Efficacy of Postoperative Adjuvant Treatments for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01033578
First received: December 15, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

December 15, 2009
December 15, 2009
October 1999
December 2009   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 1-year, 3-year, 5-year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Time to Recurrence [ Time Frame: 1-year, 3-year, 5-year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Postoperative Adjuvant Treatments for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hepatocellular Carcinoma
Other: PVIC, TACE

PVIC:5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) were continuously infused into portal vein through tube by a infusion pump. Treatment started 2 weeks after the operation and was repeated every 4 weeks for 6 cycles.

TACE: 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles.

Other Names:
  • PVIC: portal vein infusion chemotherapy
  • TACE: transcatheter arterial chemoembolization
  • No Intervention: Control
    Receive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments
    Intervention: Other: PVIC, TACE
  • Experimental: PVIC Group
    Portal Vein Infusion Chemotherapy (PVIC): 5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) was continuously infused into portal vein through tube by a infusion pump implanted in operation. Treatment started 2 weeks after the operation and was repeated every 4 weeks for six cycles.
    Intervention: Other: PVIC, TACE
  • Experimental: TACE Group
    Transcatheter Arterial Chemoembolization (TACE): 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles.
    Intervention: Other: PVIC, TACE
  • Experimental: PVIC+TACE Group
    Combination of PVIC and TACE. PVIC started 2 weeks after operation and TACE started 6 weeks after operation. Both PVIC and TACE were repeated at 8 weeks intervals for 3 cycles.
    Intervention: Other: PVIC, TACE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
December 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Xiaoying Wang, Doctor 86-21-64041990 ext 2918 xiaoyingwang@fudan.edu.cn
Contact: Jia Fan, Doctor 86-21-64041990 ext 2375 jiafan99@yahoo.com
China
 
NCT01033578
Fudan-LCI-PVTT-1
Yes
Jia Fan, Liver Cancer Institute, Zhongshan Hospital
Fudan University
Not Provided
Study Chair: Jia Fan, Doctor Zhongshan Hospital
Fudan University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP