Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
1 other identifier
interventional
38
1 country
1
Brief Summary
Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 6, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 7, 2011
September 1, 2011
2.6 years
September 6, 2011
September 6, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Time to progression (TTP)
The time from study enrollment to tumor progression or death
2 years
Secondary Outcomes (3)
overall survival
2 years
response rate
2 years
toxicity
2 years
Study Arms (1)
SOX
EXPERIMENTALTS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14
Interventions
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1\~14
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 29506478DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2011
First Posted
September 7, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 7, 2011
Record last verified: 2011-09