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Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC

NCT03744247 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-05-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with lenvtinib Alone in patients with advanced hepatocellular carcinoma (HCC)

Conditions

Interventions

DRUG

Lenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing.

DRUG

PD-1 antibody

3mg/kg intravenously every 2 weeks

DRUG

Placebo

Intravenously every 2 weeks

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Kaiping Central Hospital

    collaborator OTHER

  • Guangzhou No.12 People's Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital of University of South China

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Shi, MD · The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-21
Primary Completion
2021-01-01
Completion
2021-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03744247 on ClinicalTrials.gov