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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression (TTP)

Outcome Description:

The time from study enrollment to tumor progression or death

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

H-1010-054-336

NCT ID:

NCT01429961

Start Date:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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