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

NCT ID: NCT01914289

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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

Conditions

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Intrahepatic Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resection

To observe prognosis of resection of icc

Group Type EXPERIMENTAL

Resection

Intervention Type PROCEDURE

Radiotherapy

Intervention Type RADIATION

Radiotherapy

To observe the prognosis of radiotherapy treatment of icc

Group Type ACTIVE_COMPARATOR

Resection

Intervention Type PROCEDURE

Radiotherapy

Intervention Type RADIATION

Interventions

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Resection

Intervention Type PROCEDURE

Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

director of department of special treatment

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Aijun, MD

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

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Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Aijun, MD

Role: CONTACT

86-21-81875531

Yuan Hang

Role: CONTACT

86-21-81875531

Facility Contacts

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Li Aijun, MD

Role: primary

86-21-81875531

Yuan Hang, doctor

Role: backup

86-21-81875531

Other Identifiers

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EHBH-RCT-2013-002-02

Identifier Type: -

Identifier Source: org_study_id

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