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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04066660
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years;
* ECOG PS 0-2;
* Histologically or cytologically documented unresectable HCC;
* Measurable disease by RECIST criteria;
* HCC without well control
* Child-Pugh A-B
* Albumin ≥ 2.8 g/dl;
* Serum total bilirubin ≤ 3 mg/dl;
* INR ≤ 2.3 or PT ≤ 6 seconds above control;
* WBC ≥ 2,500/µl;
* ANC ≥ 1,000/µl;
* Platelets ≥ 50,000/µl;
* Hb ≥ 8.5 g/dl;
* Creatinine ≤ 1.5 x ULN; AND
Exclusion Criteria:
* Metastatic tumors;
* Prior or concomitant systemic anti-cancer treatment for HCC, including:
* Systemic chemotherapy (TACE is allowed)
* Investigational anti-cancer agents
* Severe and/or uncontrolled medical conditions:
* Uncontrolled high blood pressure
* History of poor compliance with anti-hypertensive agents
* Active or uncontrolled infection
* Unstable angina
* CHF
* MI or CVA \< 6 months
* GI bleeding \< 30 days
* Unable to take oral medications
* Severe renal impairment which requires dialysis; proteinuria \> grade 2;
* BMT or stem cell rescue \< 4 months; organ transplant;
* HIV infection;
* Major surgical procedure, open biopsy, or significant traumatic injury \< 4 weeks or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 2 weeks;
* Patients taking narrow therapeutic index medications will be monitored closely. These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine, and digoxin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04066660
Study Brief:
Protocol Section:
NCT04066660