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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06089369
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a histopathological diagnosis of HCC
* Undergone a curative resection
* Pathologically confirmed HCC with microvascular invasion (MVI)
* Aged 18-75 years
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread
* Full recovery from Curative resection within 4 weeks prior to randomization
* Child-Pugh: Grade A or B(7)
* ECOG-PS score: 0 or 1
* Subjects with HCV- RNA (+) must receive antiviral therapy
* Adequate organ function
Exclusion Criteria:
* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
* Any preoperative treatment for HCC including local and systemic therapy
* Have received more than 1 cycle of adjuvant TACE following surgical resection
* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* Cardiac clinical symptom or cardiovascular disease that is not well controlled
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Inability or refusal to comply with the treatment and monitoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06089369
Study Brief:
Protocol Section:
NCT06089369