NCT02253511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2014

Typical duration for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

September 29, 2014

Last Update Submit

September 29, 2014

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaHepotectomyRecurrence-free survivalOverall survival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 years

Secondary Outcomes (1)

  • Recurrence-free survival

    3 years

Other Outcomes (1)

  • Number of participants with adverse events

    3 years

Study Arms (2)

Cidan capsule

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients were only accepted operation and TACE.

Interventions

Cidan capsuleDRUG
Cidan capsule

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 Ă— 109/L and a prolonged prothrombin time of \< 5 seconds.
  • The patients would like to accept postoperative TACE.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

RECRUITING

Related Publications (1)

  • Zheng DH, Yang JM, Wu JX, Cheng SQ, Zhang SG, Wu D, Li AJ, Fu XH, Li X, Qi FC, Duan WH, Chen JH, Yang ZY, Liang L, Zeng JX, Zheng WD, Wu MC. Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Trial. Chin J Integr Med. 2023 Jan;29(1):3-9. doi: 10.1007/s11655-022-3537-4. Epub 2022 Aug 1.

    PMID: 35915317DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Mengchao Wu, MD

    Eastern Hepatobiliary Surgery Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donghai Zheng, MD

CONTACT

8613501182949rippleoo@sohu.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice-President of Beijing Weida Cancer Hospital of Chinese Traditional Medical Sciences

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

CN(1)