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

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ClinicalTrials.gov Identifier: NCT01429961
Recruitment Status : Unknown
Verified September 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Drug: SOX Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Study Start Date : May 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: 2 years ]
    The time from study enrollment to tumor progression or death


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
    overall survival

  2. response rate [ Time Frame: 2 years ]
    response rate by RECIST 1.1

  3. toxicity [ Time Frame: 2 years ]
    toxicity according to NCI-CTCAE v.3.0


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429961


Contacts
Contact: Tae-You Kim, M.D., Ph.D. +82-2-2072-3943 kimty@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Tae-You Kim    +82-2-2072-3943      
Sponsors and Collaborators
Seoul National University Hospital
More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01429961     History of Changes
Other Study ID Numbers: H-1010-054-336
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Oxaliplatin
Antineoplastic Agents