infusion of gemcitabine at a dose of 1000 mg/m2 and
GCS, chemotherapy
Sponsors
Mizuno Shugo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Person who is 20 years old or more but less than 80. 2. Person newely diagnosed as perihilar cholangiocarcinoma by imaging study and histological or cytological study. 3. Person without distant metastasis 4. Person diagnosed as resectable or borderline resectable cancer by contrast enhanced multidetector CT imaging. 5. Person who is toleable for curative resection 6. Person without previous anti-tumor treatments 7. Person whose Eastern Cooperative Oncology Group performance status is 0 or 1 8. Person with adequate hematological, hepatic, renal, and cardiopulmonary functions 9. Person who is capable of adequate oral intake 10. Person who gave written informed consent to be enrolled in the study 11. Person with enough ability to decide to participate in the study
Exclusion criteria
Exclusion criteria: Patients who: 1) is allergic to the chemotherapeutic agents. 2) has pulmonary fibrosis or intestinal pneumonia. 3) has active infectious disease. 4) has simulatenous active cancer. 5) is pregnant or possibly pregnant. 6) is defined as inapproriate to be enrolled in the clinical trial by a principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of high responder cases after GCS therapy to all eligible cases High responder: the percentage of viable carcinoma in the tumor bed is less than 30%. Low responder: the percentage of viable carcinoma in the tumor bed 30% or higher. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete treatment rate, radiographic response rate, curative-intent resection rate, degree of residual tumor, 2-year and 5-year overall survival rate, postiopeative complication rate, recurrence rate after surgery and mode of recurrence. | — |
Contacts
Public ContactNaohisa Kuriyama
Mie University School of Medicine
Outcome results
None listed