Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma

Phase 3

• Conditions: hepatocellular carcinoma

• Registration Number: JPRN-UMIN000007267
• Lead Sponsor: Okayama University Hospital

Brief Summary

Recurrence-free survival rates at 1 (3) year in the HAIC group and non-HAIC group were 82.9% (54.3%) and 74.3% (34.3%), respectively (hazard ratio [HR], 0.597; 95% confidence interval [CI], 0.320-1.091; p = 0.094]. Intrahepatic distant recurrence-free survival rate in the HAIC group was significantly better than that in the non-HAIC group (HR, 0.468; 95% CI, 0.235-0.896; p = 0.022).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-11
• Study Completion: 2019-07-31
• Results First Posted: 2021-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with histologically diagnosed mixed hepatocellular carcinoma or sarcomatoid carcinoma 2) History of any therapy to hepatocellular carcinoma 3) Patients unsuitable for RFA 4) Patients unsuitable for administration of CDDP 5) Patients who have simultaneous malignancies 6) Patients who have severe complications 7) Ascites or pleural effusion unresponsible to therapy 8) Patients inadequate in the investigator's judgement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence free survival

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events Time to treatment failure with RFA Evaluation of treatment effect with tumor markers