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

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01429961
• Other study ID #: H-1010-054-336
• Status: Recruiting
• Phase: Phase 2
• First received: September 6, 2011
• Last updated: September 6, 2011
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2011
• Source: Seoul National University Hospital
• Contact: Tae-You Kim, M.D., Ph.D.
• Phone: +82-2-2072-3943
• Email: kimty[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (TTP)	The time from study enrollment to tumor progression or death	2 years	No
Secondary	overall survival	overall survival	2 years	No
Secondary	response rate	response rate by RECIST 1.1	2 years	No
Secondary	toxicity	toxicity according to NCI-CTCAE v.3.0	2 years	Yes