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

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sorafenib; Drug: S-1; Drug: Oxaliplatin

• Registration Number: NCT02129322
• Lead Sponsor: Zhejiang University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-02
• Study Start: 2015-07
• Primary Completion: 2017-06
• Study Completion: 2019-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-1 and Sorafenib	Sorafenib	Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
S-1 and Sorafenib	Oxaliplatin	Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
Sorafenib	Sorafenib	Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
Sorafenib	S-1	Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
Sorafenib	Oxaliplatin	Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
S-1 and Sorafenib	S-1	Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance

Primary Outcome Measures

Name	Time	Method
Time to Recurrence (TTR)	within five years after liver transplantation	Time to Recurrence

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	within the five years after liver transplantation	Overall survival

Trial Locations

Locations (1)

First affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, China