extrahepatic cholangiocarcinoma
Conditions
Interventions
chemoradiotherapy group:Postoperative concurrent chemoradiotherapy
chemotherapy group:Postoperative chemotherapy alone
control group :Regular follow-up
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with hepatic hilar or terminal cholangiocarcinoma confirmed by postoperative pathology, within 4-8 weeks after surgery; 2) ECOG score 0 - 2 points, or the KPS score is = 70 points; 3) Aged 20 to 80 years old; 4) The expected survival period is more than 3 months; 5) Laboratory examination: hemoglobin (HGb) = 90g / L, white blood cells (WBC) = 3.0 × 10^9/L, neutrophils = 1.2×10^9/L, platelet (PLT) = 100×10^9/L; creatinine (Cr) = 1.2× normal upper limit (UNL); Alanine aminotransferase (ALT) / aspartate aminotransferase (AST) = 2.0 × UNL, total bilirubin (Tbil) =1.5×UNL; 6) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) History of malignant tumors in other areas, excluding curable non-melanoma skin cancer and cervical carcinoma in situ; 2) Poor general condition, ECOG score = 3 points or KPS score = 70 points; 3) Allergic to 5-Fu and gemcitabine; allergic to platinum drugs; 4) After receiving external radiotherapy or radioactive I125 particle implantation in the abdomen; 5) History of digestive tract fistula, perforation or severe ulcer; 6) a large amount of ascites, or extensive metastasis of the abdominal cavity, or distant metastases in other parts of the body; 7) Participate in other clinical trials; 8) pregnant or lactating women; 9) There are serious neurological diseases, and the treatment responder cannot be clearly stated; 10) With history of radiotherapy in the planned radiotherapy site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| toxic and side effects; | — |
Countries
China
Contacts
Public ContactDong Lihua
The First Hospital of Jilin University
Outcome results
None listed