Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1 | NCT02129322

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

NCT02129322

Sponsor

Zhejiang University

Status

Withdrawn

Last Update Posted

Feb 15, 2021Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Sorafenib
S-1
Oxaliplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

patients not enrolled

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jun 2017Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Apr 28, 2014

First Submission Date that Met QC Criteria

May 1, 2014

First Posted Date

May 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2021

Last Update Posted Date

Feb 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weijia Fang, MD, First affiliated hospital, Zhejiang University, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Zhejiang UniversityOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib	Drug		S-1 and Sorafenib Sorafenib
S-1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weijia fang	First Affiliated Hospital,Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First affiliated hospital, Zhejiang University		Hangzhou			China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077157	Sorafenib
C079198	S 1 (combination)
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided