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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01807156
Eligibility Criteria:
Inclusion Criteria:
1. Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and whose disease is not amenable to surgical or regional therapy.
2. Prior allowed therapy:
* Surgery including hepatic resection
1. Minimum of 4 weeks since any surgical procedure.
2. Patients must have adequately recovered from surgery.
* Regional therapy
1. Includes transarterial chemoembolization (TACE), drug-eluting bead \[DEB\]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization.
2. More than 2 weeks must have lapsed from therapy.
3. There must be an indicator lesion outside the treated area or clear evidence of progression in the treated lesion, not amenable for further local therapies.
4. Concomitant sorafenib with regional therapy is allowed as long as no evidence of progression on sorafenib.
* Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to disease recurrence.
3. Adequate hematological, liver and metabolic organ function.
4. Signed informed consent.
Exclusion Criteria:
1. Patients with mixed histology or fibrolamellar variant.
2. Prior systemic therapy for metastatic disease.
3. Uncontrolled hypertension (HTN).
4. Symptomatic heart failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01807156
Study Brief:
Protocol Section:
NCT01807156