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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT01251458
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
* measurable disease
* Age \>=18 years.
* Life expectancy of greater than 12 weeks.
* ECOG performance status \<= 2
* Prior systemic therapy for HCC is allowed
* Adequate haematologic, renal and hepatic function
* Absence of cirrhosis or Child's A cirrhosis
* Fasting total cholesterol \<9.1 mmol/liter and fasting triglyceride level \<4.5 mmol/liter)
Exclusion Criteria:
* Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
* Patients receiving any other investigational agents concurrently.
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01251458
Study Brief:
Protocol Section:
NCT01251458