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

Primary Purpose

Carcinoma, Hepatocellular

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Thermal Ablation

EADM

Ultra-fluid lipiodol

Gelatin sponge articles

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HCC, TACE, Thermal Ablation, Safety/Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thermal Ablation & TACE

TACE alone

Arm Description

Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time-to-Disease Progression

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.

Objective response rate (ORR)

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)

Progression free survival(PFS)

Numbers of TACE and TACE combined with ablation cycles

The times of the subjects undergoing TACE or TACE combined with ablation

Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups

Serious or mild adverse events after treatment

Full Information

NCT ID

NCT02630108

First Posted

December 3, 2015

Last Updated

October 17, 2016

Sponsor

Shanghai Zhongshan Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02630108

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

Keywords

HCC, TACE, Thermal Ablation, Safety/Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thermal Ablation & TACE

Arm Type

Experimental

Arm Description

Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Arm Title

TACE alone

Arm Type

Active Comparator

Arm Description

Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Intervention Type

Procedure

Intervention Name(s)

Thermal Ablation

Other Intervention Name(s)

Radiofrequency ablation, Microwave ablation

Intervention Description

Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.

Intervention Type

Drug

Intervention Name(s)

EADM

Other Intervention Name(s)

Epirubicin

Intervention Description

EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.

Intervention Type

Drug

Intervention Name(s)

Ultra-fluid lipiodol

Other Intervention Name(s)

lipiodol

Intervention Description

Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .

Intervention Type

Other

Intervention Name(s)

Gelatin sponge articles

Intervention Description

Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

From the date of randomization until the date of death from any cause, assessed up to 26 months

Secondary Outcome Measure Information:

Title

Time-to-Disease Progression

Description

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

Title

Objective response rate (ORR)

Description

Time Frame

Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.

Title

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.

Title

Numbers of TACE and TACE combined with ablation cycles

Description

The times of the subjects undergoing TACE or TACE combined with ablation

Time Frame

From the date of randomization until the date of death, assessed up to 26 months.

Title

Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups

Description

Serious or mild adverse events after treatment

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months; Patients with large HCC (>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC); Patients with no thrombus in main portal vein (PV) Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2; Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy; White blood cell count ≥ 3.0×10^9/L; Hemoglobin ≥ 8.5g/dl; Platelet ≥ 50×10^9/L; INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds; Blood creatinine less than 1.5 times of upper limit of reference; Patients and/or their relatives willing to join in the clinical trial and signing the informed consent. Exclusion Criteria: Patients with diffuse type of liver cancer; Cholangiocellular carcinoma Patients with main PV thrombus; Patients with hepatic vein thrombus; Patients with lymph node or distant metastasis outside of liver; Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection; Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency; Patients with intractable massive ascites; Patients' ECOG PS >2; Patients complicated with active infection, especially cholangitis; Patients with severe disorders of heart, lungs, kidneys, or brain; Patients and/or their relatives refuse to anticipate this study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianhua Wang, MD

Phone

+8613611759557

wang.jianhua@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Rong Liu, MD

Phone

+8613681971563

liu.rong@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianhua Wang, MD

Organizational Affiliation

Shanghai Zhongshan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianhua Wang, MD

Phone

+8613611749557

wang.jianhua@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Rong Liu, MD

Phone

+8613681971563

liu.rong@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Jianhua Wang, MD

First Name & Middle Initial & Last Name & Degree

Rong Liu, MD

12. IPD Sharing Statement

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Links:

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http://www.biomedcentral.com/content/pdf/1471-230X-14-11.pdf

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

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