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

September 29, 2014 updated by: Zheng Donghai

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200438
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cidan capsule
Patients who undergone operation and TACE were administered 1.35 g cidan capsules (Weida Pharmaceutical Co., Ltd., Beijing, China) three times a day for 3 months.
Drug: Cidan capsule
No Intervention: Control group
Patients were only accepted operation and TACE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zheng Donghai

Investigators

  • Principal Investigator: Mengchao Wu, MD, Eastern Hepatobiliary Surgery Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-2014
  • NST-CD (Other Grant/Funding Number: Key Project of NST, 2013ZX09104-006)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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