Clinical trial NCT01033578: Efficacy of Postoperative Adjuvant Treatments for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Official title: Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor thrombosis( PVTT).

Detailed description: 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 PVTT.

Eligibility criteria: 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 ultrasonography
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

Primary outcomes:
measure: Overall Survival
timeFrame: 1-year, 3-year, 5-year
Secondary outcomes:
measure: Time to Recurrence
timeFrame: 1-year, 3-year, 5-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Liver Cancer Insitute, Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jia Fan, Doctor
role: STUDY_CHAIR
References: