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

Primary Purpose

Intrahepatic Cholangiocarcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Resection

Radiotherapy

About this trial

This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring Intrahepatic Cholangiocarcinoma, Prognosis, Resection, Radiotherapy

Eligibility Criteria

17 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Eastern Hepatobiliary Surgery HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resection

Radiotherapy

Arm Description

To observe prognosis of resection of icc

To observe the prognosis of radiotherapy treatment of icc

Outcomes

Primary Outcome Measures

the overall survival rate of each group

Secondary Outcome Measures

Full Information

NCT ID

NCT01914289

First Posted

July 31, 2013

Last Updated

March 30, 2016

Sponsor

Eastern Hepatobiliary Surgery Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01914289

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrahepatic Cholangiocarcinoma

Keywords

Intrahepatic Cholangiocarcinoma, Prognosis, Resection, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Resection

Arm Type

Experimental

Arm Description

To observe prognosis of resection of icc

Arm Title

Radiotherapy

Arm Type

Active Comparator

Arm Description

To observe the prognosis of radiotherapy treatment of icc

Intervention Type

Procedure

Intervention Name(s)

Resection

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Primary Outcome Measure Information:

Title

the overall survival rate of each group

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Aijun, MD

Phone

86-21-81875531

ajli62@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuan Hang

Phone

86-21-81875531

yuanhang8106@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Aijun, MD

Organizational Affiliation

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Eastern Hepatobiliary Surgery Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200438

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Aijun, MD

Phone

86-21-81875531

ajli62@gmail.com

First Name & Middle Initial & Last Name & Degree

Yuan Hang, doctor

Phone

86-21-81875531

yuanhang8106@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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