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

N

Naval Military Medical University (Second Military Medical University)

Status

Unknown

Conditions

Intrahepatic Cholangiocarcinoma

Treatments

Radiation: Radiotherapy
Procedure: Resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01914289
EHBH-RCT-2013-002-02

Details and patient eligibility

About

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.

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

17 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Resection
Experimental group
Description:
To observe prognosis of resection of icc
Treatment:
Radiation: Radiotherapy
Procedure: Resection
Radiotherapy
Active Comparator group
Description:
To observe the prognosis of radiotherapy treatment of icc
Treatment:
Radiation: Radiotherapy
Procedure: Resection

Trial contacts and locations

1

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Central trial contact

Yuan Hang; Li Aijun, MD

Data sourced from clinicaltrials.gov

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