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Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria


Phase 4
65 Years
85 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Radiofrequency Ablation Versus Liver Resection for Elderly Patients With Hepatocellular Carcinoma (HCC) Within the Milan Criteria


Hepatocellular carcinoma (HCC) is a common cancer, and it is the third commonest global
cause of cancer-related death. With an increase in life-expectancy of the general
population, the number of elderly with HCC is expected to increase. Current curative
treatment options for HCC include: liver transplantation, liver resection (LR) and local
ablation therapy. Liver transplantation is a good treatment for HCC within the Milan
criteria (single HCC ≤ 5 cm or up to 3 nodules each < 3 cm). As a consequence of the lack of
liver donors, one relative contraindication for liver transplantation is age over 65 years,
or the protocol requires elderly patients to have very good general health before they can
be put on a transplant list. Transcatheter arterial chemoembolization (TACE) is used more
commonly for the treatment of intermediate and advanced-staged HCC, while liver resection
and local ablation therapy are used for early-staged HCC. Amongst the local ablative
therapies, radiofrequency ablation (RFA) is most widely used. It has the advantage of
minimally invasiveness, making it the first-line treatment for small HCC in patients with
compromised liver function or associated severe medical conditions.

Elderly patients are more likely to have poor general conditions and associated medical
diseases. RFA has the advantage of being less invasive and it causes less pain, less blood
loss and earlier recovery than LR. On the other hand, incomplete ablation of HCC and tumor
track seeding may happen. Several studies have demonstrated the safety of LR for elderly
patients. There is no good evidence in the medical literature to support whether RFA or LR
is a better treatment for elderly patients with HCC.


Inclusion Criteria:



1. age 65 - 85 years;

2. HCC within the Milan criteria (single HCC ≤ 5 cm or up to 3 nodules each ≤3 cm);

3. resectable disease, which is defined as the possibility of completely removing all
tumors and retaining a sufficient liver remnant to maintain liver function, as
assessed by our surgery team;

4. Eastern Co-operative Oncology Group performance (ECOG) status 0 ;

Exclusion Criteria:

1. severe coagulation disorders (prothrombin activity < 40% or a platelet count of <
40,000 / mm3;

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

3. Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including
ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy;

4. previous treatment.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

5 year

Safety Issue:

No

Authority:

China: Ministry of Health

Study ID:

HCC17

NCT ID:

NCT01570075

Start Date:

November 2011

Completion Date:

July 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • RFA
  • HR
  • Carcinoma
  • Carcinoma, Hepatocellular

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