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Adjuvant Hepatic Arterial Infusional Chemotherapy With 5-fluorouracil and Cisplatin After Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Study

Phase 3
18 Years
70 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Adjuvant Hepatic Arterial Infusional Chemotherapy With 5-fluorouracil and Cisplatin After Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Study

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

2-year recurrence rate and adverse events

Outcome Time Frame:


Safety Issue:


Principal Investigator

Seung Up Kim, MD

Investigator Role:

Study Director

Investigator Affiliation:

Yonsei University College of Medicine


Korea: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

December 2008

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • hepatic arterial infusion chemotherapy
  • 5-fluorouracil
  • cisplatin
  • adjuvant chemotherapy
  • hepatectomy
  • Carcinoma
  • Carcinoma, Hepatocellular