Study name |
TACE + RFA versus TACE alone for intermediate‐stage hepatocellular carcinoma |
Methods |
Experimental: TACE‐RFA 1‐2 sessions of TACE treatment, then followed by RFA treatment |
Participants |
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 extrahepatic metastases
Eastern Cooperative Oncology Group Performance Status 0‐1
Child‐Pugh Stage A or B
Treatment‐naive
Exclusion Criteria:
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 evaluable 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 iodised oil
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Interventions |
Experimental: TACE‐RFA 1‐2 sessions of TACE treatment, then followed by RFA treatment Active Comparator: TACE alone TACE treatment several times until tumour progresses to advanced stage |
Outcomes |
Primary outcome measures:
Overall survival rate [time frame: 3 years]
Secondary outcome measures :
Tumour progression rate [time frame: 2 years]
Tumour progress to advanced‐stage rate [time frame: 2 years]
Hepatic dysfunction rate [time frame: 2 years]
Adverse event rate [time frame: 3 years]
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Starting date |
April 2015 |
Contact information |
Contact: Ming Zhao, doctor +86 020 87343272, zhaoming@sysucc.org.cn Contact: Tao Pan, doctor +862087343271, pantao0909@hotmail.com
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Notes |
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