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

JRCT ID: jRCTs041180176

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Liver cancer
• Date of first enrollment: 25/05/2016
• Target sample size: 125
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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
• Exclude 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

Related Information

• Primary Sponsor: Kaneko Shuichi