Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT01429961
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01429961
Study Brief:
Protocol Section:
NCT01429961