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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914289
• Other study ID #: EHBH-RCT-2013-002-02
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2013
• Last updated: March 30, 2016
• Start date: January 2011
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Li Aijun, MD
• Phone: 86-21-81875531
• Email: ajli62[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Liver Neoplasms

Intervention

Procedure:
• Resection

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the overall survival rate of each group		3 years	No