Combine TACE and RFA Versus TACE Alone for HCC With PVTT

NCT02301091 | Unknown Phase 3 DMC

• 1 other identifier: 2014-FXY-036
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

HCC PVTT TACE RFA

Outcome Measures

Primary Outcomes (1)

• Overall survival rates

  1 year

Secondary Outcomes (3)

• Progression-free survival rates

  6 months

• Response rate of PVTT

  6 months

• Number of participants with adverse events

  1 month

Study Arms (2)

TACE-RFA

EXPERIMENTAL

2 times TACE first, RFA for residual viable tumors and PVTT within 1 month.

Procedure: TACE; Procedure: RFA; Drug: pirarubicin,mitomycin and lobaplatin

TACE alone

ACTIVE COMPARATOR

repeated TACE and 1 to 2 months interval between two sessions of TACE.

Procedure: TACE; Drug: pirarubicin,mitomycin and lobaplatin

Interventions

TACE PROCEDURE

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.

Also known as: Transcatheter Arterial Chemoembolization, Chemoembolization

TACE alone; TACE-RFA

RFA PROCEDURE

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.

Also known as: Radiofrenquency ablation, RF ablation

TACE-RFA

pirarubicin,mitomycin and lobaplatin DRUG

They were cytotoxic drugs used in the TACE procedure.

Also known as: cytotoxic drugs

TACE alone; TACE-RFA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ming Zhao: lead

Study Sites (1)

Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 500060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Chemoembolization, Therapeutic; pirarubicin; Mitomycin; lobaplatin; Cytotoxins

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Noxae; Toxic Actions; Chemical Actions and Uses

Study Officials

• Ming Zhao, doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zhao, doctor

CONTACT

+86 020 87343272; zhaoming@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician in Minimally Invasive Interventional Division,Medical Imaging Center,Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 25, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

CN (1)