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 that TACE combined with RFA have better efficacy than any of them alone for early stage HCC (single tumor ≤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 B7; no tumor thrombus or extrahepatic metastases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
241
A catheter (or a microcatheter for cases where small vessels and branches cannot be accessed with a standard angiographic catheter) will be advanced selectively or superselectively into the right or left hepatic artery or the feeding arteries directly supplying the tumor. Depending on tumor size, location, blood supply, and liver function, the interventional radiologist administers a cytotoxic agent and lipiodol emulsion (30 mg lobaplatin, 30 mg pirarubicin, and \< 15 mL lipiodol) through the catheter. Following drug infusion, embolization of the tumor vessels will be routinely performed using gelatin sponge particles.
Commercial electrode systems are used and the ablation therapy is to be performed according to manufacturer's standard recommendations. All lesions are targeted with CT images during the RFA procedure.
Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, China
Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (PFS-R)
Time frame: From the date of randomization to the date of occurrence of radiologic disease progression as determined according to the RECIST v1.1, or death (by any cause), whichever occurs first, assessed up to 10 years.
Overall survival (OS)
Time frame: From the date of randomization to the date of death (due to any cause), assessed up to 10 years.
Progression-free survival (PFS) according to HCC modified RECIST (PFS-m)
Time frame: From the date of randomization to the date of occurrence of radiologic disease progression as determined according to the HCC modified RECIST, or death (by any cause), whichever occurs first, assessed up to 10 years.
unAblation-TACEable or unTACEable progression-free survival (uAT-PFS)
Time frame: From the date of randomization to the date of the following untreatable progression or death by any cause, assessed up to 10 years.
Objective response rate (ORR) according to mRECIST (ORR-m)
Time frame: From date of randomization until the date of study completion, an average of 8 months.
Disease control rate (DCR) according to mRECIST (DCR-m)
Time frame: From date of randomization until the date of study completion, an average of 8 months.
Adverse Events
Time frame: From enrollment to until 30 days following discontinuation of study treatment or until the initiation of the first subsequent therapy following discontinuation of study treatment (whichever occurs first).
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