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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT01894269
Eligibility Criteria:
Inclusion Criteria:
Male or female patients from 18 to 75 years of age with a diagnosis of HCC. A diagnosis of HCC based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
The patient has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation, or any other treatment with chemotherapeutic agents or sorafenib.
The patient has not been previously treated with any anti-viral agents, including interferon or nucleosides analogs (NAs).
Adults patients with a diagnosis of HCC which is not amenable to surgical resection ,local ablative therapy or any other radically cured treatment.
The MDT group of HCC agree to administer TACE in this patient.
Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
No serious concurrent medical illness.
Unresectable TNM stage Ⅲ or Ⅳ disease.
Zubrod-ECOG-WHO performance status: 0 or 1. and the estimated survival more than 4 months.
Not pregnant or breast-feeding patients
No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
No current infections requiring antibiotic therapy
Not on anticoagulation or suffering from a known bleeding disorder
No unstable coronary artery disease or recent MI
Ability to understand the protocol and to agree to and sign a written informed consent document
The following laboratory parameters at baseline:
Platelet count ≥ 70,000/µL
Hemoglobin ≥ 8.5 g/dL
Absolute neutrophil count (ANC) \>1,500/mm3
Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
Serum creatinine ≤ 1.5 x upper limit of normal
PT prolong time less than 3 seconds
Cirrhotic status of Child-Pugh class A only
ALT\<2×upper limit of normal
Hepatitis B surface antigen positive
If hepatitis B e antigen positive, HBV DNA level \<2000IU/mL; If hepatitis B e antigen negative, HBV-DNA\<200IU/mL.
Exclusion Criteria:
\- History of HIV or HCV infection.
History of organ allograft
Known or suspected allergy to the investigational agents or any agent given in association with this trial.
Evidence of bleeding diathesis.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of study entry.
Serious non-healing wound, ulcer, or bone fracture
Known central nervous system tumors including metastatic brain disease
Any event \> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0
Severe complication after TACE.
History of hepatotoxic medication within 8 wk prior to the current treatment.
History of corticosteroid administration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01894269
Study Brief:
Protocol Section:
NCT01894269