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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01429961

Enrollment

Registered

2011-09-07

Start date

2011-05-31

Completion date

2013-12-31

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

Brief summary

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

Interventions

DRUGSOX

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
overall survival	2 years	overall survival
response rate	2 years	response rate by RECIST 1.1
toxicity	2 years	toxicity according to NCI-CTCAE v.3.0

Countries

South Korea

Contacts

Primary ContactTae-You Kim, M.D., Ph.D.

kimty@snu.ac.kr+82-2-2072-3943

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026