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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01914289
Recruitment Status : Unknown
Verified March 2016 by ShenFeng, Eastern Hepatobiliary Surgery Hospital.
Recruitment status was:  Recruiting
First Posted : August 2, 2013
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Procedure: Resection Radiation: Radiotherapy Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Resection and Radiotherapy in the Prognosis of Intrahepatic Cholangiocarcinoma Patients
Study Start Date : January 2011
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Resection
To observe prognosis of resection of icc
Procedure: Resection
Radiation: Radiotherapy
Active Comparator: Radiotherapy
To observe the prognosis of radiotherapy treatment of icc
Procedure: Resection
Radiation: Radiotherapy

Primary Outcome Measures :
  1. the overall survival rate of each group [ Time Frame: 3 years ]

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Ages Eligible for Study:   17 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01914289

Contact: Li Aijun, MD 86-21-81875531
Contact: Yuan Hang 86-21-81875531

China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Li Aijun, MD    86-21-81875531   
Contact: Yuan Hang, doctor    86-21-81875531   
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Study Chair: Li Aijun, MD Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Responsible Party: ShenFeng, director of department of special treatment, Eastern Hepatobiliary Surgery Hospital Identifier: NCT01914289     History of Changes
Other Study ID Numbers: EHBH-RCT-2013-002-02
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
Intrahepatic Cholangiocarcinoma

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type