Trial of Palliative Chemotherapy With TS-1 and Oxaliplati... | NCT01429961

Studies
Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

NCT01429961

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Sep 7, 2011Estimated

Enrollment

38Estimated

Phase

Phase 2

Conditions

Advanced Hepatocellular Carcinoma

Interventions

Countries

South Korea

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

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 6, 2011

First Submission Date that Met QC Criteria

Sep 6, 2011

First Posted Date

Sep 7, 2011Estimated

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

Sep 6, 2011

Last Update Posted Date

Sep 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SOX	Experimental	TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14	Drug: SOX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SOX	Drug	TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1~14	SOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression (TTP)	The time from study enrollment to tumor progression or death	2 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival	overall survival	2 years
response rate	response rate by RECIST 1.1	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
ECOG performance score of two or less
Child Pugh class A•
Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL
presence of extrahepatic measurable lesion
no prior systemic therapy (excluding sorafenib)
adequate marrow, liver, kidney function
written informed consent

Exclusion Criteria:

prior systemic therapy (excluding sorafenib)
hypersensitivity to study drugs
active gastrointestinal bleeding
other malignancies within five years
pregnant or breastfeeding female
symptomatic brain or leptomeningeal metastasis
clinically significant heart disease
interstitial pneumonia
peripheral neuropathy grade one or more
uncontrolled infection
renal impairment
prior use of investigational drug or therapy within 4 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae-You Kim, M.D., Ph.D.	Contact	+82-2-2072-3943		kimty@snu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29506478	Derived	Lee DW, Lee KH, Kim HJ, Kim TY, Kim JS, Han SW, Oh DY, Kim JH, Im SA, Kim TY. A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma. BMC Cancer. 2018 Mar 5;18(1):252. doi: 10.1186/s12885-018-4039-9.