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Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the third major
cause of cancer-related death. HCC is characterized by its propensity for portal vein
invasion. Portal vein tumor thrombosis (PVTT) can be detected macroscopically in the portal
vein in 44% to 62.2% of autopsy cases. The natural history of untreated HCC with PVTT is
dismal. The median survival of such patients was reported to be 2.7 mouths.

Non-surgical therapies, such as systemic/regional chemotherapy and transcatheter arterial
embolization / transcatheter arterial chemoembolization (TAE/TACE), are not effective in
treating HCC with PVTT. With the improvement of surgical techniques, surgical resection has
been reported to achieve promising results. However, the high rate of recurrence and
metastasis constitutes one of the most important challenges in improving surgical efficacy
for HCC with PVTT.

There is rare report about prevention and treatment of postoperative recurrence and
metastasis for HCC with macroscopical PVTT patients. We previously found the postoperative
portal vein infusion chemotherapy (PVIC) and TACE benefited PVTT patients, which required
further prospective randomized controlled studies with large case number to support our
findings. The randomized controlled trial was design to investigate the efficacy of the
different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for HCC and

Inclusion Criteria:

1. Age 18 to 75 years

2. Hepatocellular carcinoma with portal vein tumor thrombosis in the first branch and/or
main trunk of the portal vein confirmed by preoperative radiologic investigations,
intraoperative exploration and postoperative pathology.

3. No extrahepatic metastasis

4. No previous management

5. The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative

6. Good or moderate hepatic function (Child-Pugh Class A or B)

7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Exclusion Criteria:

1. Refuse to participate

2. Absolute neutrophil count <1.5*109/L, hemoglobin < 80g/L or platelet count <50 *
109/L, transaminases greater than 3 times the upper limit of normal, serum creatinine
greater than 1.5 times the upper limit of normal, INR greater than 1.5 times of
normal, which could not recover after treatment

3. Ascites refractory to diuretics

4. Variceal bleeding

5. Severe diseases of the heart or Lung

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

1-year, 3-year, 5-year

Safety Issue:


Principal Investigator

Jia Fan, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Zhongshan Hospital


China: Food and Drug Administration

Study ID:




Start Date:

October 1999

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Thrombosis
  • Carcinoma, Hepatocellular