NCT04044651

Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma With Hepatitis B Virus Infection

A Randomized, Phase IIb Study of Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma (HCC) With Hepatitis B Virus (HBV) Infection

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shi Ming · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of lenvatinib plus nivolumab compared with lenvatinib monotherapy for patients with advanced hepatitis B virus infection-related hepatocellular carcinoma.

Detailed description

Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and nivolumab was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus nivolumab compared with lenvatinib monotherapy. Thus, the investigators carried out this prospective, randomized, phase IIb study to find out it.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib	lenvatinib 12 mg (or 8 mg) by mouth (Po) once daily
DRUG	Nivolumab	nivolumab 480 mg IV infusions for 30 minutes q4w

Timeline

• Start date: 2019-10-30
• Primary completion: 2021-03-30
• Completion: 2022-09-30
• First posted: 2019-08-05
• Last updated: 2020-01-09

Locations

5 sites across 1 country: China