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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SOX
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOX

Arm Description

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

Outcomes

Primary Outcome Measures

Time to progression (TTP)
The time from study enrollment to tumor progression or death

Secondary Outcome Measures

overall survival
overall survival
response rate
response rate by RECIST 1.1
toxicity
toxicity according to NCI-CTCAE v.3.0

Full Information

First Posted
September 6, 2011
Last Updated
September 6, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01429961
Brief Title
Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Official Title
Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SOX
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
SOX
Intervention Description
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1~14
Primary Outcome Measure Information:
Title
Time to progression (TTP)
Description
The time from study enrollment to tumor progression or death
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
Description
overall survival
Time Frame
2 years
Title
response rate
Description
response rate by RECIST 1.1
Time Frame
2 years
Title
toxicity
Description
toxicity according to NCI-CTCAE v.3.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-You Kim, M.D., Ph.D.
Phone
+82-2-2072-3943
Email
kimty@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-You Kim
Phone
+82-2-2072-3943

12. IPD Sharing Statement

Citations:
PubMed Identifier
29506478
Citation
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.
Results Reference
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Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

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