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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02253511
Enrollment
400
Registered
2014-10-01
Start date
2014-07-31
Completion date
2017-07-31
Last updated
2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, Hepotectomy, Recurrence-free survival, Overall survival

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%. 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.

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.

Interventions

DRUGCidan capsule

Sponsors

Zheng Donghai
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall survival3 years

Secondary

MeasureTime frame
Recurrence-free survival3 years

Other

MeasureTime frame
Number of participants with adverse events3 years

Countries

China

Contacts

Primary ContactDonghai Zheng, MD
rippleoo@sohu.com8613501182949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026