TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

October 17, 2016 updated by: Shanghai Zhongshan Hospital

Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (>5cm in diameter) and huge HCC (>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 3

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
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Department of Interventional Radiology, Zhongshan Hospital, Fudan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianhua Wang, MD
        • Sub-Investigator:
          • Rong Liu, MD

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;
  2. Patients with large HCC (>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);
  3. Patients with no thrombus in main portal vein (PV)
  4. Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;
  5. Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;
  6. White blood cell count ≥ 3.0×10^9/L;
  7. Hemoglobin ≥ 8.5g/dl;
  8. Platelet ≥ 50×10^9/L;
  9. INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;
  10. Blood creatinine less than 1.5 times of upper limit of reference;
  11. Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.

Exclusion Criteria:

  1. Patients with diffuse type of liver cancer;
  2. Cholangiocellular carcinoma
  3. Patients with main PV thrombus;
  4. Patients with hepatic vein thrombus;
  5. Patients with lymph node or distant metastasis outside of liver;
  6. Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;
  7. Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;
  8. Patients with intractable massive ascites;
  9. Patients' ECOG PS >2;
  10. Patients complicated with active infection, especially cholangitis;
  11. Patients with severe disorders of heart, lungs, kidneys, or brain;
  12. Patients and/or their relatives refuse to anticipate this study.

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: Thermal Ablation & TACE

Transarterial chemoembolization (TACE) is performed immediately following thermal ablation.

EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Procedure: Thermal Ablation
Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
Other Names:
  • Radiofrequency ablation
  • Microwave ablation
Drug: EADM
EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
Other Names:
  • Epirubicin
Drug: Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Other Names:
  • lipiodol
Other: Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
Active Comparator: TACE alone
Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Drug: EADM
EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
Other Names:
  • Epirubicin
Drug: Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Other Names:
  • lipiodol
Other: Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From the date of randomization until the date of death from any cause, assessed up to 26 months
From the date of randomization until the date of death from any cause, assessed up to 26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-Disease Progression
Time Frame: From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months
TTDP follow-up is done at three months interval after lesions defined as stable with treatment of TACE or ablation combined with synchronous TACE six months after enrollment until lesions are defined as disease progression.
From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months
Objective response rate (ORR)
Time Frame: Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.
The ratio of CR plus PR. The efficacy is defined as complete regression (CR), partial regression (PR), stable disease (SD) and progressive disease (PD) according to modified Response Evaluation Criteria in Solid Tumors (mRESIST)
Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.
Progression free survival(PFS)
Time Frame: From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months.
From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months.
Numbers of TACE and TACE combined with ablation cycles
Time Frame: From the date of randomization until the date of death, assessed up to 26 months.
The times of the subjects undergoing TACE or TACE combined with ablation
From the date of randomization until the date of death, assessed up to 26 months.
Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups
Time Frame: From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation)
Serious or mild adverse events after treatment
From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation)

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Zhejiang Cancer Hospital
Xijing Hospital
Changhai Hospital
The First Affiliated Hospital of Anhui Medical University
LanZhou University
Sun Yat-sen University
Chinese PLA General Hospital
Henan Cancer Hospital
Qilu Hospital of Shandong University
Jilin Provincial Tumor Hospital
Shengjing Hospital
Nanfang Hospital of Southern Medical University
Guangdong Provincial People's Hospital
Jiangsu Cancer Institute & Hospital
Eastern Hepatobiliary Surgery Hospital
Hunan Provincial People's Hospital
Wuhan Union Hospital, China
Shanghai Cancer Hospital, China
First Affiliated Hospital of Xinjiang Medical University
Anhui Provincial Hospital
Sichuan Cancer Hospital and Research Institute
The Third Affiliated Hospital of Harbin Medical University
Shandong Tumor Hospital
The Affiliated Zhongshan Hospital of Dalian University

Investigators

  • Principal Investigator: Jianhua Wang, MD, Shanghai Zhongshan 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

Helpful Links

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, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2015-146R

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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