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

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ClinicalTrials.gov Identifier: NCT02301091
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Ming Zhao, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: TACE Procedure: RFA Drug: pirarubicin,mitomycin and lobaplatin Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combine Transcatheter Arterial Embolization and Radiofrequency Ablation Versus Transcatheter Arterial Embolization Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

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 Name: 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 Name: cytotoxic drugs




Primary Outcome Measures :
  1. Overall survival rates [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Progression-free survival rates [ Time Frame: 6 months ]
  2. Response rate of PVTT [ Time Frame: 6 months ]
  3. Number of participants with adverse events [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301091


Contacts
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Contact: Ming Zhao, doctor +86 020 87343272 zhaoming@sysucc.org.cn

Locations
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China, Guangdong
Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center, Recruiting
Guangzhou, Guangdong, China, 500060
Contact: Ming Zhao, doctor    +86 020 87343272    zhaoming@sysucc.org.cn   
Sponsors and Collaborators
Ming Zhao
Investigators
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Principal Investigator: Ming Zhao, doctor Sun Yat-sen University

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Responsible Party: Ming Zhao, Chief physician in Minimally Invasive Interventional Division,Medical Imaging Center,Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02301091     History of Changes
Other Study ID Numbers: 2014-FXY-036
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by Ming Zhao, Sun Yat-sen University:
HCC PVTT TACE RFA

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Chlorotrianisene
Mitomycins
Mitomycin
Pirarubicin
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors