Combine TACE and RFA Versus TACE Alone for HCC With PVTT (CORTT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: TACE; Procedure: RFA; Drug: pirarubicin,mitomycin and lobaplatin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 500060
      • Recruiting
      • Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
      • Contact: Ming Zhao, doctor; Phone Number: +86 020 87343272; Email: zhaoming@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TACE-RFA; 2 times TACE first, RFA for residual viable tumors and PVTT within 1 month.	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.; Other Names: Transcatheter Arterial Chemoembolization; Chemoembolization; Procedure: 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.; Other Names: Radiofrenquency ablation; RF ablation; Drug: pirarubicin,mitomycin and lobaplatin; They were cytotoxic drugs used in the TACE procedure.; Other Names: cytotoxic drugs
Active Comparator: TACE alone; repeated TACE and 1 to 2 months interval between two sessions of TACE.	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.; Other Names: Transcatheter Arterial Chemoembolization; Chemoembolization; Drug: pirarubicin,mitomycin and lobaplatin; They were cytotoxic drugs used in the TACE procedure.; Other Names: cytotoxic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival rates	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival rates	6 months
Response rate of PVTT	6 months
Number of participants with adverse events	1 month

Collaborators and Investigators

• Sponsor: Ming Zhao
• Investigators: Principal Investigator: Ming Zhao, doctor, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: HCC PVTT TACE RFA
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin; Pirarubicin
• Other Study ID Numbers: 2014-FXY-036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No