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

Sponsor
Shi Ming
Study ID
NCT04044651
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 30, 2019
Status verified
Jan 2020
Primary completion
Mar 30, 2021
Completion
Sep 30, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib plus nivolumab
    nivolumab 480 mg IV infusions for 30 minutes q4w+ lenvatinib 12 mg (or 8 mg) by mouth (Po) once daily
  • Active Comparator: Lenvatinib
    Lenvatinib 12 mg (or 8 mg) Po once daily

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 18 months ]

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