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Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, RFA, TACE

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
RFA
TACE-RFA
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, RFA, TACE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 18 - 75 years;
  2. Distant recurrence of HCC after initial curative treatment (including initial RFA or hepatectomy);
  3. no other treatment received except for the initial RFA or hepatectomy;
  4. Single tumor less than 4cm in diameter;
  5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
  6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
  7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -

Exclusion Criteria:

  1. the presence of vascular invasion or extrahepatic spread on imaging;
  2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
  3. an American Society of Anesthesiologists (ASA) score ≥ 3

Sites / Locations

  • Cancer Center, Sun Yat-set UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RFA

TACE-RFA

Arm Description

For RFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.

TACE first, then RFA within 2 weeks

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival

Full Information

First Posted
August 10, 2011
Last Updated
August 10, 2011
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01415063
Brief Title
Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma
Official Title
Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The combination of transcatheter arterial chemoembolization (TACE) with RFA has also reported to be an effective treatment for HCC. Studies have shown TACE combined RFA to have better efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for small HCC (≤3 cm). However, to our knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than RFA alone for the treatment of HCC recurrence after curative treatment. We hypothesized that the combination of TACE and RFA might result in better patient survival than RFA alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with RFA alone for the treatment of recurrent HCC. Recurrent HCC in this study was defined as new tumors in the remnant liver, distant from the resection or ablation site after curative treatment of RFA or hepatectomy.
Detailed Description
Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy and liver transplantation are considered to be standard curative therapies for HCC. When surgery is not possible, percutaneous ablation is usually considered to be alternative treatments for HCC . Recurrence is the most frequent serious adverse event observed during the follow-up of HCC patients treated for cure. Repeat hepatectomy is an effective treatment for HCC recurrence, with a 5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients with HCC recurrence (10.4 to 31%), either because of the poor functional liver reserve or because of widespread recurrence.(15, 17, 18) Radiofrequency ablation (RFA) has been considered to be one of the most effective percutaneous ablations for early-stage HCC in patients with or without surgical prospects . Studies using RFA to treat HCC recurrence after hepatectomy have reported a 3-year survival rate of 62% to 68%, which is comparable to those achieved by surgery. RFA is particularly suitable to treat HCC recurrence after hepatectomy because these tumors are usually detected when they are small, and because RFA causes the least deterioration of liver function in the patients. RFA is also effective for managing HCC recurrence after initial treatment of RFA. Clinical data have shown that, after repeated RFA, the estimated 3-and 5-year overall, and disease-free survival rates for patients with HCC recurrence were 67.0% and 40.1% and 68.0 and 38.0%, respectively.Therefore, we considered RFA to be an effective treatment for HCC recurrence after curative treatment. The combination of transcatheter arterial chemoembolization (TACE) with RFA has also reported to be an effective treatment for HCC. Studies have shown TACE combined RFA to have better efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for small HCC (≤3 cm). However, to our knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than RFA alone for the treatment of HCC recurrence after curative treatment. We hypothesized that the combination of TACE and RFA might result in better patient survival than RFA alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with RFA alone for the treatment of recurrent HCC. Recurrent HCC in this study was defined as new tumors in the remnant liver, distant from the resection or ablation site after curative treatment of RFA or hepatectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, RFA, TACE
Keywords
Hepatocellular Carcinoma, RFA, TACE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA
Arm Type
Experimental
Arm Description
For RFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.
Arm Title
TACE-RFA
Arm Type
Experimental
Arm Description
TACE first, then RFA within 2 weeks
Intervention Type
Procedure
Intervention Name(s)
RFA
Intervention Description
For RFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.
Intervention Type
Procedure
Intervention Name(s)
TACE-RFA
Intervention Description
TACE first, then RFA within 2 weeks
Primary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 - 75 years; Distant recurrence of HCC after initial curative treatment (including initial RFA or hepatectomy); no other treatment received except for the initial RFA or hepatectomy; Single tumor less than 4cm in diameter; lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound; no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3; Eastern Co-operative Oncology Group performance(ECOG) status 0 - Exclusion Criteria: the presence of vascular invasion or extrahepatic spread on imaging; a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy; an American Society of Anesthesiologists (ASA) score ≥ 3
Facility Information:
Facility Name
Cancer Center, Sun Yat-set University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Shan Chen, Ph.D.,M.D.
Phone
8620- 87343117
Email
Chminsh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Min-Shan Chen, M.D.,Ph.D.

12. IPD Sharing Statement

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Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma

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