Prognosis of Resection and Radiotherapy in the Treatment of Intrahepatic Cholangiocarcinoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.

Detailed Description
-----------------
Intrahepatic Cholangiocarcinoma (ICC), the second most common primary liver cancer and constitutes 10% of primary liver malignancies. Current therapies for the treatment of ICC are ineffective and the role of liver transplantation is not well defined. This study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis

Official Title
-----------------
Comparison of Resection and Radiotherapy in the Prognosis of Intrahepatic Cholangiocarcinoma Patients

Conditions
-----------------
Intrahepatic Cholangiocarcinoma

Intervention / Treatment
-----------------
* Procedure: Resection
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients > 17 years and <=60 years of age. confirmed case (patients with ICC) Tumors can be radical removed and resection volume was ≤50%. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³. Karnofsky Performance Score performance over 60. Patients who can understand this trial and have signed information consent. Exclusion Criteria: Patients who have undergone previous treatment by Resection or Radiotherapy. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer. Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C. Patients would not sign the consent to the trial.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resection<br>To observe prognosis of resection of icc | Procedure: Resection<br> <br> Radiation: Radiotherapy<br> <br> |
| Active Comparator: Radiotherapy<br>To observe the prognosis of radiotherapy treatment of icc | Procedure: Resection<br> <br> Radiation: Radiotherapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall survival rate of each group |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrahepatic Cholangiocarcinoma, Prognosis, Resection, Radiotherapy