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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT01839604
Eligibility Criteria:
Inclusion Criteria:
* Aged at least 18 years. Patient from Japan and Taiwan aged at least 20 years
* Histologically or cytologically confirmed HCC (with the exception of fibrolamellar carcinoma or mixed variants of HCC with fibrolamellar histology OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis)
* Relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
* Metastatic or locally advanced meeting ANY of the criteria below:
* HCC not suitable to receive local therapy
* Disease recurred or was refractory to last therapy (local or systemic)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks
Exclusion Criteria:
* More than 2 prior systemic treatments for HCC
* Prior grade 3 hematologic toxicity related to treatment with a JAK or STAT3 inhibitor
* Presence of hepatic encephalopathy within 4 weeks of 1st dose
* Uncontrolled massive ascites
* High likelihood of bleeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT01839604
Study Brief:
Protocol Section:
NCT01839604