HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

NCT03468231 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-03-16

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 (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Conditions

Interventions

DRUG

Sorafenib

Oral Sorafenib, 400mg, Bid

DRUG

HAIC of FOLFOX

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

DRUG

HAIC of OXA

administration of Oxaliplatin via the tumor feeding arteries

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Dongguan People's Hospital

    collaborator OTHER_GOV
  • Kaiping Central Hospital

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2019-09-09
Completion
2020-03-09

Countries

  • China

Study Locations

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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 NCT03468231 on ClinicalTrials.gov