the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

December 14, 2018 updated by: Rong-ping Guo, Sun Yat-sen University
evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • older than 18 years old and younger than 75 years;
  • ECOG PS≤1;
  • proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
  • not previous treated for tumor;
  • unresectable;
  • the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
  • sign up consent

Exclusion Criteria:

  • cannot tolerate TAI or surgery;
  • known history of other malignancy;
  • be allergic to related drugs;
  • underwent organ transplantation before;
  • be treated before (interferon included);
  • known history of HIV infection;
  • known history of drug or alcohol abuse;
  • have GI hemorrhage or cardiac/brain vascular events within 30 days;
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose
low oxaliplatin (85mg/m2)
Procedure: transarterial infusion
transarterial infusion
Active Comparator: high dose
high oxaliplatin (135mg/m2)
Procedure: transarterial infusion
transarterial infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
overall survival
From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of randomization until the date of progress from any cause, assessed up to 60 months
progression-free survival
From date of randomization until the date of progress from any cause, assessed up to 60 months
ORR
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
object response rate
From date of randomization until the date of death from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2017-005-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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