Status:
UNKNOWN
A Prospective Control Study of Cidan Capsule Combined With TACE in Hepatocellular Carcinoma
Lead Sponsor:
Zheng Donghai
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different regions of the world. The 5-year risk of recurrence of HCC after resection has been reported to be as high as 70%...
Detailed Description
Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different regions of the world. Surgical resection provides the best chance of cure for selected patients. However, we have...
Eligibility Criteria
Inclusion
- Diagnosis of HCC confirmed by pathology.
- Liver function of Child-Pugh Class A or B.
- no intrahepatic and extrahepatic metastasis.
- Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
- Patients undergone operation were confirmed to have the following high-risk recurrence factors:
- Satellite nodules, Poor differentiation, Tumor diameter \> 5cm
- No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds.
- The patients would like to accept postoperative TACE.
Exclusion
- Informed consent not available
- Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \< 25g/L or bilirubin \> 50micromol/L
- Renal impairment with creatinine \> 200micromol/L
- Severe concurrent medical illness persisting \> 6 weeks after hepatectomy
- History of other cancer
- Pregnant women
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02253511
Start Date
July 1 2014
End Date
July 1 2017
Last Update
October 1 2014
Active Locations (1)
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1
Eastern Hepatobiliary Surgery Hospital
Shanghai, China, 200438