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HAIC of Oxaliplatin, and 2400 mg/m² 5-fu vs HAIC of Oxaliplatin, and 1200 mg/m² 5-fu for Unresectable HCC: a Randomised Phase 3 Non-inferiority Trial

NCT04667351 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-12-14

No results posted yet for this study

Summary

Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.

Conditions

Interventions

DRUG

2400 mg/m² 5-fu

Hepatic arterial infusion of oxaliplatin,leucovorin and 2400 mg/m² 5-FU

DRUG

1200 mg/m² 5-fu

Hepatic arterial infusion of oxaliplatin,leucovorin and 1200 mg/m² 5-FU

Sponsors & Collaborators

  • Kaiping Central Hospital

    collaborator OTHER

  • Guangzhou No.12 People's Hospital

    collaborator OTHER_GOV

  • Sun Yat-sen University

    lead OTHER

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
2019-03-01
Primary Completion
2022-12-01
Completion
2022-12-01

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 NCT04667351 on ClinicalTrials.gov