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

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)

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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