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

NCT ID: NCT01429961

Last Updated: 2011-09-07

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-12-31

Brief Summary

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Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma

Detailed Description

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Conditions

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Advanced Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOX

TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14

Group Type EXPERIMENTAL

SOX

Intervention Type DRUG

TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1\~14

Interventions

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SOX

TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1\~14

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae-You Kim, M.D., Ph.D.

Role: CONTACT

+82-2-2072-3943

Facility Contacts

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Tae-You Kim

Role: primary

+82-2-2072-3943

References

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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.

Reference Type DERIVED
PMID: 29506478 (View on PubMed)

Other Identifiers

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H-1010-054-336

Identifier Type: -

Identifier Source: org_study_id

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