HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC

NCT03803254 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)

Conditions

Interventions

PROCEDURE

Hepatic arterial infusion chemotherapy

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

DRUG

Folfox Protocol

Oxaliplatin , fluorouracil, and leucovorin

DRUG

Lenvatinib

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

DRUG

PD-1 antibody

3mg/kg intravenously 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
2019-01-03
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT03803254 on ClinicalTrials.gov