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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT04560751
Eligibility Criteria:
Inclusion Criteria:
1. Ages of ≥ 18 and ≤ 75 years old.
2. Clinically or histopathologically diagnosed as hepatocellular carcinoma (HCC).
3. China stage IIb-IIIb patients, not suitable for surgical resection.
4. The imaging examination within 2 weeks before interventional therapy showed that there was at least one target lesion that could be measured by CT or MRI, and the lesion was suitable for repeated and accurate measurement.
5. Child-Pugh scores ≤7.
6. ECOG：0-1.
7. Intended to be treated with TACE combined with lenvatinib.
8. Good organ and bone marrow function: Blood routine: WBC\>4.0×109/L、Hb\>80g/L, PLT\>75×109/L, NEUT\>1.5×10⁹/L. Blood coagulation function: International normalized ratio (INR)\<1.2. Hepatic function: serum albumin (ALB)\>3.5 g/dl, total bilirubin (TBIL) \<1.5 × normal upper limit (ULN) (Eliminate biliary obstruction), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 × ULN. Renal dysfunction：serum creatinine (SCR) \<1.5× ULN.
9. Agreed to join the clinical trial and sign the informed consent form.
Exclusion Criteria:
1. Hepatobiliary cell carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
2. With invasion of the main portal vein or vena cava.
3. Received interventional therapy such as TACE within 2 years.
4. Received systematic treatment in the past.
5. Uncontrollable ascites, hepatic encephalopathy or esophagogastric variceal bleeding.
6. Patients with hypertension who cannot be reduced to normal range after antihypertensive treatment (systolic blood pressure \> 140mmHg, or diastolic blood pressure \> 90 mmHg).
7. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia or myocardial ischemia or myocardial infarction (The QTc interval ≥ 450ms, QTc interval is calculated by Fridericia formula).
8. There is a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding in the past 3 months, such as esophageal varices at risk of bleeding, local active ulcer lesions, fecal occult blood ≥ (+).
9. Pregnant or lactating women. A fertile patient who is unwilling or unable to use effective contraception.
10. Patients with HIV infection.
11. Suspected allergy to research drugs.
12. Other situations which the researchers considered ineligible for participating in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04560751
Study Brief:
Protocol Section:
NCT04560751