Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01088581
First received: March 16, 2010
Last updated: January 31, 2012
Last verified: January 2012

March 16, 2010
January 31, 2012
January 2006
December 2007   (final data collection date for primary outcome measure)
2-year recurrence rate and adverse events [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01088581 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 2-year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
Adjuvant Hepatic Arterial Infusional Chemotherapy With 5-fluorouracil and Cisplatin After Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatocellular Carcinoma
Drug: Adjuvant group
Adjuvant chemotherapy (5FU and cisplatin) after resection
Other Name: Adjuvant chemotherapy after resection
  • No Intervention: Observation group
    No adjuvant chemotherapy after resection
  • Active Comparator: Adjuvant group
    Adjuvant chemotherapy after resection
    Intervention: Drug: Adjuvant group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2008
December 2007   (final data collection date for primary outcome measure)

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

    1. maximum diameter of HCC ≥5 cm,
    2. microvascular or bile duct invasion upon pathological examination,
    3. 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01088581
4-2005-0203
Yes
Yonsei University
Yonsei University
Not Provided
Study Director: Seung Up Kim, MD Yonsei University
Yonsei University
January 2012

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