Lenvatinib plus Cisplatin refractory or unsuitable for ICI

JRCT ID: jRCT1041210163

Registered date:17/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 24/03/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): lenvatinib plus hepatic intra-arterial infusion chemotherapy with cisplatin

Outcome(s)

• Primary Outcome: Objective response rate according to RECIST
• Secondary Outcome: progression-free survival, overall survival, objective response rate according to modified RECIST, tumor control rate, subsequent therapies, adverse events, liver functional reserve

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: clinically diagnosed as hepatocellular carcinoma; unsuitable for local therapy; refractory or unsuitable for immune checkpoint inhibitor; Preserved liver function; 20 years or older; ECOG Performance status <=2; preservation of major organ function; written informed consent
• Exclude criteria: refractory ascites or pleural effusion; risky varices; double cancer; metastases to central nervous system; severe complication; pregnant or lactating women, or women of childbearing potential; mental disorder; patients who investigator regards as inappropriate for candidate

Related Information

• Primary Sponsor: Yamashita Taro