Pilot study of intraarterial interferon/CDDP/5-fluorouracil combination chemotherapy for advanced hepatocellular carcinoma with translational research to predict efficacy

Not Applicable

• Conditions: Advanced hepatocellular carcinoma

• Registration Number: JPRN-UMIN000005805
• Lead Sponsor: Faculty of Medical Sciences, University of Fukui

Brief Summary

The response rate was significantly higher in patients treated with HAIC (37.5%) compared to that in patients treated with sorafenib (no response). The median overall survival (18.6 and 11.7 months) and progression-free survival (4.0 and 5.0 months) were similar between the sorafenib and HAIC groups, respectively. In the sorafenib group, 58.3% of the patients discontinued treatment compared to none in the HAIC group.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-01
• Results First Posted: 2014-11-02
• Study Completion: 2017-03-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change 2) previous therapy for hepatocellular carcinoma within 30 days 3) preceded chemotherapy (excluded transcatheter arterial embolization or adjuvant chemotherapy) 4) inadequate for administration of interferon, 5-FU or cisplatin 5) active double cancer 6) severe complication 7) refractory ascites or pleural effusion 8) inappropriate for entry onto this study in the judgment of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Response rate, tumor control rate, safety, translational research