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Research on Surgery and Micro-Invasive Treatment in Recurrent Primary Liver Cancer

20 Years
60 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Research on Surgery and Micro-Invasive Treatment in Recurrent Primary Liver Cancer

The recurrence and metastasis of primary liver cancer (PLC) have always been a tough problem
for surgeons. Gu Hong-guang reported the five years recurrence rate in PLC subjects reached
75~100%, among which 60% were discovered within three years after surgeries, with the peak
appearing at 18~24 months. According to a report delivered by Zhong-Shan Hospital, the
recurrence rate of small HCC was 40%, and that of large HCC was 1.9 times of small HCC. Chen
Han agreed that the recurrence rate in 1~2 years reached 71.6%, while in 2~11 years was
28.4%. With the rapid development of iconography and surgical techniques, it is possible for
surgeon to resect the recurrent HCC now. In 1986, Nagasue et al. reported the excision of
recurrent HCC and proved that comparing with non-surgical treatment, subjects with recurrent
HCC excision got a higher survival rate. However, the excision rate of recurrent HCC has
always been an arguable point. Nakajima et al. suggested the excision rate in 133 subjects
was 24%, while Matsuda et al. agreed that in 91 subjects reached 44%, and Zhoo reported that
in 384 subjects was 35%; Kakazu et al. insisted that in 286 subjects was 17%; Nagasue et al.
said that in 290 subjects was 30%; Shoto et al. reported that in 341 subjects was 19% and
Poon et al. advocated that in 244 subjects was 10%. He Sheng summarized the 1295 subjects in
recent five years, and only 106 of them had the opportunities to have excision again
(8.18%). Sugimachi, Minagawa et al. reported separately the 5 year survival rate in
recurrent HCC subjects were 47.5% and 56.0%, which showed no significant difference with the
first surgeries, but better therapeutic effects, meanwhile, third and forth surgeries could
also get similar survival rate, which indicated that surgical excision is a vital treatment
in recurrent HCCs. Chen Han in our hospital reported the first, third, fifth, and tenth year
survival rate in 162 recurrent HCC subjects who underwent first surgical treatment were
separately 96.8%, 66.7%, 43.6% and 21.8%; while that in subjects who received second
surgical treatment were separately 94.7%, 44.9% and 25.0% at the first, third, and fifth
year (mean survival time was 45 months, and average survival time was 54 months).

In this study, we intend to divide the subjects who have been confirmed recurrent HCC into
two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio
frequency. We will compare the non-tumor survival time, long-term survival rate between the
two groups, summarize the merits and demerits of both groups, and try to establish a
standardized therapy and treatment for the this kind of patients through prospective studies
on the molecular biological difference of pathological samples between the first and second

Inclusion Criteria:

1. 20~60 years old;

2. diagnosed HCC pathologically, and confirmed recurrent HCC through ultrasonic B, CT,
MRI or DSA test;

3. has a good condition in vital organs such as heart, lung, and kidney;

4. has a good liver function: Child A level, or nearly A level after hepatoprotection

5. solitary small cancer focus (diameter <5cm), or the number of recurrent HCC focus is
no more than three and all of them grow in the same lobe of liver;

6. without jaundice (not including jaundice in the bile ducts), without ascites or
extensive metastasis outside the liver;

7. without invasion to portal vein.

Exclusion Criteria:

1. subjects refuse to participate in this study;

2. subjects cannot be followed up regularly;

3. subjects with severe heart, lung, kidney diseases;

4. subjects with liver CP level B or C, and serum creatinine ≥2×ULN;

5. subjects with severe bone marrow depression, such as neutrophil counting is lower
than 1.5 × 109.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Overall survival rate

Outcome Time Frame:

two years

Safety Issue:


Principal Investigator

Feng Shen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University


China: Ministry of Health

Study ID:




Start Date:

January 2009

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • surgery
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular