NCT04560751

TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)

TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma：A Multicenter, Single-armed, Prospective, Observational Study (Prolong)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, observational study in which subjects will be treated with lenvatinib combined with TACE in un-resectable HCC patients who had not received systematic treatment or TACE treatment in the past.

Detailed description

Only 30% of HCC patients received radical resection. Most of the patients are in the advanced stage and can only receive palliative treatment such as TACE or systemic treatment. Lenvatinib is a multi-target receptor tyrosine kinase inhibitor (TKI), which mainly inhibits vascular endothelial growth factor(VEGF) receptor-1, 2, 3; fibroblast growth factors(FGF) receptor-1, 2, 3, 4; platelet derived growth factor receptor(PDGFR)α; RET and KIT and showed significant anti-tumor effect in REFLECT study. The purpose of this study is to explore the efficacy and safety of Lenvatinib and TACE in unresectable HCC patients.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib capsules will be administered orally, once daily (for patients \<60kg, lenvatinib 8mg po; for patients ≥60kg, lenvatinib 12mg po)
PROCEDURE	TACE	TACE will be performed as needed.

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-12-31
• Completion: 2022-08-31
• First posted: 2020-09-23
• Last updated: 2020-09-23