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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT02178358
Eligibility Criteria:
Inclusion Criteria:
* Have histological evidence of a diagnosis of HCC not amenable to curative surgery.
* Have Child-Pugh Class A.
* Have the presence of measurable disease.
* Have adequate organ function.
* Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* If male or female with reproductive potential, must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
* If females with childbearing potential, must have had a negative serum pregnancy test 7 days prior to the first dose of study drug.
* Are able to swallow capsules or tablets.
* Have available diagnostic or biopsy tumor tissue.
Exclusion Criteria:
* Have received previous systemic treatment for advanced disease.
* Have known HCC with fibro-lamellar or mixed histology.
* Have presence of clinically relevant ascites.
* Have had a liver transplant.
* Have moderate or severe cardiac disease.
* Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus infection.
* Have experienced Grade 3 or 4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion or endoscopic or operative intervention.
* Have esophageal or gastric varices that require immediate intervention or represent a high bleeding risk.
* Had major surgery within 4 weeks prior to the study randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02178358
Study Brief:
Protocol Section:
NCT02178358