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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT02426450
Eligibility Criteria:
Inclusion Criteria:
1. age 18 - 75 years;
2. recurrence of HCC 12 months after initial hepatectomy;
3. no other treatment received except for the initial hepatectomy;
4. Single tumor≤5cm in diameter; or 2-3 lesions each ≤ 3.0 cm
5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
6. no severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3;
7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -1
Exclusion Criteria:
1. severe coagulation disorders (prothrombin activity \<40% or a platelet count of \<40,000 / mm3);
2. Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy;
3. Documented allergy to platinum compound or to other study drugs; Any previous oxaliplatin or doxorubicin treatment, except adjuvant treatment more than 12 months before the randomization.
4. Previous or concurrent cancer that is distinct in primary site or histology from HCC
5. History of cardiac disease congestive heart failure \> New York Heart Association (NYHA) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
6. Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]- Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0) contraindications to carboplatin, epirubicin, mitomycin, lipiodol;
7. Pregnant or breast-feeding patients;
8. contraindications to RFA；
9. Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study;
10. Known history of human immunodeficiency virus (HIV) infection
11. Patients concomitantly receiving any other anti-cancer therapy, including interferon-α and herbal medicine which was approved by local authority to be used as "anti-cancer" medicine, except radiotherapy to non-target lesion (bone metastasis, etc)
12. Do not give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02426450
Study Brief:
Protocol Section:
NCT02426450