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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT02997956
Eligibility Criteria:
Inclusion Criteria:
* Histologic evidence of HCC, Barcelona-Clinic Liver Cancer (BCLC) stage B
* FFPE (Fixed-paraffin Embedded) tumor tissue (two cores preferred) for biomarker analysis
* Prior radioembolization, local ablative therapies (radiofrequency, microwave or cryoablation), radiation (external beam or stereotactic), or hepatic resection permitted if completed ≥ 4 weeks prior to study enrollment and if patient has recovered with ≤ grade 1 toxicity and if untreated measurable disease is present.
* Radiographically measurable disease by mRECIST in at least one site not previously treated by local therapies.
* Must not be receiving treatment with other investigational agents and must not have received any other investigational agent's ≤ 4 weeks prior to registration.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Required lab and acceptable range criteria.
* Women of child-bearing potential and men must agree to use 2 methods of adequate contraception.
* No contraindications to TACE therapy
* Child-Pugh Score A-B
* Ability to understand and the willingness to sign a written informed consent, and the willingness to comply with the requirements of the protocol.
* Life expectancy greater than 3 months.
* Adequate baseline organ and marrow function
Exclusion Criteria:
* History of hepatitis B
* Women must not be pregnant or breastfeeding
* Presence of other malignancies
* Active or history of Tuberculosis
* Patients with known HIV positive status
* Conditions with impaired immunity or on immunosuppressive medications such as oral steroids, calcineurin inhibitors, or anti-proliferative agents.
* Must have no evidence of significant, uncontrolled concomitant diseases
* Must have no ongoing or active, uncontrolled infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02997956
Study Brief:
Protocol Section:
NCT02997956