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:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT01008358
Eligibility Criteria:
Inclusion Criteria:
* Unequivocal diagnosis of HCC
* unresectable disease not amenable to locoregional treatment.
* a 4-week washout period after sorafenib or any other systemic agent
* a 2-month washout period after internal or external radiation
* HCV chronic infection
* Child-Pugh stage A or B
* Measurable disease according to RECIST criteria
* ECOG \< 2
* expected survival \> 3 months
* Adequate liver, renal and blood functions
* ability to sign informed consent
Exclusion Criteria:
* previous treatment with an anti-CTL-4 agent
* serious infections or disease compromising general health status
* autoimmune disease that requires therapy
* treatment with immunosuppressors
* treatment with investigational agents
* other neoplasms except skin and bladder superficial tumors
* pregnancy or lactation
* SNC metastasis
* HIV infection
* relevant heart disease (NYHA class III or IV)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01008358
Study Brief:
Protocol Section:
NCT01008358