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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041180176

Enrollment

125

Registered

2019-03-29

Start date

2016-05-25

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

Liver cancer Liver cancer, Hepatocellualr carcinoma

Interventions

1) HAIC using FP regimen 2) HAIC using CDDP regimen

Hepatic arterial infusion chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
6 months progression-free survival rate, objective response rate, conversion therapy rate, overall survival, intrahepatic lesion control time, change of liver functional reserve, adverse event, hospitalization period, subsequential therapy	—

Contacts

Public ContactTatsuya Yamashita

Kanazawa University Hospital

ytatsuya@m-kanazawa.jp+81-76-265-2235

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026