Efficacy of Postoperative Adjuvant Treatments for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
1 other identifier
interventional
260
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Oct 1999
Longer than P75 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 16, 2009
October 1, 2009
10.2 years
December 15, 2009
December 15, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
1-year, 3-year, 5-year
Secondary Outcomes (1)
Time to Recurrence
1-year, 3-year, 5-year
Study Arms (4)
Control
NO INTERVENTIONReceive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments
PVIC Group
EXPERIMENTALPortal 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.
TACE Group
EXPERIMENTALTranscatheter 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.
PVIC+TACE Group
EXPERIMENTALCombination 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18 to 75 years
- 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.
- No extrahepatic metastasis
- No previous management
- The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative ultrasonography
- Good or moderate hepatic function (Child-Pugh Class A or B)
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
You may not qualify if:
- Refuse to participate
- 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
- Ascites refractory to diuretics
- Variceal bleeding
- Severe diseases of the heart or Lung
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Liver Cancer Insitute, Zhongshan Hospital
Shanghai, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia Fan, Doctor
Shanghai Zhongshan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
October 1, 1999
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
December 16, 2009
Record last verified: 2009-10