Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1

February 12, 2021 updated by: Weijia Fang, MD, Zhejiang University

Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1o Prevent the Tumor Recurrence for Hepatocellular Carcinoma After Liver Transplantation: A Randomized Controlled Study

The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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
      • Hangzhou, China
        • First affiliated hospital, Zhejiang University

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hepatocellular carcinoma after liver transplantation
  • Major organ (heart, lung and brain) function was normal

Exclusion Criteria:

  • Any active infectious process
  • The presence of clinically confirmed extrahepatic metastasis
  • Postoperative dysfunction of any organ

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
Active Comparator: Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
Drug: Oxaliplatin
Drug: S-1
Drug: Sorafenib
Experimental: S-1 and Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
Drug: Oxaliplatin
Drug: S-1
Drug: Sorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recurrence (TTR)
Time Frame: within five years after liver transplantation
Time to Recurrence
within five years after liver transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: within the five years after liver transplantation
Overall survival
within the five years after liver transplantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulative tumor cell (CTC) level change
Time Frame: within one year after liver transplantation
Circulative tumor cell
within one year after liver transplantation

Collaborators and Investigators

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

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Weijia Fang, First Affiliated Hospital,Zhejiang 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

July 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYYYMedOncoLT01

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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