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:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT01334112
Eligibility Criteria:
Inclusion Criteria:
* Unresectable and/or metastatic Hepatocellular Carcinoma
* Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
* Life expectancy of ≥12 weeks
* At least one tumor lesion
* At least 2 weeks since the end of prior systemic treatment
* No evidence of pre-existing uncontrolled hypertension
* ECOG 0 or 1
* Adequate organ function
* Not appropriate for curative therapy
* Child A or B7 cirrhosis
* CLIP score ≤ 4
Exclusion Criteria:
* Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
* Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment
* Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
* Severe acute or chronic medical or psychiatric condition
* Need for treatment with prohibited drugs
* Has received local therapy to all measurable lesions
* Stage B8 or higher liver cirrhosis
* Ascites refractory to diuretic therapy
* Clinically significant ECG abnormality
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01334112
Study Brief:
Protocol Section:
NCT01334112