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TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCC

NCT03782831 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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 transarterial chemoembolization (TACE) combined with programmed cell death protein-1 (PD-1) antibody compared with TACE Alone in patients with unresectable hepatocellular carcinoma (HCC)

Conditions

Interventions

PROCEDURE

TACE

Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).

DRUG

PD-1 antibody

3mg/kg intravenously every 2 weeks

DRUG

Placebos

intravenous injection every 2 weeks

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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-12-01
Completion
2020-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT03782831 on ClinicalTrials.gov