Combine TACE and RFA Versus TACE Alone for HCC With PVTT

Hepatocellular Carcinoma Clinical Trial

— CORTT  

Official title:

Combine Transcatheter Arterial Embolization and Radiofrequency Ablation Versus Transcatheter Arterial Embolization Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02301091
• Other study ID #: 2014-FXY-036
• Status: Recruiting
• Phase: Phase 3
• First received: November 13, 2014
• Last updated: April 13, 2016
• Start date: October 2014
• Est. completion date: October 2019

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: Ming Zhao, doctor
• Phone: +86 020 87343272
• Email: zhaoming[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus.

Description:

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second most common cause of death from cancer globally. Although the development of imaging techniques has improved early HCC diagnosis, portal vein tumor thrombus (PVTT) is still identified in 12.5-39.7% of HCC patients at their initial visits. Patients suffering from extremely aggressive HCC with PVTT have a median survival time of only 2.7-4.0 months if left untreated. The current standard of practice recommends sorafenib, which has been shown to prolong overall survival (OS) by nearly 3 months in advanced HCC patients and by 1.5-3.2 months in those with PVTT.

Transarterial chemoembolization (TACE) is the main treatment modality for unresectable HCC patients. Some recent prospective studies have demonstrated that TACE can serve as a safe and effective procedure in selected HCC patients with PVTT. TACE is recommend for a part of patients with HCC and PVTT by the treatment guidelines in China and Japan. However,due to the poor blood supplement of PVTT,the local control rate of PVTT after TACE treatment is low. Besides,as to some hypovascular intrahepatic tumors, TACE also could not controlled effectively. As regard to the high local control rate of radiofrequency ablation (RFA) for intrahepatic lesions and PVTT reported in some studies, we thus suggested that the combination of TACE and RFA might have higher tumor control rate and survival benefit than TACE alone.

We design this study to compare survival outcomes of TACE plus RFA and TACE alone in patients with HCC and PVTT.A total of 240 patients are needed according to statistician's calculation.They will be divided into two groups randomly by computer after sign the informed consent form.One group of patients received TACE plus RFA and the other group of patients received TACE alone.After treatment,patients will be followed-up on their survival, tumor response and adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• HCC with portal vein tumor thrombus in the first or second branch

• Refused sorafenib or could not tolerate the adverse effect of sorafenib

• A solitary HCC = 5.0 cm in diameter, or multiple HCC = 3 lesions, each = 5.0 cm in diameter

• Eastern Cooperative Oncology Group Performance Status 0-1

• Child-Pugh Score = 8

• A platelet counts of > 60,000/mm3, hemoglobin>8.5 g/dL, prothrombin time prolong <6s

• Albumin >2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase(AST)<5 times of upper limit

• Sign the informed consent.

Exclusion Criteria:

• Presence of extrahepatic metastasis except lymph node metastasis

• The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed

• Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;

• Severe heart, brain or kidney diseases

• Previous or concurrent cancer that is distinct in primary site or histology from HCC

• Pregnant women or lactating women.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• TACE
TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.
• RFA
For RFA, we used two commercially available system (Cool-Tip, Valleylab,USA) and (Octopus RF Systema,Starmed,Korea)with needle electrode with a 17-gauge internally cooled electrode.

Drug:
• pirarubicin,mitomycin and lobaplatin
They were cytotoxic drugs used in the TACE procedure.

Locations

Country	Name	City	State
China	Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Ming Zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rates		1 year	No
Secondary	Progression-free survival rates		6 months	No
Secondary	Response rate of PVTT		6 months	No
Secondary	Number of participants with adverse events		1 month	Yes