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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01415063
• Other study ID #: HCC-0013
• Status: Recruiting
• Phase: Phase 4
• First received: August 10, 2011
• Last updated: August 10, 2011
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: February 2011
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• RFA
• TACE

Intervention

Procedure:
• RFA
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-RFA
TACE first, then RFA within 2 weeks

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-set University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		1 year	No
Secondary	disease-free survival		1 year	No