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. 2022 Jan 4;2022(1):CD013345. doi: 10.1002/14651858.CD013345.pub2

NCT02435953.

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

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:
  1. Overall survival rate [time frame: 3 years]


Secondary outcome measures :
  1. Tumour progression rate [time frame: 2 years]

  2. Tumour progress to advanced‐stage rate [time frame: 2 years]

  3. Hepatic dysfunction rate [time frame: 2 years]

  4. Adverse event rate [time frame: 3 years]

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
Notes