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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Prospective Randomized Control Study of Cidan Capsule Combined With Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02253511
• Other study ID #: CD-2014
• Secondary ID: NST-CD
• Status: Recruiting
• Phase: Phase 4
• First received: September 29, 2014
• Last updated: September 29, 2014
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: September 2014
• Source: Beijing Weida Cancer Hospital of Chinese Traditional Medical Sciences
• Contact: Donghai Zheng, MD
• Phone: 8613501182949
• Email: rippleoo[@]sohu.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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 long been perplexed by high rates of tumor recurrence, which is often the main cause of long-term treatment failure. 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. However, the safy and efficacy of preventive therapy is still not clear.

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, including Rhizoma Curcumae (19%), Astragalus (19.6%), Cremastra appendiculata (9.8%), Salvia miltiorrhiza (9.8%), hive (9.8%) and Bombyx batryticatus (9.8%). Cidan has been clinically used for >10 years as a safe and nontoxic antitumor drug. A number of studies have investigated the clinical application of TCMs for HCC, demonstrating that β‑elemene, which is present in Rhizoma Curcumae and the main component of cidan, may inhibit the proliferation of HepG2 cells in a time‑ and dose‑dependent manner. The results indicated that β‑elemene exhibited positive effects on apoptosis and induced the cell cycle arrest of HepG2 cells in the G2/M phase, while Fas and Fas ligand expression levels were markedly increased.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Cidan capsule

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zheng Donghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events		3 years	No
Primary	Overall survival		3 years	No
Secondary	Recurrence-free survival		3 years	No