Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

December 20, 2015 updated by: Jia Fan, Fudan University

Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China

This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, and associated morbidity and mortality rates have escalated in recent years. Despite improvements in surveillance and clinical treatment strategies, the prognosis of HCC remains very poor due to high incidence of recurrence and metastasis. Recent clinical studies have provided evidence that circulating tumor cell (CTC) may directly participate in the metastasis cascade in various types of malignancies. The investigators previous data indicated that HCC patients with preoperative CTC levels ≥2 suffered significantly earlier recurrence (within 1 year) than patients with lower levels. However, the benefits of postoperative adjuvant therapies in preventing early recurrence in patients with preoperative CTC ≥2 remain to be elucidated. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. The investigators design a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy to reduce early recurrence rates in HCC patients with preoperative CTC level ≥2.

Study Type

Interventional

Enrollment (Anticipated)

256

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 Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center
    • Jiangsu
      • Nantong, Jiangsu, China, 226000
        • Nantong Tumor Hospital
      • Soochow, Jiangsu, China, 215000
        • The First Affiliated Hospital of Soochow University
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Zhongshan Hospital, Fudan University
      • Shanghai, Shanghai, China, 200000
        • Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
      • Shanghai, Shanghai, China, 200000
        • Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine

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:

  • HCC patients received curative hepatectomy with negative resection margin
  • Age from 18 to 75
  • Child-Pugh class A
  • ASA class I to II
  • ECOG performance status Grade 0 or 1
  • Preoperative CTC level ≥2 per 7.5 ml peripheral blood
  • No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy

Exclusion Criteria:

  • Patients diagnosed with other types of malignancies besides HCC
  • Patients receiving concomitant local ablation or previous TACE
  • Main portal vein tumor thrombus extraction during hepatectomy
  • Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors.
  • Presence of extra-hepatic or lymphatic metastasis
  • 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
  • Hepatic artery anomaly making TACE not possible
  • Allergy to 5-Fluorouracil, Epirubicin or lipiodol
  • Pregnant woman
  • Informed consent not available

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: Adjuvant TACE
TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
Procedure: TACE
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
Other Names:
  • Transcatheter Arterial Chemoembolization
  • Chemoembolization
Drug: Epirubicin
Epirubicin is a chemotherapy drug used in TACE
Other Names:
  • EADM
Drug: lipiodol
lipiodol is a kind of embolization material used in TACE
Other Names:
  • Ultra-fluid lipiodol
No Intervention: Control
no interventions were assigned after hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early recurrence rates
Time Frame: 1 year after hepatectomy
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
1 year after hepatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: up to 3 years
OS was defined as the interval from date of HCC resection to death due to any cause.
up to 3 years

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

Shanghai Zhongshan Hospital
Johnson & Johnson Medical, China

Investigators

  • Principal Investigator: Jia Fan, MD & PhD, Shanghai Zhongshan Hospital, Fudan University

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

December 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 20, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-HE-TACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Carcinoma, Hepatocellular

Clinical Trials on TACE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe