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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT01545804
Eligibility Criteria:
Inclusion Criteria:
* Histologically diagnosed HCC, OR clinically diagnosed HCC
* Documented progression with or intolerance to first-line molecular targeted therapy as first-line therapy for advanced HCC.
* Acceptable first-line molecular targeted therapies include (1) sorafenib monotherapy and sorafenib-based combination; (2) anti-angiogenic therapy including brivanib, linifanib, pazopanib, bevacizumab, dovitinib (TKI258), and vargatef (BIBF1120).
* For patients who receive first-line sorafenib monotherapy or sorafenib-based combination, patients must have received at least 14 days of sorafenib treatment with the lowest dosage of 400 mg per day.
* At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
* ECOG performance status 0 or 1.
* Child-Pugh class A liver function.
Exclusion Criteria:
* Receiving concurrent anti-cancer therapy for HCC, which includes local therapy, chemotherapy, or other experimental therapy.
* Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy administered within 4 weeks prior to enrollment.
* History of HCC tumor rupture.
* Presence of brain or leptomeningeal metastases.
* Esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding.
* History of upper gastrointestinal bleeding within 1 year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01545804
Study Brief:
Protocol Section:
NCT01545804