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DFO for advanced HCC with impaired liver functio

Phase 2
Conditions
Chemoresistant HCC
Registration Number
JPRN-jRCTs061180032
Lead Sponsor
Sakaida Isao
Brief Summary

Sorafenib which is recommended for the patients with reserved liver function, is often applied for the patients with deteriorated liver function, and entry of the patients did not progress. Furthermore, the newly molecular targeted agents made it difficult to continue this study. This is a too small number study to provide conclusions, and we describe only the results mentioned above.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
3
Inclusion Criteria

1) Patients with advanced hepatocellular carcinoma
2) Non-responders for chemotherapy with anticancer drugs
3) Patients who have no influence on previous treatment
4) Performance status(PS) 0 or 1
5) Child-Pugh B
6) Favorable function of major organs (bone marrow, kidney, heart), and meeting citeria as follows:
(1) WBC >= 2500/mm3
(2) platelet count>= 50000/mm3
(3) hemogrobin level >= 9.0g/dl
(4) total bilirubin <= 3.0mg/dl
(5) serum creatinine level < 2mg/dl
(6) BUN <= 25mg/dl
(7) prothrombin time activity >= 50%
7) age >= 20years, male and female
8)Patients provided written, informed consent to participate

Exclusion Criteria

1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis)
2) Active double cancers
3) Past history of hypersensitivity for drugs including iodine and contrast agent
4) Patients with pregnancy, lactation or possibility of pregnancy
5) Past history of interstitial pneumonia
6) Chronic respiratory failure
7) Patients who judged as inadequacy due to other reasons by the doctor

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall survival
Secondary Outcome Measures
NameTimeMethod
Response, Progression-free survival, Safety
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