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

Not Applicable

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Procedure: Resection; Radiation: Radiotherapy

• Registration Number: NCT01914289
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Primary Completion: 2015-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Radiotherapy	To observe the prognosis of radiotherapy treatment of icc
Radiotherapy	Resection	To observe the prognosis of radiotherapy treatment of icc
Resection	Resection	To observe prognosis of resection of icc
Resection	Radiotherapy	To observe prognosis of resection of icc

Primary Outcome Measures

Name	Time	Method
the overall survival rate of each group	3 years

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, Shanghai, China