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A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels

Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

A Randomized Control Trial of Hepatectomy Versus Radiofrequency Ablation for Hepatocellular Carcinoma Adjacent to Major Blood Vessels

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad
still shows a rising trend. In recent decade, the overall survival rate of the disease has
entered a platform stage with little advance despite diversified methods of treatment. The
prognosis of HCC is not so satisfying. In recent years, lots of clinical practice and a
small amount of evidence-based medicine show that: ①.Surgical treatment is still the
preferred choice of the treatment of HCC. ②. The standardization of comprehensive treatment
should be put in top priority in current treatment of HCC. Rational treatment methods should
be adopted in accordance with specific conditions of patients. The best and latest treatment
methods should also be provided to improve the efficacy to the largest extent for the
benefit of the majority of patients with HCC.

Today, tumor remaining in a patient after therapy with curative intent(eg. surgical
resection for cure ) is categorized by a system known as R classification. That is shown:
RX: presence of residual tumor can not be assessed; R0: no residual tumor; R1: microscopic
residual tumor; R2: macroscopic residual tumor; The residue with the application of R
classification not only refers to both residual tumor at the margin of surgical excision but
also residue in distant metastasis. The higher R classification is, the worse the prognosis

Most studies have been leaded a good result By now that percutaneous radiationfrequency
ablation(PRFA) is efficacious and safe for patients with HCC. In patients with HCC smaller
than 3cm, PRFA may be comparable to suegical resection in long-term outcome.

At present, radical resection (for the final R0 or R1) performed in HCC at most deep and
complex sites (including caudate lobe HCC, 8th segment hepatoma adjacent to the trunk of
inferior vena cava, hepatic vein and portal vein, etc) often lead to serious damage to major
blood vessels (i.e., hepatic vein, short hepatic vein, portal vein and inferior vena cava)
and hemorrhage during surgery. Therefore, when the surgeon performs surgery near major
sites, he should excise as few normal liver tissues as possible to avoid above-mentioned
hazard. However, the resection margin may not be complete and thus affect radical effect. In
addition, as the tumor is rather deep located, lots of normal liver tissues on the surface
of the tumor are excised with massive bleeding and serious damage. In view of this
situation, the surgeon will adopt some alternatives (PRFA is rather common) to achieve the
efficacy similar to liver excision and greatly reduce the risk of vascular injury and some
complications like hepatic insufficiency. However, there are no studies on the efficacy
comparison between this treatment method and the efficacy of liver excision, time to
recurrence (TTR)stage, disease-free survival and overall survival condition.

This study will compare and analyze the difference between hepatectomy at deep and complex
sites of patients with HCC and PRFA prognosis, recovery after treatment as well as incidence
of complications so as to establish treatment standards of HCC at these sites.

Inclusion Criteria:

- Identify patients with HCC in accordance with the clinical diagnostic criteria of HCC
passed at the Chines Eighth National Live Cancer Academic Conference. Patients with
HCC shall be diagnosed with pathology. There is at least one measurable lesion.

- Hepatoma involved in this research at complex site is located at the eighth segment
of liver, the substantial depth of liver below hepatic integument adjacent to the
trunk of inferior vena cava, hepatic vein and portal vein. The tumor is located at
hepatic caudate lobe. The maximal diameter < or=3m, AJCC/UICC—TNM stage is stage II
and above. Lesions are determined by three senior hepatobiliary experts
independently, therefore radical resection is possible. There is no possibility of
extra-hepatic metastasis and tumor thrombus of portal vein, hepatic vein, vena cava
and bile duct.

- Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper
limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2
times the upper limit of normal value. It's appropriate to perform liver resection
and minimally invasive treatment.

- No dysfunction in major organs; Blood routine, kidney function, cardiac function and
lung function are basically normal.

- Patients who can understand this trial, male or female, aged 18-70 voluntarily
participate in clinical trials and have signed information consent.

Exclusion Criteria:

- Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may
affect the treatment of liver cancer.

- Patients with other diseases which may affect the treatment mentioned here.

- Patients with medical history of other malignant tumors.

- Subjects participating in other clinical trials.

- Women in pregnancy and breast-feeding.

- Patients with tumor AJCC/UICC—TNM stage at IIIA period or below.

Type of Study:


Study Design:

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

Outcome Measure:

tumor recurrence rate in one or two years; Disease-free survival;Overall survival.

Outcome Time Frame:

1,2,or 3 years

Safety Issue:


Principal Investigator

Feng Shen, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University


China: Ministry of Health

Study ID:




Start Date:

December 2008

Completion Date:

November 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Adjacent to Major Blood Vessels
  • Surgical resection
  • Ppercutaneous radiationfrequency ablation
  • Time to recurrence
  • Disease-free survival
  • Overall survival
  • Carcinoma
  • Carcinoma, Hepatocellular