Randomized phase II study exploring better regimen of hepatic arterial infusion chemotherapy (HAIC) for the patients with advanced hepatocellular carcinoma

Phase 2

• Conditions: iver cancer; Liver cancer, Hepatocellualr carcinoma

• Registration Number: JPRN-jRCTs041180176
• Lead Sponsor: Kaneko Shuichi

Brief Summary

This study, which designed to determine a useful regimen of HAIC in patients with advanced HCC who are refractory to or ineligible for standard of care, showed that PFS was statistically significantly better in FP regimen compared to CDDP regimen. The results of this study suggested that the FP regimen was beneficial compared to CDDP regimen although it is difficult to draw a clear conclusion because the number of scheduled could not be registered.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Study Completion: 2021-05-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

clinically diagnosed as hepatocellular carcinoma; presence of intrahepatic lesion; unsuitable for local therapy; unsuitable for standard therapy including sorafenib; Child-Pugh score <=8; ECOG Performance status <=2; preservation of major organ function; written informed consent

Exclusion Criteria

technically unsuitable for HAIC; extrahepatic lesion; refractory ascites or pleural effusion, history of hepatic encephalopathy, risky varices; double cancer; metastases to central nervous system; severe complication; pregnant or lactating women, or women of childbearing potential; mental disorder; allergy for fluorouracil, cisplatin, or contrast agent of CT or/and MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified