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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01332669
Eligibility Criteria:
Inclusion Criteria:
1. Patients with confirmed diagnosis of HCC as stated below
* Cirrhotic subjects: Clinical diagnosis by AASLD criteria
* Non-cirrhotic subjects: histological confirmation is mandatory
2. Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient himself rejects above treatments and wants to do TACE (Indication for hepatectomy, liver transplantation, local ablation is decided by doctors of each center)
3. Multinodular or single nodular tumor over 5cm, (In the case of single nodule less than 5cm, if curative treatment is contraindicated or the patient rejects curative treatment)
4. Hypervascular lesion showing contrast enhancement in the early stage at the contrast media bolus injection CT or MRI.
5. At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
6. No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct by the CT or MR
7. Eastern Cooperative Oncology Group performance status is 0 - 1
8. Child-Pugh classification is A or B7
9. Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study is followed:
* white blood cell number : \> 3,000/mm2
* platelet number : \> 5 x 104/mm3
* blood bilirubin : \< 3.0 mg/dL
* ASL, ALT is within 5 times of normal range of each organ
* serum creatinine : \< 1.5 mg/dL
* hemoglobin : \> 8.0 g/dL
10. Over 20 years old
11. Expected survival more than 6 months
12. Patients who are willing to do regular visit, laboratory test, and radiological exam
13. Prior written patient consent
Exclusion Criteria:
1. ECOG performance status 2 or more, Child-Pugh class B8 or more
2. Diffuse HCC or presence of vascular or biliary invasion or extrahepatic spread.
3. Vascular or biliary invasion
4. Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
5. Tumor burden involving more than 50% of the liver
6. Patients previously treated with any anti-cancer therapy for HCC except hepatic resection or early recurrence within 1 year after resection
7. Liver cancer rupture
8. History of biliary tract repair or endoscopic biliary tract treatment
9. Clinically important refractory ascites or pleural fluid
10. Any contraindications for hepatic embolization procedures
* Known hepatofugal blood flow
* Arterio-venous shunt
* Impaired clotting test (platelet count \< 5 x 104/mm3, PT-INR \> 2.0)
11. Any contraindication for doxorubicin administration
12. Contrast media allergy contraindicating angiography
13. Acute or active following diseases
* Heart failure can't control, angina pectoris and/or arrhythmia diseases
* Myocardial infarction within the last 6months,
* Renal failure
* Active infection (virus infection can be accepted)
* Active hemorrhage of digestive system
* Other malignant tumor history
* Hepatic coma or acute mental disease
14. Pregnant, nursing or childbearing age women and men who are actively sexually available and don't want to or can't do contraception
15. Safety concerns based on researcher's judge
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01332669
Study Brief:
Protocol Section:
NCT01332669