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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT02729506
Eligibility Criteria:
Inclusion Criteria:
* Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation).
* The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection.
* Patients must not be less than 18 and not more than 80 and can be either gender.
* Patients must have a performance status of ECOG score equal to or less than 2.
* Child-Pugh's A or Early B, score 8 and above (see table)
* Patients must have adequate organ function as evidenced by:
Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥50 x 109/L Hg \>9 g/d. AST or ALT ≤5 x ULN Serum creatinine ≤2 x ULN OR creatinine clearance ≥50 mL/min (estimated by Cockcroft Gault or measured) Normal mg and K Bleeding diathesis or on Vit. K therapy.
* Patients must fulfill Child-Pugh's Score
* Life expectancy equal to or more than 12 weeks.
* Signed informed consent.
* Sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after therapy.
* Female patients at child-bearing age must have negative pregnancy test.
* No known HIV infection.
Exclusion Criteria:
* Patients with metastases outside the liver.
* Patients with co-morbid condition that will be aggravated by the investigational drug or by the intervention.
* Patients with severe cardiopulmonary diseases (including history of stable, effort-induced or unstable angina pectoris or myocardiac infarction) and other systemic diseases under poor control.
* Patients with active infection.
* Patients with history of psychiatric disorder.
* Patients with concomitant active secondary malignancies, except for surgically cured carcinoma in situ of the cervix and basal or adequately treated squamous cell carcinoma of the skin. Disease-free of malignancies \< 2 years before the study, are not eligible.
* Clinically significant third space fluid accumulation (i.e., ascites requiring paracentesis despite use of diuretics) or pleural effusion that either requires thoracocentesis or is associated with shortness of breath
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection.
* Concurrent usage of hormonal or chemotherapeutic agents.
* Patients who received surgery, radiotherapy except to bone, chemotherapy, immunotherapy, or other investigational drug within 4 weeks before initiating study are not eligible.
* Patients who are pregnant, breast-feeding or not using appropriate birth control during the course of the study.
* Patients with partner of child bearing age who are not willing to use appropriate contraceptives during and 8 week after therapy.
* Non compliance.
* Unwilling to disclose medical information.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02729506
Study Brief:
Protocol Section:
NCT02729506