TACE+RFA Versus Re-resection for Recurrent Small Hepatocellular Carcinoma (TACE-RFA)
Hepatocellular Carcinoma, Surgery, Ablation
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, repeat hepatectomy, radiofrequency ablation, transcatheter arterial chemoembolization
Eligibility Criteria
Inclusion Criteria:
- age 18 - 75 years;
- recurrence of HCC 12 months after initial hepatectomy;
- no other treatment received except for the initial hepatectomy;
- Single tumor≤5cm in diameter; or 2-3 lesions each ≤ 3.0 cm
- lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
- no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
- Eastern Co-operative Oncology Group performance(ECOG) status 0 -1
Exclusion Criteria:
- the presence of vascular invasion or extrahepatic spread on imaging;
- a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
- an American Society of Anesthesiologists (ASA) score ≥ 3 -
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TACE+RFA
re-resection
TACE was performed according to the following protocol: All patients underwent a distal super-selective catheterization of the hepatic arteries using a coaxial technique and micro-catheters (2.9 Fr, Terumo Corporation, Tokyo, Japan). Then, the same three chemotherapeutic agents at the same dosages were used throughout this study, regardless of tumor number and size. Hepatic artery infusion chemotherapy was performed using carboplatin 300 mg. After that, chemolipiodolization was performed using epirubicin 50 mg, and mitomycin C 8 mg mixed with 5 mL of lipiodol. If the territory of the chemolipiodolized artery did not show stagnant flow, pure lipiodol was then injected. RFA was performed after TACE in 2 months by using a commercially available system (RF 2000; Radio-Therapeutics Mountain View, CA), and a needle electrode with a 15 Ga insulated cannula with 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; RadioTherapeutics).
Re-resection was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant and the possibility of a negative resection margin. We performed anatomical resection aiming at a resection margin of at least 1 cm. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 minutes and 5 minutes, respectively. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.