Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Adjuvant group
Intervention type(s): Drug
Intervention description(s): Adjuvant chemotherapy (5FU and cisplatin) after resection
Other intervention name(s): Adjuvant chemotherapy after resection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; hepatic arterial infusion chemotherapy; 5-fluorouracil; cisplatin; adjuvant chemotherapy; hepatectomy