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Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Re-resection for Recurrent Hepatocellular Carcinoma


Phase 3
18 Years
75 Years
Not Enrolling
Both
Hepatocellular Carcinoma, Surgery, Ablation

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Trial Information

Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Re-resection for Recurrent Hepatocellular Carcinoma


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 lesion
and 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 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 including
ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count
of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic
encephalopathy;

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

5 year

Safety Issue:

No

Principal Investigator

minshan chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center

Authority:

China: Ministry of Health

Study ID:

TACE+RFA VS. Re-resection

NCT ID:

NCT01833286

Start Date:

July 2013

Completion Date:

July 2019

Related Keywords:

  • Hepatocellular Carcinoma
  • Surgery
  • Ablation
  • hepatocellular carcinoma
  • repeat hepatectomy
  • radiofrequency ablation
  • transcatheter arterial chemoembolization
  • Carcinoma
  • Carcinoma, Hepatocellular

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