Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Adjuvant group
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, hepatic arterial infusion chemotherapy, 5-fluorouracil, cisplatin, adjuvant chemotherapy, hepatectomy
Eligibility Criteria
Inclusion Criteria:
- age of 18 to 70 years old
- appropriate blood test results (white blood cells (WBCs) ≥3,000/mm3, platelet count ≥50,000/mm3, total bilirubin <3mg/dl)
a patient could enter this study if one of the following was fulfilled
- maximum diameter of HCC ≥5 cm,
- microvascular or bile duct invasion upon pathological examination,
- capsular invasion of HCC upon pathological examination, 4) Edmonson-Steiner grade III or IV.
Exclusion Criteria:
- patients with intra- or extrahepatic metastases at 4 weeks after resection
- Child-Pugh class B or C (n = 4)
- ECOG performance scale ≥2
- prior systemic chemotherapy, radiation, or locoregional therapy
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Observation group
Adjuvant group
Arm Description
No adjuvant chemotherapy after resection
Adjuvant chemotherapy after resection
Outcomes
Primary Outcome Measures
2-year recurrence rate and adverse events
Secondary Outcome Measures
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01088581
Brief Title
Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
Official Title
Adjuvant Hepatic Arterial Infusional Chemotherapy With 5-fluorouracil and Cisplatin After Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Several adjuvant therapies have been attempted to reduce uni-centric, and intra- or extrahepatic recurrence after curative surgical resection for hepatocellular carcinoma (HCC). However, because the efficacy of such adjuvant therapy remains unclear, there is no standard postoperative therapy.
The investigators investigated whether adjuvant hepatic arterial infusional chemotherapy with 5-fluorouracil (5-FU) and cisplatin reduces the recurrence of HCC after curative resection.
Detailed Description
Hepatocellular carcinoma (HCC) is one of the most common malignancies in the world. In particular, the global occurrence rate of HCC ranks first in males and fourth in females. Despite advances in diagnosis and medical, and surgical management, HCC is still considered a difficult disease to cure because of the high recurrence rate, even after surgical resection. The cumulative 3-year recurrence rate after resection with a curative aim is approximately 80%.1 Portal vein invasion and satellite nodules are important factors that predispose a patient to recurrence after resection.2 More importantly, recurrence after resection usually results in a high rate of mortality.3 Uni-centric or intrahepatic metastatic recurrence usually indicates metastatic spread from the primary tumor and is generally distinguished from multi-centric recurrence by a short interval between resection and recurrence (12 months for primary tumor spreading vs. 3 years for multi-centric recurrence).4,5 In this regard, several adjuvant therapies have been used to attempt to primarily reduce uni-centric, and intra- or extrahepatic recurrence after curative surgical resection for HCC. However, because the efficacy of adjuvant therapy after curative resection is still not clear, no recommendation for postoperative therapy exists.
Several chemotherapeutic agents, including doxorubicin, epirubicin, mitomycin C, 5-fluorouracil (5-FU), and cisplatin have been delivered into the hepatic artery via an implanted port system as the first-line regimen or adjuvant therapy after curative resection in HCC.6-8 A recent study reported that repetitive short-course hepatic arterial infusion of 5-FU and cisplatin showed significant anti-tumor effects in advanced HCC.9 With the hypothesis that post-operative chemotherapeutic agents delivered via the hepatic artery may eliminate residual cancer cells in the liver, we designed a prospective study to determine whether adjuvant hepatic arterial infusional chemotherapy (HAIC) with 5-FU and cisplatin reduced the incidence of recurrence of HCC and improved overall patient survival after curative resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, hepatic arterial infusion chemotherapy, 5-fluorouracil, cisplatin, adjuvant chemotherapy, hepatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation group
Arm Type
No Intervention
Arm Description
No adjuvant chemotherapy after resection
Arm Title
Adjuvant group
Arm Type
Active Comparator
Arm Description
Adjuvant chemotherapy after resection
Intervention Type
Drug
Intervention Name(s)
Adjuvant group
Other Intervention Name(s)
Adjuvant chemotherapy after resection
Intervention Description
Adjuvant chemotherapy (5FU and cisplatin) after resection
Primary Outcome Measure Information:
Title
2-year recurrence rate and adverse events
Time Frame
2-year
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
2-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age of 18 to 70 years old
appropriate blood test results (white blood cells (WBCs) ≥3,000/mm3, platelet count ≥50,000/mm3, total bilirubin <3mg/dl)
a patient could enter this study if one of the following was fulfilled
maximum diameter of HCC ≥5 cm,
microvascular or bile duct invasion upon pathological examination,
capsular invasion of HCC upon pathological examination, 4) Edmonson-Steiner grade III or IV.
Exclusion Criteria:
patients with intra- or extrahepatic metastases at 4 weeks after resection
Child-Pugh class B or C (n = 4)
ECOG performance scale ≥2
prior systemic chemotherapy, radiation, or locoregional therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Up Kim, MD
Organizational Affiliation
Yonsei University
Official's Role
Study Director
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
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