A Comparison of Recurrence After Radical Hepatectomy in Hepatocellular Carcinoma (HCC) Patients Underwent Intraoperative Adjuvant Epirubicin therapy or Not

A prospective randomized controlled trial comparing recurrence outcome of intraoperative adjuvant epirubicin therapy from gastroepiploic vein versus no adjuvant therapy for patients with hepatocellular carcinoma after radical hepatectomy

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000471987

Enrollment

Registered

2011-05-06

Start date

2011-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem that hampers the efficacy of surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective for HCC. We conducted a randomized controlled trial to investigate whether adjuvant therapy with epirubicin intraoperative could inhibit the recurrence of HCC after radical resection.

Interventions

After the radical resection, the adjuvant group received the single injection of 20mg epirubicin from gastroepiploic vein during the operation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1.Patients with histologically proven hepatocellular carcinoma 2.Underwent curative hepatectomy with less than 50% of the liver and with a tumor-free resection margin greater than 1 cm 3.Postoperative decline of alpha-fetoprotein (AFP) level to less than 20 micro g/L. 4.Child-Pugh class A:normalized hepatic function(glutamic pyruvic transaminase/glutamic oxaloacetic transaminase less than 2 times the upper normal limit; total serum bilirubin less than 34.2 micro mol/L); 5.Normal renal function & Hematological parameters (serum creatinine less than 132 micro mol/L; white blood cell (WBC) count equal to 2500×109/L; platelet count (PTL) equal to 40×109/L).

Exclusion criteria

Prior therapy with chemotherapy, allergy or history of severe adverse reactions to epirubicin, the other regrion metastases, and malignant tumors in other regions of the body over the previous five years; peripheral neuropathy, history of central nervous system diseases, abnormal electrocardiogram findings, psychiatric disorders; severe cardiac, metabolic and/or infectious diseases; active peptic ulcer disease requiring treatment, absorption disorders; Pregnant or lactating females.

Outcome results