A Prospective Control Study of Cidan Capsule Combined With TACE in Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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%. It has been proposed that best way to reduce recurrence is to search for improved adjuvant therapies. Especially for some postoperative patients who were identified with the risk factors for recurrence, several adjuvant therapies were often used, including TACE. Recently, a variety of Traditional Chinese Medicine combined with TACE for toxicity reduction and enhancing the efficacy have been investigated in the treatment of HCC. Cidan capsules are a formula containing more than ten types of plant extracts, and has been clinically used for >10 years as a safe and nontoxic antitumor drug. However, the safy and efficacy of preventive therapy is still not clear. In this prospective control study, we enroll such HCC patients experienced operation and were identifed with high risk of recurrence. After a preventive TACE, the eligible patients were divided into two groups. One group will accept Cidan therapy and another will not. Under a basis of large sample, the safty and efficacy of Cidan combined with TACE in HCC patients will be investigated and analysed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zheng Donghai

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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