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

NCT ID: NCT02129322

Last Updated: 2021-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorafenib

Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

S-1

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

S-1 and Sorafenib

Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

S-1

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Interventions

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Sorafenib

Intervention Type DRUG

S-1

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Weijia Fang, MD

First affiliated hospital, Zhejiang University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weijia fang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital,Zhejiang University

Locations

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First affiliated hospital, Zhejiang University

Hangzhou, , China

Site Status

Countries

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China

Other Identifiers

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ZYYYMedOncoLT01

Identifier Type: -

Identifier Source: org_study_id

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