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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT01029418
Eligibility Criteria:
Inclusion Criteria:
* Patients with unresectable BCLC Stage B/C hepatocellular carcinoma that is biopsy-proven ( histology or cytology from prior tumor biopsy specimen is acceptable)
* Patients without prior systemic treatment ( chemotherapy or molecular targeted therapy) except prior adjuvant therapy, if given more than 6 months ago
* Patients who had prior local therapy ( TACE; PEI; RFA) more than 4 weeks prior to study entry
* No radiotherapy within 4 weeks before entry
* Child-Pugh class A only ( Appendix A)
* Age 21 years and older
* ECOG performance status 0 or 1 ( Appendix A)
* Life expectancy \> 3 months.
* Patients must have normal organ and marrow function as defined below:
Absolute neutrophil count \> 1.5 x 109/L;Platelets\> 75 x 109/L; Haemoglobin \> 9.0g/dl;Total bilirubin \< 51umol/L ( 3 mg /dL); AST(SGOT)/ALT(SGPT) \< 5 X institutional ULN; Creatinine 1.5 ULN; INR \<1.7 or prothrombin time ( PT) \<4 seconds above ULN; Left ventricular ejection fraction (LVEF) \>50%
* Measurable disease according to RECIST. A lesion which has previously been locally treated (including TACE or RFA) is eligible as long as there is evidence of disease progression
* Suitable for oral administration of drug
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Prior systemic therapy including sorafenib or a MEK inhibitor or sunitinib or other investigational drugs
* Any prior local therapy ( surgery, radiation therapy, hepatic arterial embolization, or cryoablation) within 4 weeks of study entry.
* Prior liver transplant
* NCI CTCAE grade \> 3 hemorrhage within 4 weeks of starting study treatment, or documented variceal hemorrhage of any grade within 12 months of study entry (as documented on endoscopy)
* Presence of esophageal varices (\> Grade 2) at risk of bleeding and/or serious or non-healing wound/ulcer ( as documented by endoscopy)
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study entry
* Patients with underlying inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea
* Any of the following within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
* History of cardiac disease:
* active congestive heart failure
* cardiac arrythmias of NCI CTCAE grade \>2 or requiring pacemaker
* uncontrolled hypertension
* cardiomyopathy
* atrial fibrillation rate \>100bpm
* Patients with factors that increase the risk of QT prolongation or arrhythmic events ( hypokalemia, family history of long QT interval syndrome) or QTc interval of \> 450ms for males or \> 470ms for females on screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01029418
Study Brief:
Protocol Section:
NCT01029418