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
  Purpose

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).


Condition Intervention
Hepatocellular Carcinoma
Other: PVIC, TACE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1-year, 3-year, 5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Recurrence [ Time Frame: 1-year, 3-year, 5-year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: October 1999
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Receive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments
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
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.
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
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.
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
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.
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033578

Contacts
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

Locations
China
Liver Cancer Insitute, Zhongshan Hospital Recruiting
Shanghai, China, 200032
Contact: Jia Fan, Doctor    86-21-64041990 ext 2375    jiafan99@yahoo.com   
Contact: Xiaoying Wang, Doctor    86-21-64041990 ext 2918    xiaoyingwang@fudan.edu.cn   
Principal Investigator: Jia Fan, Doctor         
Sponsors and Collaborators
Fudan University
Investigators
Study Chair: Jia Fan, Doctor Zhongshan Hospital
  More Information

No publications provided

Responsible Party: Jia Fan, Liver Cancer Institute, Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01033578     History of Changes
Other Study ID Numbers: Fudan-LCI-PVTT-1
Study First Received: December 15, 2009
Last Updated: December 15, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Thrombosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014