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Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

NCT03791918 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL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 transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria

Conditions

Interventions

DRUG

Lenvatinib

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

DRUG

PD-1 antibody

3mg/kg intravenously every 2 weeks

PROCEDURE

TACE

A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. TACE Drug Protocol were injected.

DRUG

TACE Drug Protocol

lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Sponsors & Collaborators

  • Kaiping Central Hospital

    collaborator OTHER

  • Guangzhou No.12 People's Hospital

    collaborator OTHER_GOV

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Shi, MD · Sun Yat-sen University

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
2019-01-01
Primary Completion
2022-01-01
Completion
2022-01-01

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 NCT03791918 on ClinicalTrials.gov