Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil

NCT02987699 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-12-28

No results posted yet for this study

Summary

The purpose of this phase II study is to determine the recommended dose, as well as the safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular carcinoma (HCC).

Conditions

Interventions

DRUG

5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2

DRUG

5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2

DRUG

5-Fu, oxaliplatin , leucovorin

Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Shi, Doctor · The Department of Hepatobiliary Pancreatic Oncology of Sun Yat-sen University Cancer Center

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
2016-11-30
Primary Completion
2017-04-30
Completion
2017-05-31

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 NCT02987699 on ClinicalTrials.gov