Lenvatinib Plus TACE Versus Sorafenib Plus TACE for HCC With PVTT

Summary

Hepatocellular carcinoma (HCC) is the fourth most common cancer in China, with a crude incidence rate of 26.67 per 100,000 population. Moreover, 357,800 new liver cancer cases are predicted to be diagnosed in China in 2020. HCC represents approximately 90% of all cases of primary liver cancer. HCC has a high predilection for portal vein invasion, which occurs in 44-62% of living patients with HCC. Patients with PVTT usually have an aggressive disease course, decreased liver function reserve, limited treatment options, thus worse overall survival. Among untreated HCC patients with PVTT, the median overall survival has been reported as low as 2 to 4 months with supportive care. Sorafenib is the first-line treatment for HCC patients with PVTT, however, it has shown unsatisfactory benefit. Notably, sorafenib combined with TACE significantly improved the TTP over sorafenib alone, albeit for no more than 1 month in the median TTP, and the median OS was not significantly prolonged. A promising drug-lenvatinib was approved in China on September 2018, in the China patients subgroup analysis showed an encouraging results. Lenvatinib group had showed a significant benefit in TTP, PFS and ORR. Also median overall survival time was significantly improved in China subgroup (Lenvatinib group: 15 months VS Sorafenib group: 10.2 months). However, REFLECT didn't enrolled patients who had tumors invading the maint portal vein. The mechanisms of lenvatinib or sorafenib combined with TACE were still unknown, and clinical data were limited.

This study was to explore lenvatinib plus TACE versus sorafenib plus TACE for HCC with PVTT: efficacy and safety. Biomarkers expression of VEGFR, FGFR, FDGF-α, IL-2,etc would be detected to find the difference between the two groups, finally to analyze the relationship between clinical outcomes and biomarkers' expression. A better treatment modality to HCC with PVTT patients would be expected and promoted.

Conditions

• Carcinoma, Hepatocellular
• Portal Vein Tumor Thrombus

Interventions

DRUG

Lenvatinib Pill

Lenvatinib capsules will be administered orally, once daily in continuous 28-day cycles. Body weight (BW)\>60 kilograms(kg)-Lenvatinib 12 mg (taken as three 4-mg capsules); BW\<60kg-Lenvatinib 8 mg (taken as two 4-mg capsules)

PROCEDURE

Transarterial chemoembolization(TACE)

TACE will be performed one day after oral administration of lenvatinib . TACE with either cTACE or DEB-TACE can be used, depending on the condition of center.

DRUG

Sorafenib

Sorafenib capsules will be administered orally, 400 mg twice daily (BID) oral dosing.

PROCEDURE

Transarterial chemoembolization(TACE)

TACE will be performed one day after oral administration of Sorafenib. TACE with either cTACE or DEB-TACE can be used, depending on the condition of center.

Sponsors & Collaborators

• Beijing Ditan Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2021-08-01

Completion

2021-12-01

Countries

• China

Study Locations