TACE+RFA Versus Re-resection for Recurrent Small Hepatocellular Carcinoma

Last updated: April 12, 2013
Sponsor: Sun Yat-sen University
Overall Status: Trial Status Unknown

Phase

3

Condition

Surgery

Liver Disease

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT01833286
TACE+RFA VS. Re-resection
5010
  • Ages 18-75
  • All Genders

Study Summary

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence of HCC after partial hepatectomy is common and was reported to be more than 77% within 5 years after surgery. Repeat hepatectomy is an effective treatment for intrahepatic HCC recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the poor functional liver reserve or because of widespread intrahepatic recurrence. In the past two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment modality and has attracted great interest because of its effectiveness and safety for small HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors are usually detected when they are small and PRFA causes the least deterioration of liver function in the patients. Our previous retrospective study demonstrated that RFA was comparable to re-resection for recurrent HCC, and our recent RCT showed that RFA combined with TACE is superior to RFA for HCC ≤7.0cm. So our hypothesis is that RFA combined with TACE is superior to re-resection for recurrent small HCC. The aim of this retrospective study is to compare the outcome of reresection with TACE+RFA for small recurrent HCC after partial hepatectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age 18 - 75 years;

  2. recurrence of HCC 12 months after initial hepatectomy;

  3. no other treatment received except for the initial hepatectomy;

  4. Single tumor≤5cm in diameter; or 2-3 lesions each ≤ 3.0 cm

  5. lesions visible on ultrasound and with an acceptable and safe path between the lesionand the skin as shown on ultrasound;

  6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;

  7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -1

Exclusion

Exclusion Criteria:

  1. the presence of vascular invasion or extrahepatic spread on imaging;

  2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation includingascites, severe coagulation disorders (prothrombin activity < 40% or a platelet countof < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;

  3. an American Society of Anesthesiologists (ASA) score ≥ 3 -

Study Design

Total Participants: 200
Study Start date:
July 01, 2013
Estimated Completion Date:
July 31, 2019

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.