Clinical trial NCT02435953: TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma
Official title: Transarterial Chemoembolization Plus Radiofrequency Ablation Versus Transarterial Chemoembolization Alone for Intermediate-stage Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Chemoembolization, Therapeutic
Ablation Techniques, RFA
Keywords: Hepatocellular Carcinoma,TACE,Chemoembolization, RFA,Intermediate-stage
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter arterial chemoembolization (TACE) alone.The combination of TACE with RFA has also reported to be an effective treatment for HCC. Some prospective studies have shown TACE combined RFA to have better efficacy than any of them alone for early stage HCC (single tuomor ≤5 cm). However, to the investigators' knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than TACE alone for the treatment of intermediate-stage HCC. The investigators hypothesized that the combination of TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions, largest tumor size ≤7 cm; ECOG-PS 0;Child-pugh A or B;no tumor thrombus or extrahepatic metastases.


Eligibility criteria: Inclusion Criteria:

* Multiple HCC (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple HCC (4-10 lesions), each ≤ 7 cm in diameter
* No vascular invasion or etrahepatic metastases
* Eastern Cooperative Oncology Group Performance Status 0-1
* Child-Pugh Stage A or B
* Treatment naive

Exclusion Criteria:

* A platelet counts of \<40×109/L，prothrombin time activity \<40%;
* Albumin \>2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit
* No evaluale target lesions
* 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
* Be allergic to adriamycin, lobaplatin, mitomycin and iodized oil

Primary outcomes:
measure: Overall survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Tumor progression rate
timeFrame: 2 years
measure: Tumor progress to advanced-stage rate
timeFrame: 2 years
measure: Hepatic dysfunction rate
timeFrame: 2 years
measure: Adverse event rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
state: Guangdong
Study officials:
affiliation: Principal Investigator, Clinical Professor
name: Ming Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References: