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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT02814461
Eligibility Criteria:
Inclusion Criteria:
* Age of 20-85 years, with ECOG performance 0-2.
* Advanced hepatocellular carcinoma (HCC), histologically or clinically diagnosed. (Multiple tumors, portal vein thrombosis, nodal metastasis or distant metastasis is allowed.)
* Unsuitable for resection, liver transplantation, radiofrequency ablation (RFA) or transarterial chemoembolization (TACE), or recurrent / refractory after prior local-regional treatment.
* ≥ One measurable tumor.
* Child-Pugh score A or B.
* Patients who fulfill all of the following criteria:
1. Serum total bilirubin ≤ 3 mg/dL
2. Serum alanine transaminase (ALT) ≤ 5 times ULN
3. INR ≤ 2.20
4. Platelet count ≥ 50,000 /mm3
5. WBC count ≥ 3,000 /mm3 or ANC ≥ 1,500 /mm3
6. Serum creatinine ≤ 2.0 mg/dL
* Normal thyroid function confirmed.
* Absence of grant for sorafenib.
* Sorafenib failure or intolerability (if ever used).
Exclusion Criteria:
* Considered to have high risk of bleeding (e.g. active peptic ulcer, unstable esophageal/gastric varices, history of aneurysm, and requirement of anticoagulant therapy).
* Pre-existing uncontrolled hypertension (systolic \>140 mmHg, diastolic \>90 mmHg) or proteinuria ≧500 mg/24 hours.
* Prior history of coronary artery disease.
* The patient is participating in other clinical trials.
* Pregnant women.
* Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Patients with non-healing wound.
* Requiring the use of potent CYP3A4/5 inhibitors or inducers (see Appendix).
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT02814461
Study Brief:
Protocol Section:
NCT02814461