NAC Lenvatinib plus Cisplatin

JRCT ID: jRCT1041220110

Registered date:25/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 12/01/2023
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Lenvatinib plus hepatic intra-arterial infusion chemotherapy with cisplatin

Outcome(s)

• Primary Outcome: Time to recurrence beyond the Milan criteria
• Secondary Outcome: progression-free survival, overall survival, objective response rate, tumor control rate, adverse events, liver functional reserve, subsequent therapies

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: clinically diagnosed as hepatocellular carcinoma; Preserved liver functional reserve and scheduled for resection; diagnosed as high-risk hepatocellular carcinoma recurrence beyond the Milan criteria; 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 Tatsuya